ModifiedPremera BluecrossPolicy 7.01.48

Autologous Chondrocyte Implantation for Focal Articular Cartilage Lesions

Defines medical necessity, site-of-service considerations, documentation, and coding for autologous chondrocyte implantation (ACI/MACI) primarily for focal full-thickness knee cartilage lesions; indicates ACI is investigational for other joints.

Policy Summary

PayerPremera Bluecross

PolicyAutologous Chondrocyte Implantation for Focal Articular Cartilage Lesions

Policy CodePolicy 7.01.48

Change TypeModified (ASC site-of-service criteria addeddocumentation corrected)

Effective DateNov 7, 2025

Next Review Date

Key ActionObtain prior authorization documenting that age, lesion characteristics, stability, alignment, joint space, and lesion location meet policy criteria before scheduling ACI/MACI.

SourceLink

POLICY UPDATE CHANGES

Added Site of Service Ambulatory Service Center (ASC) Select Surgical Procedures and ASC criteria; effective November 7, 2025.

Replaced related policy 7.01.78 Osteochondral Autografts in the Treatment of Articular Cartilage Lesions with 7.01.607 Autografts and Allografts in the Treatment of Focal Articular Cartilage Lesions.

Removed Related Policy 11.01.524 Site of Service: Select Surgical Procedures.

Correction to Documentation Requirements to remove BMI and need for MRI results which were inadvertently left on when criteria updated in August 2023.

Removed CPT code 29870 from coding.

>=1.5 cm2minimum lesion size

Grade III/IVlesion depth

11/07/2025

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ASC site-of-service effective

insufficientnon-knee joints

Coverage Criteria for Autologous Chondrocyte Implantation (ACI/MACI)

inv-01: Covered - Knee ACI

Autologous chondrocyte implantation (MACI) may be considered medically necessary when ALL of the following are met:

Age and candidacy: Adolescent individuals should be skeletally mature with documented closure of growth plates (e.g., age >=15); OR adult individuals are too young to be appropriate candidates for total knee arthroplasty or other reconstructive knee surgery (e.g., younger than 55 years).age 15-55 considered

See policy age considerations

Symptom severity: Severe disabling knee pain and loss of knee function caused by acute or repetitive trauma that interferes with activities of daily living or work ability is present.clinical

Lesion characteristics: Focal, full-thickness (Outerbridge grade III or IV) unipolar lesions of the weight-bearing surface of the femoral condyles, trochlea, or patella that are at least 1.5 cm^2 in size; documented minimal to absent degenerative changes in surrounding articular cartilage (Outerbridge grade II or less) and normal-appearing hyaline cartilage surrounding the border of the defect.location and size

Minimum lesion size >= 1.5 cm^2

Joint condition: All of the following on exam: stable knee with intact or reconstructed ligaments (or repairs planned with the procedure), normal joint alignment, and normal joint space.stability/alignment/space

Misalignment and instability are contraindications unless corrected concurrently.

inv-03: Knee ACI (covered with criteria)

Covered when ALL of the following are met (evidence supports ACI for large disabling full-thickness knee cartilage lesions):

Knee ACI coverage: Patient has focal full-thickness articular cartilage lesion(s) of the weight-bearing surface of the femoral condyles, trochlea, or patella.

Large lesions have demonstrated better outcomes with ACI versus microfracture in RCTs, systematic reviews, and observational studies.

Product availability: Use of an FDA-approved MACI product when ACI is selected.

MACI is the only ACI product available in the U.S. after 2017.

inv-02: Investigational indications

Investigational / Not covered indications:

Non-knee joints: Autologous chondrocyte implantation for all other joints (including talus/ankle, hip, etc.) and any indications other than those listed for the knee is considered investigational/not medically necessary because evidence is insufficient to determine improvement in net health outcome.

Based on case series and noncomparative studies; comparative trials are needed.

inv-04: ACI for non-knee joints (not covered/investigational)

Not covered / investigational for non-knee joints due to insufficient evidence:

Non-knee joints investigational: ACI for focal articular cartilage lesions in joints other than the knee (e.g., talus/ankle, hip) is considered investigational because available evidence (case series, systematic reviews of case series, and noncomparative studies) is insufficient to determine improvement in net health outcome.

Greatest amount of literature is for talus; comparative trials are needed.

inv-05: Medical necessity vs investigational

Policy statements from prior history: ACI/MACI may be considered medically necessary when criteria are met; considered investigational when criteria not met.

General stance: Autologous chondrocyte implantation may be considered medically necessary when specified criteria are met and is considered investigational (not medically necessary) when criteria are not met.

This statement appears in policy history across multiple reviews and renumbering events.

Autologous chondrocyte implantation (ACI/MACI) is considered investigational when performed for joints other than the knee (for example, the talus). In addition, misalignment and instability are contraindications to ACI unless these issues are identified and corrected (for example, with concurrent ligament repair or osteotomy) at the time of implantation. These limitations reflect the policy’s requirement for a stable, well-aligned joint when ACI is performed and the limited evidence supporting ACI outcomes in non-knee joints.

The National Institute for Health and Care Excellence (NICE TA508) recommends ACI for symptomatic femoral condyle and patellar articular cartilage defects (ICRS grade III or IV) in adults only if the person has not had previous surgery to repair articular cartilage defects, has minimal osteoarthritic damage, and the defect is > 2 cm2. This NICE condition regarding prior cartilage repair surgery is noted in the policy as a conditional recommendation that may inform prior authorization and clinical decision-making.

Previous policy statements that required demonstration of prior conservative care failure and a body mass index threshold of ≤ 35 were removed in August 2023. A subsequent correction clarified documentation language to remove BMI and mandatory MRI result requirements that had been inadvertently retained when criteria were updated.

Use of ACI for joints other than the knee, and any indications that do not meet the specified knee criteria (focal, full-thickness weight-bearing femoral condyle, trochlea, or patellar lesions meeting size and surrounding cartilage requirements), is considered not medically necessary/investigational under this policy because evidence for benefit outside the knee or for nonconforming indications is insufficient.

Autologous chondrocyte implantation for focal articular cartilage lesions in joints other than the knee (for example, the talus or hip) is considered investigational. The available literature consists largely of case series and noncomparative studies, and comparative trials are lacking to demonstrate an improvement in net health outcome.

When the policy’s medical necessity criteria are not satisfied, autologous chondrocyte implantation is classified as investigational (not medically necessary). This general stance has been stated since the policy’s inception and reiterated in subsequent reviews.

Coding and Procedural Codes

Covered CPT CodesCPTCovered

27412

Autologous chondrocyte implantation, knee

Related Arthroscopy CPT CodesCPT

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
29881	Arthroscopy, knee, surgical; with meniscectomy (medial OR lateral, including any meniscal shaving) including debridement/shaving of articular cartilage (chondroplasty), same or separate compartment(s), when performed
29882	Arthroscopy, knee, surgical; with meniscus repair (medial OR lateral)
29883	Arthroscopy, knee, surgical; with meniscus repair (medial AND lateral)

HCPCS / Supply CodesHCPCSCovered

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

Removed CPT Codes (example)CPTNot Covered

29870

Arthroscopy, knee, surgical; debridement/shaving of articular cartilage (chondroplasty), with or without meniscectomy (Note: removed from policy coding list).

inv-16: Minimum lesion size — numeric clinical threshold

Minimum lesion size>= 1.5 cm^2

Policy age range contextApplies to focal knee lesions in patients generally considered between 15–55 years for candidacy

Location requirementWeight-bearing surface of femoral condyles, trochlea, or patella

inv-17: Lesion grade — Outerbridge grade III or IV (full-thickness)

Required lesion gradeOuterbridge grade III or IV (full-thickness)

Grade III definitionPartial-thickness cartilage loss with focal ulceration / fibrillation

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for autologous chondrocyte implantation (ACI/MACI). ACI is reviewed for medical necessity and site of service; providers must obtain prior authorization before scheduling the procedure. Coverage is subject to member benefit limits and site-of-service rules; procedures performed in a non-medically necessary site (for example, inpatient when outpatient ASC is appropriate) may be denied.

Effective November 7, 2025: Site-of-service ASC criteria may apply per related Site of Service Ambulatory Surgical Center (ASC) policy (11.01.525).

Documentation Required

Regulatory Documentation — MACI (Vericel)

MACI (Vericel) is the FDA-approved matrix-induced autologous chondrocyte implantation product currently available in the U.S. The culturing of chondrocytes is regulated by the FDA as manipulated autologous structural cells and subject to biologic licensing requirements. Other ACI products and second‑generation methods are in development or available outside the U.S., but are not FDA‑approved.

Background and Clinical Context

Autologous chondrocyte implantation (ACI/MACI) is a two-stage procedure. First, a diagnostic arthroscopy is performed with biopsy of normal cartilage to harvest chondrocytes. The harvested cells are then cultured and expanded, often seeded onto an absorbable collagen matrix (matrix-induced ACI). In a second operative procedure (arthrotomy), the cultured chondrocytes on the matrix are implanted into the prepared full-thickness cartilage defect, followed by a structured postsurgical rehabilitation program.

Definitions and Terminology

inv-33: ACI / MACI — Definition

Definition of ACI/MACIAutologous chondrocyte implantation involves harvesting chondrocytes, expanding them in vitro, then implanting them into the chondral defect.

Procedure stepsTwo-stage process: arthroscopic biopsy of healthy cartilage for cell culture, then surgical implantation into prepared defect

MACI noteMACI refers to matrix-induced ACI where cultured cells are applied using a scaffold or membrane

inv-34: Modified Outerbridge Classification

Classification systemModified Outerbridge Classification, Grades I–IV

Grade III correlationPartial-thickness cartilage loss with focal ulceration / fibrillation (MRI and arthroscopy correlation)

Revision History and Policy Changes

2026-04-01coding update

CPT code 29870 was removed from the policy coding list.

2025-11-07related policy / site-of-service change

Site-of-service ASC criteria became effective and related policy 11.01.525 (Site of Service Ambulatory Service Center Select Surgical Procedures) was added; related policy 7.01.78 was replaced with 7.01.607.

2025-08-01related policy removed

Policy Summary

PayerPremera Bluecross

PolicyAutologous Chondrocyte Implantation for Focal Articular Cartilage Lesions

Policy CodePolicy 7.01.48

Change TypeModified (ASC site-of-service criteria addeddocumentation corrected)

Effective DateNov 7, 2025

Next Review Date

Key ActionObtain prior authorization documenting that age, lesion characteristics, stability, alignment, joint space, and lesion location meet policy criteria before scheduling ACI/MACI.

SourceLink

On This Page

Grade IV definitionFull-thickness cartilage loss with exposed subchondral bone

inv-18: Defect size threshold (NICE) — NICE: > 2 cm2

NICE minimum defect size> 2 cm2

NICE conditional criteriaAlso requires no prior cartilage repair surgery and minimal osteoarthritic damage

ScopeApplies to symptomatic articular cartilage defects of the femoral condyle and patella (ICRS grade III/IV)

inv-19: Lesion size mentioned in clinical input — > 4 cm2 (some reviewers recommended prior surgery not be required)

Lesion size referenced by clinical reviewers> 4 cm2

Reviewer recommendation about prior surgeryMost reviewers recommended that a prior surgical procedure not be required for lesions >4 cm2

Clinical note on outcomesReviewers noted lower success when ACI is performed after prior microfracture

MACI (Vericel) is the only ACI product available in the U.S.; Carticel production was phased out in 2017.

Regulatory status: culturing of chondrocytes requires appropriate FDA licensing.

Documentation Required

Clinical Input on Prior Microfracture and Documentation

Clinical input and peer review noted that success rates for ACI are lower when performed after prior microfracture. Reviewers generally supported ACI for large patellar lesions and recommended that prior surgical procedure should not be mandated for lesions >4 cm2. Medical records submitted for prior authorization should document prior treatments and rationale if ACI is being considered after microfracture.

Clinical input (2015): lower success rates for ACI following prior microfracture; most reviewers recommended not requiring prior surgery for lesions >4 cm2.
Required documentation: include office visit notes, history, lesion size/description, Outerbridge grade, and prior surgical history.

Grade IV correlationFull-thickness cartilage loss with exposed subchondral bone

inv-35: Second-generation ACI / MACI

Second-generation ACI (MACI)Autologous chondrocytes cultured and seeded onto a bioresorbable porcine-derived collagen membrane (MACI).

Regulatory statusMACI (Vericel) is FDA-approved and, after 2017, is the only ACI product available in the U.S.

Implant characteristicsMACI supplied as a sheet that is cut to size and fixed with fibrin glue; multiple implants can be used if multiple defects exist.

inv-36: NICE TA508 — Reference to NICE technology appraisal on ACI for symptomatic articular cartilage defects

NICE guidance referenceNICE Technology Appraisal TA508: Autologous chondrocyte implantation for symptomatic articular cartilage defects of the knee (2018)

Key NICE conditionsUse only if no prior cartilage repair surgery, minimal osteoarthritic damage, and defect >2 cm2

ApplicabilityCovers femoral condyle and patella ICRS/Outerbridge grade III or IV defects in adults

inv-37: AAOS CPG on Osteochondritis Dissecans — Reference to AAOS guideline (updated Dec...)

AAOS guideline citationAmerican Academy of Orthopaedic Surgeons Clinical Practice Guideline on Diagnosis and Treatment of Osteochondritis Dissecans (Updated December 1, 2023)

Access informationGuideline available from AAOS clinical practice guideline repository; referenced in policy literature list

Related policy 11.01.524 (Site of Service: Select Surgical Procedures) was removed during interim review.

2024-07-01annual review

Annual review with literature update through February 20, 2024; references added and policy statements unchanged.

2023-09-08documentation correction

Correction to Documentation Requirements to remove BMI and requirement for MRI results that had been inadvertently retained after August 2023 updates.

2023-08-01policy renumbering / content change

Policy renumbered from 7.01.569 to 7.01.48 and prior statements on conservative care failure and BMI ≤ 35 were removed.

2023-07-01annual review

Annual review with literature update through February 16, 2023; references added and wording standardized from 'patient' to 'individual'; policy statements unchanged.

2020-07-01policy replacement

Policy 7.01.48 replaced policy 7.01.569 which was deleted effective July 1, 2020; updated with literature (history entry).

2018-01-05new policy effectiveLatest

New policy (7.01.48) approved September 12, 2017 and became effective January 5, 2018.