Clinical Policy Title: Computerized gait analysis

Transcription

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: May 1, 2018 Next Review Date: May 2019 Related policies: Policy contains: Specialized laboratories. Gait dysfunction. Cerebral palsy. Orthopedic surgery. None. ABOUT THIS POLICY: Prestige Health Choice has developed clinical policies to assist with making coverage determinations. Prestige Health Choice s 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 Prestige Health Choice 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. Prestige Health Choice s 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. Prestige Health Choice s clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, Prestige Health Choice will update its clinical policies as necessary. Prestige Health Choice s clinical policies are not guarantees of payment. Coverage policy Prestige Health Choice considers the use of computerized gait analysis (also referred to as comprehensive motion analysis) to be clinically proven and, therefore, medically necessary for the evaluation of musculoskeletal function upon gait to aid in planning for orthopedic surgery or interventional neurology (e.g., nerve blocks to reduce spasticity orthotic application) in ambulatory members with certain gait dysfunction) (National Institute for Health and Care Excellence [NICE], 2012; Wren, 2009; 2013): Limitations: Cerebral palsy (CP). Meningomyelocele. Traumatic brain injury. Incomplete quadriplegia. Spastic hemiplegia. Spastic diplegia. 1

2 Coverage determinations are subject to benefit limitations and exclusions as delineated by the state Medicaid authority. The Florida Medicaid website may be accessed at All other uses of computerized gait analysis are not medically necessary. These services are payable only in a facility setting. Comprehensive computerized gait analysis studies are limited to one study performed once prior to planned intervention (e.g., surgery or nerve blocks to reduce spasticity orthotic application), and may be performed once after intervention to evaluate the results of the intervention. 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 CP. 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. Neurodevelopmental disorders are impairments of growth and development of the brain and central nervous system occurring in infancy or childhood that unfolds 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. Among the most common are CP and spinal bifida. Computerized or instrumented gait analysis: Providers have historically diagnosed and classified gait by observation, but common adaptation patterns to failing gaits, threatened stability, and declining performance cause classifications of gait to overlap or otherwise lack 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. Types of gait analysis include: comprehensive computer-based motion analysis by videotaping; threedimensional kinematics; dynamic plantar pressure measurements during walking; and dynamic surface electromyography of multiple muscles during walking or other functional activities. Gait analyses are used to diagnose, plan treatments, and evaluate outcomes. 2

3 Searches Prestige Health Choice searched PubMed and the databases of: UK National Health Services Centre for Reviews and Dissemination. Agency for Healthcare Research and Quality s National Guideline Clearinghouse and other evidence-based practice centers. The Centers for Medicare & Medicaid Services (CMS). We conducted searches on March 15, Search terms were: gait analysis, Gait Disorders, Neurologic/analysis [MeSH], Gait Disorders, Neurologic/diagnosis [MeSH], Cerebral Palsy/rehabilitation [MeSH], Cerebral Palsy/surgery [MeSH], and Spinal Dysraphism [MeSH]. We included: 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. 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. Research is still defining those gait measures with the sensitivity and specificity likely to make them clinically useful. Thus, research is currently confined to its technical ability to provide necessary and accurate information for clinical decision making. While studies often show that gait analysis impacts decisions, many studies fail to address impacts on patient outcomes. Policy updates: In 2016, we identified no new evidence for this policy. We found one new CMS Local Coverage Determination that covers Florida, Puerto Rico, and the U.S. Virgin Islands and is reflected in the policy for Medicare members only. In 2017, we identified one evidence-based guideline from the National Collaborating Centre for Women's and Children's Health in the United Kingdom for this policy (NICE, 2012). The routine use of computerized gait analysis remains controversial. While it can alter decision making in some cases, it is less clear if the decisions based on computerized gait analysis lead to better patient outcomes. However, in ambulatory children with certain gait dysfunction (e.g., CP) who are candidates for orthopedic surgery, it can aid in 3

4 surgical planning by identifying common patterns of muscle overactivity and deformity and determining what type of muscle, tendon, or joint surgery would be most helpful. Therefore, this policy was amended to reflect this information. In 2018, no new evidence was identified. The guideline published by National Collaborating Centre for Women's and Children's Health (NICE, 2012) was updated in 2016 but the changes do not affect this coverage policy. The two CMS Local Coverage Determination documents that were previously included have both been retired. Summary of clinical evidence: Citation Wren (2013) Outcomes of lower extremity orthopedic surgery in ambulatory children with CP with and without gait analysis NICE (2012) Management of spasticity and co-existing motor disorders and their early musculoskeletal complications Hamacher (2011) Kinematic measures for gait stability in the elderly Wren (2011) Content, Methods, Recommendations A randomized controlled trial (RCT) of 83 children with gait analysis, 73 without. Outcomes assessed before surgery and 1.3 years post-operatively. Child Health Questionnaire showed improvement 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. On average, only 42% of recommendations based on gait report were followed versus 35% in the control group (p = 0.23). The decision to perform orthopedic surgery to improve gait should be informed by a thorough pre-operative functional assessment, preferably including gait analysis (either instrumented or video analysis). Systematic review of 29 relevant original articles, 1980 to March Best for distinguishing those at increased risk of falling from those at lower risk: 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 fall-prone. Biomechanical measures promising for identifying individuals at risk of falling and can be obtained by relatively low-cost clinical assessment. Combined retrospective and prospective studies that incorporate the most promising measures for understanding fall risk and designing preventive strategies are warranted. Efficacy of clinical gait analysis Literature review of 116 studies that addressed technical feasibility of clinical gait analysis: 89 addressed diagnostic performance; 11 addressed impact on clinical diagnosis and treatment decision making; 7 addressed patient outcomes; 1 addressed impact on societal burden. All observational or non-randomized studies. Overall quality: unclear. 4

5 Citation Sharma (2009) Factors influencing early rehab after total hip arthroplasty Wren (2009) Effects of preoperative gait analysis on costs Hayes (2006) Content, Methods, Recommendations Greater volume of evidence for technical feasibility, diagnostic accuracy, impact of gait analysis on diagnosis and treatment decisions, but very limited evidence for its effect on patient outcome/cost-effectiveness without RCTs. Systematic review of 16 clinical trials (2,060 total subjects) with various interventions. Preoperative physical therapy, aggressive post-operative pain control and minimally invasive surgical procedures (but not gait analysis) improved functional recovery. 462 subjects 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/$3,009 for gait/non-gait subjects. Rehabilitation of children with CP and spina bifida Systematic review of 12 studies: prospective controlled/comparative (6); prospective uncontrolled (1); case series (1); retrospective (4). Diagnoses: CP; 28 spina bifida; 57 post-surgical orthopedic. Assessment of surgical decisions or treatment planning in 87 subjects. Overall quality: low with high risk of bias. 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. References Professional society guidelines/other: 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 National Collaborating Centre for Women's and Children's Health. Spasticity in children and young people with non-progressive brain disorders. Management of spasticity and co-existing motor disorders and their early musculoskeletal complications. London (UK); 2012 Jul. Updated 2016 Nov. 54 p. (NICE clinical guideline; no. 145). National Institute for Health and Clinical Excellence (NICE) website. Accessed March 15, Peer-reviewed references: 5

6 Cimolin V, Galli M. Summary measures for clinical gait analysis: a literature review. Gait Posture. 2014; 39(4): Dobson F, Morris ME, Baker R, Graham HK. Gait classification in children with cerebral palsy: a systematic review. Gait Posture. 2007; 25(1): Hamacher D, Singh NB, Van Dieen JH, Heller MO, Taylor WR. Kinematic measures for assessing gait stability in elderly individuals: a systematic review. J R Soc Interface. 2011; 8(65): Hayes Inc., Hayes Medical Technology Report. Computerized gait analysis for cerebral palsy, spina bifida, and orthopedic disorders. Lansdale, Pa. Hayes Inc.; McClelland JA, Webster KE, Feller JA. Gait analysis of patients following total knee replacement: a systematic review. Knee. 2007; 14(4): Sharma V, Morgan PM, Cheng EY. Factors influencing early rehabilitation after THA: a systematic review. Clin Orthop Relat Res. 2009; 467(6): Wren TA, Gorton GE, 3rd, Ounpuu S, Tucker CA. Efficacy of clinical gait analysis: A systematic review. Gait Posture. 2011; 34(2): Wren TA, Kalisvaart MM, Ghatan CE, et al. Effects of preoperative gait analysis on costs and amount of surgery. J Pediatr Orthop. 2009; 29(6): Wren TA, Otsuka NY, Bowen RE, et al. Outcomes of lower extremity orthopedic surgery in ambulatory children with cerebral palsy with and without gait analysis: results of a randomized controlled trial. Gait Posture. 2013; 38(2): CMS National Coverage Determinations (NCDs): No NCDs were identified as of the writing of this policy. Local Coverage Determinations (LCDs): L33902 Comprehensive Motion Analysis Studies. CMS website. Accessed May 10, Note: this policy was retired for services rendered on or after May 10, L34310 Medicine: Physical Therapy Outpatient. CMS website. Accessed May 10, Note: this policy was retired for services rendered on or after February 17, Commonly submitted codes 6

7 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 Code Description Comments 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 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-10 Code Description Comments G80.0-G80.9 Cerebral palsy G81.10-G81.14 Spastic hemiplegia G82.52 Incomplete quadriplegia, C1-C4 level G82.54 Incomplete quadriplegia, C5-C7 level Q05.0-Q05.9 Spina bifida Q07.00-Q07.03 Arnold-Chiari syndrome 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 S06.1X0- S06.9X9S Traumatic brain injury HCPCS Level II Code N/A Description Comments 7