An electrical osteogenesis stimulator is a device that provides electrical stimulation to augment bone repair. A noninvasive electrical stimulator is characterized by an external power source which is attached to a coil or electrodes placed on the skin or on a cast or brace over a fracture or fusion site.

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.

For any item to be covered, it must:

1. be eligible for a defined Medicare benefit category;
2. be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member; and
3. meet all other applicable statutory and regulatory requirements.

For the items addressed in this medical policy, the criteria for "reasonable and necessary" are defined by the following indications and limitations of coverage.

For an item to be covered, a written signed and dated order must be received by the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving the completed order, the item will be denied as not medically necessary.

Nonspinal Electrical Osteogenesis Stimulator (E0747)
A nonspinal electrical osteogenesis stimulator (E0747) is covered only if any of the following criteria are met:

1. Nonunion of a long bone fracture (See Glossary section) defined as radiographic evidence that fracture healing has ceased for three or more months prior to starting treatment with the osteogenesis stimulator; or
   
   
2. Failed fusion of a joint other than in the spine where a minimum of nine months has elapsed since the last surgery; or
   
   
3. Congenital pseudarthrosis.

Nonunion of a long bone fracture must be documented by a minimum of two sets of radiographs obtained prior to starting treatment with the osteogenesis stimulator, separated by a minimum of 90 days, each including multiple views of the fracture site, and with a written interpretation by a physician stating that there has been no clinically significant evidence of fracture healing between the two sets of radiographs.

A nonspinal electrical osteogenesis stimulator will be denied as not medically necessary if none of the criteria above are met.

Spinal Electrical Osteogenesis Stimulator (E0748)
A spinal electrical osteogenesis stimulator (E0748) is covered only if any of the following criteria are met:

1. Failed spinal fusion where a minimum of nine months has elapsed since the last surgery; or
   
   
2. Following a multilevel spinal fusion surgery (See Glossary section); or
   
   
3. Following spinal fusion surgery where there is a history of a previously failed spinal fusion at the same site.

A spinal electrical osteogenesis stimulator will be denied as not medically necessary if none of the criteria above are met.

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

1. Nonunion of a fracture documented by a minimum of two sets of radiographs obtained prior to starting treatment with the osteogenic stimulator, separated by a minimum of 90 days. Each radiograph set must include multiple views of the fracture site accompanied by a written interpretation by a physician stating that there has been no clinically significant evidence of fracture healing between the two sets of radiographs; and
   
   
2. The fracture is not of the skull or vertebrae; and
   
   
3. The fracture is not tumor related.

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

Use of an ultrasonic osteogenic stimulator for the treatment of a fresh fracture or delayed union will be denied as not medically necessary.

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

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

Services that do not meet the medical necessity criteria on this policy will be considered not medically necessary. Effective January 26, 2009, a 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, in the form of a Pre-Service Denial Notice, should be maintained in the provider's records.

Documentation Requirements

An order for each item billed must be signed and dated by the treating physician, kept on file by the supplier, and made available upon request. Items billed before a signed and dated order has been received by the supplier must be submitted with an EY modifier added to each affected procedure code.

For electrical and ultrasonic osteogenesis stimulators, a Certificate of Medical Necessity (CMN) which has been completed, signed, and dated by the treating physician must be kept on file by the supplier and made available upon request. The CMN may act as a substitute for a written order if it contains all of the required elements of an order. The initial claim must include a copy of the CMN.

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.

Ultrasound conductive coupling gel is billed using code A4559.

Codes E0747, E0748, and E0760, are Class III devices which must be submitted with a KF modifier.

Effective August 1, 2009, suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items. https://www.dmepdac.com/

Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider." It is expected that the patient’s medical records will reflect the need for the care provided. The patient’s medical records include the physician’s office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.

CMS Pub. 100-3, Medicare National Coverage Determination Manual, Chapter 1, Section 150.2

Equipment

Supplies/Other

Covered Diagnosis Codes

For procedure code E0747

For procedure code E0748

For procedure code E0760