Non Union Fracture

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

• Nonunion of a fracture (at least 3 months have passed since the date of the fracture); and
• The fracture is not of the skull or vertebrae; and
• Serial radiographs have confirmed that no progressive signs of healing have occurred; and
• The fracture gap is 1 cm or less; and
• The patient can be adequately immobilized and is able to maintain a non-weight bearing status.

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 treatment of any of the following:

• As an adjunct to (i.e., at the time of or immediately after) bunionectomy procedures (When such surgery results in nonunion the medically necessary criteria above may apply); or
• As an adjunct to (i.e., at the time of or immediately after) distraction osteogenesis procedures for any indication (e.g., limb lengthening, nonunion, or tibial defects); or
• Axial skeleton fractures, including the skull and vertebrae; or
• Congenital pseudoarthrosis; or
• Delayed fracture unions(Delayed unions are defined as a decelerating healing process as determined by serial X-rays.); or
• Fresh fractures that are Open Grade II or III, or require surgical intervention (with or without internal fixation), or are otherwise too unstable for closed reduction/; or
• Patellar tendinopathy; or
• Pathological fractures due to bone pathology or tumor/malignancy; or
• Stress fractures; or used with other noninvasive osteogenesis stimulators (E0747)

Fresh Closed Fractures

Low-intensity ultrasound accelerated fracture healing systems are considered medically necessary and, therefore, covered as an adjunct to conventional management (ie, closed reduction and cast immobilization) for the treatment of fresh, closed fractures of a skeletally mature individual, who is determined to be at high risk for delayed fracture healing or nonunion fractures, that includes having at least ONE of the following indications: a comorbidity OR location of fracture:

The individual has one of the following comorbidities:

• Diagnosis of alcoholism
• Current tobacco use
• Diagnosis of diabetes
• Current use of prescribed steroid
• Diagnosis of osteoporosis
• Diagnosis of renal disease
• Current use of prescribed anticoagulation medications
  
  OR

The individual has one of the following fracture locations:

• Fracture of metatarsal, including Jones fracture (5th metatarsal)
• Navicular bone fracture of the wrist (also known as the scaphoid)
• Fractures associated with extensive soft tissue or vascular damage

 It will be necessary for the provider to submit medical records and/or additional documentation to determine coverage in these situations.

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 criteria of this policy will not be considered medically necessary. A Delaware participating, preferred or network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records. Out of Network/Non-participating providers and providers located outside of Delaware may be able to bill members if the service is denied.

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.