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DESCRIPTIONPositional magnetic resonance imaging (MRI) allows imaging of the patient in various positions, including sitting and standing. This technology is being evaluated for the diagnosis of patients with position-dependent back pain.
Determining the cause of back pain is a complex task. In some patients, extensive evaluation with various imaging modalities does not lead to a definitive diagnosis. Some recent studies have suggested that imaging the body in various positions with “loading” of the spine may lead to more accurate diagnosis. This loading can be accomplished by having the patient stand upright or sit. Also, imaging can be completed with the patient in the position that causes the symptom(s). This is being evaluated in suspected nerve root compression and in some cases of spondylolisthesis.
An open magnetic resonance imaging (MRI) system has been developed that allows imaging of the patient in various positions. The imaging can be conducted with partial or full weight bearing. Dynamic-kinetic imaging (images obtained during movement) can also be obtained with this system. Conventional MR imaging of the spine is typically completed with the patient in a recumbent position. Weight-bearing can be simulated by imaging in the supine position with a special axial loading device.
One concern with positional MRI is the field strength of the scanners. Today’s clinical MRI scanners may operate at a field strength between 0.1 Tesla (T) to 3 T and are classified as either low-field (<0.5 T), mid-field (0.5-1.0 T), or high-field (>1.0 T). Low-field MRI is typically used in open scanners. Open scanners are designed for use during interventional or intraoperative procedures, when a conventional design is contraindicated (eg, an obese or claustrophobic patient), or for changes in patient positioning.
In general, higher field strength results in an increase in signal-to-noise ratio, spatial resolution, contrast and speed. Thus, low-field scanners produce poorer-quality images compared with high-field scanners, and the longer acquisition times with low-field scanners increases the possibility of image degradation due to patient movement. However, field strength has less of an effect on the contrast-to-noise ratio, which determines the extent to which adjacent structures can be distinguished from one another.
FONAR Corporation has 510(k) marketing clearance from the U. S. Food and Drug Administration (FDA) for a MRI system that performs positional MRI scans (i.e., FONAR’s Upright® MRI).
POLICYPositional (non-recumbent) magnetic resonance imaging (MRI) is considered investigational, including its use in the evaluation of patients with cervical, thoracic, or lumbosacral back pain.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
POLICY GUIDELINESInvestigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY5/6/2008: Policy added
4/27/2009: Policy reviewed, no changes
04/27/2010: Policy description updated. Policy statement unchanged. FEP verbiage added to the Policy Exceptions section.
06/21/2011: Policy reviewed; no changes.
05/09/2012: Policy reviewed; no changes.
08/07/2013: Policy reviewed; no changes.
06/13/2014: Policy reviewed; description updated regarding concern with positional MRI. Policy statement unchanged.
08/14/2015: Code Reference section updated for ICD-10. Removed ICD-9 procedure code 88.90 from the Code Reference section.
09/14/2015: Policy reviewed; policy statement unchanged. Investigative definition updated in the Policy Guidelines section.
SOURCE(S)Blue Cross & Blue Shield Association Policy # 6.01.48
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.