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Currentblue cross blue shield - kansasPolicy N/A

Autologous Chondrocyte Implantation for Focal Articular Cartilage Lesions

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Defines medical necessity criteria, guidelines, and regulatory context for autologous chondrocyte implantation in focal full‑thickness articular cartilage defects of the knee and states ACI for other joints is investigational. Applies to BCBS Kansas members and providers.

Policy Summary

Payerblue cross blue shield - kansas

PolicyAutologous Chondrocyte Implantation for Focal Articular Cartilage Lesions

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateApr 8, 2020

Last ReviewMay 28, 2025

Next Review DateMay 28, 2025

Key ActionObtain prior authorization and document lesion size, location, grade, prior treatments, and planned concurrent alignment or stabilizing procedures.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yearminimum follow-up

≥1.5 cm2minimum lesion size

<=55age guidance

BMI>35obesity threshold

MACIFDA-approved product

N=144pivotal RCT (SUMMIT)

Coverage Criteria for Autologous Chondrocyte Implantation (ACI)

Initial Therapy — ACI for knee

Covered when ALL of the following are met

ACI medical necessity criteria: 1. Patient is skeletally mature (documented growth-plate closure, e.g., ≥15 years) or an adult considered too young for total knee arthroplasty (example cutoff: <55 years); 2. Focal, full-thickness (Outerbridge grade III or IV) unipolar lesion(s) of the weight-bearing surface of the femoral condyles, trochlea, or patella measuring at least 1.5 cm^2; 3. Minimal to absent degenerative change in surrounding articular cartilage (Outerbridge grade II or less) with normal-appearing hyaline cartilage bordering the defect; 4. Normal knee biomechanics, alignment, and stability, or documentation that these will be corrected concurrently with ACI;see text

All criteria must be met for coverage

Investigational indications

Not covered - other joints/indications: ACI for all other joints (including talar) and any indications other than those listed for the knee is considered experimental/investigational.

Policy Summary

Payerblue cross blue shield - kansas

PolicyAutologous Chondrocyte Implantation for Focal Articular Cartilage Lesions

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateApr 8, 2020

Last ReviewMay 28, 2025

Next Review DateMay 28, 2025

Key ActionObtain prior authorization and document lesion size, location, grade, prior treatments, and planned concurrent alignment or stabilizing procedures.

SourceLink

On This Page

Initial therapy (trial-aligned coverage)

Covered when trial-aligned selection criteria are met

Core eligibility: Patient has a symptomatic focal cartilage defect of the knee (International Cartilage Repair Society/Outerbridge grade III or IV) on the femoral condyles or trochlea; documented lesion size consistent with trial inclusion ranges (example trial ranges: 1–4 cm^2 and ≥3 cm^2 up to 20 cm^2 as reported in RCTs); knee is stable with intact or partially intact meniscus; baseline symptomatic threshold consistent with trials (e.g., moderate-to-severe KOOS pain <55 in SUMMIT); prior treatment history documented (including any prior marrow stimulation procedures).see trials

Derived from SUMMIT and Niemeyer RCT inclusion criteria

Subgroup considerations

Population considerations from observational review

Favorable subgroups: Younger, active males with smaller lesions had the best reported outcomes; older, less active patients and patients with lesions >6 cm^2 had poorer outcomes and higher failure rates.lesion >6 cm^2 poorer outcomes

From Sacolick et al. (systematic review of OCD cases)

General coverage considerations and evidence summary

Covered when clinical evidence and patient factors align with improved outcomes versus alternatives

Primary considerations: Patient has a symptomatic focal articular cartilage lesion suitable for repair and lesion characteristics (size, location) are consistent with ACI use; documentation of prior treatments and any planned concomitant procedures (realignment, meniscal/ligament repair) is provided; prior marrow-stimulation procedures are noted as they increase failure risk and reduce long-term graft survival.lesion size and prior treatment documented

Evidence shows ACI superior to marrow stimulation for larger lesions and worse outcomes after prior marrow stimulation

Comparative-effectiveness logic

Choice of ACI/MACI compared with comparators depends on lesion size and location

When ACI preferred: Defects greater than approximately 4 cm^2 or large/deep osteochondral defects (situations where bilayer MACI has been evaluated) — evidence indicates improved outcomes with ACI versus osteochondral autograft transfer (OAT) or marrow stimulation for larger lesions.>4 cm^2 or deep osteochondral defects

Randomized and observational studies support advantage of ACI in larger defects

General evidence criteria

Evidence summary and coverage implications for ACI in non-knee joints

Evidence basis: Evidence for ACI in joints other than the knee (most commonly talus; occasional reports for acetabulum) is primarily from case series and systematic reviews of case series with few prospective controlled trials and limited RCT evidence; comparative trials are needed to establish benefit over alternatives.

See systematic reviews (Migliorini 2022, Hu 2021, Niemeyer 2012)

Outcome and follow-up

Outcomes and follow-up considerations

Follow-up requirement: Clinical benefit should be demonstrated with at least 1 year of follow-up (minimum) using validated outcome measures appropriate to the joint (examples: KOOS for knee; AOFAS for talus); documentation of improvement in validated scores and monitoring for adverse events is recommended.>=1 year

Minimum follow-up requirement described in Outcomes section

Comparative context

Comparative effectiveness considerations

Comparators considered: Alternatives relevant to decision-making include marrow stimulation (microfracture), osteochondral autograft transfer (OAT/mosaicplasty), and cell-free scaffold techniques (AMIC); comparative effectiveness varies by technique and defect characteristics and is heterogeneous across studies.

Provider should justify choice based on lesion characteristics and prior treatments

Coverage criteria referenced

Referenced external and historical policy criteria and indications for ACI (excerpted from NICE and internal policy revision history):

NICE ACI adult knee criteria: ACI may be used for symptomatic articular cartilage defects of the femoral condyle and patella (ICRS/Outerbridge grade III or IV) in adults only if: the person has not had previous surgery to repair articular cartilage defects; there is minimal osteoarthritic damage to the knee; and the defect is over 2 cm^2.defect > 2 cm^2

External guideline (NICE 2018)

Policy coding applicability: Procedure and supply codes listed in the policy (informational) are considered medically necessary only when the procedure itself meets the Policy section medical necessity criteria.

Coding informational note from policy

Autologous chondrocyte implantation (ACI) is considered experimental/investigational for all joints other than the knee, including the talus. The policy limits medical necessity to focal, full‑thickness (Outerbridge grade III or IV) unipolar defects of the weight‑bearing femoral condyles, trochlea, or patella meeting the specific knee criteria; indications outside those listed for the knee are excluded from coverage.

To ensure valid evidence synthesis, studies with duplicative or overlapping populations were excluded from the review. Comparative controlled prospective trials were preferred, with single-arm and long‑term series used only when appropriate to capture durability and adverse events.

Systematic reviews and trial reports identified poorer outcomes in certain subgroups: lesions >6 cm2 and older or less active patients demonstrated worse outcomes and may be excluded from standard coverage pathways or require additional justification in authorization reviews.

The clinical review in this section concentrates on joints other than the knee (primarily the talus and, less commonly, the acetabulum). Applicability of knee-derived evidence to non‑knee joints is limited, and the evidence base for non‑knee joints is smaller and less well‑established.

Although there are no explicit policy exclusion clauses beyond the investigational stance for non‑knee joints in this section, the document notes insufficient evidence that ACI improves outcomes for the talus and other non‑knee joints, supporting an investigational classification in those contexts.

Historically, matrix‑induced ACI (MACI) has had evolving policy language; prior revisions to the policy text and item edits are documented, reflecting variable prior policy status for MACI before the current criteria were established.

Multiple cohort and registry analyses report that a history of prior marrow stimulation (e.g., microfracture) is associated with substantially increased ACI failure rates and lower long‑term graft survival. Prior marrow stimulation is therefore an important factor to consider when assessing eligibility for ACI and may influence coverage decisions.

Joint malalignment and instability are contraindications for ACI unless corrected; the policy also notes that severe obesity (BMI >35 kg/m2) may negatively affect outcomes and should be considered when assessing medical necessity.

Use of ACI/MACI outside the patient populations, lesion sizes, and other eligibility features represented in randomized trials — or without documentation of indication, lesion characteristics, and prior treatments — may not be supported by the evidence and therefore may be considered not medically necessary.

Lesions previously treated with marrow‑stimulation techniques have a substantially higher risk of ACI failure and reduced graft survival. Use of ACI for defects after prior marrow stimulation without clear documentation of expected benefit may therefore be unsupported unless specific justification is provided.

Because prospective randomized comparative trials for ACI in the talus and other non‑knee joints are lacking or limited, the benefit of ACI over alternative treatments in these joints is not established — evidence is insufficient to conclude superiority or routine medical necessity.

The coding list provided in the policy is informational only. Inclusion of procedure or supply codes does not imply coverage; medical necessity must be documented and the procedure must meet the Policy section criteria for the member to be eligible for coverage.

Coding and Size/Follow-up Thresholds

Coding referencedmixed

Not specified in this segment

No explicit CPT/HCPCS/ICD-10 codes are present in these chunks.

Procedure and supply codes referencedmixed

27412	Autologous chondrocyte implantation, knee.
29870	Arthroscopy, knee, diagnostic, with or without synovial biopsy (separate procedure).
29871	Arthroscopy, knee, surgical; for infection, lavage and drainage.
29873	Arthroscopy, knee, surgical; with lateral release.
29874	Arthroscopy, knee, surgical; for removal of loose body or foreign body (e.g., osteochondritis dissecans fragmentation, chondral fragmentation).
29875	Arthroscopy, knee, surgical; synovectomy, limited (e.g., plica or shelf resection) (separate procedure).
29876	Arthroscopy, knee, surgical; synovectomy, major, 2 or more compartments (e.g., medial or lateral).
29877	Arthroscopy, knee, surgical; debridement/shaving of articular cartilage (chondroplasty).
29879	Arthroscopy, knee, surgical; abrasion arthroplasty (includes chondroplasty where necessary) or multiple drilling or microfracture.
29880	Arthroscopy, knee, surgical; with meniscectomy (medial AND lateral, including any meniscal shaving) including debridement/shaving of articular cartilage (chondroplasty), same or separate compartment(s), when performed.

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Lesion size — coverage threshold

Minimum lesion size for coverage≥ 1.5 cm^2

Anatomic locations specifiedWeight-bearing femoral condyles, trochlea, or patella

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

Patient maturity/age noteSkeletally mature adolescents (growth plate closure) or adults typically younger than 55 years

Consider marrow stimulation prior to ACI

Consider marrow stimulation first when lesion is< 4 cm^2

Context for step therapyIf debridement is the only prior surgical treatment, marrow-stimulating techniques should be considered before ACI for smaller lesions

Trial alignment noteMany RCTs compared MACI with microfracture, supporting marrow stimulation as a relevant comparator for small defects

Obesity threshold affecting outcomes

Obesity threshold influencing outcomesBMI > 35 kg/m^2

RationaleIncreased stress on weight-bearing surfaces may negatively affect outcomes

Coverage considerationSevere obesity is a consideration when determining medical necessity and may argue against routine coverage without justification

Minimum follow-up requirement

Minimum follow-up to demonstrate efficacy1 year (minimum)

Outcome measures expectedValidated instruments such as CKRS/mCKRS, IKDC, KOOS, WOMAC, AOFAS, SF-12/SF-36

Follow-up range in literatureReported follow-up ranges from 1 to 10 years; longer-term data preferred for durability

Lesion size thresholds used in trials

Typical trial inclusion lesion range≥1 to 20 cm^2 (SUMMIT range 3–20 cm^2; average 4.8 cm^2)

Niemeyer trial range1–4 cm^2 (example RCT inclusion criteria)

Basad trial range4–10 cm^2 (randomized trial population)

Minimum follow-up to demonstrate efficacy

Minimum follow-up to demonstrate efficacy (evidence consensus)≥ 1 year

Outcome documentationClinical benefit demonstrated with validated outcome measures and absence of serious adverse events

Longer-term evidenceStudies report follow-up up to 5+ years; 1 year is the minimum for initial efficacy assessment

Lesion size favoring ACI vs OAT

Lesion size where ACI may be favored over OAT> 4 cm^2

Supporting evidenceRandomized and observational studies report improved outcomes with ACI for larger defects versus osteochondral autograft

Typical study mean defect sizesMany studies report mean defect sizes ~3.5–6 cm^2

NICE defect size threshold (knee)

NICE knee defect size threshold> 2 cm^2

NICE eligibility conditionsAdults with symptomatic ICRS/Outerbridge grade III or IV femoral condyle or patellar defects, minimal osteoarthritic damage, and no prior cartilage repair surgery

Guideline sourceNICE guidance update 2018

Defect size threshold — external guidance

Defect size threshold (per NICE recommendation)> 2 cm^2

ScopeApplies to symptomatic femoral condyle and patellar defects (ICRS grade III/IV) in adults

Additional NICE conditionsNo prior cartilage repair surgery and minimal osteoarthritic damage

Prior Authorization, Documentation, and Authorization Considerations

Prior Authorization

Prior Authorization Required

Prior authorization is required for autologous chondrocyte implantation (ACI/MACI) when the procedure is proposed for a patient. Prior authorization should confirm that patient selection aligns with trial inclusion features for knee ACI/MACI (symptomatic focal full-thickness grade III/IV defects of the femoral condyles, trochlea, or patella, documented lesion characteristics, skeletally mature, appropriate age relative to arthroplasty candidacy) and that all applicable medical necessity criteria in the Policy section are met. Prior authorization may be required per payer processes established by the Blue Cross Blue Shield of Kansas Orthopedic Liaison Committee.

Confirm skeletal maturity (documented growth plate closure) and age considerations (e.g., adolescents ≥ ~15 years; adults generally <55 years unless otherwise appropriate).
Confirm lesion is focal, unipolar, full-thickness (Outerbridge grade III/IV) and lesion size meets policy threshold (≥1.5 cm2; many trials enrolled larger lesions and average size ~5 cm2).
Document minimal surrounding degenerative change (Outerbridge grade II or less) and normal-appearing hyaline cartilage border.
Confirm normal knee biomechanics/alignment and stability or that corrective procedures are planned/concurrent.
Document prior treatments, including prior debridement, marrow stimulation (microfracture), osteochondral autograft (OAT/mosaicplasty), and any previous knee surgeries.

Documentation Required

Required Clinical Documentation & Comparators

Documentation submitted with authorization requests should provide detailed lesion characteristics, prior treatment history, procedural staging, and planned concomitant procedures. The most relevant comparators are marrow stimulation (microfracture) and osteochondral autograft; evidence and prior treatment history (especially prior marrow-stimulation procedures) influence expected outcomes and authorization decisions.

Lesion details: size (cm2), exact location (medial/lateral femoral condyle, trochlea, patella), number of lesions (unipolar vs bipolar), Outerbridge grade, and imaging or arthroscopic confirmation.
Prior treatments: specify any prior debridement, marrow stimulation/microfracture (document date and outcome), prior cartilage repair attempts, and other knee surgeries; prior marrow stimulation substantially increases failure risk.
Procedure staging: document first-stage arthroscopy and biopsy and planned second-stage arthrotomy for implantation; indicate timeline between stages and whether initial arthroscopy served diagnostic purposes or biopsy only.
Planned concomitant procedures: note any corrective osteotomy, ligament/meniscal repair or transplantation, or other procedures to address malalignment/instability that are being performed concurrently or sequentially.

Note

Evidence-Limited Coverage Considerations

Evidence for ACI/MACI in non-knee joints (e.g., talus, hip, acetabulum) is limited, consisting largely of case series and systematic reviews of case series. Prior authorization reviewers should consider that the quality of evidence outside the knee is lower and may be insufficient to support coverage except in select circumstances with supporting documentation.

Most evidence for ACI in talus and other non-knee joints arises from case series (limited RCT data); systematic reviews report heterogeneous study designs and follow-up.
Minimum acceptable follow-up to demonstrate efficacy is generally ≥1 year; many studies report outcomes at 2–5 years or longer.
When requested for non-knee joints, provide robust rationale, outcome expectations, and at least 1 year of follow-up data when prior procedures have been performed.

Note

Evidence & Follow-Up Requirements

Follow-up and outcome documentation should be provided. A minimum of 1 year of follow-up is considered necessary to demonstrate efficacy; longer-term follow-up (2–5+ years) may be requested to assess durability. Use validated outcome measures when available.

Provide preoperative and postoperative outcome scores (e.g., KOOS, IKDC, CKRS/mCKRS, AOFAS, WOMAC, modified Harris Hip Score) with dates and duration of follow-up.
Report any adverse events, graft hypertrophy, delamination, need for reintervention, or treatment failures with timing relative to index procedure.
Minimum follow-up to support effectiveness: ≥12 months; insufficent (<12 months) follow-up may be considered inadequate for determining efficacy.

Denial Risk

Denial Risk & Triggers

Denial may be appropriate when requested ACI/MACI does not meet documented medical necessity or lacks required supporting documentation. Prior marrow-stimulation treatments and unsupported indications increase denial risk.

Denial triggers include: lesion not full-thickness grade III/IV, lesion size below policy threshold (e.g., <1.5 cm2), bipolar or widespread degenerative disease, uncorrected malalignment or instability, severe degenerative change (Outerbridge > II), and patient not skeletally mature when indicated.
Procedures outside studied indications or joints (e.g., non-knee indications without adequate supporting evidence) are considered experimental/investigational and may be denied.
Prior marrow-stimulation (microfracture) or prior failed chondral treatment substantially increases risk of graft failure; document prior treatments and justify ACI candidacy if prior marrow stimulation occurred.
Inclusion of CPT/HCPCS codes in documentation does not guarantee coverage — codes are medically necessary only if the clinical criteria in this policy are met.

Billing Rule

Affected Codes — Verify Medical Necessity

Coding and billing notes: the listed procedure and supply codes are provided for informational purposes. Providers should ensure submitted codes accurately reflect services performed and that the clinical record demonstrates that policy criteria are met; coding alone does not imply coverage.

Codes listed are medically necessary ONLY if the procedure meets policy criteria; inclusion or exclusion of codes does not guarantee member coverage or reimbursement.
Commonly referenced codes include: 27412 (ACI, knee); arthroscopy codes (29870–29881) for diagnostic arthroscopy and debridement/microfracture; product/drug supply codes (e.g., J-codes/S-codes) if applicable — verify current payer-specific lists.
Providers should reference member contract benefits and follow payer-specific prior authorization submission instructions; attach operative notes, imaging, pathology/culture reports (if relevant), and outcome measures when requested.

Clinical Background

BACKGROUND: Articular cartilage defects have limited intrinsic healing capacity and can lead to pain, functional loss, and eventual osteoarthritis. Conventional marrow‑stimulating techniques (debridement, microfracture) typically yield fibrocartilage of lower durability, whereas ACI/MACI and osteochondral grafts aim to restore hyaline‑like cartilage; these differences underpin selection of repair strategies based on lesion size, patient factors, and long‑term durability considerations.

Definitions and Abbreviations

Autologous chondrocyte implantation (ACI) — definition and description

Definition of ACIAutologous chondrocyte implantation involves harvesting healthy cartilage, expanding chondrocytes in vitro, and implanting the cells into the cartilage defect

Technique variantsSecond- and third-generation techniques include scaffold- or matrix-based methods (e.g., MACI) combining chondrocytes with biocompatible matrices

Typical procedure stepsHarvest biopsy (arthroscopy), cell culture, and later implantation via arthrotomy with post-surgical rehabilitation

Outerbridge grading scale (I–IV)

Outerbridge Grade IIIFragmentation and deeper fissuring of more than one-half inch (full-thickness cartilage loss)

Outerbridge Grade IVErosion of the cartilage down to bone

Grading scaleOuterbridge scale I–IV used to classify cartilage damage severity

Minimal clinically important difference (MCID) values

MCID examples providedCKRS/mCKRS: MCID at 6 months = 14.0; 12 months = 26.0; IKDC subjective: change >20.5% indicates perceived improvement; SF-12 physical component MCID = 4.3–5.0

Outcome instruments referencedCKRS, mCKRS, IKDC, KOOS, WOMAC, SF-12/SF-36, TAS

Use in documentationMCID/MDC values are used to interpret clinical significance of reported outcome changes in trials and registries

ACI / MACI — abbreviations and summary

ACI abbreviationAutologous chondrocyte implantation (ACI)

MACI abbreviationMatrix-induced autologous chondrocyte implantation (MACI) — chondrocytes cultured on a collagen membrane scaffold

Technique noteMACI is a scaffold-based second-generation ACI technique and the only FDA-approved ACI product in the U.S.

MF — abbreviation and context

MF abbreviationMF = microfracture (marrow stimulation)

RoleCommon comparator to ACI/MACI in trials and a recommended consideration for smaller lesions

Coding mentionMicrofracture procedures referenced under arthroscopy codes (29879)

OAT — abbreviation and context

OAT abbreviationOAT = osteochondral autograft transfer

Comparative contextOAT often compared with ACI; similar outcomes for smaller lesions, ACI may be superior for defects >4 cm^2

Trial relevanceOAT (mosaicplasty) is a relevant alternative when considering cartilage repair technique selection

Bilayer MACI — bilayer (Sandwich) technique

Indications in literatureEmployed for large/deep lesions (e.g., >5 cm^2 and >8 mm depth) with reported functional improvements

EvidenceUsed in prospective randomized and observational studies with mean defect sizes around 6 cm^2

Procedure staging — two-stage ACI process

Procedure stagingFirst-stage arthroscopy to obtain a cartilage biopsy; second-stage arthrotomy for implantation of cultured chondrocytes

Biopsy purposeCartilage biopsy during diagnostic arthroscopy supplies tissue for cell culture prior to implantation

Documentation expectationProcedure staging and biopsy site should be documented for prior authorization and clinical records

MACI / ACI — matrix-induced technique and evidence

MACI describedMatrix-induced ACI (MACI) delivers cultured autologous chondrocytes on a bioresorbable collagen membrane scaffold

Technique noteMACI reduces need for periosteal patch suturing; implant is cut to size and fixed with fibrin glue

Evidence baseMultiple randomized trials and long-term observational studies evaluate MACI versus microfracture and other comparators

AMIC — autologous membrane-induced chondrogenesis (definition)

AMIC definitionAutologous membrane-induced chondrogenesis (AMIC) — a cell-free scaffold-based technique often compared with ACI and microfracture

Comparative roleIncluded as a comparator in network meta-analyses and systematic reviews of cartilage repair

Study typesEvidence for AMIC often comes from case series and comparative observational studies

ACI coding elements — common HCPCS/CPT codes

Autologous cultured chondrocytes implant codeJ7330

Cartilage harvest codeS2112

Procedure code for ACI knee27412

NICE 2018 ACI recommendation summary

NICE 2018 ACI recommendation — defect size> 2 cm^2

NICE eligibility criteriaAdults with symptomatic ICRS/Outerbridge grade III or IV femoral condyle or patellar defects, minimal osteoarthritic damage, and no prior cartilage repair surgery

Guideline sourceNational Institute for Health and Care Excellence (2018)

MACI evidence and key trials

MACI evidence noteMACI is evaluated in randomized trials (e.g., SUMMIT) and multiple randomized and long-term studies cited comparing MACI with microfracture

Key trialSUMMIT (N=144) compared MACI vs microfracture for defects ≥3 cm^2; average lesion 4.8 cm^2 with improved KOOS outcomes for MACI

Long-term follow-upBrittberg et al reported sustained advantages at 5 years in SUMMIT follow-up