Clinical Policy Title: Computerized gait analysis

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1 Clinical Policy Title: Computerized gait analysis Clinical Policy Number: Effective Date: October 1, 2014 Initial Review Date: May 21, 2014 Most Recent Review Date: June 17, 2015 Next Review Date: May 2016 Policy contains: Specialized laboratories. Cerebral palsy. Spina bifida. Orthopedic surgery. ABOUT THIS POLICY: AmeriHealth Caritas Louisiana has developed clinical policies to assist with making coverage determinations. AmeriHealth Caritas Louisiana clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies, along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan- specific definition of medically necessary, and the specific facts of the particular situation are considered by AmeriHealth Caritas Louisiana when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. AmeriHealth Caritas Louisiana clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. AmeriHealth Caritas Louisiana clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, AmeriHealth Caritas Louisiana will update its clinical policies as necessary. AmeriHealth Caritas Louisiana clinical policies are not guarantees of payment. Coverage policy AmeriHealth Caritas Louisiana considers computerized gait analysis to be investigational and therefore, not medically necessary. Limitations: None. Alternative covered services: Observational clinical gait analysis. Background Gait and balance disorders are common in the elderly (where they constitute a significant contributor to falls), after orthopedic surgery, and in neurodevelopmental disorders, such as spina bifida and cerebral palsy. The clinical heterogeneity of gait disorders reflects the large and complex neuromuscular systems involved and the vulnerability of walking to neurologic disease at every level.

2 Neurodevelopmental disorders are impairments of growth and development of the brain and central nervous system occurring in infancy or childhood that unfold during the rest of life. These disorders have widespread effects that can impact such things as learning, memory and other cognitive functions, as well as voluntary muscle control (coordination, mobility, speech articulation). Neurodevelopmental disorders are attributable to genetics, metabolic or infectious diseases, physical trauma, and toxic or other environmental exposures. Specific examples covered by the reviews tabulated on pages 2 and 3 are: Cerebral palsy (CP) A group of permanent disorders causing physical disability (paralysis or uncontrollable muscle movements) and sometimes problems with sensation, depth perception and communication. Most cases are caused by damage to the motor cortex during pregnancy or childbirth, although a few are genetic. Improved prenatal and newborn care has decreased incidence to approximately two per 1,000 live births. CP is not treatable per se, but managed through problem-focused physical, occupational, and speech therapies, along with specialized education. Improved delivery, pre- and neonatal care have decreased incidence to approximately two per 1,000 live births. remove (duplicate) Spina bifida A congenital disorder caused by incomplete closure of the embryonic neural tube, which results in malformation of some vertebrae, usually in the lower thoracic and lumbar areas of the spine, along with protrusion of the spinal cord through an opening in the bone and myelomeningocele. While some mild forms of spina bifida are occult (not clinically evident), many forms are associated with nerve damage (e.g., ambulatory problems, loss of sensation, or skeletal malformations, such as hip dislocation or scoliosis, and bladder or bowel malfunction). Hydrocephalus may also accompany spina bifida, and along with it attention deficits and poor academic performance. Computerized or instrumented gait analysis is a technique used for certain conditions. Providers have historically diagnoses and classified gait by observation but common adaptation patterns to failing gaits, threatened stability, and declining performance make these classifications overlapping or otherwise lacking in discrimination. Standardized gait analysis in specialized laboratories equipped with cameras, floor sensors, and other equipment has been developed in response to the problems inherent in descriptive classification. Gait analyses are used to diagnose, plan treatments and evaluate outcomes. Definitions include: Comprehensive computer-based motion analysis by videotaping; three-dimensional kinematics; and dynamic plantar pressure measurements during walking. Dynamic surface electromyography of multiple muscles during walking or other functional activities. 2

3 Diagnostic testing has been the subject of much methodological discussion, summarized by Muir Gray (1997) and Sackett (1991). Understanding diagnostic test analysis through the progression of research is important to interpretation of the literature, and to rational clinical selection and use of tests. Briefly, evaluation of a diagnostic technology entails five levels (Banta and Luce, 1993): 1. Technical evaluation The technical output gives accurate information concerning the structure of the body part imaged. 2. Diagnostic accuracy This output concerns information that potentially improves the clinician s ability to diagnose disease and assess the patient s prognosis. 3. Diagnostic impact The information can alter plans for additional diagnostic tests. 4. Therapeutic impact The information can lead to changes in therapeutic plans for patients. 5. Health impact The end result may be improved patient outcome. Methods Searches (April 2014 to May 2014): AmeriHealth Caritas Louisiana searched PubMed and the databases of: UK National Health Services Centre for Reviews and Dissemination. Agency for Healthcare Research and Quality Guideline Clearinghouse and evidence-based practice centers. The Centers for Medicare & Medicaid Services (CMS). Search terms were gait disorders, and diagnosis. Included were: Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies. Guidelines based on systematic reviews. Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes sometimes referred to as efficiency studies which also rank near the top of evidence hierarchies. Overview of the literature: systematic reviews/guidelines and economic analyses for computerized gait analysis; reverse chronological order and then alphabetically by first author Findings: Computerized three-dimensional gait analysis is promising for identifying individuals in need of preventive measures (for falling) or rehabilitation (for walking) but is a complex process producing vast amounts of data. 3

4 Research is still defining those gait measures with the sensitivity and specificity likely to make them clinically useful. Thus, research is currently confined to the diagnostic accuracy level outlined above. While studies often show that gait analysis impacts decisions, many studies fail to address impacts on patient outcomes. Citation Health Net (2014) Wren and Ostuka (2013) Cincinnati Children s Hospital Medical Center (2011) Hamacher (2011) Wren and Gorton (2011) Content, Methods, Recommendations Computerized gait analysis: Observational analysis is sufficient to characterize most gait pathologies. However, with increasing walking complexity, objective analysis may become necessary. No CMS National or Local Coverage Determinations listed. Patient outcomes if surgeon had/didn t have results of gait analysis: 156 subjects, children with cerebral palsy For 83 and 73, surgeon did/did not receive the patient gait analysis report. Outcomes assessed before surgery and 1.3 years post-operatively. Child Health Questionnaire much better in 56% with report, 38% without. Pediatric Outcomes Data Collection Instrument for upper extremity showed better outcomes in patients whose surgeon received gait analysis report. Idiopathic toe walking in children and young adults: Does not address computerized gait analysis. Kinematic measures for gait stability in the elderly: Relevant original articles, 1980-Mar /9889 studies included. Best for distinguishing fallers from non-fallers: linear variability of temporal measures for swing and stance; old versus young adults: width and stride velocities. Linear and non-linear measures of foot-time series during gait predict healthy versus fallprone; Biomechanical measures promising for identifying individuals at risk of falling and can be obtained by relatively low cost clinical assessment. Efficacy of clinical gait analysis 1528 references, addressed technical accuracy efficacy. 89 addressed diagnostic accuracy efficacy. 11 addressed diagnostic and therapeutic efficacy. 7 addressed patient outcomes efficacy. 1 addressed societal efficacy. Strong evidence of efficacy overall. Patient outcome/cost-effectiveness efficacy found, without randomized controlled trials. 4

5 Citation Sharma (2009) Wren and Kalisvaart (2009) Content, Methods, Recommendations Factors influencing early rehab after total hip arthroplasty: CCTs, trials (2060 subjects). Preoperative physical therapy, aggressive post-operative pain control, and minimally invasive surgical procedures (but not gait analysis) improved functional recovery. Effects of preoperative gait analysis on costs 462 subject with CP, 313/149 with/without gait analysis preoperatively. 11% and 32% of gait/non-gait subjects had additional surgeries. Costs per person-year were $916/$3009 for gait/non-gait subjects. Tomie (1997) Alberta Heritage Foundation Hayes (2006) Cerebral palsy, spina bifida, orthopedic disorders: Gait analysis is potentially useful in the management of walking disabilities but its efficacy has not been established. Rehabilitation of children with cerebral palsy and spina bifida: Relevant peer-reviewed English-language clinical studies, 1996 October studies: prospective controlled/comparative (6); prospective uncontrolled (1); case series (1); retrospective (4) CP subjects; 28 spina bifida; post-surgical orthopedic (57); surgical decisions or treatment planning (87). Most studies used Vicon motion analysis systems but number, placement of monitors, and data collect varied; overall, heterogeneity precluded analysis of consistency among outcomes. Sample sizes too small for valid comparisons among study groups and no usable orthopedic patient data. Limited evidence that gait analysis can distinguish normal versus abnormal gaits and may influence clinical decisions but insufficient evidence to assess impact on continuum of care or outcomes. Glossary Hydrocephalus An abnormal accumulation of cerebrospinal fluid in the ventricles or cavities within the brain. It can cause increased pressure and neurological symptoms such as convulsions, vision abnormalities, or headache. It can be treated by shunting the excess fluid by catheter into other body cavities, but this does not resolve neurologic defects. Myelomeningocele A protuberance of the spinal cord and covering tissues (meninges) through the spine defect in spina bifida. Since many individuals with disabling spina bifida also have myelomeningocele, the terms are sometimes (incorrectly) used interchangeably. 5

6 Scoliosis Curvature of the spine from side to side, forming an S shape on radiographs. Sensitivity The proportion of people with the disease who have a positive test result. Specificity The proportion of people without a disease who have a negative test result. Related Policies AmeriHealth Caritas Louisiana Utilization Management program description. References Professional society guidelines: Banta HD, Luce BR. Health Care Technology and its Assessment: An International Perspective. New York: Oxford University Press, 1993: 384 Pages. Cincinnati Children s Hospital Medical Center. Evidence-based care guideline for management of idiopathic toe walking in children and young adults ages 2 through 21 years. Cincinnati (OH): Cincinnati Children s Hospital Medical Center Hayes, Inc. Computerized gait analysis for cerebral palsy, spina bifida, and orthopedic disorders. Lansdale: Hayes, Inc. Directory Publication Tomie J-A, Hailey D. Computerized gait analysis in the rehabilitation of children with cerebral palsy and spina bifida. Alberta Heritage Foundation for Medical Research (AHFMR)1997:38. Peer-reviewed references: Cimolin V, Galli M. Summary measures for clinical gait analysis: a literature review. Gait and Posture 2014;39(4): Dobson F, Morris ME, et al. Gait classification in children with cerebral palsy: a systematic review. Gait and Posture 2007 Jan;25(1): Ewen AM, Stewart S, St. Clair GA, Kashyap SN, Caplan N. Post-operative gait analysis in total hip replacement patients: a review of the current literature and meta-analysis. Gait and Posture 2012;36(1):1 6. Hamacher D, Singh NB, Van Dieën JH, Heller MO, Taylor WR. Kinematic measures for assessing gait stability in elderly individuals: a systematic review. Journal of the Royal Society Interface 2011: Hogan N, Coote S. Therapeutic interventions in the treatment of people with multiple sclerosis with mobility problems: a literature review. Physical Therapy Reviews 2009;14(3): Honaker JA. Clinical use of the gaze stabilization test for screening risk in community-dwelling older adults. Otology and Neurology 2013 Jun;34(4):

7 McClellan JA, Webster KA, Feller JA. Gait analysis of patients following total knee replacement: a systematic review. The Knee 2007 Aug: Sharma V, Morgan PM, Cheng EY. Factors influencing early rehabilitation after total hip arthroplasty: a systematic review. Clinical Orthopedics and Related Research 2009;467(6): Wren TA, Elihu KJ et al. Differences in implementation of gait analysis recommendations based on affiliation with a gait laboratory. Gait and Posture 2013 Feb;37(2): Wren TA, Otsuka NY et al. Outcomes of lower extremity orthopedia surgery in ambulatory children with Cerebral Palsy with and without gait analysis: results of a randomized controlled trial. Gait and Posture 2013 Jun;38(2): Wren TA, Gorton GE, et al. Efficacy of clinical gait analysis: a systematic review. Gait and Posture 2011 Jun;34(2): Wren TA, Kalisvaart MM et al. Effects of preoperative gait analysis on costs and amount of surgery. Journal of Pediatric Orthopedics 2009 Sep;29(6): Clinical trials: Reviews in the evidence table (page 3 to page 6) cover trials published through CMS National Coverage Determinations (NCDs): There are no CMS NCDs as of the policy update. Local Coverage Determinations (LCDs): There are no LCDs as of the policy update. Commonly submitted codes Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill accordingly. CPT/HCPCS codes Code Description Comprehensive computer-based motion analysis by videotaping and 3- D kinematics Comprehensive computer-based motion analysis by video-taping and 3-D kinematics; with dynamic plantar pressure measurements during walking Dynamic surface electromyography, during walking or other functional activities, 1-12 muscles 7

8 96003 Dynamic fine wire electromyography, during walking or other functional activities, 1 muscle Review and interpretation by physician or other qualified health care professional of comprehensive computer-based motion analysis dynamic plantar pressure measurements, dynamic surface electromyography during walking or other functional activities, and dynamic fine wire electromyography, with written report ICD-9 Codes Description Gait disorder Cerebral palsy Spina bifida ICD-10 Code ICD-10 Description G80.0 Spastic quadriplegic cerebral palsy G80.1 Spastic diplegic cerebral palsy G80.2 Spastic hemiplegic cerebral palsy G80.8 Other cerebral palsy Q05.0 Cervical spina bifida with hydrocephalus Q05.1 Thoracic spina bifida with hydrocephalus Q05.2 Lumbar spina bifida with hydrocephalu Q05.3 Sacral spina bifida with hydrocephalus Q05.4 Unspecified spina bifida with hydrocephalus Q05.5 Cervical spina bifida without hydrocephalus Q05.6 Thoracic spina bifida without hydrocephalus Q05.7 Lumbar spina bifida without hydrocephalus Q05.8 Sacral spina bifida without hydrocephalus Q05.9 Spina bifida, unspecified Q07.00 Arnold-Chiari syndrome without spina bifida or hydrocephalus Q07.01 Arnold-Chiari syndrome with spina bifida Q07.02 Arnold-Chiari syndrome with hydrocephalus Q07.03 Arnold-Chiari syndrome with spina bifida and hydrocephalus R26.0 Ataxic gait R26.1 Paralytic gait R26.81 Unsteadiness on feet R26.89 Other abnormalities of gait and mobility R26.9 Unspecified abnormalities of gait and mobility 8