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Section: Durable Medical Equipment
Number: E-35
Topic: Osteogenesis Stimulators
Effective Date: January 1, 2007
Issued Date: April 20, 2009

General Policy Guidelines | Procedure Codes | Coding Guidelines | References | Attachments | Procedure Code Attachments | Diagnosis Codes | Glossary

General Policy

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.

Indications and Limitations of Coverage

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.

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 (diagnosis codes - 810.00-810.13, 812.00-813.93, 815.00-815.19, 820.00-821.39, 823.00-824.9, 825.25, 825.35)(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 (diagnosis code V45.4) where a minimum of nine months has elapsed since the last surgery; or

  3. Congenital pseudarthrosis (diagnosis code 755.8).

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 (diagnosis code V45.4) where a minimum of nine months has elapsed since the last surgery; or

  2. Following a multilevel spinal fusion surgery (diagnosis code V45.4)(See Glossary section); or

  3. Following spinal fusion surgery (diagnosis code V45.4) 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 (diagnosis codes - 807.00-807.3, 808.0-808.9, 810.00-816.13, 820.00-826.1) 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.

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.

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.

All claims for an osteogenesis stimulator and related supplies must include a diagnosis code that describes the condition requiring the device and/or supply.

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.

Procedure Codes

Coding Guidelines

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.

References

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" (42 U.S.C. section 1395l(e)). 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

www.cms.gov
www.medicare.gov

Attachments

Procedure Code Attachments

Equipment

E0747E0748E0760 

Supplies/Other

A4559   

Diagnosis Codes

For procedure code E0747

755.8810.00-810.13 812.00-813.93 815.00-815.19
820.00-821.39 823.00-824.9 825.25825.35
V45.4   

For procedure code E0748

V45.4   

For procedure code E0760

807.00-807.3808.0-808.9810.00-816.13820.00-826.1

Glossary

TermDescription

Multilevel spinal fusion

 

Involves 3 or more vertebrae (e.g., L3-L5, L4-S1, etc)

 

Long bone

Limited to a clavicle, humerus, radius, ulna, femur, tibia, fibula, metacarpal, or metatarsal






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.

Medical policies are designed to supplement the terms of a member's contract. The member's contract defines the benefits available; therefore, medical policies should not be construed as overriding specific contract language. In the event of conflict, the contract shall govern.

Medical policies do not constitute medical advice, nor the practice of medicine. Rather, such policies are intended only to establish general guidelines for coverage and reimbursement under Medicare Advantage plans. Application of a medical policy to determine coverage in an individual instance is not intended and shall not be construed to supercede the professional judgment of a treating provider. In all situations, the treating provider must use his/her professional judgment to provide care he/she believes to be in the best interest of the patient, and the provider and patient remain responsible for all treatment decisions.

Medicare Advantage retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Medicare Advantage. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.



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