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

1. Nonunion of a fracture; 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.

If the above criteria are not met, an ultrasonic osteogenesis stimulator will be denied as not medically necessary. This includes, but is not limited to, ultrasonic osteogenic stimulators used in the treatment of delayed unions. Delayed unions are defined as a decelerating healing process as determined by serial X-rays.

An ultrasonic osteogenesis stimulator (E0760) will be denied as not medically necessary if it is used with other noninvasive osteogenesis stimulators (E0747).

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.

Services that do not meet the medical necessity criteria on this policy will be considered not medically necessary. A participating, preferred, or network provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement should be maintained in the provider's records.

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.