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ModifiedBlue Cross Blue Shield - South DakotaPolicy N/A

Autologous Chondrocyte Implant for Focal Articular Cartilage Lesions

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This policy governs coverage and medical necessity criteria for autologous chondrocyte implantation (including MACI) for symptomatic full-thickness cartilage defects of the knee and addresses investigational status for other indications and combined ACI/OATS procedures; it affects providers and members of Blue Cross Blue Shield - South Dakota.

Policy Summary

PayerBlue Cross Blue Shield - South Dakota

PolicyAutologous Chondrocyte Implant for Focal Articular Cartilage Lesions

Policy CodePolicy N/A

Change TypeEvidence and guideline update (2022–2025)

Effective DateMay 1, 2014

Last ReviewJun 1, 2025

Next Review DateN/A

Key ActionSubmit required operative and diagnostic documentation (lesion size/location, prior procedures, symptom scores) with prior authorization to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

References and recent evidence syntheses (2022-2025) and updated guideline citations (AAOS 2023, NICE 2018) were incorporated into the evidence review.

Policy history updated with annual reviews and revisions through June 2025.

15-55age range for medically necessary ACI

>=1.5 cm2minimum lesion size for coverage

Outerbridge III/IVrequired lesion severity

1 yearminimum follow-up

MACIFDA-approved product

27412, J7330key billing codes listed

Coverage Criteria for Autologous Chondrocyte Implantation (ACI/MACI)

inv-01: Medically necessary ACI (knee) — Covered when ALL of the following are met

Medically necessary ACI (knee) — Covered when ALL of the following are met:

ALL of the following

The individual is age 15 to 55 years (adolescent individuals should be skeletally mature with documented closure of growth plates).
Focal, full-thickness (Outerbridge Classification grade III or IV) unipolar lesions of the weight-bearing surface of the femoral condyles, trochlea, or patella at least 1.5 cm^2 in size.
Documented minimal to absent degenerative changes in the surrounding articular cartilage (Outerbridge Classification grade II or less), with normal-appearing hyaline cartilage surrounding the border of the defect.
Normal knee biomechanics or alignment and stability achieved concurrently with autologous chondrocyte implantation (realignment or stabilization procedures may be performed at the same time).

Policy Summary

PayerBlue Cross Blue Shield - South Dakota

PolicyAutologous Chondrocyte Implant for Focal Articular Cartilage Lesions

Policy CodePolicy N/A

Change TypeEvidence and guideline update (2022–2025)

Effective DateMay 1, 2014

Last ReviewJun 1, 2025

Next Review DateN/A

Key ActionSubmit required operative and diagnostic documentation (lesion size/location, prior procedures, symptom scores) with prior authorization to support medical necessity.

SourceLink

On This Page

inv-03: Coverage criteria — ACI for focal knee cartilage lesions — Covered when ALL of the following are met

Coverage criteria — ACI for focal knee cartilage lesions — Covered when ALL of the following are met:

ALL of the following

Diagnosis: symptomatic full-thickness cartilage defect(s) of the weight-bearing surface of the femoral condyles, trochlea, or patella caused by acute or repetitive trauma.
Lesion characteristics: focal, unipolar, full-thickness (Outerbridge grade III or IV) and size meeting the policy-specified minimum (see inv-01).
Patient factors: skeletally mature (or age 15–55 with documented growth plate closure for adolescents), not severely obese (BMI ≤35 kg/m^2 preferred), and active enough for expected benefit.
Prior treatments and joint status: minimal to absent degenerative change surrounding the defect, and any joint misalignment or instability corrected prior to or at the time of implantation; lesions previously treated with marrow stimulation techniques have markedly higher failure rates and should be considered separately (prior marrow stimulation is associated with worse outcomes).

inv-02: Investigational / Not covered indications — The following are considered investigational

Investigational / Not covered indications — The following are considered investigational (not medically necessary):

ALL of the following

ACI (including MACI) not meeting the specified knee criteria (see inv-01/inv-03).
ACI for all other joints (non-knee), including the talus and other sites — evidence consists mainly of case series and is insufficient to demonstrate improvement in net health outcome.
Combined (hybrid repair) ACI/OATS (autologous chondrocyte implantation combined with osteochondral autograft transfer) — current evidence limited to case studies and is insufficient to determine safety and efficacy.
Products or methods not FDA-approved in the U.S., or novel/experimental ACI techniques without adequate comparative evidence.

inv-04: Evidence summaries — no coverage criteria in excerpt — 0 top-level nodes

Evidence summaries — key points from systematic reviews, randomized trials, and observational studies relevant to coverage:

ALL of the following

Systematic reviews and network meta-analyses indicate ACI/MACI often ranks favorably versus microfracture and other marrow stimulation techniques, particularly for larger lesions and at long-term follow-up (e.g., lower failure rates at 10 years).
Randomized trials (including SUMMIT and other RCTs) show MACI/MACI has superior or noninferior functional outcomes compared with microfracture for lesions ≥3 cm^2 and improvements in KOOS subscales; benefits are more apparent for larger defects and longer follow-up.
Comparisons of ACI versus osteochondral autograft transfer generally show similar short-term outcomes; ACI may have advantages for larger defects (>4 cm^2).
Long-term observational studies report variable graft survival (e.g., ~78% at 5 years, ~51% at 10 years in pooled cohorts) and failure rates influenced by prior marrow stimulation, lesion size, graft location, and presence of uncorrected malalignment or instability.
Graft hypertrophy has been reported with matrix-induced ACI (up to ~26% at 24 months in some series); clinical impact of hypertrophy on long-term outcomes remains uncertain and requires longer follow-up.
Evidence for joints other than the knee (e.g., talus) is mainly case series and systematic reviews of nonrandomized data showing improved scores but insufficient comparative evidence to establish efficacy.
Combined (hybrid) ACI/OATS evidence is limited to case reports/series and lacks RCTs; therefore efficacy and safety remain unestablished.

inv-05: Candidate selection for ACI/MACI — Evidence indicates ACI/MACI demonstrates better outcomes primarily in the following population characteristics

Candidate selection for ACI/MACI — Evidence indicates ACI/MACI demonstrates better outcomes primarily in the following population characteristics:

ALL of the following

Younger, active patients (commonly studied mean ages in trials often <40 years) with focal, symptomatic defects.
Lesion size: small-to-moderate to large focal full-thickness defects; ACI shows particular benefit over microfracture for larger lesions (commonly ≥3–4 cm^2).
Lesion type: unipolar, focal, full-thickness defects on femoral condyles, trochlea, or patella with minimal surrounding degenerative change.
Patients without prior failed marrow stimulation procedures have higher graft survival; prior microfracture is associated with higher failure rates and poorer outcomes after subsequent ACI.

inv-06: Clinical criteria and considerations (informational) — Clinical factors associated with better or worse outcomes and key trial eligibility features (informational for medical necessity determi...)

Clinical criteria and considerations (informational) — Clinical factors associated with better or worse outcomes and common trial eligibility features (informational for medical necessity determinations):

ALL of the following

Age: outcomes tend to be better in younger patients; older adults may have worse outcomes.
Activity level: more active individuals fare better; less active individuals have worse outcomes.
Lesion size: larger lesions (>4 cm^2, and particularly >6 cm^2) are associated with worse outcomes in some studies but may derive greater relative benefit from ACI versus microfracture.
Prior procedures: prior marrow stimulation (e.g., microfracture) or failed chondral treatments are associated with higher failure rates for ACI; evidence shows markedly higher failure after prior marrow stimulation.
Joint status and biomechanics: misalignment, instability, or meniscal deficiency should be corrected (concurrent osteotomy, ligament/tendon repair, or meniscal allograft transplantation may be performed) to optimize outcomes; severe obesity (BMI >35 kg/m^2) may adversely affect outcomes.
Graft considerations: first-generation periosteal-covered ACI had higher complication rates (e.g., hypertrophy) than later-generation collagen-membrane techniques; MACI is the currently available FDA-approved product in the U.S. (since 2016).
Follow-up: minimum 1 year follow-up is generally considered necessary to demonstrate efficacy in trials; many studies include longer-term follow-up up to 10+ years for durability assessment.

inv-07: Evidence-derived clinical factors affecting ACI/MACI outcomes — Factors associated with better or worse outcomes reported in the evidence include:

Evidence-derived clinical factors affecting ACI/MACI outcomes — Factors associated with better or worse outcomes reported in the evidence include:

ALL of the following

Better outcomes: younger age, higher activity level, primary (no prior marrow stimulation) lesions, smaller lesion size (within limits), correction of malalignment/instability, concomitant realignment procedures for patellar lesions.
Worse outcomes: older age, lower activity level, prior marrow stimulation or failed chondral procedures, large lesions (>6 cm^2 in some reports), severe obesity, uncorrected malalignment or instability.
Procedure-specific risks: graft hypertrophy (reported with matrix-induced ACI), donor-site morbidity with osteochondral autograft techniques, and potential need for reoperation or revision in a subset of patients.

inv-08: Evidence and coverage rationale — Coverage considerations and evidence strength

Evidence and coverage rationale — Coverage considerations and evidence strength:

ALL of the following

Randomized trials and systematic reviews provide moderate-quality evidence that ACI/MACI can improve functional outcomes versus microfracture for larger defects and may have more durable results long-term; however, evidence quality varies and many trials are moderate-to-poor quality or industry-sponsored.
Comparative evidence with osteochondral autograft is mixed, with similar short-term outcomes; ACI may have an advantage for larger defects (>4 cm^2).
Evidence for non-knee joints and for combined (hybrid) ACI/OATS is limited and of low quality (case series), supporting investigational status for these indications.
Policy balances demonstrated benefit in selected knee lesion populations against limitations (heterogeneity of studies, variable long-term durability, and higher failure after prior marrow stimulation) to define coverage criteria focused on population and lesion characteristics most likely to benefit.

inv-09: Guidance and clinical input constraints — Situations noted by external guidance and clinical input that may affect coverage

Guidance and clinical input constraints — Situations noted by external guidance and clinical input that may affect coverage:

ALL of the following

NICE (2018) recommends ACI only for adults with minimal osteoarthritic damage, defect >2 cm^2, and no prior cartilage repair surgery; this influenced cautious use and criteria regarding prior procedures and osteoarthritic changes.
AAOS guidance (2023) found insufficient evidence to recommend for or against specific cartilage repair techniques for certain OCD presentations, reflecting uncertainty in some clinical scenarios.
Clinical input from specialty societies and academic centers supports ACI for larger patellar lesions and emphasizes benefit when realignment procedures are performed concurrently; many experts recommend caution when ACI follows prior marrow stimulation.

inv-10: Referenced clinical criteria and guideline findings — Coverage considerations referenced from external guidance and evidence:

Referenced clinical criteria and guideline findings — Coverage considerations referenced from external guidance and evidence:

ALL of the following

NICE (2018): limit ACI to adults without prior cartilage repair surgery, minimal osteoarthritic damage, and defect >2 cm^2.
FDA/regulatory status: MACI approved (2016) for repair of symptomatic full-thickness knee cartilage defects in adults; other products exist outside the U.S. or are investigational.
Systematic reviews/meta-analyses: evidence supports ACI/MACI over microfracture for larger lesions and improved long-term failure rates in some analyses; heterogeneity and study quality limit strength of conclusions.

Coding and Billing

See Codes tablemixed

No codes listed

Covered CPT Codesmixed

No codes listed

ACI/MACI procedural codes (not specified in excerpt)mixed

exact code

procedure codes for ACI/MACI (codes not specified in this excerpt)

Provider CPT codesCPT

27412	Autologous chondrocyte implantation, knee.
27599	Unlisted procedure, femur or knee.

HCPCS / supply codesHCPCS

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

inv-32: Lesion size — >= 1.5 cm^2

Lesion size requirement>= 1.5 cm^2

Lesion locationFocal, full-thickness (Outerbridge grade III or IV) unipolar lesions of femoral condyles, trochlea, or patella

Surrounding cartilageMinimal to absent degenerative changes (Outerbridge grade II or less) with normal-appearing hyaline cartilage bordering defect

inv-33: Patient age — 15 to 55 years (skeletally mature adolescents)

Age range for coverage15 to 55 years

Adolescent requirementAdolescents must be skeletally mature with documented growth plate closure

RationalePolicy specifies this age range for medically necessary ACI of the knee

inv-34: Treatable lesion area (Agili-C FDA approval) — 1 to 7 cm2

Agili-C FDA-approved treatable area1 to 7 cm2

Device typeAgili-C is a cell-free biodegradable tapered implant acting as 3D scaffold

Approval yearAgili-C FDA approval noted in 2021

inv-35: Lesion size — mean 3.9 cm2 (reported); defect >4 cm2 predictive of better outcomes with ACI vs other techniques in one review

Reported mean lesion size in trials/reviewsmean 3.9 cm2

Predictive thresholdDefect >4 cm2 was predictive of better outcomes with ACI vs other techniques in one review

Evidence sourceSystematic reviews of randomized trials and level I studies reported these findings

inv-36: Lesion size thresholds used in trials — 1–4 cm2; ≥3 cm2; 4–10 cm2 (various studies used these ranges)

Common trial lesion size ranges1–4 cm2; ≥3 cm2; 4–10 cm2

SUMMIT trial range≥3 cm2 (average 4.8 cm2; range 3–20 cm2)

Basad et al. trial range4–10 cm2

inv-37: Defect size — > 2 cm^2

NICE defect-size criterion> 2 cm^2

ContextNICE recommends ACI for femoral condyle and patella defects only if defect is over 2 cm2 (plus other conditions)

ApplicabilityGuideline pertains to adults and influences consideration of defect-size thresholds

Prior Authorization, Documentation, and Operational Considerations

Documentation Required

Prior approval / documentation

Prior Approval / Documentation: Prior approval is noted as not applicable in this policy excerpt; however, required documentation (see below) must be provided with any request for ACI/MACI to support medical necessity and confirm eligibility criteria are met.

Prior approval: Not applicable (POLICY states "Prior Approval: Not applicable").
Required documentation (must be submitted with request): progress report, history and/or operative notes confirming injury and prior treatments/therapies; reports documenting normal alignment and stability and absence of OA/RA; arthroscopy report (if performed) documenting cartilage defect with measurements and normal surrounding cartilage; MRI or CT arthrogram results documenting defect and surrounding cartilage.
Documentation should support patient meets ALL policy criteria (age 15–55, lesion size ≥1.5 cm2, Outerbridge grade III/IV, minimal surrounding degenerative change, normal biomechanics/alignment or concurrent correction).

Documentation Required

Product and lesion verification

Product and lesion verification: Prior authorization or submitted documentation should confirm that the implanted product is an FDA‑approved cultured autologous chondrocyte product when applicable (e.g., MACI) and include lesion site, size, location, and characteristics.

Verify use of FDA-approved cultured autologous chondrocyte product (MACI is the currently available FDA‑approved MACI product).
Provide lesion verification: site (femoral condyle, trochlea, patella), lesion size in cm2 (policy threshold ≥1.5 cm2 for knee), Outerbridge grade, and confirmation of minimal surrounding degenerative change.
Include operative/laboratory product identity (see Operative and product documentation block).

Note

Prior authorization not specified

Prior authorization not specified: The policy excerpt explicitly states prior approval is not applicable; no separate prior authorization requirements are specified, but clinical and operative documentation listed in this section are required to substantiate coverage.

Operational note: Although "Prior Approval" is listed as not applicable, providers must submit required clinical and operative documentation to demonstrate that policy criteria are met.
If a payer-specific prior authorization process exists outside this policy, follow that payer’s operational rules in addition to submitting the documentation described here.

Documentation Required

Prior authorization: documentation of prior treatments and follow-up

Prior authorization — documentation of prior treatments and follow-up: Requests should document prior conservative treatments and any prior cartilage procedures (e.g., microfracture, marrow stimulation, osteochondral graft), and provide baseline and follow-up outcome measures where available.

Document prior conservative therapy and prior surgical procedures (including dates and outcomes).
If prior marrow stimulation/microfracture was performed, document that history; prior marrow stimulation is associated with higher failure rates and should be considered when authorizing ACI/MACI.
Provide baseline functional scores and available follow-up data (minimum 1 year follow-up preferred to demonstrate efficacy per policy).

Prior Authorization

Coverage contingent on meeting ALL criteria

Coverage contingent on meeting ALL criteria: Coverage for ACI/MACI for the knee is contingent on meeting all listed clinical criteria in the POLICY section; requests that do not meet all criteria should be considered investigational/not covered.

Policy criteria to confirm: age 15–55 (skeletally mature), focal full‑thickness unipolar lesion (Outerbridge grade III/IV) of weightbearing femoral condyles, trochlea or patella, lesion size ≥1.5 cm2, minimal surrounding degenerative change (Outerbridge ≤II), and normal knee biomechanics/alignment/stability or documentation that these were corrected concurrently.
If ALL criteria are not met, ACI/MACI is considered investigational per policy and may be denied.

Note

Follow-up duration

Follow-up duration: A minimum of 1 year of follow-up is considered necessary to demonstrate efficacy in the literature and is expected in documentation when available; many studies report outcomes out to 5–10 years for durability assessments.

Minimum recommended follow-up: ≥1 year to demonstrate efficacy.
Longer-term durability data (eg, 5–10 years) may be relevant for evaluating graft survival and failure risk in decision-making.

Note

None stated in these chunks

None stated in these chunks: There are no additional provider operational actions or payer step-therapy rules explicitly stated beyond the documentation, verification, and clinical-eligibility items summarized here.

No provider actions beyond documentation, product/lesion verification, and demonstration of meeting policy criteria are specified in the provided excerpt.

Denial Risk

Patient selection may affect coverage

Patient selection may affect coverage: Patient factors (age, activity level, lesion size >6 cm2, and presence of degenerative changes) influence expected outcomes and may affect authorization decisions.

Younger, active patients with small-to-moderate lesions tend to have better outcomes; older or less active patients and lesions >6 cm2 fare worse and may be at higher risk of denial.
Document activity level and lesion characteristics to support expected benefit and patient selection.

Denial Risk

Impact of prior marrow stimulation on success

Impact of prior marrow stimulation on success: Prior marrow stimulation procedures (microfracture) are associated with substantially higher failure rates and reduced graft survival; this history should be clearly documented and considered during authorization.

Evidence: prior marrow stimulation linked to 3-fold (or greater) increases in ACI failure; primary graft survival substantially higher than after prior microfracture (examples: primary 79% vs post‑microfracture 44% in cited cohorts).
If prior marrow stimulation was performed, include details (procedure, date, outcome) — this may lead to denial or closer review due to higher failure risk.

Denial Risk

Prior surgery considerations / Prior surgery exclusion noted by NICE

Prior surgery considerations and NICE prior-surgery exclusion: Clinical input and guideline recommendations note mixed opinions on requiring prior surgery; NICE recommends offering ACI only when no previous cartilage repair surgery has been performed.

Clinical input: reviewers generally indicated outcomes are worse when ACI is performed after prior microfracture; many reviewers recommended prior surgical procedure not be required for lesions >4 cm2.
NICE (2018) recommendation: ACI as an option only if person has not had previous surgery to repair articular cartilage defects; minimal osteoarthritic damage; and defect >2 cm2.
Operational implication: Document prior cartilage repair history; consider guideline positions (eg, NICE) when evaluating prior‑surgery exclusions or denial risk.

Step Therapy

Comparators/preceding therapies and step-therapy

Comparators / Preceding therapies and step-therapy considerations: Common comparators include marrow stimulation (microfracture) and osteochondral autograft transfer (OATS); the provided excerpt does not specify any step-therapy requirement that microfracture must be attempted before ACI/MACI, though prior conservative or marrow stimulation history should be documented.

Comparators: microfracture (marrow stimulation) and osteochondral autograft are the primary comparators in trials and systematic reviews.
No explicit step therapy: The policy does not require prior microfracture or marrow stimulation as a mandatory step prior to ACI/MACI; however, prior treatments should be documented and may influence coverage decisions.
Relation to prior procedures: Some trials excluded or stratified by prior marrow stimulation; evidence shows outcomes vary by lesion size and prior treatments — document these for adjudication.
Consideration: Clinical input and evidence indicate worse outcomes after prior microfracture; policies may locally adopt a requirement for prior conservative therapy or may consider primary ACI for larger lesions (>4 cm2).

Billing Rule

Required documentation; Operative and product documentation; Suggested documentation elements; Coding and documentation

Required clinical and operative documentation; suggested supporting elements; and coding: Provide operative notes and product documentation for the multi-stage ACI/MACI process, plus suggested baseline and follow-up outcome measures. Report appropriate CPT/HCPCS codes with supporting documentation.

Required clinical documentation: description of lesion (location, size, Outerbridge grade), prior cartilage procedures (eg, microfracture), documentation of alignment and stability and absence of OA/RA.
Operative and product documentation: arthroscopic biopsy details, operative reports describing lesion debridement and implantation, laboratory/cell‑culture product identity (eg, MACI), and product labeling/lot information where available.
Suggested supporting documentation elements: baseline and follow-up functional scores (eg, IKDC, KOOS, CKRS), imaging reports (MRI/arthrogram) with measurements, and documentation of concurrent corrective procedures (eg, realignment, meniscal/ligament repair).
Coding and billing: include appropriate CPT (eg, 27412, 27599), HCPCS (eg, J7330, S2112) and other applicable codes on claims and include operative and diagnostic documentation to support coding.
Operational note: Provide at least 1 year of follow-up data when possible to support efficacy evaluation; long‑term graft survival data may be requested for complex cases.

Definitions and Key Terms

inv-72: Autologous chondrocyte implantation (ACI / MACI) — Procedure harvesting a patient's own chondrocytes, expanding them in vitro, and implanting them into a chondral defect; MACI refers to ma...

Procedure definitionHarvest patient’s chondrocytes, expand in vitro, and implant into chondral defect

MACI distinctionMACI refers to autologous chondrocytes cultured onto a bioresorbable collagen membrane (matrix-induced ACI)

Typical technique stepsTwo-stage procedure: arthroscopic biopsy followed by implantation via arthrotomy

inv-73: Outerbridge classification — Scale classifying cartilage lesion severity from 0 (normal) to IV (exposed subchondral bone); grade III/IV denote fragmentation/large fis...

Scale range0 to IV

Grade IIIFragmentation and fissures in area larger than 0.5 inch in diameter

Grade IVExposed subchondral bone

inv-74: Matrix-induced autologous chondrocyte implantation (MACI)

MACI definitionSecond-generation ACI where autologous chondrocytes are cultured onto a bioresorbable collagen membrane (sheet) that is cut to size and fixed for implantation

AdvantagesEliminates need for periosteal harvest and suturing; technically easier and less time-consuming than first-generation ACI

FDA-approved productMACI is the only ACI product available in the U.S. per policy

inv-75: Autologous chondrocyte implantation (ACI) — A two-stage procedure involving arthroscopic biopsy of healthy cartilage, ex vivo enzymatic digestion and expansion of chondrocytes, foll...

ACI procedural stepsTwo-stage: arthroscopic biopsy of healthy cartilage, ex vivo enzymatic digestion and cell expansion, then implantation into prepared defect

Cell culture durationCells typically cultured for 11 to 21 days before implantation

Implantation approachImplantation performed via arthrotomy with lesion preparation to normal surrounding cartilage

inv-76: Autologous chondrocyte implantation (ACI) — A cartilage repair technique using cultured autologous chondrocytes implanted into a focal cartilage defect...

ACI technique summaryCartilage repair using cultured autologous chondrocytes implanted into a focal cartilage defect; evaluated across generational techniques

Comparative contextEvaluated versus microfracture, osteochondral autograft transfer, and different ACI generations in trials and reviews

Outcomes variabilityReported outcomes vary by lesion size, prior procedures, and technique generation

inv-77: Microfracture (MF) — Marrow-stimulation technique that creates small fractures in subchondral bone to stimulate fibrocartilage repair.

Microfracture definitionMarrow-stimulation technique that creates small fractures in subchondral bone to stimulate fibrocartilage repair

Comparator roleCommon comparator in trials assessing ACI/MACI effectiveness

Durability notesClinical outcomes after microfracture often deteriorate after 18–24 months in some studies

inv-78: Osteochondral autograft transfer (OAT) — Autograft transfer of osteochondral plugs from non-weight-bearing areas to the cartilage defect.

OAT definitionAutograft transfer of osteochondral plugs from non-weight-bearing areas to the cartilage defect

Comparative useUsed as comparator to ACI/MACI in trials; associated with donor-site morbidity

Indication contextMay provide rapid improvement but with potential increased arthrofibrosis and donor-site issues

inv-79: ACI/MACI — Autologous chondrocyte implantation and matrix-induced autologous chondrocyte implantation, cellular cartilage repair techniques for focal defects.

ACI/MACI descriptionCellular cartilage repair techniques using a patient’s cultured autologous chondrocytes (MACI uses cells on a collagen scaffold)

Typical candidateYounger, active patients with focal full-thickness lesions and minimal surrounding degeneration

Evidence basisEvaluated in randomized trials and systematic reviews with mixed comparative results versus microfracture and OAT

inv-80: MF — Microfracture, a marrow stimulation cartilage repair technique commonly used as comparator in trials.

MF as comparatorMicrofracture is a common comparator in RCTs and reviews comparing cartilage repair techniques

Performance vs ACI/MACIMicrofracture associated with higher failure rates at long-term follow-up in some analyses

ConsiderationPrior microfracture is associated with worse outcomes when ACI/MACI is performed subsequently

inv-81: MACI — Second-generation ACI technique in which cultured autologous chondrocytes are implanted within or on a scaffold/matrix rather than inject...

MACI (second-generation ACI)Cultured autologous chondrocytes implanted within/on a scaffold/matrix rather than injected under a periosteal cover

Practical benefitEasier implantation using a collagen membrane sheet fixed with fibrin glue

Regulatory noteMACI is FDA-approved and is the only ACI product available in the U.S. (Carticel phased out)

inv-82: Bilayer MACI (Sandwich technique) — A technique employing a bilayer matrix, sometimes used for large or deep osteochondral defects...

Bilayer MACI (Sandwich) techniqueEmploys a bilayer matrix sometimes used for large or deep osteochondral defects and occasionally combined with bone grafting

Use caseApplied in patients with large defects (~6 cm2 in some trials)

EvidenceCompared in randomized trials with conventional ACI showing similar 1-year outcomes

inv-83: MACI / matrix-induced autologous chondrocyte implantation — Second-generation ACI where chondrocytes are seeded onto a bioresorbable collagen scaffold for implantation.

MACI definitionChondrocytes seeded onto a bioresorbable collagen scaffold for implantation

Billing referenceReported under HCPCS J7330 and CPT 27412 in the policy coding section

Clinical advantageAvoids periosteal harvest and suturing required by first-generation ACI

inv-84: AMIC / autologous membrane-induced chondrogenesis — A scaffold-based technique for cartilage repair evaluated alongside MACI and MF in talus studies.

AMIC definitionAutologous membrane-induced chondrogenesis: a scaffold-based technique for cartilage repair evaluated alongside MACI and MF

Evidence contextEvaluated in talus studies and compared with MACI in systematic reviews

Study typesMost evidence consists of retrospective case series with limited RCT data for talus

inv-85: Combined (hybrid repair) ACI/OATS — A technique where a small number of osteochondral autograft cores are moved to the defect to restore cartilage height and mechanical func...

Combined (hybrid) ACI/OATS techniqueSmall osteochondral autograft cores restore cartilage height and mechanical function, overlaid with periosteal graft, then chondrocytes implanted to fill remaining areas

PurposeRestores condylar contour and promotes chondral integration when defect has osseous component

EvidenceCurrent evidence limited to case reports and small case series; no RCTs identified

inv-86: Minimum follow-up to demonstrate efficacy — A minimum of 1 year of follow-up is considered necessary to demonstrate efficacy given variable lengths of follow-up in literature (1–10 ...

Minimum follow-up to demonstrate efficacyMinimum of 1 year of follow-up

RationaleExisting literature follow-up ranges from 1 to 10 years; 1 year considered necessary to demonstrate efficacy

ImplicationInsufficient follow-up (<1 year) may trigger denial per policy guidance

inv-87: MACI / Matrix-associated autologous chondrocyte implantation — Autologous cultured chondrocytes implanted on a collagen membrane; reported under HCPCS J7330 and others.

MACI definition and codingAutologous cultured chondrocytes implanted on a collagen membrane for defect repair; listed under HCPCS J7330

Associated CPT codesCPT 27412 (ACI, knee) and unlisted 27599 referenced for provider reporting

Policy noteMACI is the only FDA-approved ACI product currently available in the U.S.

inv-88: NICE eligibility — NICE recommends ACI only for adults with symptomatic femoral condyle or patellar cartilage defects (ICRS grade III/IV) if no prior cartil...

NICE eligibility summaryNICE recommends ACI only for adults with symptomatic femoral condyle or patellar cartilage defects (ICRS grade III/IV) if no prior cartilage repair surgery, minimal osteoarthritic damage, and defect >2 cm2

ConditionsNo previous cartilage repair surgery; minimal OA damage; defect >2 cm2

Use in guidanceGuidance may influence coverage decisions and documentation expectations

Policy Revision History

2025-06Policy updateLatest

Annual Review and Policy Revised (June 2025) reflecting updated evidence through 2025.

2024-06Policy update

Annual Review and Policy Revised (June 2024).

2023-06Policy update

Annual Review and Policy Renewed (June 2023); includes incorporation of AAOS 2023 guidance in evidence considerations.

2023-02Policy update

Annual Review and Policy Revised (February 2023) as part of ongoing evidence surveillance.

2022-02Policy update

Annual Review and Policy Revised (February 2022) updating evidence base prior to later HTAs and reviews.

2024-09Evidence addendum

Hayes evolving evidence review on hybrid ACI/OATS (September 2024) cited in references informing investigational status of combined procedures.

2023-08Evidence addendum

Hayes Health Technology Assessment on MACI procedure (August 2023) added to references informing coverage rationale.

2022-03Evidence addendum

Multiple systematic reviews (2022) added to references (eg, Angele 2022, Dhillon 2022) to update the evidence synthesis.

Autologous Chondrocyte Implant for Focal Articular Cartilage Lesions

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Coverage Criteria for Autologous Chondrocyte Implantation (ACI/MACI)

Coding and Billing

Prior Authorization, Documentation, and Operational Considerations

Background and Rationale

Definitions and Key Terms

Policy Revision History