Description
The standard treatment of problem fractures or osseous defects has been an autologous cancellous bone graft harvested from the iliac crest. Limitations of this approach include morbidity at the graft site and the lack of adequate bone stock in some patients. Autologous bone graft is considered the gold standard 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 nondifferentiated 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, thus enabling 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 different 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 three preparations that have received 510(k) marketing clearance are the Wright Medical Allomatrix^®, Exactech Resorbable Bone Paste and DBX^® from the Musculoskeletal Transplant Foundation.

Bone morphogenetic protein (BMP) is another bone graft alternative and consists of a bioengineered equivalent of one of the components of bone matrix. Various BMP preparations have been FDA approved through the more rigorous PMA process, which does require evidence of clinical efficacy.

Policy
The percutaneous treatment of fracture non-unions or bone defects with the use of bone marrow aspirate with or without demineralized bone matrix is considered INVESTIGATIONAL.

Policy Guidelines
There are no specific CPT codes for the above procedure and no specific coding for the BMP products. If autologous bone marrow aspirate is used, the CPT code 38220 will be used for the aspiration procedure.

Benefit Application:
BlueCard/National Account Issues
State or federal mandates (e.g., FEP) may dictate that all devices approved by the U.S. Food and Drug Administration (FDA) may not be considered investigational, and, thus, these devices may be assessed only on the basis of their medical necessity.

Rationale:
In the treatment of fractures, an autologous bone graft is considered when a fracture nonunion is present (usually defined as a three-month period without evidence of further fracture healing). However, the minimally invasive nature of a percutaneous approach may prompt a broadening of the patient selection criteria. For example, on the manufacturer’s website for the Ignite^™ ICS product, the following indications are listed¹:

• Suspect delayed union at six to eight weeks following index procedure with no sign of callus formation
• Delayed union with well-fixed hardware
• Fresh fracture for "high risk" patients with one or more comorbidities, such as smoking, diabetes, steroid use, etc.
• Stable non-unions with no prior surgical intervention

A literature search based on the MEDLINE database did not identify any controlled trials comparing the standard treatment of autologous bone graft to treatment with autologous bone marrow aspirate used either alone or in conjunction with demineralized bone matrix (DBM). The published literature, including citations from the 1990s, consisted primarily of single institution case series with heterogeneous groups of patients. In 1995, Connolly published a retrospective review of the use of bone marrow aspirate used either alone or in combination with DBM in 100 cases.² The author states that the results were at least equivalent to autologous grafting, but did not provide detailed results or statistical analysis. Skoff reported on a prospective case series of 19 patients with a localized skeletal defect requiring bone grafting.³ The patients were treated with cancellous cubes of allograft bone that were combined with autologous bone marrow aspirate. The composite graft was implanted through a stab incision over the skeletal defect. A total of 100 percent of patients achieved clinical healing. In 2003, Wilkins and colleagues reported on a prospective study of 66 patients with stiff non-unions (i.e., no gross motion) who were treated with a percutaneous administration of a mixture of autologous bone marrow and DBM.⁴ A total of 88 percent of patients achieved union at 8.1 months. Finally, Goel and colleagues reported on a prospective case series of 20 patients with tibial non-unions who received a percutaneous bone marrow injection alone. The authors reported a 75 percent union rate.⁵ In summary, published data are inadequate to permit scientific conclusions.

References:

1. Connolly JF. Injectable bone marrow preparations to stimulate osteogenic repair. Clin Orthop Rel Res 1995; (313):8-18.
2. Skoff HD. Bone marrow/allograft component therapy. A clinical trial. Am J Orthop 1995; 24(1):40-7.
3. Wilkins RM, Chimenti BT, Rifkin RM. Percutaneous treatment of long bone nonunions: the use of autologous bone marrow and allograft bone matrix. Orthopedics 2003; 26(5 suppl):s549-54.
4. Goel A, Sangwan SS, Siwach RC et al. Percutaneous bone marrow grafting for the treatment of tibial non-union. Injury 2005; 36(1):203-6.
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. Wright JG, Yandow S, Donaldson S et al; Simple Bone Cyst Trial Group. A randomized clinical trial comparing intralesional bone marrow and steroid injections for simple bone cysts. J Bone Joint Surg Am 2008; 90(4):722-30.

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved" 

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