MEDICAL POLICY 7.01.78 Autografts and Allografts in the Treatment of Focal Articular Cartilage Lesions

Coverage Summary

This policy defines medical necessity criteria, site-of-service considerations, documentation and coding guidance for use of osteochondral autografts and fresh osteochondral allografts to treat focal articular cartilage lesions in the knee, ankle/talus, elbow, and shoulder. Autografts (patient's own tissue) are typically used for smaller focal lesions whereas fresh allografts (donor cadaver tissue) are used for larger or salvage lesions. Emerging technologies — including minced/particulated cartilage, decellularized osteochondral allograft plugs, and reduced osteochondral allograft discs — are considered investigational due to insufficient evidence.

Key coverage thresholds and requirements include: lesion area considered large > 1.5 cm2 and lesion volume considered > 3.0 cm3 (talus/ankle indications), autograft effectiveness range for unipolar weight-bearing femoral condyle/trochlea/patella lesions of 1.0 to 2.5 cm2, mosaicplasty/autograft size guidance of ≤ 1.5–2 cm, and age considerations of skeletal maturity (≥ 15 years) with adults generally ≤ 55 years for autograft candidacy. Site-of-service and inpatient indication considerations reference an ASA III or higher anesthesia risk threshold and other inpatient risk factors. (Policy effective date: 2025-01-01; Last review: 2025-06-09.)

Key Thresholds

Lesion area threshold> 1.5 cm2 (large lesion; talus) / mosaicplasty generally ≤ 1.5–2 cm

Lesion volume threshold> 3.0 cm3 (cystic or large-volume lesion)

Autograft size range1.0 to 2.5 cm2 (unipolar weight-bearing femoral condyle/trochlea/patella); mosaicplasty most effective ≤ 1.5–2 cm

Age considerationsSkeletal maturity (≥ 15 years) required; adults generally ≤ 55 years considered candidates (too young for total knee arthroplasty)

ASA thresholdASA III or higher considered an inpatient site-of-service indication

Prolonged surgery threshold> 3 hours (inpatient site-of-service consideration)

BMI considerationsSevere obesity (BMI > 35 kg/m2) may affect outcomes; BMI ≥ 50 listed as inpatient risk factor

Medical Necessity Criteria

Investigational / Not Medically Necessary

Denial Risk

Investigational technologies not covered

Claims for autologous/minced particulated cartilage, allogeneic minced cartilage (e.g., BioCartilage, DeNovo NT), decellularized plugs (e.g., Chondrofix), and reduced allograft discs (e.g., ProChondrix, Cartiform) are considered investigational and not medically necessary and may be denied.

Investigational items: autologous minced/particulated cartilage, allogeneic minced/particulated cartilage, decellularized osteochondral allograft plugs, reduced osteochondral allograft discs
Potential claim denial risk if these technologies are used

Coding

Covered CPT codes for osteochondral grafting procedures (examples listed)CPTCovered

27415	Osteochondral allograft; knee, open
27416	Osteochondral autograft(s), knee, open (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)

No National Coverage Determinationmixed

No codes listed

Provider Actions / Prior Authorization & Documentation

Prior Authorization

Medical necessity review required

Elective osteochondral grafting procedures and the proposed site of service will be reviewed for medical necessity prior to coverage. Preferred outpatient sites include off-campus or on-campus outpatient hospital/medical center and ambulatory surgical center. Inpatient care is considered medically necessary only when the individual meets specific increased-risk criteria (for example ASA III or higher, recent MI, uncompensated heart failure, prolonged surgery >3 hours, advanced liver disease, severe pulmonary, renal disease, morbid obesity, bleeding disorders, pregnancy, or anticipated transfusion).

Documentation Required

Medical record documentation required

Submit clinical documentation that demonstrates medical necessity, including the diagnosis/condition, history and physical documenting severity, conservative care attempted with duration, pertinent imaging reports, and if applicable, indications supporting inpatient admission.

Background and Evidence Summary

Osteochondral autografts involve harvesting one or more small osteochondral plugs from non-weight-bearing donor sites of the patient and press-fitting them into the prepared defect (mosaicplasty/autologous osteochondral transplantation). Autografts are limited by donor-site morbidity and the finite amount of available donor tissue, which constrains their use to smaller focal lesions.

Fresh osteochondral allografts use donor cadaver osteochondral tissue and are typically used for larger or salvage lesions when autografting would be inadequate. Fresh (non-cryopreserved) allografts are preferred for certain joints (e.g., ankle) because cryopreservation reduces chondrocyte viability and fresh tissue better preserves graft viability.

Minced or particulated cartilage (autologous or allogeneic), decellularized osteochondral allograft plugs, and reduced osteochondral allograft discs are emerging/novel approaches under investigation. These technologies have limited and mixed clinical evidence; some decellularized products have been associated with high short-term failure rates, and overall the evidence is insufficient to support routine coverage.

Evidence Topic	Findings
Knee - autograft evidence	RCTs, systematic reviews, and observational studies show improved outcomes versus marrow stimulation for medium-size lesions (2–6 cm2); evidence judged sufficient for net health outcome improvement; mosaicplasty generally used for smaller focal femoral condyle lesions ≤1.5–2 cm
Knee - allograft evidence	Case series and systematic reviews support salvage use of fresh osteochondral allografts when autografting is inadequate due to lesion size, location, or depth; evidence sufficient for net health outcome improvement
Ankle - autograft evidence	Observational studies and systematic reviews: autograft effective for some lesions; marrow stimulation preferred for small lesions (<1.5 cm2); autograft supported for large or revision lesions; evidence sufficient for improvement in select indications
Ankle - allograft evidence	Small RCT data and case series support fresh allografts for large (>1.5 cm2) or cystic (volume >3.0 cm3) talar lesions or revision after failed marrow stimulation; evidence sufficient for these indications
Autograft size thresholds	Osteochondral autografting indicated for focal unipolar weight-bearing femoral condyle/trochlea/patella lesions between 1.0 and 2.5 cm2; mosaicplasty generally used for lesions ≤1.5–2 cm
Large lesion thresholds	Lesion area >1.5 cm2 or volume >3.0 cm3 define large or cystic talar lesions where allograft or autograft may be required
Investigational technologies	Autologous/allogeneic minced or particulated cartilage, decellularized osteochondral allograft plugs, and reduced allograft discs are considered investigational/not medically necessary due to insufficient evidence and reports of high short-term failure for some decellularized products
Donor source and graft type guidance for ankle	Preferred allograft source for the ankle is from the ankle (not the knee) and preferred type is fresh rather than frozen
Clinical outcomes and limitations	Allograft/autograft used as salvage for large defects; outcomes vary; donor-site morbidity and concerns about future salvage (arthrodesis/prosthesis) noted; evidence strength varies by joint and indication

Definitions

Outerbridge grade II or less: minimal to absent degenerative changes in surrounding articular cartilage (policy uses the Outerbridge classification table).

Full-thickness (grade III or IV): a chondral defect extending down to bone (see Outerbridge Table).

ASA III: American Society of Anesthesiologists Physical Status Classification III — severe systemic disease (used as a threshold for considering inpatient site of service).

Osteochondral autograft (mosaicplasty): harvesting and transplanting autologous osteochondral plugs to fill focal cartilage defects, typically indicated for smaller lesions.

Osteochondral allograft: transplantation of donor osteochondral tissue (fresh preferred for the ankle) for larger or salvage lesions.

Decellularized osteochondral allograft: an allograft processed to remove cellular components; clinical evidence and experience are limited and some products have reported high short-term failure rates.

Revision History

Jul. 8, 2025revision

Policy revised with a Last Revised date of Jul. 8, 2025; document header notes changes effective November 7, 2025 (link to view changes).

Jun. 9, 2025annual_review

Annual Review approved June 9, 2025; policy updated with literature review through February 18, 2025 and references added with minor editorial refinements to listed order of policy statements; intent unchanged.

Aug. 1, 2025interim_reviewLatest

Interim Review approved August 1, 2025; Related Policy 11.01.524 (Site of Service: Select Surgical Procedures) removed (policy deleted effective August 1, 2025).