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Date Printed: May 21, 2018: 08:13 PM

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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.

02-20000-25

Original Effective Date: 08/15/03

Reviewed: 04/26/18

Revised: 05/15/18

Subject: Meniscal Allograft Transplantation

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:

Meniscal allografts and other meniscal implants (eg, collagen or polyurethane) are intended to improve symptoms and reduce joint degeneration in those who have had a total or partial resection of the meniscus. Many years ago, torn and damaged menisci were routinely excised. However, it is now known that the menisci are an integral structural component of the human knee, functioning to absorb shocks and providing load sharing, joint stability, congruity, proprioception, and lubrication and nutrition of the cartilage surfaces. Surgical principles of treating torn or damaged menisci have evolved to favor repair and preservation whenever possible.

Meniscal allograft transplantation has been investigated in individuals with a previous meniscectomy, and in those who require a total or near total meniscectomy for irreparable tears. There are 3 general groups of people who have been treated with meniscal allograft transplantation:

Four primary ways of processing and storing allografts (fresh, fresh frozen, cryopreserved, lyophilized) have been reported. Fresh implants, harvested under sterile conditions, are less frequently used because the grafts must be used within a couple of days to maintain viability. Alternatively, the harvested meniscus can be fresh frozen for storage until needed. Another commonly used method, cryopreservation, freezes the graft in glycerol, which aids in preserving the cell membrane integrity and donor fibrochondrocyte viability. In addition to freezing, donor tissue may be dehydrated (freeze-dried or lyophilized), permitting storage at room temperature.

POSITION STATEMENT:

Meniscal allograft transplantation meets the definition of medical necessity when ALL of the following are met:

Meniscal allograft transplantation also meets the definition of medical necessity when performed in combination (either concurrently or sequentially) with treatment of focal articular cartilage lesions using any of the following procedures:

The use of meniscal implants incorporating materials such as collagen are considered experimental or investigational. Data in published medical literature are inadequate to permit scientific conclusions on long-term and net health outcomes.

BILLING/CODING INFORMATION:

CPT Coding:

29868

Arthroscopy, knee, surgical; meniscal transplantation (includes arthrotomy for meniscal insertion), medial or lateral

HCPCS Coding

G0428

Collagen meniscus implant procedure for filling meniscal defects (e.g., CMI, collagen scaffold, Menaflex) (investigational)

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:

The following National Coverage Determination (NCD) was reviewed on the last guideline reviewed date: National Coverage Determination (NCD) for Collagen MENISCUS Implant (150.12), located at cms.gov.

The following Local Coverage Determination (LCD) was reviewed on the last guideline reviewed date: Noncovered Services (L33777) located at fcso.com.

DEFINITIONS:

Allograft: tissue obtained from a donor.

Meniscus: a crescent-shaped fibrocartilaginous structure that cushions and stabilizes the joint.

Outerbridge classification system: a grading system for joint cartilage breakdown; classifications range from grade 0 to grade IV:

• Grade 0: normal cartilage

• Grade I: cartilage with swelling and softening

• Grade II: partial thickness defect with fissures on the surface that do not reach subchondral bone or exceed 1.5 cm in diameter

• Grade III: fissuring to the level of subchondral bone in an area with a diameter greater than 1.5 cm

• Grade IV: exposed subchondral bone

RELATED GUIDELINES:

Autologous Chondrocyte Implantation (ACI), 02-20000-17

OTHER:

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.

ReGen Collagen Scaffold collagen meniscus implant

MenaFlex™ CMI collagen meniscus implant

CMI® collagen meniscus implant

Actifit® polyurethane meniscal implant

REFERENCES:

  1. American Academy of Orthopaedic Surgeons. Meniscal transplant surgery. Your Orthopaedic Connection 2009, accessed at orthoinfo.aaos.org 04/08/11.
  2. Ayala Mejias JD, et al. A case report of semitendinosus tendon autograft for reconstruction of the meniscal wall supporting a collagen implant. BMC Sports Sci Med Rehabil. 2013 Mar 28;5:4.
  3. Blue Cross and Blue Shield Association Medical Policy Reference Manual 7.01.15 – Meniscal Allograft Transplantation, April 2017.
  4. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC) – Meniscal Allograft Transplantation. TEC Assessments 1997.
  5. Bulgheroni P, et al. Polyurethane scaffold for the treatment of partial meniscal tears. Clinical results with a minimum two-year follow-up. Joints. 2014 Mar 21;1(4):161-6.
  6. Centers for Medicare & Medicaid Services. National Coverage Determination (NCD) for Collagen MENISCUS Implant (150.12) (05/25/10).
  7. Crook TB, Ardolino A, Williams LA, Barlow IW. Meniscal allograft transplantation: a review of the current literature. Ann R Coll Surg Engl. 2009 Jul;91(5):361-5.
  8. ECRI Health Technology Assessment Information Services – Windows on Medical Technology – "Meniscal Allograft Transplantation for Damaged or Removed Meniscus", (Oct 2001).
  9. ECRI, HTAIS Hotline Service Custom Reports. Meniscal Allograft Transplantation for Damaged or Removed Meniscus. Updated 03/07/07.
  10. First Coast Service Options, Inc. Local Coverage Determination (LCD) for Noncovered Services (L29288), 02/02/09 (revised 02/07/15). Retired 09/30/15.
  11. First Coast Service Options, Inc. Local Coverage Determination (LCD) for Noncovered Services (L33777) (10/01/15).
  12. Galley NK, et al. Frictional properties of the meniscus improve after scaffold-augmented repair of partial meniscectomy: a pilot study. Clin Orthop Relat Res. 2011 Oct;469(10):2817-23.
  13. Hannink G, et al. Changes in articular cartilage after meniscectomy and meniscus replacement using a biodegradable porous polymer implant. Knee Surg Sports Traumatol Arthrosc. 2011 Mar;19(3):441-51.
  14. Hayes, Inc. Hayes Medical Technology Directory – "Meniscal Allograft" Lansdale, PA: Hayes, Inc.; April 2004. Update performed 06/13/06.
  15. Howell R, Kumar NS, Patel N, Tom J. Degenerative meniscus: Pathogenesis, diagnosis, and treatment options. World J Orthop. 2014 Nov 18;5(5):597-602.
  16. Lee BS, Kim JM, Sohn DW, Bin SI. Review of Meniscal Allograft Transplantation Focusing on Long-term Results and Evaluation Methods. Knee Surg Relat Res. 2013 Mar;25(1):1-6.
  17. Mickiewicz P, Binkowski M, Bursig H, Wróbel Z. Preservation and sterilization methods of the meniscal allografts: literature review. Cell Tissue Bank. 2014 Sep;15(3):307-17.
  18. Zaffagnini S, et al. MRI evaluation of a collagen meniscus implant: a systematic review. Knee Surg Sports Traumatol Arthrosc. 2015 Nov;23(11):3228-37.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 04/26/18.

GUIDELINE UPDATE INFORMATION:

08/15/03

New Medical Coverage Guideline. Separate MCG developed with meniscal allograft information pulled from MCG 02-20000-10 (Autologous Chondrocyte Implantation).

06/15/04

Review and revision to guideline consisting of updated references.

01/01/05

Annual HCPCS update; consisting of deletion of 0014T and addition of 29868.

08/15/05

Review and revision of guideline consisting of the addition of coverage criteria.

07/15/06

Review and revision of guideline consisting of updated references.

08/15/07

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

07/15/09

Scheduled review; no change in position statement. Update references.

05/15/11

Scheduled review; position statement maintained and references updated.

05/11/14

Revision: Program Exceptions section updated.

03/15/15

Scheduled review. Revised description, position statement and definitions. Updated references and reformatted guideline.

05/15/18

Revision: added coverage statement regarding use of meniscal implants incorporating materials such as collagen and polyurethane (E/I). Revised program exceptions section, index terms, and HCPCS coding (added code G0428). Updated references. Formatted guideline.

Date Printed: May 21, 2018: 08:13 PM