CurrentRegence BlueCross BlueShieldPolicy 87

Autologous Chondrocyte Implantation for Focal Articular Cartilage Lesions

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This policy governs coverage of autologous chondrocyte implantation (ACI), including MACI, for focal full-thickness articular cartilage defects. It applies to provider requests for treatment of disabling knee cartilage lesions and identifies when the procedure is medically necessary versus investigational.

Policy Summary

PayerRegence BlueCross BlueShield

PolicyAutologous Chondrocyte Implantation for Focal Articular Cartilage Lesions

Policy CodePolicy N/A

Change TypeNo material change

Effective DateNovember 1, 2026

Last ReviewSep 1, 2026

Next Review DateJuly 1, 2027

Key ActionSubmit history and physical or chart notes documenting BMI, symptoms, treatments, the FDA-approved therapy, growth-plate closure when applicable, imaging, and knee biomechanics, alignment, and stability.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥1.5 cm²Minimum lesion size

<35BMI threshold

III–IVLesion grade

Knee only

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CurrentRegence BlueCross BlueShieldPolicy 87

Autologous Chondrocyte Implantation for Focal Articular Cartilage Lesions

Customize your policy alerts

Sign up for regence Policy 87 alerts

Get alerted when Policy 87 changes without checking for updates manually.

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Policy Summary

PayerRegence BlueCross BlueShield

PolicyAutologous Chondrocyte Implantation for Focal Articular Cartilage Lesions

Policy CodePolicy N/A

Change TypeNo material change

Effective DateNovember 1, 2026

Last ReviewSep 1, 2026

Next Review DateJuly 1, 2027

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥1.5 cm²Minimum lesion size

<35BMI threshold

III–IVLesion grade

Knee only

Medical Necessity and Investigational Criteria

Medically Necessary — Qualifying Knee Lesions

Autologous chondrocyte implantation (ACI) may be considered medically necessary for disabling full-thickness articular cartilage defects of the knee caused by acute or repetitive trauma when all of the following criteria are met:

ALL of the following

Adolescent patients are skeletally mature with documented closure of growth plates (e.g., age 15 years or older); adult patients are too young to be considered an appropriate candidate for total knee arthroplasty or other reconstructive knee surgery (e.g., younger than 55 years).
Focal, full-thickness (grade III or IV) unipolar lesion of the patella or the weight-bearing surface of the femoral condyles or trochlea.>= 1.5 cm²
Documented Outerbridge grade II or less degenerative changes in the surrounding articular cartilage, with normal-appearing hyaline cartilage surrounding the border of the defect.
Normal knee mechanics, alignment, and stability are present before ACI or are planned to be restored simultaneously with the ACI procedure.
Body mass index (BMI) is less than 35.

Investigational — Nonqualifying Uses

ACI is considered investigational in the following circumstances:

ANY of the following

Criterion I is not met.
Treatment involves a joint other than the knee, including the talus.
Treatment is for any indication other than those listed in the medically necessary knee-lesion criteria.

Medically Necessary — Knee Lesions

Current evidence indicates that ACI can improve symptoms in some patients with articular cartilage lesions of the knee who are too young for total knee replacement and have limited treatment options. ACI may therefore be considered medically necessary when the qualifying criteria are met.

ACI is medically necessary only for qualifying disabling full-thickness articular cartilage defects of the knee meeting all required criteria.

Autologous chondrocyte implantation for treatment of articular cartilage lesions in non-knee joints, including the talus, is considered investigational. There are no clinical practice guidelines recommending ACI for cartilage lesions of any type outside the covered knee indications.

Autologous chondrocyte implantation for treatment of lesions of the articular cartilage of the knee in patients who do not meet the medically necessary criteria is considered investigational because evidence is insufficient to show improvement in health outcomes.

Autologous chondrocyte implantation when Criterion I is not met and for all other joints, including the talar joint, or for any indications other than those listed above is considered investigational.

Misalignment and instability of the joint are contraindications to ACI. Normal knee mechanics, alignment, and stability must be present before the procedure or restored simultaneously with ACI. Additional procedures, such as ligament or tendon repair or osteotomy for joint realignment, may be performed concurrently. Meniscal allograft transplantation may be performed in combination with ACI either concurrently or sequentially.

Second-generation matrix-induced ACI products described in European studies are not approved in the United States and are considered investigational. MACI® is a next-generation matrix-induced ACI and is currently the only ACI therapy on the market approved by the FDA.

ACI for articular cartilage lesions outside the knee is considered investigational because evidence is insufficient to evaluate efficacy and impact on health outcomes. This includes lesions of the patella and talus when treated under indications outside the qualifying knee-lesion criteria.

Codes and Operational Thresholds

CPTCPT

27412

Autologous chondrocyte implantation, knee

HCPCSHCPCS

J7330	Autologous cultured chondrocytes, implant
S2112	Arthroscopy, knee, surgical for harvesting of cartilage (chondrocyte cells)

Minimum lesion size

Minimum sizeAt least 1.5 cm²

Lesion typeFocal, full-thickness, unipolar articular cartilage lesion

Qualifying locationsPatella or weight-bearing surface of the femoral condyles or trochlea

BMI

Required BMILess than 35

Policy criterionThe patient’s body mass index must be < 35

Clinical consideration

Documentation and Review Risks

Documentation Required

Required Clinical Documentation

Submit the complete clinical and product record needed to determine whether the policy criteria are met, including chart notes, BMI, symptoms, diagnoses, treatments, the FDA-approved therapy name, and site-specific imaging. For adolescents, include documentation of growth-plate closure; also document that knee biomechanics, alignment, and stability are normal or will be restored during the requested procedure.

History and physical/chart notes, including BMI
Symptoms, associated diagnoses, and prior or current treatments
Name of the FDA-approved therapy
For adolescents, documentation of growth-plate closure
Imaging supporting the patellar lesion and surrounding degenerative changes
Documentation that knee biomechanics, alignment, and stability are normal or will be achieved concurrently

Clinical Background

Autologous chondrocyte implantation (ACI) is a staged cartilage-repair procedure in which healthy cartilage cells are harvested, expanded in vitro, and then implanted to resurface an articular cartilage defect.

Terms and Clinical Concepts

Autologous chondrocyte implantation (ACI)

Cell sourceChondrocytes are harvested from healthy tissue

Cell preparationThe harvested cells are expanded in vitro

PurposeThe expanded cells are implanted to resurface an articular cartilage defect

MACI

TechniqueA next-generation, matrix-induced autologous chondrocyte implantation technique

Cell scaffoldAutologous chondrocytes are cultured on a bioresorbable porcine-derived collagen membrane

Regulatory status

Policy Summary

PayerRegence BlueCross BlueShield

PolicyAutologous Chondrocyte Implantation for Focal Articular Cartilage Lesions

Policy CodePolicy N/A

Change TypeNo material change

Effective DateNovember 1, 2026

Last ReviewSep 1, 2026

Next Review DateJuly 1, 2027

SourceLink

On This Page

BMI greater than 35 kg/m² may affect outcomes because of increased stress on weight-bearing joint surfaces

Adolescent skeletal maturity

Skeletal maturityDocumented closure of growth plates is required for adolescent patients

Example age15 years or older

ApplicabilityThe age example does not replace documentation of growth-plate closure

Adult age example

Example age criterionYounger than 55 years

Patient considerationThe adult patient should be too young to be an appropriate candidate for total knee arthroplasty or other reconstructive knee surgery

ContextThe age example reflects patients who are not appropriate candidates for those reconstructive procedures

Surrounding cartilage degeneration

Permitted degenerationOuterbridge grade II or less

Surrounding cartilageThe surrounding articular cartilage must have documented Outerbridge grade II or less degenerative changes

Defect borderNormal-appearing hyaline cartilage must surround the border of the defect

Smaller lesion consideration

Smaller lesion thresholdLesions smaller than 4 cm²

Prior treatmentDebridement must be the only prior surgical treatment

Treatment considerationConsider marrow-stimulating techniques before autologous chondrocyte implantation

Denial Risk

Investigational Indication or Site

ACI is considered investigational when the covered indication and site requirements are not met. This includes indications other than the specified qualifying knee lesions and treatment of joints outside the qualifying knee indication, including talar or other non-knee sites.

Do not represent nonqualifying indications or sites as medically necessary under this policy.
Review whether the requested site and indication satisfy every Criterion I requirement before submitting for coverage.

Denial Risk

Failure to Meet Medical-Necessity Criteria

Failure to meet any required medical-necessity criterion creates denial risk. Covered ACI requires a skeletally mature adolescent or an adult generally too young for total knee arthroplasty or other reconstructive knee surgery; a focal, full-thickness grade III or IV unipolar lesion of the patella, weight-bearing femoral condyle, or trochlea measuring at least 1.5 cm²; surrounding cartilage with Outerbridge grade II or less degeneration and normal-appearing hyaline cartilage at the defect border; normal or concurrently restorable knee mechanics, alignment, and stability; and BMI < 35.

All criteria A–E must be documented and satisfied.
Adolescents should have documented closure of growth plates, such as age 15 years or older.
Adults should generally be younger than 55 years and not appropriate candidates for total knee arthroplasty or other reconstructive knee surgery.

Documentation Required

Insufficient Documentation

Missing, incomplete, or inadequate records may prevent Regence from confirming eligibility and may affect the review outcome and coverage decision. Ensure the submission supports the requested diagnosis, treatment, product, lesion, and operative-planning details before review.

Incomplete records can delay or adversely affect review.
Documentation should be specific to the requested knee lesion and proposed ACI procedure.

Denial Risk

Unapproved Matrix-Induced ACI Product

Matrix-induced ACI products that are not approved in the United States are considered investigational and should not be presented as covered FDA-approved therapy under this policy.

Verify the product’s United States FDA approval status.
Identify the FDA-approved therapy in the submitted documentation.

Denial Risk

Knee Criteria Not Met

ACI for a knee articular-cartilage lesion is considered investigational when the patient or lesion does not satisfy the policy’s required criteria. The evidence is insufficient to show improved health outcomes for patients who do not meet the specified knee criteria.

Confirm lesion grade, size, location, surrounding cartilage, knee mechanics, patient age or skeletal maturity, and BMI.
Do not assume that treatment of a knee lesion is covered solely because the anatomic site is the knee.

Denial Risk

Non-Knee Joint Treatment

ACI for patellar, talar, or other non-knee articular-cartilage sites is considered investigational when the site or indication falls outside the qualifying criteria. Confirm that the requested anatomy matches the policy’s covered knee-lesion requirements before pursuing authorization.

Non-knee joints, including the talar site, are investigational under the policy.
Patellar treatment must satisfy all applicable qualifying lesion and knee criteria; otherwise it is investigational.

The only ACI therapy currently approved by the FDA and available in the United States

Full-thickness lesion

Lesion definitionA full-thickness articular cartilage lesion

Outerbridge classificationGrade III or IV

Policy contextQualifying knee lesions are focal and full-thickness

SUMMIT trial

Trial typePivotal, industry-sponsored, multicenter randomized open-label trial

Intervention comparedMatrix-induced autologous chondrocyte implantation (MACI) versus microfracture

Lesion size studiedLarger symptomatic cartilage defects measuring at least 3 cm²

MACI for talar osteochondral lesions

ProcedureMatrix-induced autologous chondrocyte implantation (MACI)

Anatomic siteOsteochondral lesions of the talus

Evidence contextThe reported evidence includes a systematic review of 11 studies involving 166 patients

Matrix-induced autologous chondrocyte implantation (MACI)

Core techniqueA matrix is seeded with cultured autologous chondrocytes

Difference from first-generation ACIIt does not use a periosteum covering

Surgical accessIt does not require tibial or fibular osteotomy to gain adequate surgical access

Autologous chondrocyte implantation (ACI)

TechniqueA cartilage-repair technique using cultured chondrocytes obtained from the patient

First-generation methodFirst-generation techniques may use a periosteal covering

Later techniquesLater matrix-based techniques use a cell-seeded scaffold