Autologous Chondrocyte Implantation and MACI Form

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Autologous Chondrocyte Implantation (ACI) and Matrix- induced Autologous Chondrocyte Implant (MACI) Medical Guideline

Service: Autologous Chondrocyte Implantation (ACI) and Matrix-induced Autologous Chondrocyte Implant (MACI®)

PUM 250-0032-1812

Medical Guideline Committee Approval Q3-2025 Effective Date 03/01/2026

Related Medical Guidelines:

• Cartilage Transfer Procedures: Osteoarticular Transfer System (OATS) and Mosaicplasty Medical Guideline • Meniscal Allograft Transplantation Medical Guideline • Knee Replacement Surgery Medical Guideline • Non-covered Services and Procedures Medical Guideline

Coverage for Autologous Chondrocyte Implantation and Matrix-induced Autologous Chondrocyte Implantation may vary across plans. Refer to the member’s benefit plan document for coverage details.

Description:

Autologous chondrocyte implantation (ACI) uses an individual’s own cells to repair damaged cartilage. ACI consists of two separate procedures: First, an arthroscopic biopsy is performed to remove healthy articular cartilage. The removed cartilage is then sent to a laboratory, and the chondrocytes (cartilage cells) are separated out. The chondrocytes are seeded into and multiplied on a collagen membrane. The second procedure (arthrotomy) is performed to implant the membrane containing the cells into the damaged area to help repair and regenerate the articular (weight-bearing / contacting) surface.

Matrix-induced autologous chondrocyte implant (MACI®) is used as part of the ACI procedure. It consists of autologous (the individual’s own) cultured chondrocytes on a porcine collagen membrane (collagen scaffold). The surgeon trims the MACI® film / membrane to fit the area of damage and implants it to improve cartilage healing.

Indications of Coverage:

Repair of cartilage defects of the knee by autologous chondrocyte implantation (ACI) / matrix- induced autologous chondrocyte implant (MACI®) is considered medically necessary for an

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individual who has given informed consent and agreed to post-operative restrictions and rehabilitation when all of the following are met:

A. The individual is between the ages of 15 and 55 years old, with body mass index (BMI) of 35 or less. Documentation of closure of growth plate is required for individuals less than 18 years old.

B. The individual experiences knee catching / locking or pain that affects ability to ambulate or complete activities of daily living.

C. The individual has completed a two-month trial of medication management.

D. Other surgical interventions have been tried and failed or are contraindicated (e.g., osteochondral autograft/allograft abrasion arthroplasty, microfracture, drilling).

E. There is local articular cartilage defect (caused by acute or repetitive trauma) down to, but not extending through, the subchondral bone on a load bearing surface of the patella or the trochlea, lateral or medial femoral condyle.

F. The solitary cartilage defect does not exceed 6.0 centimeters (cm) in length, 7 millimeters (mm) in depth, and 10 square cm area.

G. Imaging demonstrates intact meniscus and no joint space narrowing.

H. Knee is aligned and stable with normal weight distribution within the joint, or procedure to ensure this is planned in combination with or prior to the chondrocyte implantation.

I. There is no arthritis of the knee present on imaging and the procedure is not being performed as a treatment for degenerative arthritis.

J. The individual is not a candidate for a total knee replacement.

Limitations of Coverage:

Benefit Limitations: Please note that in listing services or examples, when we say “this includes,” it is not our intent to limit the description to that specific list. When we do intend to limit a list of services or examples, we state specifically that the list “is limited to.”

A. Review contracts and endorsements for exclusions and prior authorization or benefit requirements.

B. If used for a condition/diagnosis other than is listed in the Indications of Coverage, it will be considered experimental, investigational, and unproven to affect health outcomes.

C. If used for a condition/diagnosis that is listed in the Indications of Coverage; but the criteria are not met, it will be considered not medically necessary.

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D. ACI / MACI® will be considered experimental, investigational, and unproven to affect health outcomes in any of the following circumstances:

1. Presence of osteochondritis dissecans (OCD) lesions

2. History of total meniscectomy

3. Presence of malignancy in the area of cartilage biopsy or implantation

4. Presence of osteoarthritis, inflammatory arthritis, or inflammatory joint disease

5. When performed on an individual less than 15 years old or greater than 55 years old

6. When performed on any joint other than the knee

7. When performed on an individual with uncorrected congenital blood coagulation disorder

8. When performed on an individual who has undergone a prior knee surgery in the past 6 months (excluding the cartilage biopsy / harvest or procedure to prepare the knee for autologous chondrocyte implant)

9. When performed as the initial cartilage preserving procedure on the knee, that is, no prior microfracture or drilling, or abrasion, or osteochondral allograft/autograft.

   E. The following are considered experimental, investigational, and unproven to affect health outcomes:

10. Combined autologous chondrocyte implantation and meniscal allograft

11. Combined autologous chondrocyte implantation and osteochondral autograft transfer system (OATS)

12. Combined autologous and allograft chondrocyte implantation

13. Combined meniscus reconstruction and autologous chondrocyte implantation

14. Bone marrow aspirate concentrate (BMAC) injection/treatment

15. Microfragmented adipose tissue (MFAT) injection/treatment (such as, but not limited to Lipogems®)

16. Stem cell therapy, stem cell injections

17. Platelet-rich plasma (PRP) injection/treatment

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9. Platelet Lysate (PL)

10. Viscosupplementation, hyaluronic acid injections (including, but not limited to Orthovisc®, Synvisc®)

11. Juvenile cartilage allograft tissue implantation (such as, but not limited to, DeNovo NT® Natural Tissue Graft, DeNovo ET® engineered tissue graft)

12. Cryopreserved viable osteochondral allograft product (including, but not limited to Cartiform®)

13. Peripheral nerve block or ablation

14. Genicular nerve injections or genicular nerve radiofrequency ablation

15. iovera® System

16. Coolief® Cooled RF (radiofrequency)

17. Cryotherapy

18. Subchondral calcium phosphate injections

    Documentation Required:

    • Standard Written Order (SWO), prescribed by a qualified healthcare provider concerning the member’s diagnosis.
    • Medical record information (including continued need/use if applicable) and medical necessity. Office visit notes
    • Correct coding for the item/service that meets all the coding guidelines.

    Disclaimer: This guideline is for informational purposes only and does not constitute medical advice, plan authorization, an explanation of benefits, or a guarantee of payment. Benefit plans vary in coverage and some plans may or may not provide coverage for all services listed in this guideline. Coverage decisions are subject to all terms and conditions of the applicable benefit plan, including specific exclusions and limitations, and to applicable state and federal law. Some benefit plans administered by the organization may not utilize Medical Affairs medical guideline in all their coverage determinations. Contact customer services as listed on the member card for specific plan, benefit, and network status information.

    Medical guidelines are based on constantly changing medical science and are reviewed annually and subject to change. The organization uses tools developed by third parties, such as the evidence-based clinical guidelines developed by MCG to assist in administering health benefits. This medical guideline and MCG guidelines are intended to be used in conjunction with the independent professional medical judgment of a qualified health care provider. To obtain additional information about MCG, email medical.policies@wpsic.com. Coverage of all services is subject to medical necessity and services deemed experimental, investigational, and/or unproven are therefore not considered medically necessary under the terms of the clinical guidelines and will not be covered.

    Autologous Chondrocyte Implantation and Matrix-induced autologous chondrocyte implantation are considered medically necessary only when indicated per the most current medical references and specialty society guidelines, such as MCG, NCCN, etc.

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State mandates, laws or benchmark supersede this medical guideline.

Guideline Review History:

Implemented 01/01/20, 01/01/2021, 12/01/21, 01/01/23, 01/01/24, 11/01/24, 03/01/26 Medical Guideline Committee Approval 09/27/19, 11/19/20, 11/18/21, 12/15/22, 12/14/23, 10/31/24, Q3 2025

Reviewed

11/19/20, 11/18/21, 12/15/22, 12/14/23, 10/31/24, Q3 2025 Developed 09/27/19

Approved by the Medical Director

Codes: The following codes for treatments and procedures applicable to this document are included below for informational purposes. Code Description 0054T COMPUTER-ASSISTED MUSCULOSKELETAL SURGICAL NAVIGATIONAL ORTHOPEDIC PROCEDURE, WITH IMAGE-GUIDANCE BASED ON FLUOROSCOPIC IMAGES (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE) (SUBCHONDROPLASTY) 0055T COMPUTER-ASSISTED MUSCULOSKELETAL SURGICAL NAVIGATIONAL ORTHOPEDIC PROCEDURE, WITH IMAGE-GUIDANCE BASED ON CT/MRI IMAGES (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE) (SUBCHONDROPLASTY) 20985 COMPUTER-ASSISTED SURGICAL NAVIGATIONAL PROCEDURE FOR MUSCULOSKELETAL PROCEDURES, IMAGE-LESS (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE) 27412 AUTOLOGOUS CHONDROCYTE IMPLANTATION, KNEE J7330 AUTOLOGOUS CULTURED CHONDROCYTES, IMPLANT S2112 ARTHROSCOPY, KNEE, SURGICAL FOR HARVESTING OF CARTILAGE (CHONDROCYTE CELLS) S2900 SURGICAL TECHNIQUES REQUIRING USE OF ROBOTIC SURGICAL SYSTEM (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)