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Date Printed: June 26, 2017: 11:33 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.

02-20000-33

Original Effective Date: 08/15/06

Reviewed: 09/21/09

Revised: 11/01/15

Subject: Percutaneous Treatment of Fracture Non-unions or Bone Defects with Autologous Bone Marrow with or without Demineralized Bone Matrix (DBM)

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 Update  

DESCRIPTION:

Autologous bone graft harvested from the iliac crest is considered the gold standard for problem fractures or osseous defects because it includes components of all three processes considered to be essential for bone healing: osteoconductivity (i.e., a support structure), osteoinductivity (i.e., ability of graft to induce non-differentiated stem cells to differentiate into osteoblast) and osteogenic cells. Therefore, bone graft substitutes, used either alone or in combination are designed to reproduce these components. The extracellular bone matrix includes a wide range of bone growth factors, proteins and other bioactive materials necessary for osteoinduction. These factors can be removed from allograft bone by using a demineralizing agent, resulting in demineralized bone matrix (DBM). Several different preparations of DBM are commercially available, including putty, gel and paste, which can be used as an adjunct to a variety of open surgical procedures. In contrast, the Ignite™ ICS product consists of a DBM that is designed to be injectable, therefore allows for percutaneous treatment. Autologous bone marrow aspirate is designed to provide marrow stromal cells and osteogenic cells, and has been investigated as a stand-alone treatment of fracture, or in conjunction with demineralized bone marrow.

The Ignite™ ICS product is specifically designed to be used in conjunction with bone marrow aspirate, and has the following labeled indication:

“After the powder is mixed with autologous bone marrow aspirate, the resultant composite material can then be injected into the defect site. Ignite™ ICS is indicated only for bone voids or gaps that are not intrinsic to the stability of the bony structure. Ignite™ ICS is intended to be injected into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.”

Various preparations of DBM are commercially available, regulated by the U.S. Food and Drug Administration (FDA) as either human tissue or cleared through the 510(k) marketing clearance process. An example of a DBM preparation that is regulated as a human tissue is Osteotech’s Grafton® and two preparations that have received 510(k) marketing clearance are the Wright Medical Allomatrix® and Exactech Resorbable Bone Paste.

Bone morphogenetic protein (BMP) is another bone graft alternative and consists of a bioengineered equivalent of one of the components of bone matrix. BMP is discussed in a separate guideline, 02-20000-32 Bone Morphogenetic Protein.

POSITION STATEMENT:

The percutaneous treatment of fracture non-unions of bone defects with the use of bone marrow aspirate with or without demineralized bone matrix is considered experimental or investigational, as randomized controlled trials comparing outcomes of percutaneous injection of bone marrow aspirate with bone grafts are lacking and the development of appropriate graft materials is still evolving.

BILLING/CODING INFORMATION:

There is no specific CPT or HCPCS code that describes this therapy, although 38220 may be reported for the bone marrow aspirate portion of the procedure.

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:

No guideline specific definitions apply.

RELATED GUIDELINES:

Bone Morphogenetic Protein (BMP), 02-20000-32

OTHER:

Indexing terms:

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.

Allomatrix®
Demineralized bone matrix, fracture nonunion
Exactech Resorbable Bone Paste
Fracture nonunion, bone marrow aspirate and demineralized bone matrix
Grafton®
Ignite™ ICS

REFERENCES:

  1. Agency for Healthcare Research and Quality (AHRQ) Technology Assessment Program. “The Role of Bone Growth Stimulating Devices and Orthobiologics in Healing Nonunion Fractures”; 09/21/05; Prepared by ECRI Evidence-based Practice Center; accessed 07/08/08.
  2. Blue Cross Blue Shield Association Medical Policy2.01/75; “Percutaneous Treatment of Fracture Non-Unions or Bone Defects with Autologous Bone Marrow with or without Demineralized Bone Matrix (DBM)”; 06/12/08; archived 07/09/09.
  3. deAndrade, JR. Treatment of a Femoral Nonunion Using a Bone Graft Gel Composite; an initial report. May 1992.
  4. ECRI Institute Hotline Response Article: Comparative Efficacy of Demineralized Bone Matrix Products for Orthopedic Procedures Updated 02/28/08.
  5. Hernigou P, Poignard A, Beaujean F et al. Percutaneous autologous bone marrow grafting for nonunions. Influence of the number and concentration of progenitor cells. J Bone Joint Surg Am 2005; 87(7): 1430-7.
  6. Lieberman, JR. Percutaneous Autologous Bone-Marrow Grafting for Nonunions. Commentary and Perspective. J Bone Joint Surg Am 2005.
  7. Resnick DK, Choudhri TF, Dailey AT, Groff MW, Khoo L, Matz PG, Mummaneni P, Watters WC 3rd, Wang J, Walters BC, Hadley MN, American Association of Neurological Surgeons/Congress of Neurological Surgeons. Guidelines for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 16: bone graft extenders and substitutes. J Neurosurg Spine 2005 Jun; 2 (6): 733-6. [8 references] PubMed. (Summary of this guideline was completed 01/08/07 by ECRI.)
  8. U.S. Food and Drug Administration. 510(K) Summary of Safety and Effectiveness. VIAGRAF DBM Paste. (12/05/05).
  9. U.S. Food and Drug Administration. Jurisdictional Update: Human Demineralized Bone Matrix. (01/19/01).
  10. U.S. Food and Drug Administration. 510(K) Summary of Safety and Effectiveness. Exactech resorbable calcium salt bone void filler device. (02/08/06).
  11. Wright’s Biologics Products website; accessed 07/08/08.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 09/21/09.

GUIDELINE UPDATE INFORMATION:

08/15/06

New Medical Coverage Guideline.

07/15/07

Scheduled review; reformatted guideline; updated references.

09/15/08

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

10/15/09

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

05/11/14

Revision: Program Exceptions section updated.

11/01/15

Revision: ICD-9 Codes deleted.

Date Printed: June 26, 2017: 11:33 AM