Low-intensity pulsed ultrasound has been investigated as a treatment of fracture nonunions. Low-intensity ultrasound can be delivered noninvasively with the use of a transducer applied to the skin surface overlying the fracture site and can be self-administered once daily for 20 minutes and continuing until the fracture has healed.

Devices used in this treatment (E0760) must be approved by the Food and Drug Administration (FDA). The Exogen 2000, also known as the Sonic Accelerated Fracture Healing System (SAFHS), has been approved for ultrasonic treatment of established nonunions, excluding the skull and vertebra. A nonunion fracture is defined as a fracture that has not united within a minimum of 3 months of the original fracture.

Therefore, low-intensity pulsed ultrasound treatment administered via an approved device, e.g., SAFHS, is considered medically necessary as a treatment of fracture nonunions of bones (733.82) excluding the skull and vertebra.

However, low-intensity ultrasound treatment used as an adjunct to conventional management (i.e., closed reduction and cast immobilization) for the treatment of fresh, closed fractures is considered not medically necessary. As such, it is not covered. A participating, preferred, or network provider cannot bill the member for the denied service.

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 for the denied service.

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:

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

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).

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.

MCIM 35-48

Ultrasound Accelerated Fracture Healing Device, Medical Policy Reference Manual, Policy 1.01.05, 08/2000