Dynamic Spinal Visualization and Vertebral Motion Analysis

POLICY NUMBER

A.6.01.46

DESCRIPTION

Dynamic spinal visualization is a general term addressing different imaging technologies that simultaneously visualize spine (vertebrae) movements and external body movement. Vertebral motion analysis uses similar imaging as dynamic spinal visualization, with the addition of controlled movement and computerized tracking. These technologies have been proposed for the evaluation of spinal disorders including neck and back pain.

Flexion/Extension Radiography

Dynamic spinal visualization and vertebral motion analysis are proposed for individuals who are being evaluated for back or neck pain and are being considered for standard flexion/extension radiographs. Flexion/extension radiographs may be performed with a passive external force or by the patient’s own movement. Typically, radiographs are taken at the end ranges of flexion and extension and the intervertebral movements (rotation and translation) are measured to assess spinal instability. Flexion/extension radiographs may be used to assess radiographic instability in order to diagnose and determine the most effective treatment (eg, physical therapy, decompression, or spinal fusion) or to assess the efficacy of spinal fusion.

Dynamic Spinal Visualization

Digital Motion X-RayMost spinal visualization technologies use x-rays to create images either on film, video monitor, or computer screen. Digital motion x-ray involves the use of film x-ray or computer-based x-ray "snapshots" taken in sequence as a patient moves. Film x-rays are digitized into a computer for manipulation, while computer-based x-rays are automatically created in a digital format. Using a computer program, the digitized snapshots are then sequenced and played on a video monitor, creating a moving image of the inside of the body. This moving image can then be evaluated by a physician alone or by using computer software that evaluates several aspects of the body’s structure, such as intervertebral flexion and extension, to determine the presence or absence of abnormalities.

Videofluoroscopy and CineradiographyVideofluoroscopy and cineradiography are different names for the same procedure, which uses fluoroscopy to create real-time video images of internal structures of the body. Unlike standard x-rays, which take a single picture at one point in time, fluoroscopy provides motion pictures of the body. The results of these techniques can be displayed on a video monitor as the procedure is being conducted, as well as recorded, to allow computer analysis or evaluation at a later time. Like digital motion x-ray, the results can be evaluated by a physician alone or with the assistance of computer software.

Dynamic Magnetic Resonance ImagingDynamic magnetic resonance imaging (MRI) is also being developed for imaging of the cervical spine. This technique uses an MRI-compatible stepless motorized positioning device and a real-time true fast imaging with steady-state precession sequence to provide passive kinematic imaging of the cervical spine. The quality of the images is lower than a typical MRI sequence, but is proposed to be adequate to observe changes in the alignment of vertebral bodies, the width of the spinal canal, and the spinal cord. Higher-resolution imaging can be performed at the end positions of flexion and extension.

Vertebral Motion AnalysisVertebral motion analysis systems like the KineGraph VMA (Vertebral Motion Analyzer) provide assisted bending with fluoroscopic imaging and computerized analysis. The device uses facial recognition software to track vertebral bodies across the images. Proposed benefits of the vertebral motion analysis are a reduction in patient-driven variability in bending and assessment of vertebral movement across the entire series of imaging rather than at the end range of flexion and extension.

In 2012, the KineGraph VMA™ (Vertebral Motion Analyzer, Ortho Kinematics) received clearance for marketing through the FDA’s 510(k) process. The system includes a Motion Normalizer™ for patient positioning, standard fluoroscopic imaging, and automated image recognition software. Processing of scans by Ortho Kinematics is charged separately. The table below lists a sampling of the spinal visualization and motion analysis devices currently cleared by the U.S. Food and Drug Administration.

Spinal Visualization and Motion Analysis Devices Cleared by the U.S. Food and Drug Administration

POLICY

The use of dynamic spinal visualization is considered investigational.

Vertebral motion analysis is considered investigational.

POLICY EXCEPTIONS

Federal 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 GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Investigative 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. 

POLICY HISTORY

12/13/2006: Policy added.

3/22/2007: Reviewed and approved by the Medical Policy Advisory Committee (MPAC).

4/1/2008: Policy reviewed, no changes.

04/09/2010: Policy statement unchanged. FEP verbiage added to the Policy Exceptions section.

11/17/2010: Policy reviewed; no changes.

10/05/2011: Policy reviewed; no changes.

11/30/2012: Policy reviewed; no changes.

11/15/2013: Policy reviewed; no changes.

10/20/2014: Policy reviewed; description updated regarding devices. Policy statement unchanged.

07/20/2015: Code Reference section updated for ICD-10.

11/06/2015: Policy description updated. Policy statement unchanged. Investigative definition updated in policy guidelines section.

05/31/2016: Policy number A.6.01.46 added.

03/28/2017: Policy description updated. Policy statement unchanged.

11/02/2018: Policy title changed from "Dynamic Spinal Visualization" to "Dynamic Spinal Visualization and Vertebral Motion Analysis." Policy description updated regarding patient population and vertebral motion analysis. Added policy statement that vertebral motion analysis is considered investigational.

10/22/2019: Policy description updated regarding devices. Policy statements unchanged.

10/14/2020: Policy description updated regarding devices. Policy statements unchanged.

03/03/2022: Policy description updated regarding devices. Policy statements unchanged.

12/01/2022: Policy reviewed; no changes.

10/12/2023: Policy reviewed; no changes.

12/12/2024: Policy reviewed; no changes.

SOURCE(S)

Blue Cross Blue Shield Association Policy # 6.01.46

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.