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BONES

EBI Medical Systems Bone Growth Stimulators, April 2, 1991

DATE: April 2, 1991

RE: EBI Medical Systems Bone Growth Stimulators

Updated guidelines and fees have been established with EBI Medical Systems for its one healing system. Written recommendation for usage and follow-up must come from the attending physician.

DVR will cover use of this unit for fracture nonunion of the appendicular skeletal system. The following uses of the until will be covered:

Nonunion of Bone Fractures (Six or More Months Post Injury)

Failed fusion (Failed Spinal Fusion Not Covered)

Congenital Pseudoarthrosis.

DVR will not cover use of EBI's non-invasive stimulator for failed spinal fusion as this unit has not been FDA approved for general clinical use.

DVR will provide coverage for the implantable Orthogen or Osteogen stimulator for the following use:

Nonunion of Long Bone Fractures.

DVR will not provide coverage for this unit for use in treatment of delayed union of long bone fractures, congenital pseudoarthosis, and bone defects.

DVR coverage for the implantable spinal stimulator as an adjunct to spinal fusion may be provided only when one of the following conditions has been documented by the referring physician:

One or more previous failed fusions

Grade II or worse spondylolisthesis

Extensive bone grafting necessary for a multiple level fusion

Other high risk factors for failure of fusion, including metabolic bone disease.

The following services are included in the unit price:

Patient Education

Consultation to Treating Physician

Application Assistance

Calibration.

EBI will provide a new unit at no additional charge if the unit is to be recalibrated in event of cast changes, continued use for direct to skin placement, or in conjunction with graft surgery.

CONTACT REGARDING AUTHORIZATION INQUIRIES: 1-800-526-2579