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Date Printed: August 22, 2017: 07:14 AM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

02-20000-17

Original Effective Date: 09/01/01

Reviewed: 07/27/17

Revised: 08/15/17

Subject: Autologous Chondrocyte Implantation (ACI)

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates    
           

DESCRIPTION:

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 activities of daily living and adversely affect quality of life. Conventional treatment options include debridement, subchondral drilling, microfracture, and abrasion arthroplasty. Debridement involves the removal of synovial membrane, osteophytes, loose articular debris, and diseased cartilage and is capable of producing symptomatic relief. Subchondral drilling, microfracture, and abrasion arthroplasty attempt to restore the articular surface by inducing the growth of fibrocartilage into the chondral defect.

Autologous chondrocyte implantation (ACI) attempts to regenerate hyaline-like cartilage and thereby restore durable function. With ACI, a region of healthy articular cartilage is identified and biopsied through arthroscopy. The tissue is sent to a facility licensed by the U.S. Food and Drug Administration (FDA) where it is minced and enzymatically digested, and the chondrocytes are separated by filtration. The isolated chondrocytes are cultured for 11 to 21 days to expand the cell population, tested, and then shipped back for implantation. With the patient under general anesthesia, an arthrotomy is performed, and the chondral lesion is excised up to the normal surrounding cartilage. Methods to improve the first-generation ACI procedure have been developed, including the use of a scaffold or matrix-induced autologous chondrocyte implantation (MACI) composed of biocompatible carbohydrates, protein polymers, or synthetics.

Desired features of articular cartilage repair procedures are the ability to (1) be implanted easily; (2) reduce surgical morbidity; (3) not require harvesting of other tissues; (4) enhance cell proliferation and maturation; (5) maintain the phenotype; and (6) integrate with the surrounding articular tissue. In addition to the potential to improve the formation and distribution of hyaline cartilage, use of a scaffold with MACI eliminates the need for harvesting and suture of a periosteal patch. A scaffold without cells may also support chondrocyte growth.

Juvenile cartilage allograft tissue implantation has been developed and is intended to repair damaged cartilage in joints such as the shoulder, elbow, hip, knee, ankle, and great toe. This allograft transplant process involves transplanting minced juvenile donor cartilage into a cartilage defect using adhesive. Tissues are harvested from juvenile donor joints and manually minced, which assists with cell migration from the extracellular matrix. During the implantation procedure, the minced juvenile tissue is mixed in a fibrin glue adhesive.

REGULATORY STATUS

The culturing of chondrocytes is considered by the U.S. Food and Drug Administration (FDA) to fall into the category of manipulated autologous structural cells, which are subject to a biologic licensing requirement. In 1997, Carticel received FDA approval for the repair of clinically significant symptomatic cartilaginous defects of the femoral condyle (medial lateral or trochlear) caused by acute or repetitive trauma. 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. In 2017, production of Carticel was phased out and MACI is the only ACI product that is available in the United States.

POSITION STATEMENT:

Autologous chondrocyte implantation (ACI) meets the definition of medical necessity when ALL of the following are met:

Autologous chondrocyte implantation (ACI) for all other joints, including but not limited to the shoulder, hip, tibia, ankle, and talus, is considered experimental or investigational. There is a lack of clinical scientific evidence published in peer-reviewed literature to permit conclusions on safety and net health outcomes.

Juvenile cartilage allograft tissue implantation is considered experimental or investigational. There is insufficient published clinical evidence to support its safety and effectiveness.

BILLING/CODING INFORMATION:

CPT Coding:

27412

Autologous chondrocyte implantation, knee

HCPCS Coding:

S2112

Arthroscopy, knee, surgical for harvesting of cartilage (chondrocyte cells)

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline reviewed date.

DEFINITIONS:

Autologous: derived from the implantation recipient.

Carticel: trade name for autologous cultured chondrocytes.

Chondrocyte: mature cells found in cartilage.

RELATED GUIDELINES:

Meniscal Allograft Transplantation, 02-20000-25
Unicondylar Interpositional Spacer Devices for the Treatment of Unicompartmental Arthritis of the Knee, 02-2000-26

OTHER:

Other terms for ACIs:

Note: The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

DeNovo® NT Natural Tissue Graft (juvenile cartilage allograft tissue)

REFERENCES:

  1. American Academy of Orthopaedic Surgeons. Clinical practice guideline on the diagnosis and treatment of osteochondritis dissecans. 2010. Accessed at http://www.aaos.org/research/guidelines/OCD_guideline.pdf.
  2. Basad E, et al. Matrix-induced autologous chondrocyte implantation versus microfracture in the treatment of cartilage defects of the knee: a 2-year randomised study. Knee surgery, sports traumatology, arthroscopy: official journal of the ESSKA 18.4 (2010): 519.
  3. Baums MH, Schultz W, Kostuj T, Klinger HM. Cartilage repair techniques of the talus: An update. World J Orthop. 2014 Jul 18;5(3):171-9.
  4. Blue Cross and Blue Shield Association Medical Policy Reference Manual 7.01.48 – Autologous Chondrocyte Transplantation. April 2017.
  5. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC) – Autologous Chondrocyte Transplantation TEC Assessments 2003, Tab 2.
  6. Buckwalter JA, Bowman GN, Albright JP, Wolf BR, Bollier M. Clinical outcomes of patellar chondral lesions treated with juvenile particulated cartilage allografts. Iowa Orthop J. 2014;34:44-9.
  7. Clar C, Cummins E, McIntyre L, Thomas S, Lamb J, Bain L, Jobanputra P, Waugh N. Clinical and cost-effectiveness of autologous chondrocyte implantation for cartilage defects in knee joints: systematic review and economic evaluation. Health Technology Assessment Vol.9: No.47. 2005:98. The National Coordinating Centre for Health Technology Assessment (NCCHTA).
  8. Cuéllar R, Cuéllar A, Ponte J, Ruiz-Ibán MA. Arthroscopic technique for the treatment of patellar chondral lesions with the patient in the supine position. Arthrosc Tech. 2014 Jun 2;3(3):e373-6.
  9. Dunkin BS, Lattermann C. New and Emerging Techniques in Cartilage Repair: MACI. Oper Tech Sports Med. 2013 Jun 1;21(2):100-107.
  10. ECRI Health Technology Assessment Information Services – Health Technology Assessment News – "Long Term Results of Autologous Chondrocyte Transplantation" (May-June 2000).
  11. ECRI Health Technology Assessment Information Services – Windows on Medical Technology – "Autologous Chondrocyte Implantation for Knee Cartilage Defects" (July 2004. Issue No. 112).
  12. Gikas PD, Morris T, Carrington R, Skinner J, Bentley G, Briggs T. A correlation between the timing of biopsy after autologous chondrocyte implantation and the histological appearance. J Bone Joint Surg Br. 2009 Sep; 91(9):1172-7.
  13. Gobbi A, et al. Matrix-Induced Autologous Chondrocyte Implantation versus Multipotent Stem Cells for the Treatment of Large Patellofemoral Chondral Lesions: A Nonrandomized Prospective Trial. Cartilage. 2015 Apr;6(2):82-97.
  14. Harris JD, et al. Failures, re-operations, and complications after autologous chondrocyte implantation – a systematic review. Osteoarthritis and cartilage 19.7 (2011): 779-791.
  15. Hayes, Inc Hayes Medical Technology Directory – "Autologous Chondrocyte Transplantation of the Knee" Lansdale, PA: Hayes, Inc.; January 2005. Update performed 02/01/07.
  16. Lee YH, Suzer F, Thermann H. Autologous Matrix-Induced Chondrogenesis in the Knee: A Review. Cartilage. 2014 Jul;5(3):145-53.
  17. Macmull S, Jaiswal PK, Bentley G, Skinner JA, Carrington RW, Briggs TW. The role of autologous chondrocyte implantation in the treatment of symptomatic chondromalacia patellae. Int Orthop. 2012 Jul;36(7):1371-7.
  18. Mancò A, et al. Microfracture versus microfracture and platelet-rich plasma: arthroscopic treatment of knee chondral lesions. A two-year follow-up study. Joints 4.3 (2016): 142.
  19. Marlovits S, Aldrian S. Clinical and Radiological Outcomes 5 Years After Matrix-Induced Autologous Chondrocyte Implantation in Patients With Symptomatic, Traumatic Chondral Defects. Am J Sports Med. 2012 Oct;40(10):2273-80.
  20. National Institute for Clinical Excellence. The use of autologous chondrocyte implantation for the treatment of cartilage defects in knee joints. London: National Institute for Clinical Excellence (NICE). 2005:28. National Institute for Clinical Excellence (NICE).
  21. Perera JR, Gikas PD, Bentley G. The present state of treatments for articular cartilage defects in the knee. Ann R Coll Surg Engl. 2012 Sep;94(6):381-7.
  22. Seo SS, Kim CW, Jung DW. Management of focal chondral lesion in the knee joint. Knee Surg Relat Res. 2011 Dec;23(4):185-96.
  23. Teo BJ, Buhary K, Tai BC, Hui JH. Cell-based therapy improves function in adolescents and young adults with patellar osteochondritis dissecans. Clin Orthop Relat Res. 2013 Apr;471(4):1152-8.
  24. Vannini F, Cavallo M, Baldassarri M, Castagnini F, Olivieri A, Ferranti E, Buda R, Giannini S. Treatment of juvenile osteochondritis dissecans of the talus: current concepts review. Joints. 2015 Feb 13;2(4):188-91.
  25. Wasiak J, Clar C, Villanueva E. Autologous cartilage implantation for full thickness articular cartilage defects of the knee. Cochrane Database of Systematic Reviews 2006, Issue 3. Art. No.: CD003323. DOI: 10.1002/14651858.CD003323.pub2.
  26. Zhang Z, et al.Matrix-induced autologous chondrocyte implantation for the treatment of chondral defects of the knees in Chinese patients. Drug Des Devel Ther. 2014 Dec 5;8:2439-48.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 07/27/17.

GUIDELINE UPDATE INFORMATION:

09/01/01

Coding changes.

01/01/02

Coding changes.

02/15/02

Various revisions.

03/15/03

Reviewed; revised to remove unrelated coding.

08/15/03

Coverage statement for ACI changed; meniscal allograft information removed and separate MCG developed; unrelated coding information removed.

01/01/04

HCPCS coding update.

07/15/04

Review and revision of guideline; consisting of updated references.

01/01/05

Annual HCPCS update; consisting of the addition of 27412 and deletion of S2113.

07/15/05

Review and revision of guideline; consisting of updates references.

09/15/07

Review and revision of guideline consisting of updated references and reformatted guideline.

10/15/09

Scheduled review; no change in position statement.

05/11/14

Revision: Program Exceptions section updated.

03/15/15

Scheduled review. Revised description, position statement, CPT/HCPCS coding, and definitions. Updated references and reformatted guideline.

12/15/15

Revision; updated description section; added coverage for lesions of the patella, and deleted requirement for prior surgical procedure. Added coverage statement (E/I) for juvenile cartilage allografts. Updated index terms and references. Reformatted guideline.

08/15/17

Revision: updated description section. Deleted E/I coverage statement for matrix-induced autologous chondrocyte implantation (MACI). Updated references. Reformatted guideline.

Date Printed: August 22, 2017: 07:14 AM