mp-511
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Dynamic Spinal Visualization and Vertebral Motion Analysis

Policy Number: MP-511

Latest Review Date: September 2021

Category: Radiology                                                             

Policy Grade: C

POLICY:

Effective for dates of service on or after October 1, 2018:

The use of dynamic spinal visualization is considered investigational.

Vertebral motion analysis is considered investigational.


Effective for dates of service prior to September 30, 2018:

The use of dynamic spinal visualization is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Dynamic spinal visualization is a general term addressing different imaging technologies 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 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 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 (e.g., physical therapy, decompression, or spinal fusion) or to assess the efficacy of spinal fusion.

Dynamic Spinal Visualization

Digital Motion X-Ray

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 then 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

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

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 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.

Vertebral Motion Analysis

Vertebral 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.

KEY POINTS:

This policy has been updated regularly with searches of the MEDLINE database. The most recent literature update was performed through July 23, 2021.

Summary of Evidence

For individuals who have back or neck pain who receive dynamic spinal visualization, the evidence includes comparative trials. Relevant outcomes are test accuracy, symptoms, and functional outcomes. Techniques include digital motion x-rays, cineradiography/videofluoroscopy, or dynamic magnetic resonance imaging of the spine. Most available studies compare spine kinetics in patients with neck or back pain to that in healthy controls. In a feasibility study of 21 patients examining dynamic MRI for the detection of spondylolithesis, 3 dynamic MRI protocols demonstrated sensitivities of 68.8% to 78.6% when compared to standard flexion-extension radiographs. No evidence was identified on the effect of this technology on symptoms or functional outcomes. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have back or neck pain who receive vertebral motion analysis, the evidence includes comparisons to standard flexion/extension radiographs. Relevant outcomes are test accuracy, symptoms, and functional outcomes. These studies reported that vertebral motion analysis reduces variability in measurement of rotational and translational spine movement compared with standard flexion/extension radiographs. Whether the reduction in variability improves diagnostic accuracy or health outcomes is uncertain. The single study that reported on diagnostic accuracy lacked a true criterion standard, limiting interpretation of findings. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

No guidelines or statements were identified.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Cineradiography, Digital Motion X-ray, Videofluorography, Videofluoroscopy, Videoradiography, Vertebral Motion Analysis, VMA, KineGraph VMA, Motion Normalizer, Ortho Kinematics

APPROVED BY GOVERNING BODIES:

In 2012, the KineGraph VMA™ (Vertebral Motion Analyzer; Ortho Kinematics) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process (K133875). 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. Table 1 lists a sampling of the spinal visualization and motion analysis devices currently cleared by the FDA.

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

Device

Manufacturer

Date Cleared

510(k) No.

Indication

SuRgical Planner (SRP) BrainStorm

Surgical Theater, Inc.

07/17/2020

K201465

For use in spinal visualization and motion analysis for neck and back pain

Bone VCAR (BVCAR)

GE Medical Systems SCS

4/8/2019

K183204

For use in spinal visualization and motion analysis for neck and back pain

mediCAD 4.0

mediCAD Hectec Gmbh

9/7/2018

K170702

For use in spinal visualization and motion analysis for neck and back pain

VirtuOst Vertebral Fracture Assessment

O.N. Diagnostics LLC.

8/3/2018

K171435

For use in spinal visualization and motion analysis for neck and back pain

Surgical Planning Software Version 1.1

Ortho Kinematics Inc.

11/8/2017

K173247

For use in spinal visualization and motion analysis for neck and back pain

VMA System version 3.0

Ortho Kinematics Inc.

8/25/2017

K172327

For use in spinal visualization and motion analysis for neck and back pain

OKI Surgical Planning Software

Ortho Kinematics Inc.

8/22/2017

K171617

For use in spinal visualization and motion analysis for neck and back pain

UNiD Spine Analyzer

MEDICREA INTERNATIONAL

5/24/2017

K170172

For use in spinal visualization and motion analysis for neck and back pain

Dynamika

IMAGE ANALYSIS LIMITED

5/17/2017

K161601

For use in spinal visualization and motion analysis for neck and back pain

spineEOS

ONEFIT MEDICAL

4/8/2016

K160407

For use in spinal visualization and motion analysis for neck and back pain

Philips Eleva Workspot with SkyFlow

Philips Medical Systems DMC GmbH

12/22/2015

K153318

For use in spinal visualization and motion analysis for neck and back pain

Centricity Universal Viewer

GE HEALTHCARE

5/26/2015

K150420

For use in spinal visualization and motion analysis for neck and back pain

SPINEDESIGN Spine Surgery Planning (Software Application)

MEDTRONIC SOFAMOR DANEK USA INC.

5/22/2015

K142648

For use in spinal visualization and motion analysis for neck and back pain

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan.  FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

CURRENT CODING: 

CPT Codes:

76120

Cineradiography/videoradiography, except where specifically included

76125

Cineradiography/videoradiography to complement routine examination (list separately in addition to code for primary procedure)

REFERENCES:

  1. 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):1677-1685.
  2. Breen AC, Muggleton JM, Mellor FE. An objective spinal motion imaging assessment (OSMIA): reliability, accuracy and exposure data. BMC Musculoskelet Disord 2006; 7:1.
  3. Cheng B, Castellvi AE, Davis RJ, et al. Variability in flexion extension radiographs of the lumbar spine: a comparison of uncontrolled and controlled bending. Int J Spine Surg. Jul 2016;10:20.
  4. Davis RJ, Lee DC, Wade C, et al. Measurement performance of a computer assisted vertebral motion analysis system. Int J Spine Surg. Aug 2015;9:36.
  5. 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):444-450.
  6. 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):93-99.
  7. 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):163-168.
  8. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
  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):E811-817.
  10. 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):1743-174.
  11. 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):1858-1865.
  12. 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):313-325.
  13. Walter WR, Alizai H, Bruno M, et al. Real-time dynamic 3-T MRI assessment of spine kinematics: a feasibility study utilizing three different fast pulse sequences. Acta Radiol. Jan 2021; 62(1): 58-66.
  14. 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):1636-1641.
  15. Xu N, Wang S, Yuan H, et al. Does Dynamic Supine Magnetic Resonance Imaging Improve the Diagnostic Accuracy of Cervical Spondylotic Myelopathy? A Review of the Current Evidence. World Neurosurg. Apr 2017; 100: 474-479.
  16. Yeager MS, Cook DJ, Cheng BC. Reliability of computer-assisted lumbar intervertebral measurements using a novel vertebral motion analysis system. Spine J. Feb 1 2014;14(2):274-281.

POLICY HISTORY:

Medical Policy Group, September 2012 (4)

Medical Policy Administration Committee, October 2012

Available for comment October 24 through December 10, 2012

Medical Policy Group, September 2013 (4): Updated Key points, Approved Governing Bodies, and References. No changes were made to the policy statement. 

Medical Policy Panel, September 2014

Medical Policy Group, September 2014 (3): 2014 Updates to Key Points; no change in policy statement.

Medical Policy Panel, September 2015

Medical Policy Group, September 2015 (2):2015 Updates to Description and Key Points, no change in policy statement.

Medical Policy Panel, March 2017

Medical Policy Group, March 2017 (3): 2017 Updates to Key Points and Coding. No References added; no change in policy statement.

Medical Policy Panel, September 2018

Medical Policy Group, November 2018 (7): Updates to Title, Description, Key Points, and References. Added Keywords: Vertebral Motion Analysis, VMA, KineGraph VMA. Policy statement updated to add vertebral motion analysis as investigational.

Medical Policy Panel, September 2019

Medical Policy Group, October 2019 (7): Update to Key Points. No References added; no change in policy statement.

Medical Policy Panel, September 2020

Medical Policy Group, October 2020 (7): Update to Key Points, Approved by Governing Bodies and References. No change in policy statement.

Medical Policy Panel, September 2021

Medical Policy Group, September 2021 (7): Updates to Description, Key Points, Key Words, Governing Bodies, Practice Guidelines, Coding and References. Policy statement updated to remove “not medically necessary,” no change to policy intent.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

  1. The technology must have final approval from the appropriate government regulatory bodies;
  2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
  3. The technology must improve the net health outcome;
  4. The technology must be as beneficial as any established alternatives;
  5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

  1. In accordance with generally accepted standards of medical practice; and
  2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
  3. Not primarily for the convenience of the patient, physician or other health care provider; and
  4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.