An ultrasonic osteogenesis stimulator (E0760) is covered only if all of the following criteria are met:

1. Nonunion of a fracture 733.82; and
2. The fracture is not of the skull or vertebrae.

A nonunion fracture is defined as a fracture that has not united within a minimum of 3 months of the original fracture.

Low-intensity ultrasound treatment may also be considered medically necessary when used as an adjunct to conventional management (i.e., closed reduction and cast immobilization) for the treatment of fresh, closed fractures in skeletally mature individuals. It will be necessary for the provider to submit medical records and/or additional documentation to determine coverage in this situation.

An ultrasonic osteogenesis stimulator will be denied as not medically necessary if any of the criteria above are not met.

Other applications of low-intensity ultrasound treatment are experimental/investigational, since they do not have FDA approval. This includes, but is not limited to, treatment of delayed unions and congenital pseudarthroses. Delayed unions are defined as a decelerating healing process as determined by serial X-rays. A participating, preferred, or network provider can bill the member.

Ultrasound conductive coupling gel (A4559) is covered and separately payable if an ultrasonic osteogenesis stimulator is covered.

Although ultrasound treatment is applied by the patient in the home setting, there may be physician involvement with this device. Eligible physician's services (20979) include assistance in positioning the device over an existing cast and instruction to the patient in the use of the device.

NOTE:

A participating, preferred or network provider cannot bill the member for services denied for medical necessity.

See Medical Policy Bulletin S-89 for information on Electrical Osteogenesis Bone Stimulation.

Coverage for DME is determined according to individual or group customer benefits.

NOTE:

Total payments for a rental item may not exceed its allowable purchase price, except for those items identified as life sustaining DME. For information on continuous rental of life sustaining DME, see Medical Policy Bulletin E-38, Continuous Rental of Life Sustaining Durable Medical Equipment (DME).

Description

An ultrasonic osteogenesis stimulator is a noninvasive device that emits low intensity, pulsed ultrasound. The ultrasound signal is applied to the skin surface at the fracture location via ultrasound conductive coupling gel in order to stimulate fracture healing.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

This medical policy may not apply to FEP. Medical policy is not an authorization, certification, explanation of benefits, or a contract. Benefits are determined by the Federal Employee Program.

PRN References

12/2008, Ultrasound osteogenesis stimulators