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DESCRIPTIONGait analysis (GA) is the quantitative laboratory assessment of coordinated muscle function, typically requiring a dedicated facility and staff and analysis of a video recorded observation of a patient walking. Gait analysis has been proposed as an aid in surgical planning, primarily for children with cerebral palsy (CP). It is also a potential tool to help plan rehabilitative strategies for ambulatory problems related to cerebral palsy, aging, stroke, spinal cord injury, and other conditions.
Gait analysis is the quantitative laboratory assessment of coordinated muscle function, typically requiring a dedicated facility and staff. At its core is videotaped observation of patient walking. Videos can be observed from several visual planes at slow speed, allowing detection of movements not detectable at normal speed. Joint angles can be measured, and various time-distance variables can be measured including step length, stride length, cadence, and cycle time. Electromyography (EMG), assessed during walking, measures timing and intensity of muscle contractions. This allows determination of whether a certain muscle’s activity is normal, out of phase, continuous, or clonic.
Kinematics is the term used to describe movements of joints and limbs such as angular displacement of joints and angular velocities and accelerations of limb segments. The central element of kinematic assessment is some type of marker system that is used to represent anatomic landmarks, which are then visualized and quantitatively assessed during analysis of videotaped observations. Movement data are compiled by computer from cameras oriented in several planes, and the movement data are processed so that the motion of joints and limbs can be assessed in 3 dimensions. The range and direction of motion of a particular joint can be isolated from all the other simultaneous motions that are occurring during walking. Graphic plots of individual joint and limb motion as a function of gait phase can be generated.
Kinetics is the term used to describe those factors that cause or control movement. Evaluating kinetics involves the use of principles of physics and biomechanics to explain the kinematic patterns observed and generate analyses that describe the forces generated during normal and abnormal gait analysis.
Gait analysis has been proposed as an aid in surgical planning, primarily for cerebral palsy but also for other conditions such as clubfoot. In addition, it is being investigated as a means to plan rehabilitative strategies (i.e., orthotic-prosthetic devices) for ambulatory problems related to cerebral palsy, aging, stroke, spinal cord injury. etc.
The ElectrodynogramTM (EDG) is one of many technologies used in gait analysis. It is a computerized diagnostic device that quantitatively measures and times the weight bearing forces exerted on the feet and legs. EDG use is proposed in diagnosing orthopedic conditions, in rehabilitative medicine and physical therapy, for peripheral vascular disease, diabetes, neurological disorders, and for prosthetics and orthotics. The ElectrodynogramTM is often used in conjunction with various other components of gait analysis (e.g., electromyography and videotaping).
Gait analysis may also involve the use of a electromyographic device and many such devices have 510(k) marketing clearance from the FDA (e.g., MA-300 Electromyographic System by Motion Lab Systems, Inc., ADR-2000 Ambulatory Data Recording System by Aaron Laboratories). In addition, several commercially available systems have received FDA 510(k) marketing clearance for movement recordings. These include Orthotrak by Motion Analysis Corporation, 2K-QDA Motion/Gait Analysis System by Human Performance Technologies, and Coda MPX30 Motion Analysis System by Pinsco Inc.
In May 2003, the Peak Motus Motion Measurement System (Peak Performance Technologies) was cleared for marketing by the FDA through the 510(k) process. This system uses off-the-shelf video cameras and sensors and proprietary software to document human movement in two- or three-dimensional space. The FDA determined that this device was substantially equivalent to existing devices and is indicated for assessment and training of limb or body motion in gait analysis, pre- or post-rehabilitation evaluation, physical therapy, and similar applications.
POLICYComprehensive gait analysis may be considered medically necessary as an aid in surgical planning in patients with gait disorders associated with cerebral palsy.
Comprehensive gait analysis is considered investigational for all other applications including but not limited to:
Gait analysis that is not comprehensive is considered investigational.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all devices approved by the FDA may not be considered investigational. Therefore, FDA-approved devices may be assessed on the basis of their medical necessity.
Comprehensive gait analysis includes a quantitative assessment of coordinated muscle function in a dedicated laboratory.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good 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. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY11/1989: Approved by Medical Policy Advisory Committee (MPAC)
3/1994: Reviewed by MPAC; investigational status maintained
1/18/2002: New technologies added to "description" section; "sources" section updated.
2/12/2002: Investigational definition added
2/21/2002: Title renamed "Gait (Motion) Analysis"
2/25/2002: Code Reference, Sources, Type of Service, and Place of Service sections updated
5/1/2002: Type of Service and Place of Service deleted
6/5/2002: Code Reference section updated
4/19/2004: Policy reviewed, Description revised to be consistent with BCBSA policy # 2.01.03
8/9/2005: Code Reference section reviewed, no changes
8/3/2007: Policy reviewed, no changes
6/23/2010: Policy Title revised to remove "Motion." Policy Description section revised to add language about the use gait analysis as an aid in surgical planning primarily for children with cerebral palsy and FDA marketing clearance of the Peak Motus Motion Measurement System. Policy Statement section revised to add that comprehensive gait training may be considered medically necessary as an aid in surgical planning in patients with gait disorders associated with cerebral palsy; however, all other applications remain investigational. Gait analysis that is not comprehensive is considered investigational. Policy Guidelines section revised to add that comprehensive gait analysis must include a quantitative assessment of coordinated muscle function in a dedicated laboratory. FEP verbiage was added to the Policy Exception section. Code Reference section was revised to remove the non-covered codes table. A Covered Codes Table was added. The following CPT Codes were moved to covered: 96000, 96001, 96002, 96003 and 96004. ICD-9 Diagnosis Codes 343.0 - 343.9 were added to the Covered Codes Table. CPT Code 97116 was removed from the table.
05/17/2011: The second policy statement was revised to specify that gait analysis for surgical planning for conditions other than gait disorders associated with cerebral palsy, and post-operative evaluation, rehabilitation planning and/or evaluation for all conditions is considered investigational. Removed outdated references from the Sources section.
03/02/2012: Policy reviewed; no changes.
04/17/2013: Policy reviewed; no changes.
08/28/2015: Medical policy revised to add ICD-10 codes. Code description updated for CPT code 96004 in the Code Reference section.
04/26/2016: Policy Guidelines updated to add medically necessary and investigative definitions.
SOURCE(S)Blue Cross Blue Shield Association policy # 2.01.03
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.