CAM 20175

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

Category:Medicine   Last Reviewed:May 2019
Department(s):Medical Affairs   Next Review:May 2999
Original Date:May 2013    

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 of 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 listed (1):

  • 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

Codes Number Description
CPT  20939 (effective 1/1/2018)  Bone marrow aspiration for bone grafting, spine surgery only, through separate skin or fascial incision (List separately in addition to code for primary procedure. 
    (Use 20939 in conjuncton with 11219, 22532. 22533. 22534, 22548, 22551, 22552, 22554, 22556, 22558, 22590, 22595, 22600, 22610, 22612, 22630, 22633, 22634, 22800, 22802, 22804, 22808, 22810, 22812) 
    (For bilateral procedure, use 20939 with modifier 50) 
    (For aspiration of bone marrow for the purpose of bone grafting, other than spine surgery and other therapeutic musculoskeletal applications, use 20999) 
    (For bone marrow aspiration(s) for platelet-rich stem cell injection, use 0232T) 
    (For diagnostic bone marrow aspiration(s), see 38220, 38222) 
  38220 Bone marrow aspirate
ICD-9 Diagnosis 733.8 Malunion or nonunion of fracture
ICD-10-CM (effective 10/01/15) S42009P Fracture of unspecified part of unspecified clavicle, subsequent encounter for fracture with malunion
  S4290XP Fracture of unspecified shoulder girdle, part unspecified, subsequent encounter for fracture with malunion
  S5290XP Unspecified fracture of unspecified forearm, subsequent encounter for closed fracture with malunion
  S5290XQ Unspecified fracture of unspecified forearm, subsequent encounter for open fracture type I or II with malunion
  S5290XR Unspecified fracture of unspecified forearm, subsequent encounter for open fracture type IIIA, IIIB, or IIIC with malunion
  S6290XP Unspecified fracture of unspecified wrist and hand, subsequent encounter for fracture with malunion
  S7290XP Unspecified fracture of unspecified femur, subsequent encounter for closed fracture with malunion
  S7290XQ Unspecified fracture of unspecified femur, subsequent encounter for open fracture type I or II with malunion
  S7290XR Unspecified fracture of unspecified femur, subsequent encounter for open fracture type IIIA, IIIB, or IIIC with malunion
  S82009P Unspecified fracture of unspecified patella, subsequent encounter for closed fracture with malunion
  S82009Q Unspecified fracture of unspecified patella, subsequent encounter for open fracture type I or II with malunion
  S82009R Unspecified fracture of unspecified patella, subsequent encounter for open fracture type IIIA, IIIB, or IIIC with malunion
  S8290XP Unspecified fracture of unspecified lower leg, subsequent encounter for closed fracture with malunion
  S8290XQ Unspecified fracture of unspecified lower leg, subsequent encounter for open fracture type I or II with malunion
  S8290XR Unspecified fracture of unspecified lower leg, subsequent encounter for open fracture type IIIA, IIIB, or IIIC with malunion
  S92909P Unspecified fracture of unspecified foot, subsequent encounter for fracture with malunion
  S92919P Unspecified fracture of unspecified toe(s), subsequent encounter for fracture with malunion
  S0291XK Unspecified fracture of skull, subsequent encounter for fracture with nonunion
  S0292XK Unspecified fracture of facial bones, subsequent encounter for fracture with nonunion
  S12000K Unspecified displaced fracture of first cervical vertebra, subsequent encounter for fracture with nonunion
  S12001K Unspecified nondisplaced fracture of first cervical vertebra, subsequent encounter for fracture with nonunion
  S12100K Unspecified displaced fracture of second cervical vertebra, subsequent encounter for fracture with nonunion
  S12101K Unspecified nondisplaced fracture of second cervical vertebra, subsequent encounter for fracture with nonunion
  S12200K Unspecified displaced fracture of third cervical vertebra, subsequent encounter for fracture with nonunion
  S12201K Unspecified nondisplaced fracture of third cervical vertebra, subsequent encounter for fracture with nonunion
  S12300K Unspecified displaced fracture of fourth cervical vertebra, subsequent encounter for fracture with nonunion
  S12301K Unspecified nondisplaced fracture of fourth cervical vertebra, subsequent encounter for fracture with nonunion
  S12400K Unspecified displaced fracture of fifth cervical vertebra, subsequent encounter for fracture with nonunion
  S12401K Unspecified nondisplaced fracture of fifth cervical vertebra, subsequent encounter for fracture with nonunion
  S12500K Unspecified displaced fracture of sixth cervical vertebra, subsequent encounter for fracture with nonunion
  S12501K Unspecified nondisplaced fracture of sixth cervical vertebra, subsequent encounter for fracture with nonunion
  S12600K Unspecified displaced fracture of seventh cervical vertebra, subsequent encounter for fracture with nonunion
  S12601K Unspecified nondisplaced fracture of seventh cervical vertebra, subsequent encounter for fracture with nonunion
  S229XXK Fracture of bony thorax, part unspecified, subsequent encounter for fracture with nonunion
  S329XXK Fracture of unspecified parts of lumbosacral spine and pelvis, subsequent encounter for fracture with nonunion
  S42009K Fracture of unspecified part of unspecified clavicle, subsequent encounter for fracture with nonunion
  S42209K Unspecified fracture of upper end of unspecified humerus, subsequent encounter for fracture with nonunion
  S4290XK Fracture of unspecified shoulder girdle, part unspecified, subsequent encounter for fracture with nonunion
  S5290XK Unspecified fracture of unspecified forearm, subsequent encounter for closed fracture with nonunion
  S5290XM Unspecified fracture of unspecified forearm, subsequent encounter for open fracture type I or II with nonunion
  S5290XN Unspecified fracture of unspecified forearm, subsequent encounter for open fracture type IIIA, IIIB, or IIIC with nonunion
  S6290XK Unspecified fracture of unspecified wrist and hand, subsequent encounter for fracture with nonunion
  S7290XK Unspecified fracture of unspecified femur, subsequent encounter for closed fracture with nonunion
  S7290XM Unspecified fracture of unspecified femur, subsequent encounter for open fracture type I or II with nonunion
  S7290XN Unspecified fracture of unspecified femur, subsequent encounter for open fracture type IIIA, IIIB, or IIIC with nonunion
  S8290XK Unspecified fracture of unspecified lower leg, subsequent encounter for closed fracture with nonunion
  S8290XM Unspecified fracture of unspecified lower leg, subsequent encounter for open fracture type I or II with nonunion
  S8290XN Unspecified fracture of unspecified lower leg, subsequent encounter for open fracture type IIIA, IIIB, or IIIC with nonunion
  S92909K Unspecified fracture of unspecified foot, subsequent encounter for fracture with nonunion
  S92919K Unspecified fracture of unspecified toe(s), subsequent encounter for fracture with nonunion

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 and Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

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

History From 2014 Forward     

05/08/2019 

Annual review, no change to policy intent. 

05/21/2018 

Annual review, no change to policy intent. 

12/05/2017 

Updating policy with 2018 coding. No other changes made to policy.

05/23/2017 

Annual review, no change to policy intent. 

05/02/2016 

Annual review, no change to policy intent. 

05/04/2015 

Annual review, no change to policy intent. Added guidelines and coding. 

05/05/2014

Annual review. No change to policy intent.


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