Autologous Chondrocyte Implantation or Transplantation Form

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Autologous Chondrocyte Implantation or Transplantation - Medical Policy
Updated Revision Effective: May 1, 2024 Policy Number:

UM256POL

Approval Date: 12/27/2024

Line(s) of Business:

Commercial
Medicare Advantage
Medicaid (BeHealthy)

Description

Autologous chondrocyte implantation (ACI) is a procedure to resurface articular cartilage defect that involves harvesting chondrocytes from healthy tissue, expanding the cells in vitro, and implanting the expanded cells into the chondral defect.

Damaged articular cartilage typically fails to heal on its own and can be associated with pain, loss of function and disability, and may lead to debilitating osteoarthritis over time. These manifestations can severely impair an individual’s activities of daily living and adversely affect quality of life. Osteochondral grafts and autologous chondrocyte implantation (ACI) attempt to regenerate hyaline-like cartilage and thereby restore durable function.

In December 2016, MACI® (Vericel), a matrix-induced autologous chondrocyte implantation, was approved by FDA for “the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults.” MACI® consists of autologous chondrocytes which are cultured onto a bioresorbable porcine-derived collagen membrane.

 Line of Business

Commercial:
Refer to criteria under Policy section in this medical policy.

Medicaid – BeHealthy:
Refer to criteria under Policy section in this medical policy. There are no MassHealth guidelines for Autologous Chondrocyte Implantation or Transplantation.

Medicare:
Refer to criteria under Policy section in this medical policy. Medicare does not have a National Coverage Determination (NCD) or a Local Coverage Determination (LCD) for Autologous Chondrocyte Implantation or Transplantation.

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Policy

Autologous Chondrocyte Transplants (ACT)/Matrix-Induced Chondrocyte Implantation (MACI) is considered MEDICALLY NECESSARY for the treatment of disabling full-thickness articular cartilage defects of the knee caused by acute or repetitive trauma when ALL of the criteria from A. to E. are met:

A. The patient is skeletally mature with documented closure of growth plates and not considered an appropriate candidate for total knee arthroplasty or other reconstructive knee surgery; AND B. Has focal, full-thickness (grade III or IV) unipolar lesions of the weight bearing surface of the femoral condyles, trochlea, or patella at least 1.5 cm² in size; AND C. Has documented minimal-to-absent degenerative changes in the surrounding articular cartilage (Outerbridge Grade II or less), and normal-appearing hyaline cartilage surrounding the border of the defect; AND D. Has normal knee biomechanics or alignment and stability; AND E. Not considered to have contraindications to the procedure or its preparation (e.g., allergy to gentamicin, sensitivities to bovine cultures) or contradictory conditions (e.g., active infection or inflammation or history of musculoskeletal cancer in the affected limb).

Autologous chondrocyte implantation for all other joints, including the talar, and any indications other than those listed above are considered EXPERIMENTAL and INVESTIGATIONAL.

Policy Guidelines and Definitions

Definitions:

Autologous: Cells or tissues from the same individual.

Autologous Chondrocyte Transplant (ACT): State-of-the-art procedure to treat full-thickness articular cartilage defects that are down to the bone in the knee. The two-step process entails harvesting member’s own healthy chondrocytes or cartilage cells and then growing these in the lab to generate more cells. Once completed, the chondrocytes are then sent back to surgeon for implantation.

MACI (Matrix-Induced Autologous Chondrocyte Implantation): Autologous cultured chondrocytes on porcine collagen membrane, made up of one’s own (autologous) cells that are expanded and then placed on a film that is implanted into area of cartilage damage and is then absorbed back into one’s own tissue. MACI is used for the repair of symptomatic cartilage damage of an adult knee. The amount of MACI applied depends upon the size of the cartilage damage. Surgeon trims to match size and shape of the damage to ensure complete coverage.
MACI - next generation matrix-induced autologous chondrocyte implantation (ACI) is the only FDA approved product in the United States.

Outerbridge Classification System: Based on direct visualization of the joint, either arthroscopic or open, this classification system was developed to be a simple, easy-to-use, and reproducible grading system of articular cartilage lesions. There are several different grades of articular cartilage damage on the Outerbridge Scale; this scale ranges from 0 (no cartilage damage) to 4 (most severe cartilage damage):

Grade 0 Normal cartilage Grade 1 (I) Articular cartilage has softening and swelling. Grade 2 (II) Articular cartilage has a partial-thickness defect with fissures on the surface that do not reach subchondral bone or exceed 1.5 cm in diameter.

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Grade 3 (III) Articular cartilage has fissuring to the level of subchondral bone in an area with a diameter more than 1.5 cm.
Grade 4 (IV) Articular cartilage is worn to the extent that there is exposed subchondral bone.

Coding Guidance

Code
Description
PA CPT Code:

27412 Autologous chondrocyte implantation, knee Yes

HCPC Codes:

J7330 Autologous cultured chondrocytes, implant
Yes S2112 Arthroscopy, knee, surgical, for harvesting of cartilage Yes

CPT® Copyright 2024 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Note: CPT/HCPCS codes are included for informational purposes and may not be all inclusive. Inclusion or exclusion of a CPT/HCPCS code(s) does not signify or imply that the service described by the code is a covered or non-covered health service. Benefit coverage for health services is determined by the member’s specific benefit plan document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee of payment. Other policies and coverage determination guidelines may apply.

References

1. Matrix-Induced Autologous Chondrocyte Implantation (MACI) Procedure for Repair of Articular Cartilage of the Knee . Health Technology Assessment, Aug 26, 2020; Annual Review:Aug 3, 2023.
   https://evidence.hayesinc.com/report/dir.matrixknee4713 (Subscription required)

2. Comparative Effectiveness Review of First-Generation Autologous Chondrocyte Implantation of the Knee. (2019, August 30). Health Technology Assessment, July 13, 2017; Annual Review: July 9, 2020. https://evidence.hayesinc.com/report/dir.autochondrocyte222
   (Subscription required)

3. Overview: Autologous chondrocyte implantation for treating symptomatic articular cartilage defects of the knee: Guidance. (2017, October 4).
   https://www.nice.org.uk/guidance/ta477

4. Biological Reconstruction of Localized Full-Thickness Cartilage Defects of the Knee: A Systematic Review of Level 1 Studies with a Minimum Follow-Up of 5 Years. Peter Angele, Johannes Zellner, Steffen Schröter, Johannes Flechtenmacher, Jürgen Fritz, and Philipp Niemeyer. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9924981/

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5. Surgical Techniques for Knee Cartilage Repair: An Updated Large-Scale Systematic Review and Network Meta-analysis of Randomized Controlled Trials. Radoslav Zamborsky M.P.H., Ph.D., Lubos Danisovic M.Sc., Ph.D. https://www.sciencedirect.com/science/article/abs/pii/S0749806319310850

6. Howard, J. S., Mattacola, C. G., Mullineaux, D. R., Robert, & Lattermann, C. (2019, May 15). Patient- Oriented and Performance-Based Outcomes After Knee Autologous Chondrocyte Implantation: A Timeline for the First Year of Recovery in: Journal of Sport Rehabilitation Volume 23 Issue 3 (2014).

   https://journals.humankinetics.com/view/journals/jsr/23/3/article-p223.xml

7. Bhosale, A. M., Myint, P., Roberts, S., Menage, J., Harrison, P., Ashton, B., Richardson, J. B. (2007, October). Combined autologous chondrocyte implantation and allogenic meniscus transplantation: a biological knee replacement https://www.ncbi.nlm.nih.gov/pubmed/17689085

8. Cartilage Grading: Outerbridge Scale. http://www.wahlmd.com/dr-wahl-blog/cartilage-grading-outerbridge-scale

9. Classifications in Brief: Outerbridge Classification of Chondral Lesions. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6259817/

10. Articular Cartilage Restoration - OrthoInfo - AAOS. (n.d.).

    https://orthoinfo.aaos.org/en/treatment/articular-cartilage-restoration

11. UpToDate: Overview of surgical therapy of knee and hip osteoarthritis. Literature review current through Dec 2023. This topic last updated on Aug 01, 2022. https://sso.uptodate.com/contents/overview-of-surgical-therapy-of-knee-and-hip-osteoarthritis

    Policy Implementation

    Approved by the Medical and Pharmacy Policy Committee

    Kate McIntosh MD MBA

    Chief Medical Officer

    Saad Usmani MD MBA

    Medical Director

    Date Update 05/2023 Policy brought back from archived status. Slight updates in criteria and references. 1/2024 Added Line of Business Section. References updated.

    Medical Criteria Disclaimer

    Property of Health New England. All rights reserved. The treating physician or primary care provider must submit to Health New England the clinical evidence that the patient meets the criteria for the treatment, testing or

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surgical procedure. Without this documentation and information, Health New England will not be able to properly review the request for prior authorization. The clinical review criteria reflect how Health New England determines whether certain services or supplies are medically necessary. Health New England established the clinical review criteria based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors).
Health New England expressly reserves the right to revise these conclusions as clinical information changes, and welcomes further relevant information. Each benefit program defines which services are covered. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered and/or paid for by Health New England, as some programs exclude coverage for services or supplies that Health New England considers medically necessary. If there is a discrepancy between this guideline and a member's benefits program, the benefits program will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the Federal Government or the Centers for Medicare & Medicaid Services (CMS) for Medicare and Medicaid members. All coding and web site links are accurate at time of publication. Health New England has adopted the herein policy in providing management, administrative and other services to its Health Plan.