ModifiedPremera BluecrossPolicy N/A

Autografts and Allografts in the Treatment of Focal Articular Cartilage Lesions

Criteria for medical necessity, site-of-service, documentation, and coding for use of osteochondral autografts and allografts to treat focal full‑thickness articular cartilage lesions (primarily knee and talus). Applies to Premera Blue Cross review of elective surgical procedures and site-of-service determinations.

Policy Summary

PayerPremera Bluecross

PolicyAutografts and Allografts in the Treatment of Focal Articular Cartilage Lesions

Policy CodePolicy N/A

Change TypeMaterial coverage revisions and site-of-service criteria added

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document lesion size, prior treatments, and rationale when requesting fresh osteochondral allograft for defects >2.5 cm².

SourceLink

POLICY UPDATE CHANGES

Added related policy 11.01.525 Site of Service Ambulatory Service Center (ASC) Select Surgical Procedures and ASC criteria.

Added criteria 'when defect size is greater than 2.5 cm²' to policy statement that fresh osteochondral allografting may be considered medically necessary.

Minor editorial refinements to listed order of policy statements; intent unchanged.

Removed Related Policy 11.01.524 Site of Service: Select Surgical Procedures (policy deleted effective August 1, 2025).

2.5 cm²knee lesion size threshold

1.0–2.5 cm²autograft knee range

1.5 cm² / 3.0 cm³talus size/volume

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15–55 yrsage consideration

5 codeslisted procedure codes

No NCDNo Medicare NCD

Coverage Criteria: Osteochondral Autografts & Allografts

inv-01: Osteochondral allografting — medically necessary indications

Covered when ALL of the following criteria are met:

Knee lesions: Full-thickness chondral defects of the knee caused by acute or repetitive trauma when defect size is greater than 2.5 cm² and other cartilage repair techniques (microfracture, osteochondral autografting, or autologous chondrocyte implantation) would be inadequate due to lesion size, location, or depth.>2.5 cm²

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Talus lesions: Large (area greater than 1.5 cm²) or cystic (volume greater than 3.0 cm³) osteochondral lesions of the talus when autografting would be inadequate due to lesion size, depth, or location.>1.5 cm² or >3.0 cm³

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Revision indications: Revision surgery after failed prior marrow stimulation for large (area greater than 1.5 cm²) or cystic (volume greater than 3.0 cm³) osteochondral lesions of the talus when autografting would be inadequate due to lesion size, depth, or location.N/A

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inv-02: Osteochondral autografting — medically necessary indications

Covered when ALL of the following are met:

Age and skeletal maturity: Adolescents should be skeletally mature with documented closure of growth plates (e.g., ≥15 years). Adults should be young enough that total knee arthroplasty or other reconstructive knee surgery is not appropriate (e.g., ≤55 years).15–55 years

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Lesion characteristics (knee): Focal, full-thickness (grade III or IV) unipolar lesions on the weight-bearing surface of the femoral condyles, trochlea, or patella that are between 1.0 and 2.5 cm² in size.1.0–2.5 cm²

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Surrounding cartilage: Documented minimal to absent degenerative changes in surrounding articular cartilage (Outerbridge grade II or less) and normal-appearing hyaline cartilage at the border of the defect.

inv-03: Investigational / unproven techniques

Not established / investigational:

Autologous minced or particulated cartilage: Treatment with autologous minced or particulated cartilage (e.g., Cartilage Autograft Implantation System [CAIS], Reveille Cartilage Processor) is considered investigational.N/A

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Allogeneic minced or particulated cartilage: Treatment with allogeneic minced or particulated cartilage (e.g., BioCartilage, DeNovo NT) is considered investigational.N/A

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Decellularized osteochondral allograft plugs: Use of decellularized osteochondral allograft plugs (e.g., Chondrofix) is considered investigational due to limited evidence and reports of delamination and high failure rates.N/A

inv-04: Osteochondral autograft — knee — Covered when ALL of the following are met (knee-specific criteria)

Covered when ALL of the following are met:

Primary criteria (knee): Full-thickness articular cartilage lesions of the knee (femoral condyle, trochlea, or patella) of moderate size (example range ~2–6 cm²) in which osteochondral autografting is appropriate; correction of malalignment as needed; evidence shows decreased failure rates and improved outcomes compared with abrasion techniques for medium-size lesions.~2–6 cm²

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inv-05: Fresh osteochondral allograft — knee (salvage)

Considered when ALL are met:

Salvage indication (knee): Fresh osteochondral allograft may be considered as a salvage operation in younger individuals to repair full-thickness chondral defects of the knee when autografting or other cartilage repair techniques would be inadequate due to lesion size, location, or depth.lesion size > 2.5 cm²

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inv-06: Ankle lesions — autograft and allograft

Coverage stance varies by lesion size and prior treatment:

Small primary ankle lesions: Primary full-thickness ankle lesions <1.5 cm²: marrow-stimulation procedures (microfracture) are effective; autologous osteochondral transplantation is not supported as primary treatment for small lesions because of donor-site morbidity and similar short-term outcomes.lesion area <1.5 cm²

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Large or cystic ankle lesions: Large (area >1.5 cm²) or cystic (volume >3.0 cm³) ankle lesions: autologous osteochondral transplantation or fresh osteochondral allograft may be considered when autografting would be inadequate due to lesion size, depth, or location; evidence supports improved outcomes in this subgroup.lesion area >1.5 cm² OR volume >3.0 cm³

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Revision ankle lesions: Lesions of the ankle that have failed primary treatment: revision autologous osteochondral transplantation or fresh allograft may improve outcomes; clinical studies support benefit, particularly for larger or cystic lesions.

inv-07: Other joints and technologies (elbow, shoulder, particulated cartilage, decellularized plugs, reduced discs)

Investigational or insufficient evidence in many settings:

Elbow: Osteochondral autograft for elbow lesions (e.g., osteochondritis dissecans) has limited evidence (meta-analysis of case series); randomized controlled trials are needed — evidence insufficient to determine net health benefit.N/A

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Shoulder: Osteochondral autograft for shoulder lesions: evidence limited to case series and is insufficient to determine net health benefit.N/A

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Particulated/minced cartilage (autologous/allogeneic): Use of autologous or allogeneic minced/particulated cartilage shows limited RCTs and case series with mixed outcomes (subchondral edema, nonhomogeneous surface, graft hypertrophy, delamination); evidence insufficient for definitive coverage.

inv-08: Evidence-informed coverage considerations

Coverage considerations informed by professional society positions and consensus:

AOFAS position for talus: AOFAS endorses osteochondral autograft and allograft transplantation for talus lesions, particularly large-diameter lesions, cystic lesions, and those that have failed previous surgical treatment; AOFAS does not consider these procedures experimental in patients who have failed nonoperative management.after failed nonoperative management

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International Consensus (ankle): International Consensus Group recommends osteochondral allograft plugs may be preferred over autografts for lesions >1.5 cm, advises using ankle-sourced fresh allografts rather than knee-sourced or frozen grafts, and notes absence of clinical evidence for decellularized plugs.lesion >1.5 cm

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NICE guidance (mosaicplasty): NICE guidance states evidence is adequate to support mosaicplasty (autologous osteochondral transplantation) for symptomatic knee cartilage defects.

inv-09: Fresh osteochondral allograft — medical necessity conditions

Covered when ALL of the following are met (as clarified in history entries and policy replacement):

Fresh osteochondral allograft medical necessity: Fresh osteochondral allografting may be considered medically necessary to repair full-thickness chondral defects of the knee when other cartilage repair techniques (microfracture, osteochondral autografting, or autologous chondrocyte implantation) would be inadequate due to lesion size, location, or depth.lesion size > 2.5 cm²

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Osteochondral allografting for joints other than the knee and talus (for example, shoulder, elbow, or other peripheral joints) is considered investigational based on insufficient evidence to demonstrate improvement in net health outcome.

Current evidence does not support the use of autologous osteochondral transplantation as primary treatment for small ankle lesions <1.5 cm²; marrow‑stimulating procedures (e.g., microfracture) are effective for many small talar lesions and autograft primary use is limited by donor‑site morbidity.

Consensus statements and available case series note an absence of clinical evidence and clinical experience for decellularized osteochondral allograft plugs, and small case series of decellularized plugs have reported delamination and high failure rates; therefore these products lack sufficient evidence to support routine use.

The policy changes described do not apply to Medicare Advantage plans, and the added site‑of‑service review requirements do not apply to Indian Health Service (IHS) facilities.

Use of autologous or allogeneic minced/particulated cartilage, decellularized osteochondral allograft plugs, and reduced osteochondral allograft discs (for example, ProChondrix/Cartiform) is considered investigational or not medically supported because current evidence is insufficient to demonstrate a consistent net health benefit.

Particulated juvenile or autologous cartilage technologies and decellularized plugs/discs are judged investigational/insufficient due to limited clinical data, reported complications (delamination, graft hypertrophy, nonhomogenous repair surface), and the need for larger, longer‑term studies to establish safety and effectiveness.

The International Consensus Group highlighted an absence of clinical evidence and clinical experience for decellularized osteochondral allograft plugs, a finding that informed the policy determination that these plugs are investigational.

Small case series of decellularized osteochondral allograft plugs have reported implant delamination and high failure rates for some products in knee cartilage lesions; such outcomes may support non‑coverage decisions for specific decellularized grafts when failure evidence is present.

Coding and Lesion Thresholds

Covered CPT CodesCPTCovered

27415	Osteochondral allograft, knee, open
27416	Osteochondral autograft(s), knee, open (e.g., mosaicplasty) (includes harvesting of autograft[s])
28446	Open osteochondral autograft, talus (includes obtaining graft[s])
29866	Arthroscopy, knee, surgical; osteochondral autograft(s) (e.g., mosaicplasty) (includes harvesting of the autograft[s])
29867	Arthroscopy, knee, surgical; osteochondral allograft (e.g., mosaicplasty)

Lesion size and volume thresholds — summary

Knee — fresh allograft threshold> 2.5 cm²

Knee — autograft range1.0–2.5 cm²

Talus — area threshold> 1.5 cm²

Talus — cystic volume threshold> 3.0 cm³

Lesion area threshold (ankle primary treatment)

Ankle/ Talus lesion area threshold1.5 cm²

Use in primary ankle lesionsMicrofracture effective for lesions <1.5 cm²; autograft/allograft generally reserved for larger or revision lesions

Provider Actions, Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required; elective osteochondral autograft and allograft procedures and the proposed site of service will be reviewed for medical necessity. There is no Medicare national coverage determination for these procedures; payer-specific prior authorization requirements apply and requests will be evaluated against the policy criteria and site-of-service guidance.

Prior authorization required for listed CPT codes and elective osteochondral autograft/allograft procedures
Site-of-service will be reviewed for medical necessity (ASC, outpatient hospital, inpatient)

Prior Authorization

Site-of-Service Prior Authorization Implications

Site-of-service criteria were updated effective November 7, 2025; providers should expect prior authorization review to include site-of-service appropriateness (preferred: ASC or outpatient settings when safe and cost-effective). Failure to meet ASC/outpatient criteria (for example, performing an elective case inpatient without documented need) may render the chosen site not medically necessary and lead to denial.

Effective 11/07/2025 — site-of-service ASC criteria added; provider notification occurred per policy history

Background & Context

Focal articular cartilage lesions can progress to full‑thickness defects and osteoarthrosis. Osteochondral autografts (mosaicplasty) harvest small cylindrical plugs from a non‑weight‑bearing area (typically 6–10 mm diameter) and transplant bone‑and‑cartilage to the defect, while allografts use donor bone‑and‑cartilage to restore hyaline cartilage, often reserved for larger or cystic lesions when marrow‑stimulating techniques are inadequate.

Definitions and Graft Types

Autograft — definition and notes

DefinitionGraft tissue taken from the patient’s own body

Common useSmall osteochondral plugs harvested and press-fit into prepared defect sites (mosaicplasty/autograft)

Clinical noteAutografts typically used for smaller focal defects; donor-site morbidity is a consideration

Allograft — definition and notes

DefinitionGraft tissue obtained from donor (cadaver) tissue

Common useTypically used for larger lesions where autograft is inadequate

Product form

Policy Summary

PayerPremera Bluecross

PolicyAutografts and Allografts in the Treatment of Focal Articular Cartilage Lesions

Policy CodePolicy N/A

Change TypeMaterial coverage revisions and site-of-service criteria added

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document lesion size, prior treatments, and rationale when requesting fresh osteochondral allograft for defects >2.5 cm².

SourceLink

On This Page

Knee biomechanics: Normal knee biomechanics or alignment and stability achieved concurrently with osteochondral grafting.N/A

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Talus autograft consideration: Large (area >1.5 cm²) or cystic (volume >3.0 cm³) osteochondral lesions of the talus may be treated with autografting when autograft is appropriate.>1.5 cm² or >3.0 cm³

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Reduced osteochondral allograft discs (e.g., ProChondrix, Cartiform) are considered investigational/insufficient evidence pending larger, longer-term studies.N/A

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prior failed microfracture or marrow stimulation

Decellularized osteochondral plugs: Decellularized osteochondral allograft plugs have case series reporting delamination and high failure rates; evidence insufficient to support coverage.N/A

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Reduced allograft discs (ProChondrix/Cartiform): Reduced osteochondral allograft discs have limited prospective case series with short-to-mid term positive results; larger and longer-term studies are needed and evidence is insufficient for definitive coverage.N/A

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symptomatic knee cartilage defects

Contested clinical areas: Clinical input was mixed on requirements for inadequate response to prior surgery, lesion size cutoffs, and absence of meniscal pathology; these contested areas may affect case-by-case coverage determinations.variable

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Referenced in guidance/consensusInternational Consensus and policy statements cite 1.5 cm² as cutoff for small vs large talar lesions

Lesion cystic volume threshold

Cystic lesion volume threshold3.0 cm³

Application — talusDefines cystic talar lesions for consideration of autograft or allograft

Revision contextUsed to define lesions considered for revision after failed marrow stimulation

New lesion size threshold for fresh osteochondral allograft

New policy threshold for fresh osteochondral allograft> 2.5 cm²

Context of changeAdded to clarify when fresh allografting may be considered medically necessary for knee defects

Effective policy replacement referenceAdded to policy 7.01.607 replacing 7.01.78 (history entry)

Medically necessary sites: ASC, off-campus outpatient hospital, on-campus outpatient hospital (inpatient only when criteria met)

Denial Risk

Site-of-Service Denials — Watch for Documentation

Requests lacking documentation that justify the inpatient setting or that are inconsistent with updated ASC/outpatient criteria face site-of-service denials. Examples include elective procedures submitted as inpatient when outpatient/ASC is appropriate per the policy definitions, or when no geographically accessible ASC with necessary capability/privileges exists and no supporting documentation is provided.

Site-of-service denials likely when elective inpatient placement is not supported in the record
ASC unavailable exceptions must be documented (no ASC within 30 miles, no equipment, no physician privileges, patient age ≤18, or concomitant service requiring hospital)

Denial Risk

Indication-Based Coverage Risk

Coverage decisions are indication- and lesion-size dependent. There is evidence supporting autograft for moderate-sized knee lesions (e.g., 2–6 cm²) and fresh allograft as salvage for large knee defects; requests outside those indications (site, lesion size, prior treatment) may be limited or denied.

Autograft supported for moderate-sized symptomatic full-thickness chondral lesions of femoral condyle/trochlea/patella
Fresh osteochondral allograft considered for knee defects when autograft/inferior techniques are inadequate due to size/location/depth

Denial Risk

Areas of Contested Criteria — Denial Risk If Not Met

Requests may be contested or denied when criteria around prior nonoperative/surgical management, lesion size, prior surgical response, or feasibility of autograft are not met or not documented. Clinical input and specialty society guidance have noted variability in opinions on required prior surgical failure, lesion-size thresholds, and joint-specific indications.

Potential denial when no documented failed conservative care or prior surgical management as required
Contested areas include adequacy of prior surgical response, exact lesion-size cutoffs, and investigational status in some joints

Denial Risk

Denial Risk from Site-of-Service and Lesion-Size Criteria

Claims or authorization requests lacking documented lesion size, or that do not align with updated site-of-service or lesion-size thresholds (for example, fresh allograft requested without lesion size >2.5 cm² for knee or without demonstrating autograft infeasibility), are at elevated risk for denial. Ensure the request matches the specific size/volume criteria for knee and ankle when seeking approval.

Denial risk when lesion size not documented or does not meet thresholds (knee >2.5 cm² for fresh allograft per updated criteria)
Ankle large lesion thresholds: area >1.5 cm² or cystic volume >3.0 cm³ for consideration of allograft/autograft

Documentation Required

Required Clinical Documentation

Medical records submitted for prior authorization must document diagnosis, history and physical (severity), conservative care attempted with duration, pertinent imaging reports, prior treatments (including microfracture or other marrow stimulation), and whether autograft is feasible. If inpatient care is requested, include specific indications supporting inpatient need.

Required: diagnosis/condition, history & physical, severity of condition
Required: conservative care attempted and length of trial
Required: pertinent imaging reports and documentation of prior surgical treatments and their outcomes
If inpatient: explicit indications supporting inpatient procedure

Documentation Required

Regulatory Documentation for Allografts

When implanting allograft tissue, documentation should reflect compliance with FDA regulations for human cells and tissues (21 CFR parts 1270 and 1271). Include donor/tissue regulatory documentation and any tissue-bank processing or storage details relevant to the request.

Document compliance with 21 CFR parts 1270 and 1271 for human cells and tissues
Include tissue source, processing/storage dates, and regulatory compliance where applicable

Documentation Required

Lesion Size Documentation — Required for Allograft Requests

When requesting fresh osteochondral allograft, explicitly document lesion size and provide rationale for allograft (e.g., lesion exceeds autograft capacity, large/cystic lesion, prior failed techniques). For knee fresh allograft requests, indicate lesion area (>2.5 cm² per updated criteria) or other clinical justification.

Document lesion measurements (area/volume) and imaging source
State why autograft or marrow stimulation is inadequate or unfeasible for this lesion

Step Therapy

Step Therapy Preference and Marrow Stimulation

Prior to osteochondral grafting, consider step therapy: marrow-stimulating techniques (e.g., microfracture) should be considered especially when débridement is the only prior surgical treatment. For small ankle lesions (<1.5 cm²), marrow stimulation is effective as primary treatment and autograft/allograft is generally reserved for revision or larger lesions.

Consider microfracture or other marrow stimulation before osteochondral grafting when appropriate
For ankle lesions <1.5 cm², marrow stimulation (microfracture) is preferred primary treatment; autograft usually for revision cases

Note

Prior Nonoperative/Surgical Management and Stepwise Consideration of Alternatives

Prior nonoperative measures and prior surgical management should be documented; the AOFAS position and clinical input support considering prior nonoperative care and previous surgical failure before osteochondral transplantation. Fresh allograft is typically considered in a stepwise approach when other repair techniques are unsuitable or have failed.

Document prior nonoperative management and duration
Document prior surgical procedures and outcomes; indicate failures if considering revision grafting
Fresh allograft considered when microfracture or autograft are unsuitable or have failed

Fresh osteochondral allografts (human cadaver tissue) are described as preferred for ankle lesions

Mosaicplasty / Autologous osteochondral transplantation

ProcedureHarvest multiple cylindrical osteochondral autograft plugs and press-fit into recipient tunnels (mosaicplasty/autologous osteochondral transplantation)

Donor plug diameters6–10 mm

ApproachCan be performed open or arthroscopically; commonly from peripheral non-weight-bearing femoral condyle

Reduced osteochondral allograft discs (ProChondrix/Cartiform)

Product descriptionWafer-thin allografts with reduced bony portion that contain hyaline cartilage and extracellular matrix

Storage durationsProChondrix: stored fresh up to 28 days; Cartiform: stored frozen up to 2 years

Typical useInserted after microfracture and secured with fibrin glue and/or sutures; shaped to defect

DeNovo NT — definition

Product typeJuvenile allogeneic minced cartilage product mixed intraoperatively with fibrin glue

UseMinced tissue implanted into prepared lesions as a single-stage procedure (DeNovo NT)

Regulatory/clinical noteDescribed as investigational in broader policy context due to limited evidence

Osteochondral allograft/autograft — general definition

DefinitionTransplantation of bone-and-cartilage grafts from the patient (autograft) or a donor (allograft) to repair focal cartilage defects

IndicationsAutografts for smaller focal defects; allografts for larger or cystic lesions or when autograft is inadequate

Clinical considerationTechnique selection depends on lesion size, depth, location, and prior treatments

Graft types referenced

Referenced graft typesParticulated juvenile articular cartilage (e.g., DeNovo NT)

Referenced graft typesDecellularized osteochondral allografts (e.g., Chondrofix) — limited evidence and reported failures

Policy stanceParticulated juvenile cartilage and decellularized allografts are discussed as investigational or of uncertain benefit