Currentblue cross blue shield - south dakotaPolicy 07.01.65

Osteochondral Allografts and Autografts in the Treatment of Focal Articular Cartilage Lesions

Clinical coverage policy governing use of osteochondral autograft (OATS/mosaicplasty) and fresh osteochondral allograft procedures to treat focal full-thickness articular cartilage lesions of the knee, ankle (talus), elbow, and shoulder for Blue Cross Blue Shield - South Dakota members.

Policy Summary

Payerblue cross blue shield - south dakota

PolicyOsteochondral Allografts and Autografts in the Treatment of Focal Articular Cartilage Lesions

Policy CodePolicy 07.01.65

Change TypeNo material clinical or coverage changes in this revision

Effective DateMay 1, 2014

Next Review DateJun 1, 2025

Key ActionRequest prior authorization and document lesion size, prior conservative therapy failure, and skeletal maturity to demonstrate medical necessity.

SourceLink

1.5 cm^2lesion area threshold used repeatedly for talus/ankle decisions

3 monthsminimum conservative therapy before autograft

1–2.5 cm^2knee autograft size range

3.0 cm^3cystic lesion volume threshold

82% at 10y

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graft survival (systematic review)

Coverage Criteria for Osteochondral Grafting

Fresh Osteochondral Allografting - Medically Necessary Indications

Fresh osteochondral allografting is considered medically necessary when any of the following indications are met:

Fresh allograft indications: 1) Full-thickness chondral defects of the knee caused by acute or repetitive trauma when other cartilage repair techniques (eg, microfracture, osteochondral autografting, or autologous chondrocyte implantation) would be inadequate due to lesion size, location, or depth; 2) Large (area >1.5 cm^2) or cystic (volume >3.0 cm^3) osteochondral lesions of the talus when autografting would be inadequate due to lesion size, depth, or location; 3) Revision surgery after failed prior marrow stimulation (eg, microfracture, drilling) for large (area >1.5 cm^2) or cystic (volume >3.0 cm^3) osteochondral lesions of the talus when osteochondral autografting would be inadequate due to lesion size, depth, or location.see node text

Fresh osteochondral allografting not meeting these criteria and for all other joints is considered investigational.

Osteochondral Autografting (OATS/Mosaicplasty) - Medically Necessary Criteria

Osteochondral autografting (OATS/mosaicplasty) is considered medically necessary when ALL the following criteria are met (knee and talus pathways specified):

Knee autograft pathway: For symptomatic full-thickness cartilage defects of the knee caused by acute or repetitive trauma in individuals who have had an inadequate response to a prior surgical procedure, all of the following must be met: (a) Adolescent individual is skeletally mature with documented growth plate closure OR adult individual is not a candidate for total knee arthroplasty or other reconstructive knee surgery; (b) A focal, full-thickness (Outerbridge Grade III or IV) unipolar lesion(s) on the weight-bearing surface of the femoral condyles, trochlea, or patella sized between 1 and 2.5 cm^2; (c) Documented minimal to absent degenerative changes in surrounding articular cartilage (Outerbridge Grade II or less) with normal-appearing hyaline cartilage at the defect border; (d) Normal knee biomechanics or alignment and stability achieved concurrently with osteochondral grafting; (e) Pain impacts activities of daily living and failure of 3 months of conservative treatment (PT, home exercise, NSAIDs/analgesics, adjunctive medications, and/or intraarticular corticosteroid injections) except in documented unusual circumstances.see node text

Autografting not meeting these criteria and for other joints is investigational.

Talus autograft/revision pathway: Large (area >1.5 cm^2) or cystic (volume >3.0 cm^3) osteochondral lesion(s) of the talus, or revision after failed marrow stimulation (eg, microfracture, drilling), when all of the following are met: (a) Individual is skeletally mature with documented growth plate closure; (b) Absence of inflammatory arthritis or other systemic disease affecting joints; (c) Pain impacts activities of daily living and failure of 3 months of conservative treatment (PT, home exercise, NSAIDs/analgesics, adjunctive medications, and/or intraarticular corticosteroid injections).see node text

These talus autograft indications align with clinical input supporting autograft as primary for large talar lesions or as revision after failed marrow stimulation.

Osteochondral autografting (knee) — Covered when ALL criteria met

Covered when ALL of the following are met

Knee autograft criteria: For symptomatic full-thickness cartilage defects of the knee caused by acute or repetitive trauma in individuals with an inadequate response to a prior surgical procedure: skeletally mature or adult not candidate for TKA; focal unipolar Outerbridge Grade III–IV lesion on weight-bearing femoral condyle, trochlea, or patella sized 1–2.5 cm^2; minimal surrounding degenerative change (Outerbridge II or less); normal biomechanics/alignment and stability achieved; pain impacts ADLs and failure of ≥3 months conservative therapy (PT, home exercise, NSAIDs/analgesics, adjunctive meds, and/or intraarticular corticosteroid injections).1–2.5 cm^2; Outerbridge Grade III–IV; ≥3 months conservative therapy

Exceptions to PT may be allowed if clearly documented (eg, intractable pain).

Osteochondral autografting (talus) — Covered when ALL criteria met

Covered when ALL of the following are met

Talar autograft criteria: Large (area >1.5 cm^2) or cystic (volume >3.0 cm^3) osteochondral lesion(s) of the talus, or revision after failed marrow stimulation; individual skeletally mature with documented growth plate closure; absence of inflammatory arthritis or systemic joint disease; pain impacts ADLs and failure of ≥3 months conservative therapy (PT, home exercise, NSAIDs/analgesics, adjunctive meds, and/or intraarticular corticosteroid injections).>1.5 cm^2 or >3.0 cm^3; ≥3 months conservative therapy

Autografting for talus meets these criteria when marrow stimulation is unlikely to succeed or has failed.

Investigational — Not covered

Investigational products: Use of autologous or allogeneic minced/particulated cartilage, decellularized osteochondral allograft plugs (eg, Chondrofix), or reduced osteochondral discs (eg, ProChondrix, Cartiform) for treatment of focal cartilage lesions is considered investigational due to insufficient evidence to demonstrate improved net health outcome.

These technologies are not considered to improve net health outcome.

When autograft or fresh allograft are appropriate

Coverage considerations based on lesion size, patient factors, and prior treatments:

Autologous osteochondral transplantation most appropriate when: Patient has a full-thickness focal knee cartilage lesion in the effective lesion-size range (approximately 1–4 cm^2, with optimal outcomes reported in mid-term data for ~2–6 cm^2), is younger (eg, ≤50 years), and malalignment/instability are corrected; factors associated with better outcomes include male sex, younger age, and lesions <3 cm^2.lesion size ~1–4 cm^2; age ≤50 years

Derived from observational series and systematic reviews.

Fresh osteochondral allograft considerations: Recommended for larger defects (>2 cm^2), complex or deep lesions, or as salvage after failed prior cartilage repair; evidence reports substantial graft survival (eg, ~82% at 10 years in some series) though failure and reoperation rates increase with larger defect size.>2 cm^2

Used when other techniques are inadequate.

Fresh osteochondral allograft — knee (salvage)

Covered when ALL of the following are met (knee — fresh allograft salvage context):

Knee fresh allograft salvage criteria: 1) Full-thickness chondral defect of the knee caused by acute or repetitive trauma; 2) Lesion size, location, or depth makes other cartilage repair techniques (microfracture, autologous osteochondral transplantation, autologous chondrocyte implantation) inadequate; 3) Procedure is used as primary option for large lesions or as salvage after failed restoration treatments.see node text

Considered salvage operation in younger patients when other repair techniques are inadequate.

Autologous osteochondral transplantation — ankle (large or post-failure)

Covered when ALL of the following are met (ankle — autologous osteochondral transplantation):

Ankle autograft criteria for large or failed lesions: 1) Full-thickness focal articular cartilage lesion of the ankle that is either: a) large (area >1.5 cm^2) OR b) cystic (volume >3.0 cm^3); 2) Lesion is a primary large lesion or has failed prior marrow stimulation/arthroscopic procedure; 3) Expected benefits (pain, function) outweigh risks including donor-site morbidity.area >1.5 cm^2; volume >3.0 cm^3

Derived from evidence that marrow stimulation is preferred for lesions <1.5 cm^2 and that larger/cystic lesions have poorer marrow stimulation outcomes.

Indications for autologous osteochondral transplantation

Covered when ANY of the following apply (per evidence in this section):

Indication - large or cystic lesion: Autologous osteochondral transplantation for talar lesions when the lesion is large (area >1.5 cm^2) or cystic (volume >3.0 cm^3).area >1.5 cm^2 or volume >3.0 cm^3

Based on studies showing marrow stimulation has lower success for lesions ≥1.5 cm^2.

Indication - prior failure: Autologous osteochondral transplantation for osteochondral lesions of the talus that have failed previous marrow stimulation procedures.failed prior marrow stimulation

Nonrandomized comparative trials and case series report improved outcomes vs repeat marrow stimulation.

Evidence summary

Evidence considerations and limits:

RCT evidence: A single randomized controlled trial (Gobbie et al. 2006) with 24-month follow-up showed similar improvements for autograft, microfracture, and chondroplasty in large talar lesions; longer-term durability differences were not reported. Postoperative pain was greater after autograft in the RCT.24 months follow-up

Longer-term differences between hyaline and fibrocartilage cannot be determined from this RCT.

Observational evidence: Multiple observational studies and case series report good-to-excellent mid-term outcomes (mean follow-up ~4–7 years) for autograft in large or cystic lesions and after failed marrow stimulation; nonrandomized trials suggest better outcomes with autograft versus repeat marrow stimulation, and outcomes may be better when autograft is performed as primary rather than revision therapy.mean follow-up 4–7 years

Evidence primarily from case series and nonrandomized studies.

Coverage criteria for fresh osteochondral allograft in large/cystic ankle lesions

Covered when ALL of the following are met

Large_or_cystic_indication: Lesion is large (area >1.5 cm^2) or cystic (volume >3.0 cm^3)>1.5 cm^2 or >3.0 cm^3

Supported by rationale that autograft may be inadequate for such lesions.

Autograft_inadequate_or_not_feasible: Autologous osteochondral transplantation is inadequate or not feasible due to lesion size, depth, location, or donor-site limitations; documentation must state why autograft is not appropriate.n/a

Document reason autograft not appropriate.

Comparator_attempt_or_contraindication: Microfracture/marrow stimulation is not appropriate or has failed when applicable (especially for lesions >1.5 cm^2 or recurrent lesions).

Non-coverage stance for small primary lesions

Not recommended / Not appropriate when ANY of the following apply

Small_primary_lesion: Primary full-thickness ankle lesions <1.5 cm^2 where microfracture is effective.<1.5 cm^2

Use of allograft or autograft for small primary lesions is not appropriate; marrow stimulation is preferred.

Fresh osteochondral allograft for ankle (large/cystic lesions or revision)

Covered when ALL of the following are met

Ankle - Large or Cystic Lesions (allograft): Lesion area >1.5 cm^2 OR lesion volume >3.0 cm^3; AND prior procedures have failed (eg, microfracture) or autograft is inadequate or would cause significant donor-site morbidity; AND patient counseling provided about higher allograft failure/reoperation rates and potential impact on future arthroplasty/arthrodesis; AND plan for long-term follow-up (≥5 years).area >1.5 cm^2 or volume >3.0 cm^3; follow-up ≥5 years

Evidence includes small RCT and systematic reviews of case series showing symptom and function improvement but higher failure/reoperation rates for allografts.

Autologous osteochondral transplantation for elbow (capitulum)

Covered when ALL of the following are met

Elbow - Autologous osteochondral transplantation: Full-thickness articular cartilage lesion of the elbow (capitulum); AND lesion size/severity for which marrow stimulation is not likely adequate or surgical treatment is indicated; AND expectation of improved function/return to sport; AND follow-up at least 6 months (longer-term recommended).follow-up ≥6 months

Evidence from systematic reviews of case series shows improved functional scores and high rates of return to sport with autograft transplantation.

Autologous osteochondral transplantation — elbow

Evidence summaries and applicability

OAT for elbow (osteochondritis dissecans): Evidence from case series and systematic reviews suggests improved functional scores and high return-to-sport rates after autologous OAT for advanced capitellar osteochondritis dissecans, but studies are nonrandomized and primarily level 4; comparative benefit versus other surgical options is suggested but not definitive.

Donor-site morbidity and need for higher-quality comparative studies should be considered.

Autologous osteochondral transplantation — shoulder

Shoulder osteochondral autograft

OAT for shoulder: Evidence is very limited (small case series with long-term follow-up) and does not allow strong conclusions about efficacy.

Coverage decisions should reflect the limited evidence base for shoulder OAT.

Minced/particulated cartilage transplantation

Particulated cartilage transplantation (knee, ankle, elbow, shoulder)

Minced/particulated cartilage procedures: Autologous or allogeneic particulated/minced cartilage procedures are proposed alternatives to marrow stimulation or autologous chondrocyte implantation; available evidence requires follow-up of 1–2 years or longer to assess symptoms, function, QOL, and morbidity.follow-up 1–2 years+

Evidence base includes small RCT(s) and case series; further high-quality trials needed.

Particulated/minced cartilage — knee and ankle

Consider coverage when clinical evidence demonstrates benefit and patient selection matches studied populations

Knee particulated/minced cartilage (autologous) - evidence summary: A small randomized trial (Cole et al. 2011) found improvements in IKDC and KOOS at 12 and 24 months for an autologous cartilage autograft implantation system versus microfracture.RCT evidence exists

Single small RCT (29 randomized patients); longer-term follow-up and larger trials needed.

Allogeneic particulated cartilage (DeNovo NT) - evidence: Evidence limited to case reports and small case series showing improvement from baseline but with findings of graft hypertrophy, delamination, subchondral edema, and nonuniform repair on MRI.case-series evidence only

Largest prospective series N=25; outcomes improved but imaging and some second-look arthroscopies show variable repair quality.

Decellularized osteochondral allograft plugs

Evidence raises concerns about durability and implant integrity

Decellularized osteochondral allograft plugs (eg, Chondrofix): Multiple case series report high structural failure rates (eg, 72% structural failure in one series) and substantial revision rates (eg, 29% required implant removal in another series); reports note delamination and poor implant durability.high reported failure rates

Consistent signal of poor outcomes across case series suggests insufficient evidence of long-term benefit.

Evidence insufficiency

Evidence summary and coverage implication

Primary evidence limitation: Available evidence for reduced osteochondral allograft discs consists only of small case reports and case series without controlled comparative trials.

Insufficient to draw conclusions about treatment efficacy.

Covered with clinical criteria

Clinical input summarized (ankle and elbow): covered when criteria below are met

Ankle - lesion size: Osteochondral autografts are appropriate for primary treatment of osteochondral lesions of the talus with a surface area >150 mm^2.>150 mm^2

Supported by multiple cited studies showing poorer outcomes with microfracture for lesions >150 mm^2.

Ankle - revision or failed treatment: Osteochondral autograft or allograft transplantation is a valid option for lesions that failed nonoperative management or prior arthroscopic marrow stimulation (microfracture).failed nonoperative treatment or failed microfracture

Multiple case series and comparative studies cited showing improved outcomes after grafting in failures.

Elbow - specific situations: Large osteochondritis dissecans lesions of the capitellum in patients failing nonoperative treatment, debridement, or microfracture may benefit from osteochondral autografts.

Indications for osteochondral grafting of talus

Covered when ALL of the following are met

Primary large cystic lesions: Lesion is a large cystic osteochondral lesion of the talus defined as surface area >150 mm^2 OR volume >3000 mm^3.surface area >150 mm^2 OR volume >3000 mm^3

Arthroscopic marrow stimulation techniques are unreliable for these lesions; primary osteochondral allograft/autograft is reasonable.

Failed prior therapy: Failed nonoperative treatment or failed microfracture/arthroscopic debridement when applicable; document prior failed therapies.document prior failed therapies

Autograft/allograft used in revision situations with reasonable success.

Autograft vs Allograft selection: Autograft preferred when feasible due to trend for superior graft healing, but allograft may be necessary for extraordinarily large lesions or lesions involving areas where autograft is impractical; document donor-site morbidity concerns or lesion size/location that preclude autograft.

Fresh osteochondral allografting and osteochondral autografting that do not meet the specific clinical criteria in this policy or that are proposed for joints outside those addressed (knee, talus/ankle, elbow, shoulder) are considered investigational and are not covered. The policy’s medical necessity pathways require documentation of lesion characteristics (size/volume and grade), skeletal maturity, prior conservative therapies, and biomechanical considerations before these procedures are considered appropriate.

Autologous or allogeneic minced/particulated cartilage, decellularized osteochondral allograft plugs (e.g., Chondrofix), and reduced osteochondral allograft discs (e.g., ProChondrix, Cartiform) are considered investigational for treatment of focal cartilage lesions due to insufficient evidence demonstrating improvement in net health outcome.

Comparative evidence is limited and inconsistent: some systematic reviews and RCTs suggest no short-term superiority of advanced grafting techniques over abrasion/marrow-stimulation methods, while longer-term and observational data indicate autograft may reduce failure rates versus microfracture for certain mid-sized knee lesions. Given these mixed results, selection between marrow stimulation, autograft, and allograft should be guided by lesion size, location, patient factors, and documented prior treatments.

Current evidence does not support routine use of osteochondral autograft as primary treatment for small talar/ankle lesions (< 1.5 cm^2). Marrow-stimulation techniques (eg, microfracture) produce comparable outcomes for these small lesions with lower donor-site morbidity, and autografting in this setting is generally discouraged.

For primary small talar lesions (< 1.5 cm^2), marrow-stimulation (microfracture/drilling/abrasion) is generally the preferred initial therapy because multiple studies report high success rates and lower morbidity compared with osteochondral graft harvest.

Use of fresh osteochondral allograft for primary small ankle lesions (< 1.5 cm^2) is not appropriate. Microfracture is effective for most small lesions, and reported allograft failure/nonunion rates are higher, making allograft an unsuitable primary option for these cases.

When deciding between allograft and autograft, autograft is preferred when feasible because observational studies and a RCT have shown higher nonunion and failure rates with allografts and because allograft use may negatively affect future arthroplasty or arthrodesis. Allograft remains an option for very large or complex lesions where adequate autograft volume would cause unacceptable donor-site morbidity.

Evidence for osteochondral grafting in the shoulder is very limited and consists primarily of small case series; efficacy is not established. For the elbow (capitulum) the literature is mainly case series and meta-analyses of case series, suggesting benefit but lacking high-quality randomized data to confirm comparative effectiveness.

Many ankle series include concomitant procedures (eg, osteotomy, hardware removal, treatment for impingement or instability) that limit attribution of outcome improvements solely to the graft procedure. Documentation should specify all concomitant procedures when evaluating the evidence and clinical decision-making.

Reduced osteochondral allograft discs are supported only by small case series; evidence is insufficient and these devices are considered investigational pending larger controlled studies.

Multiple case series have reported high structural failure and revision rates for certain decellularized osteochondral allograft plugs (eg, reports of substantial delamination and high short-term failure), raising concerns about durability and implant integrity.

Marrow-stimulation techniques (eg, microfracture) may be inappropriate as primary treatment for talar lesions with surface area > 150 mm^2 (≈ > 1.5 cm^2); outcomes are poorer for these larger lesions and grafting should be considered instead.

Arthroscopic marrow-stimulation techniques are considered unreliable for lesions with surface area > 150 mm^2 and are not appropriate as primary treatment for these large or cystic talar defects; evidence supports primary grafting strategies for such lesions.

Various emerging graft technologies (autologous/allogeneic particulated cartilage, decellularized plugs, reduced allograft discs) have limited and mixed evidence consisting mainly of small RCTs or case series with variable outcomes including graft hypertrophy, nonuniform repair on imaging, and occasional failures.

Overall, the investigational graft types summarized in this policy lack sufficient high-quality evidence to conclude they improve net health outcomes; these technologies remain investigational until larger, controlled studies with longer follow-up demonstrate consistent benefit and acceptable safety.

Randomized trials and systematic reviews are limited in number and quality, and outcomes are mixed: some RCTs show similar short-term improvements across techniques while observational data suggest longer-term durability advantages for autograft in selected lesion sizes. These limitations create uncertainty about comparative effectiveness and long-term outcomes.

Procedure and Threshold Coding

Listed procedure CPT codesCPT

24999	Unlisted procedure, humerus, or elbow.
27415	Osteochondral allograft, knee, open.
27416	Osteochondral autograft(s), knee, open (e.g., mosaicplasty) (includes harvesting of autograft[s]).
27899	Unlisted procedure, leg or ankle.
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).
29885	Arthroscopy, knee, surgical; drilling for osteochondritis dissecans with bone grafting, with or without internal fixation (including debridement of base of lesion).
29892	Arthroscopically aided repair of large osteochondritis dissecans lesion, talar dome fracture, or tibial plafond fracture, with or without internal fixation (includes arthroscopy).
29999	Unlisted procedure, arthroscopy.

CPT codes for osteochondral proceduresCPT

24999	Unlisted procedure, humerus, or elbow.
27415	Osteochondral allograft, knee, open.
27416	Osteochondral autograft(s), knee, open (e.g., mosaicplasty) (includes harvesting of autograft[s]).
27899	Unlisted procedure, leg or ankle.
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).
29885	Arthroscopy, knee, surgical; drilling for osteochondritis dissecans with bone grafting, with or without internal fixation (including debridement of base of lesion).
29892	Arthroscopically aided repair of large osteochondritis dissecans lesion, talar dome fracture, or tibial plafond fracture, with or without internal fixation (includes arthroscopy).
29999	Unlisted procedure, arthroscopy.

inv-50: Lesion area threshold

Threshold> 1.5 cm^2

ContextUsed to define 'large' talar/ankle lesions where marrow-stimulation has lower success and grafting is considered

Clinical implicationLesions >1.5 cm^2 often treated with autograft or allograft rather than primary microfracture

inv-51: Cystic lesion volume threshold

Threshold> 3.0 cm^3

ContextDefines a cystic talar/ankle lesion where marrow-stimulation outcomes are unreliable and grafting may be indicated

Prior Authorization, Documentation, and Denial Risks

Prior Authorization

Prior Authorization Required and Verification

Prior authorization is required for osteochondral graft procedures when medical necessity criteria are met; providers should obtain authorization before scheduling services for large or cystic lesions or when prior-treatment failure is claimed. When a prior authorization request is submitted, include documentation that verifies lesion size (surface area in cm2 and/or volume in cm3) and any prior procedures attempted (e.g., microfracture, drilling, debridement) with outcomes.

Confirm lesion surface area (e.g., >1.5 cm2 threshold) or volume (>3.0 cm3) on imaging or operative measurement prior to authorization.
If claiming revision status, submit operative reports and outcomes showing failure of prior marrow stimulation (microfracture/drilling) or other prior cartilage repair.
Obtain PA prior to elective scheduling for fresh allograft, osteochondral autograft, or investigational graft products when coverage criteria hinge on lesion size or prior-treatment failure.

Documentation Required

Required Clinical Documentation to Support Medical Necessity

Background and Evidence Context

Osteochondral autografting harvests small osteochondral plugs from non–weight-bearing sites of the patient and transplants them into full-thickness chondral defects; fresh osteochondral allografting uses donor osteochondral tissue to replace larger or more complex defects when autograft is inadequate due to lesion size, depth, or location. Emerging options such as particulated cartilage, decellularized plugs, and reduced allograft discs have limited evidence and reported concerns (eg, implant delamination or heterogeneous repair).

Evidence summary (duplicate placement for clinical context)

Evidence considerations and limits (clinical context):

RCT versus observational evidence: A single RCT showed similar short-term outcomes across autograft, microfracture, and chondroplasty for large talar lesions at 24 months; observational series report favorable mid-term outcomes (4–7 years) for autograft in large or cystic lesions, but higher-quality comparative data are limited.24 months (RCT) vs 4–7 years (observational)

Longer-term durability differences are not well characterized.

Comparative evidence for techniques shows short-term uncertainty: systematic reviews report that advanced grafting techniques do not consistently outperform abrasion/marrow-stimulation approaches in the short term, though some mid- and long-term data suggest reduced failure with autograft for appropriately sized knee lesions. Clinical selection should therefore be individualized based on lesion size, patient age, and expected durability.

Definitions and Terminology

inv-121: Osteochondral autograft (OATS/Mosaicplasty) definition

DefinitionTransplantation technique using one or more osteochondral cores harvested from the patient and press-fit into the defect (autograft mosaicplasty/OATS)

Typical donor siteNon–weight-bearing regions of the knee used to harvest plugs

Clinical roleUsed for focal full-thickness cartilage defects; indicated when lesion size and location are suitable

inv-122: Fresh osteochondral allograft definition

DefinitionUse of donor osteochondral tissue to replace injured cartilage and underlying bone

IndicationsTypically used for larger defects or when autograft is inadequate due to lesion size, depth, or location

Policy Revision History

2025-06-01Annual review / Policy renewalLatest

Policy underwent annual review and was renewed (June 2025).

2024-08-01Annual review / Policy update

Policy underwent annual review and was renewed (August 2024).

Policy Summary

Payerblue cross blue shield - south dakota

PolicyOsteochondral Allografts and Autografts in the Treatment of Focal Articular Cartilage Lesions

Policy CodePolicy 07.01.65

Change TypeNo material clinical or coverage changes in this revision

Effective DateMay 1, 2014

Next Review DateJun 1, 2025

Key ActionRequest prior authorization and document lesion size, prior conservative therapy failure, and skeletal maturity to demonstrate medical necessity.

SourceLink

On This Page

Microfracture is first-line for lesions <1.5 cm^2 per review.

failed nonoperative/debridement/microfracture

Clinical input respondents recommended autografts for large capitellar OCD lesions.

document donor-site morbidity concerns or lesion size/location

Donor-site morbidity for autograft reported 0–26%.

Clinical implication

Cystic lesions with volume >3.0 cm^3 are considered for autograft/allograft when autograft is feasible or as allograft salvage

inv-52: Knee autograft lesion size range

Size range1 to 2.5 cm^2

Site specificationUnipolar lesions on weight-bearing femoral condyles, trochlea, or patella

Required lesion gradeFull-thickness (Outerbridge Grade III or IV)

inv-53: Conservative therapy duration

Minimum duration>= 3 months

Included therapiesPhysical therapy, home exercise, NSAIDs/analgesics, adjunctive meds, intraarticular corticosteroid injection(s)

ExceptionsException to PT requirement allowed if clearly documented (eg, intractable pain)

inv-54: Required cartilage grade for knee autograft

Required gradeOuterbridge Grade III or Grade IV

Definition sourceOuterbridge/Modified Outerbridge classifications describe Grade III (fragmentation/fissuring >1 cm^2) and Grade IV (subchondral bone exposed)

Clinical roleSpecifies full-thickness cartilage defects appropriate for knee osteochondral autograft consideration

inv-55: Lesion size/volume thresholds summary

KneeCovered lesions: 1–2.5 cm^2 (full-thickness, Outerbridge III–IV)

Talar large/cysticArea >1.5 cm^2 OR volume >3.0 cm^3

Small lesionsLesions <1.5 cm^2 generally managed with marrow stimulation (microfracture)

inv-56: Lesion size threshold comments

Evidence basis1.5 cm^2 threshold derived from studies showing marrow-stimulation success decreases for talar lesions ≥1.5 cm^2

Clinical consequenceAutograft/autograft considered for lesions above threshold due to higher marrow-stimulation failure

Proportion affectedApproximately 20% of talar lesions are considered too large for marrow stimulation

inv-57: Lesion area threshold (ankle)

Ankle threshold (area)1.5 cm^2

ContextDefines 'large' talar lesions for autograft consideration or revision after failed marrow stimulation

Relation to small lesionsLesions <1.5 cm^2 typically treated with marrow stimulation (microfracture)

inv-58: Cystic lesion volume threshold (repeat)

Cystic volume threshold> 3.0 cm^3

Clinical implicationVolume >3.0 cm^3 denotes cystic lesions less likely to respond to marrow stimulation and considered for grafting

Evidence examplesUsed in RCTs and systematic reviews evaluating large/cystic ankle lesions

inv-59: Lesion area threshold (repeat)

Lesion area> 1.5 cm^2

ApplicationThreshold used across ankle/talar indications to distinguish small vs large lesions

Treatment implicationGuides selection between marrow stimulation vs autograft/allograft

inv-60: Cyst volume threshold (repeat)

Cyst volume> 3.0 cm^3

Alternative unitsAlso expressed as >3000 mm^3 in some sections

Clinical noteLarge cystic lesions often require grafting; marrow stimulation unreliable

inv-61: Lesion area / volume thresholds consolidated

Small< 1.5 cm^2

Large> 1.5 cm^2

Cystic> 3.0 cm^3

inv-62: Lesion size thresholds (area/volume)

Ankle criteriaArea >1.5 cm^2 or Volume >3.0 cm^3

Follow-up expectationLong-term follow-up recommended (≥5 years) for ankle allograft outcomes

Clinical cautionAllografts have higher reported failure/revision rates vs autografts in some reviews

inv-63: Follow-up duration expectations

Ankle follow-up5 years or longer recommended for ankle outcomes

Elbow follow-up6 months or longer (longer-term recommended) for elbow interventions

RationaleLonger follow-up needed to assess graft survival, reoperation, and functional outcomes

inv-64: Lesion size thresholds reported in studies

Knee lesions reported1–5 cm^2 (mean example 2.7 cm^2)

Talar lesions reported96–308 mm^2 (mean example 125 mm^2)

Knee mean in allograft seriesMean allograft size reported up to 8.2 cm^2 in observational series

inv-65: Ankle lesion surface area threshold (mm2)

Threshold (mm^2)>= 150 mm^2

Relation to cm^2150 mm^2 = 1.5 cm^2 (used interchangeably in ankle sections)

Clinical meaningSurface area ≥150 mm^2 often considered 'large' and may prompt grafting over microfracture

inv-66: Lesion size thresholds (surface area or volume)

Primary thresholdsSurface area >150 mm^2 (1.5 cm^2) OR volume >3000 mm^3 (3.0 cm^3)

UsageApplied to decide when marrow stimulation is unreliable and grafting is appropriate

Clinical noteExpressed either as surface area or as cyst volume depending on study/report

Provide complete clinical documentation with the authorization request and in the medical record to support medical necessity and expected outcomes. Documentation should demonstrate skeletal maturity (growth plate closure) when applicable, absence of inflammatory arthritis, and correction or stabilization of malalignment/instability when required.

Document skeletal maturity (imaging or notes confirming physeal closure) for adolescent patients.
Report lesion location, precise size (cm2) and/or volume (cm3), cystic vs noncystic characteristics, and cartilage grading (Outerbridge) surrounding the defect.
Describe baseline symptoms and objective outcome measures (e.g., AOFAS, Lysholm, IKDC, VAS) and how pain/function limit ADLs.
If malalignment or instability exists, include operative plan and documentation that correction/stabilization will be performed concurrently or has been addressed prior to grafting.

Step Therapy

Step Therapy and Treatment Sequencing Expectations

Providers must show evidence of a failed course of conservative therapy or prior surgical therapy per the policy’s step-therapy expectations before certain grafting procedures. For small talar lesions (<1.5 cm2), marrow stimulation is preferred as the initial standard-of-care; larger lesions or failed marrow stimulation justify progression to grafting.

Conservative therapy: at least 3 months including physical therapy (unless contraindicated), home exercise program, NSAIDs/analgesics, adjunctive medications, and consideration of intraarticular corticosteroid injection(s).
Step therapy: document prior marrow stimulation (microfracture, drilling, abrasion) attempts and outcomes when grafting is requested for talar lesions.
Preferred sequence: debridement → marrow stimulation for lesions <1.5 cm2 → autograft/allograft for larger or refractory lesions; autograft preferred when feasible with acceptable donor-site morbidity.

Denial Risk

Evidence, Patient-Selection, and Denial Risks

Be aware of evidence-based patient-selection risks that may lead to additional review or denial. Allografts have higher failure and nonunion rates in some series compared with autografts; limited or low-quality evidence for newer or niche products may prompt denial or requests for more information.

Potential denial risk if autograft is requested as primary treatment for small ankle lesions (<1.5 cm2) where marrow stimulation is standard and less morbid.
Higher observed allograft failure/nonunion rates should be documented and justified when allograft is proposed, particularly for small primary lesions.
Limited evidence for products (minced particulated cartilage, decellularized plugs, reduced discs) may trigger additional clinical review or be considered investigational.
Insufficient evidence from small case series or single-surgeon reports can lead to requests for longer-term outcomes, objective scoring, or denial if claimed benefit is not supported.

Billing Rule

Prior Authorization and Coding Reminder

Accurate coding and service documentation are required with authorization and claims submission. Incorrect or incomplete coding may result in claim denials or delays; include operative reports, graft type, and any concurrent procedures.

Use the appropriate CPT/HCPCS codes for the performed procedure (see policy code list) and document whether the procedure was open or arthroscopic and whether autograft or allograft was used.
Include operative reports that describe lesion measurements, graft harvest or allograft type, fixation method, and any concomitant procedures (eg, osteotomy, ligament repair, meniscal allograft).
Coding-related denial risk: verify unlisted procedure codes are accompanied by detailed operative documentation and that code selection matches the service rendered to avoid claim denial.

Evidence for osteochondral grafting in the shoulder is very limited, consisting mostly of small series; because of this paucity of data, efficacy for shoulder indications remains unproven and coverage decisions should reflect this limited evidence base.

Reports from multiple case-series identify high failure and revision rates for some decellularized allograft products; these findings have prompted concerns about implant durability and have informed the policy’s investigational stance for those products.

The overall evidence base is limited by small RCTs and many nonrandomized case series, short follow-up for newer graft technologies, and heterogeneous reporting of concomitant procedures and lesion characteristics. Because of these limitations, evidence is insufficient to fully establish efficacy for many newer graft types and for some joint indications.

Clinical considerationsMay be used as salvage after failed restoration procedures; potential implications for future arthroplasty/arthrodesis

inv-123: Kellgren-Lawrence Grading System

DefinitionRadiographic grading system for osteoarthritic changes of the tibiofemoral knee joint (Grade 0–IV)

UseReported on plain x-rays to describe osteoarthritis severity relevant to surgical candidacy

Grades summaryGrade 0 (none) to Grade IV (large osteophytes, marked joint-space narrowing)

inv-124: Outerbridge / Modified Outerbridge Classification

DefinitionSystems for grading articular cartilage injury from Grade I (softening) to Grade IV (subchondral bone exposed)

Clinical useUsed to define lesion severity appropriate for repair techniques (eg, Outerbridge Grade III–IV for autograft)

Grade examplesGrade III: fragmentation/fissuring >1 cm^2; Grade IV: subchondral bone exposed

inv-125: Kissing Lesion definition

DefinitionAn articular cartilage defect on opposing joint surfaces that contact each other (bipolar lesion)

Clinical relevanceKissing lesions may affect repair strategy and are associated with worse outcomes

ApplicationConsidered when assessing candidacy for grafting versus other interventions

inv-126: Autologous osteochondral transplantation definition

DefinitionRemoval of injured cartilage and underlying bone and replacement with graft harvested from another area of the patient's joint (autograft)

TechniqueOne or more osteochondral plugs harvested and implanted to fill defect

Clinical roleUsed for focal full-thickness defects when donor-site morbidity acceptable

inv-127: Fresh osteochondral allograft transplantation definition

DefinitionReplacement of injured cartilage and underlying bone with graft tissue harvested from a donor (fresh osteochondral allograft)

IndicationUsed for larger or deep lesions where autograft is inadequate or would cause significant donor-site morbidity

Clinical cautionAllografts may have higher failure/revision rates and potential impact on future arthroplasty

inv-128: Large lesion (ankle) definition

DefinitionAnkle lesion with area >1.5 cm^2 or cystic lesion volume >3.0 cm^3

Clinical implicationClassified as 'large' for treatment decision-making (grafting vs marrow stimulation)

UsageThreshold used to recommend autograft or allograft over microfracture for talar lesions

inv-129: Fresh osteochondral allograft (knee) definition

DefinitionTransplantation of fresh donor osteochondral tissue to replace full-thickness chondral defects of the knee, often used as salvage

IndicationsUsed when lesion size, depth, or location make autograft or other repairs inadequate

Evidence summarySystematic reviews and case series show functional improvement and prolonged graft survival in many cases

inv-130: Large lesion definition (repeat)

DefinitionArticular cartilage lesion of the talus with area >1.5 cm^2 (equivalent to >150 mm^2)

Clinical consequenceConsidered large and less likely to respond to marrow stimulation

Treatment implicationMay prompt primary autograft/allograft or revision grafting after failed microfracture

inv-131: Cystic lesion definition

DefinitionFull-thickness articular cartilage lesion with associated cystic component where cyst volume >3.0 cm^3

Clinical implicationCystic lesions are less likely to respond to marrow stimulation and often considered for grafting

Alternate unitsExpressed as >3000 mm^3 in some sections

inv-132: Marrow stimulation definition

DefinitionProcedures (eg, microfracture, drilling, abrasion) that debride damaged cartilage and puncture underlying bone to stimulate fibrocartilage repair

Clinical rolePreferred first-line therapy for small primary lesions (<1.5 cm^2) and comparator before grafting

LimitationsOutcomes poor for larger (>1.5 cm^2) or cystic lesions

inv-133: Small primary full-thickness talar lesion definition

DefinitionSmall primary full-thickness talar lesion: area <1.5 cm^2; microfracture typically effective

Clinical implicationAutograft or allograft generally not indicated as primary treatment for these lesions

Evidence basisMultiple studies and reviews support favorable microfracture outcomes for lesions <1.5 cm^2

inv-134: Large or cystic talar lesion definition

DefinitionLarge or cystic talar lesion: area >1.5 cm^2 OR cyst volume >3.0 cm^3 where autograft may be inadequate

Clinical implicationMay require allograft (fresh) if autograft volume inadequate or donor-site morbidity unacceptable

Evidence basisSupported by RCTs, systematic reviews, and case series showing poorer marrow-stimulation outcomes

inv-135: Fresh osteochondral allograft (repeat def)

Definition (repeat)Donor cartilage and bone transplanted to replace injured cartilage and subchondral bone (fresh osteochondral allograft)

Clinical roleSalvage option for large/deep lesions or failed prior repairs

Outcome considerationsGraft survival and reoperation rates vary; long-term follow-up recommended

inv-136: Autologous osteochondral transplantation (autograft) definition

DefinitionAutologous osteochondral transplantation (autograft): cartilage and subchondral bone harvested from patient's body to replace damaged surface

TechniqueHarvesting osteochondral plugs and implanting into defect (mosaicplasty/OAT)

Clinical considerationsDonor-site morbidity risk must be considered

inv-137: Autologous osteochondral transplantation (OAT) definition

DefinitionAutologous osteochondral transplantation (OAT): removal of injured cartilage and underlying bone and replacement with graft harvested from another area of the patient

Evidence noteNICE IPG607 supports mosaicplasty for knee defects

Typical outcomesImproved durability vs marrow stimulation for medium-sized knee lesions

inv-138: Minced/particulated articular cartilage transplantation definition

DefinitionMinced/particulated cartilage transplantation: cartilage mechanically minced into 1–2 mm pieces to release chondrocytes and implanted (autologous or allogeneic)

Clinical evidenceLimited RCT and small case series exist; outcomes variable with MRI findings of heterogeneous repair

StatusConsidered investigational/limited evidence in many contexts

inv-139: Decellularized osteochondral allograft plugs definition

DefinitionDecellularized osteochondral allograft plugs: allografts processed to remove cells/lipids and sterilized to extend shelf life

Evidence concernsCase series report high structural failure and delamination rates for some products (eg, Chondrofix)

Clinical stanceConsidered investigational due to inconsistent outcomes and high failure reports

inv-140: Particulated/minced cartilage definition

DefinitionParticulated/minced cartilage: small pieces of autologous or juvenile allogeneic cartilage implanted, sometimes with scaffold or fibrin glue

ExamplesProducts such as DeNovo NT and Cartilage Autograft Implantation System

EvidenceLimited to case series and small studies showing variable MRI and clinical findings

inv-141: Reduced osteochondral allograft discs definition

DefinitionReduced osteochondral allograft discs: laser-etched allograft discs containing hyaline cartilage with chondrocytes and extracellular matrix components

EvidenceCurrently limited to small case series; insufficient evidence to confirm efficacy

Regulatory/clinical noteConsidered investigational in absence of stronger comparative data

inv-142: Microfracture (marrow stimulation) definition

DefinitionMicrofracture (marrow stimulation): debridement and puncture of subchondral bone to stimulate fibrocartilage repair

IndicationPreferred initial therapy for small primary lesions (<1.5 cm^2)

LimitationLess reliable for larger (>1.5 cm^2) or cystic lesions

inv-143: Mosaicplasty definition and NICE guidance reference

DefinitionMosaicplasty: autologous osteochondral grafting technique for focal cartilage defects using multiple plugs (OATS); NICE IPG607 supports its use

Guideline noteNICE concluded evidence adequate to support mosaicplasty for knee defects

Clinical implicationMosaicplasty is an established autograft technique for appropriate lesions

inv-144: Particulated juvenile cartilage and decellularized allografts

DefinitionParticulated juvenile cartilage and decellularized allografts: biologic graft options studied for focal cartilage defects with variable outcomes

EvidenceCase reports/series show mixed outcomes; some decellularized products associated with high failure

Clinical stanceUse with caution; many are considered investigational pending stronger evidence

inv-145: Critical lesion size (ankle) key value

Critical size (surface area)> 150 mm^2

Clinical implicationLesions >150 mm^2 often have poorer outcomes with microfracture and may be appropriate for primary osteochondral transplantation

Evidence basisMultiple retrospective series and comparative reports support this threshold

inv-146: Large cystic lesion definition (alternate units)

Alternate unitsLarge cystic lesion defined as surface area >150 mm^2 OR volume >3000 mm^3

Clinical exampleRaikin study reported mean cyst volume 6059 mm^3 with good/excellent results after fresh allograft

Treatment implicationMarrow stimulation unreliable for these lesions; grafting recommended

inv-147: Large-volume cystic OLT example (Raikin)

Example studyRaikin prospective study: mean lesion volume 6059 mm^3 with good/excellent results in 11/15 patients

Outcome metricsAOFAS improved from 38 to 83 at mean 44 months; graft resorption observed in some but few required arthrodesis

Clinical implicationLarge-volume cystic lesions may benefit from fresh osteochondral allograft when other options are inadequate