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MP 6.01.46 Dynamic Spinal Visualization

Medical Policy    
Section
Radiology 
Original Policy Date
12/12/06
Last Review Status/Date
Reviewed with literature search/9:2013
Issue
9:2013
  Return to Medical Policy Index

Disclaimer

Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.  Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.  Medical technology is constantly changing, and we reserve the right to review and update our policies periodically. 


Description

Dynamic spinal visualization is a general term addressing different imaging technologies, including digital motion x-ray and videofluoroscopy (also known as cineradiography) that allow the simultaneous visualization of movement of internal body structures such as the spine (vertebrae) with external body movement. These technologies have been proposed for the evaluation of spinal disorders including low back pain.

Background

Most spinal visualization methods use x-rays to create images either on film, video monitor, or computer screen. Digital motion x-ray involves the use of either 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 put in order 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 a computer 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 cineradiography are different names for the same procedure, which uses a technique called 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 analysis software.

Dynamic magnetic resonance imaging (MRI) is also being developed for imaging of the cervical spine. This technique uses an MRI-compatible stepless motorized positioning device (NeuroSwing, Fresenius/Siemens) and a real-time true fast imaging with steady-state precession (FISP) 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.

Regulatory Status

The KineGraph VMA™ (Vertebral Motion Analyzer, Ortho Kinematics) received clearance for marketing through the U.S. Food and Drug Administration’s (FDA) 510(k) process in 2012. 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.


Policy 

The use of dynamic spinal visualization is considered investigational.


Policy Guidelines 

There are specific CPT codes for these techniques:
76120: Cineradiography/videoradiography, except where specifically included
76125: Cineradiography/videoradiography to complement routine examination (list separately in addition to code for primary procedure)
CPT code 76120 can be used once per anatomical area with modifier -59 (distinct procedural service) appended to the code when it is used for additional anatomic regions.


Benefit Application
BlueCard/National Account Issues
State or federal mandates (e.g., FEP) may dictate that all FDA-approved devices may not be considered investigational and, thus, these devices may be assessed only on the basis of their medical necessity.


Rationale

This policy was created in 2006 and updated periodically using the MEDLINE database. The most recent literature update was performed through August 15, 2013.

At the time this policy was created, the literature evaluating the clinical utility of dynamic spinal visualization techniques, including digital motion x-ray and cineradiography (videofluoroscopy) for the evaluation and assessment of the spine, was limited to a few studies involving small numbers of participants. (1-3) No evidence was identified to indicate that clinical use improves health outcomes. While there were reports of the correlation of this technique to disc degeneration, (4) no studies had evaluated the incremental value of this information compared to the standard evaluation. In addition, although some studies had shown that abnormalities in spinal motion are found in individuals with low back pain, particularly those with spondylolisthesis, the test did not always separate those with disease from those without disease. (5)

As of the most recent literature update, the evidence on dynamic spinal visualization remains predominantly of comparisons of spine kinetics in patients with neck or back pain with healthy controls. For example, Teyhen et al. compared 20 patients with lower back pain to 20 healthy controls to provide construct validity for a clinical prediction rule that would identify patients likely to benefit from stabilization exercises, (6) while Ahmadi and colleagues used digital videofluoroscopy to compare 15 patients with lower back pain and 15 controls to assist in identifying better criteria for diagnosis of lumbar segmental instability. (7) Breen et al. reported on objective spinal motion imaging assessment (OSMIA) in 30 healthy volunteers using a passive motion table and automated frame-to-frame registration of vertebral position. (8) Another study from 2009 used dynamic fluoroscopy to assess lateral flexion in 30 healthy controls, noting that data pooling from multiple studies would be needed to establish a complete database of reference limits from asymptomatic individuals. (9)

A feasibility study of dynamic magnetic resonance imaging (MRI) was reported in 2012. (10) This study used a prototype of the NeuroSwing positioning device and evaluated cervical spine kinematics in 32 patients who had previously undergone anterior cervical discectomy and fusion (ACDF). The quality of images was considered to be adequate, although there was some artifact from the titanium implants used in ACDF.

Summary

The evidence at this time is insufficient to evaluate the effect on health outcomes of digital motion x-rays, cineradiography/videofluoroscopy, or dynamic MRI of the spine for any indication. Therefore, dynamic spinal visualization is considered investigational.

Medicare National Coverage

There is no national coverage determination.

References:

 

 

  1. Hino H, Abumi K, Kanayama M et al. Dynamic motion analysis of normal and unstable cervical spines using cineradiography. An in vivo study. Spine (Phila Pa 1976) 1999; 24(2):163-8.
  2. Takayanagi K, Takahashi K, Yamagata M et al. Using cineradiography for continuous dynamic-motion analysis of the lumbar spine. Spine (Phila Pa 1976) 2001; 26(17):1858-65.
  3. Wong KW, Leong JC, Chan MK et al. The flexion-extension profile of lumbar spine in 100 healthy volunteers. Spine (Phila Pa 1976) 2004; 29(15):1636-41.
  4. Fujiwara A, Tamai K, An HS et al. The relationship between disc degeneration, facet joint osteoarthritis, and stability of the degenerative lumbar spine. J Spinal Disord 2000; 13(5):444-50.
  5. Okawa A, Shinomiya K, Komori H et al. Dynamic motion study of the whole lumbar spine by videofluoroscopy. Spine (Phila Pa 1976) 1998; 23(16):1743-9.
  6. Teyhen DS, Flynn TW, Childs JD et al. Arthrokinematics in a subgroup of patients likely to benefit from a lumbar stabilization exercise program. Phys Ther 2007; 87(3):313-25.
  7. Ahmadi A, Maroufi N, Behtash H et al. Kinematic analysis of dynamic lumbar motion in patients with lumbar segmental instability using digital videofluoroscopy. Eur Spine J 2009; 18(11):1677-85.
  8. Breen AC, Muggleton JM, Mellor FE. An objective spinal motion imaging assessment (OSMIA): reliability, accuracy and exposure data. BMC Musculoskelet Disord 2006; 7:1.
  9. Mellor FE, Muggleton JM, Bagust J et al. Midlumbar lateral flexion stability measured in healthy volunteers by in vivo fluoroscopy. Spine (Phila Pa 1976) 2009; 34(22):E811-7.
  10. Gerigk L, Bostel T, Hegewald A et al. Dynamic magnetic resonance imaging of the cervical spine with high-resolution 3-dimensional T2-imaging. Clin Neuroradiol 2012; 22(1):93-9.

 

 Codes  Numbers  Description
CPT 76120 Cineradiography/videoradiography,
except where specifically included
  76125 Cineradiography/videoradiography
to complement routine examination
(list separately in addition to code
for primary procedure)
ICD-9 Diagnosis   Invetsigational for all codes
ICD-9 Procedure    
HCPCS    
ICD-10-CM (effective 10/1/14)    Investigational for all relevant diagnoses  
    M54.5 Low back pain  
ICD-10-PCS (effective 10/1/14)     ICD-10-PCS codes are only used for inpatient services.  
    BR10ZZZ, BR17ZZZ,
BR19ZZZ, BR1GZZZ 
Imaging, axial skeleton, fluoroscopy, codes for cervical,
thoracic, lumbar and whole spine 
Type of Service Radiology  
Place of Service Outpatient  


Index

Cineradiography
Digital Motion X-ray
Videofluorography
Videofluoroscopy
Videoradiography


Policy History 

12/12/06  Add to Radiology Section  New Policy
02/15/07 Replace policy – correction only Last sentence of “Rationale” section
“insufficient” corrected to “sufficient” 
03/13/08 Replace policy  Policy updated with literature review;
references 7 and 8 added; policy statement unchanged
09/10/09 Replace policy Policy updated with literature review;
no new references added; policy statement unchanged.
09/16/10 Replace policy Policy updated with literature review through July 2010; two references
removed and references reordered; new references 7 and 8 added; policy statement unchanged
09/01/11 Replace policy

Policy updated with literature review through July 2011; no new
references added; policy statement unchanged

9/13/12 Replace policy Policy updated with literature review through July 2012; reference 9 added; policy statement unchanged
9/12/13 Replace policy Policy updated with literature review through August 15, 2013; reference 8 added; policy statement unchanged