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National Coverage Determination (NCD)

Osteogenic Stimulation

150.2

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Tracking Information

Publication Number
100-3
Manual Section Number
150.2
Manual Section Title
Osteogenic Stimulation
Version Number
1
Effective Date of this Version
01/01/2001
Ending Effective Date of this Version
04/27/2005
Implementation Date
01/01/2001
Implementation QR Modifier Date

Description Information

Benefit Category
Durable Medical Equipment


Please Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

Item/Service Description

Electrical stimulation to augment bone repair can be attained either invasively or noninvasively. Invasive devices provide electrical stimulation directly at the fracture site either through percutaneously placed cathodes or by implantation of a coiled cathode wire into the fracture site. The power pack for the latter device is implanted into soft tissue near the fracture site and subcutaneously connected to the cathode, creating a self-contained system with no external components. The power supply for the former device is externally placed and the leads connected to the inserted cathodes. With the noninvasive device, opposing pads, wired to an external power supply, are placed over the cast. An electromagnetic field is created between the pads at the fracture site.
Indications and Limitations of Coverage

A - Noninvasive Stimulator

The noninvasive stimulator device is covered only for the following indications:

  • Nonunion of long bone fractures.
  • Failed fusion, where a minimum of nine months has elapsed since the last surgery.
  • Congenital pseudarthroses.
  • As an adjunct to spinal fusion surgery for patients at high risk of pseudarthrosis due to previously failed spinal fusion at the same site or for those undergoing multiple level fusion. A multiple level fusion involves three or more vertebrae (e.g., L3-L5, L4-S1, etc).

B - Invasive (Implantable) Stimulator

The invasive stimulator device is covered only for the following indications:

  • Nonunion of long bone fractures.
  • As an adjunct to spinal fusion surgery for patients at high risk of pseudarthrosis due to previously failed spinal fusion at the same site or for those undergoing multiple level fusion. A multiple level fusion involves 3 or more vertebrae (e.g., L3-L5, L4-S1, etc).
  • Nonunion of long bone fractures, for both noninvasive and invasive devices, is considered to exist only after 6 or more months have elapsed without healing of the fracture.
  • Nonunion of long bone fractures, for both noninvasive and invasive devices, is considered to exist only when serial radiographs have confirmed that fracture healing has ceased for three or more months prior to starting treatment with the electrical osteogenic stimulator. Serial radiographs must include a minimum of two sets of radiographs, each including multiple views of the fracture site, separated by a minimum of 90 days.

B - Ultrasonic Osteogenic Stimulators

An ultrasonic osteogenic stimulator is a non-invasive device that emits low intensity, pulsed ultrasound. The ultrasound signal is applied to the skin surface at the fracture location via ultrasound, conductive gel in order to stimulate fracture healing.

Ultrasonic osteogenic stimulators are covered as medically reasonable and necessary for the treatment of non-union fractures. In demonstrating nonunion of fractures, CMS would expect:

  1. 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 must include multiple views of the fracture site accompanied 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.
  2. Indications that the patient failed at least one surgical intervention for the treatment of the fracture.

Non-unions of the skull, vertebrae, and those that are tumor-related are excluded from coverage.

The ultrasonic osteogenic stimulator may not be used concurrently with other non-invasive osteogenic devices. The national non-coverage policy related to ultrasonic osteogenic stimulators for fresh fractures and delayed unions remains in place. This policy relates only to non-union as defined above.
Cross Reference
Claims Processing Instructions

Transmittal Information

Transmittal Number
131
Coverage Transmittal Link
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R131CIM.pdf
Revision History

11/2000 - Permited coverage for ultrasonic osteogenic stimulators when two sets of radiographs document nonunion of fracture, and patient has failed at least one surgical intervention for treatment of fracture. Effective and implementation dates 01/01/2001. (TN 131)

02/2000 - Defined nonunion of long bone fractures when fracture healing has ceased for 3 or more months as confirmed by serial radiographs. Effective and implementation dates 04/01/2000. (TN 123) (CR 1085)

03/1997 - Denied coverage for osteogenic stimulators due to insufficient evidence to support medical necessity. Effective date 04/03/1997. (TN 92)

06/1996 - Expanded coverage to include use as an adjunct to spinal fusion surgery and provided clarification when noninvasive osteogenic stimulation is indicated after failed fusion. Effective date 07/01/1996. (TN 85)
Other

National Coverage Analyses (NCAs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with NCAs, from the National Coverage Analyses database.

Coding Analyses for Labs (CALs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with CALs, from the Coding Analyses for Labs database.

Additional Information

Other Versions
Title Version Effective Between
Osteogenic Stimulators 2 04/27/2005 - N/A View
Osteogenic Stimulation 1 01/01/2001 - 04/27/2005 You are here
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Reasons for Denial
Note: This section has not been negotiated by the Negotiated RuleMaking Committee. It includes CMS’s interpretation of it’s longstanding policies and is included for informational purposes. Tests for screening purposes that are performed in the absense of signs, symptoms, complaints, or personal history of disease or injury are not covered except as explicity authorized by statue. These include exams required by insurance companies, business establishments, government agencies, or other third parties. Tests that are not reasonable and necessary for the diagnosis or treatment of an illness or injury are not covered according to the statue. Failure to provide documentation of the medical necessity of tests may result in denial of claims. The documentation may include notes documenting relevant signs, symptoms, or abnormal findings that substantiate the medical necessity for ordering the tests. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysician practitioner) through documentation in the physician’s office may result in denial. A claim for a test for which there is a national coverage or local medical review policy will be denied as not reasonable and necessary if it is submitted without an ICD-9-CM code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim. If a national or local policy identifies a frequency expectation, a claim for a test that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency. Tests that are not ordered by a treating physician or other qualified treating nonphysician practitioner acting within the scope of their license and in compliance with Medicare requirements will be denied as not reasonable and necessary. Failure of the laboratory performing the test to have the appropriate Clinical Laboratory Improvement Act of 1988 (CLIA) certificate for the testing performed will result in denial of claims.
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