Clinical Policy Title: Cognitive Rehabilitation for Traumatic Brain Injury

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1 Clinical Policy Title: Cognitive Rehabilitation for Traumatic Brain Injury Clinical Policy Number: (391) Effective Date: December 1, 2013 Initial Review Date: July 17, 2013 Most Recent Review Date: Aug. 21, 2013 Next Review Date: July 16, 2014 Policy contains: Cognitive rehabilitation. Traumatic brain injury (TBI). Mild TBI (mtbi)/concussion. Multidisciplinary rehabilitation. 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 Services (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 the use of cognitive rehabilitation to be clinically proven and, therefore, medically necessary when all of the following criteria are met: There has been a traumatic brain injury. Meets criteria for admission to a rehabilitation facility or for outpatient rehabilitation treatment. Requires intensive interdisciplinary services at least three hours per day five to seven days/week of at least two different types of therapy (physical, occupational, speech, cognitive, and pulmonary. Responsive to verbal or visual stimuli and demonstrates ability or potential to make progress and achieve goals (i.e., not comatose or in a vegetative state). No current substance abuse or acute psychiatric disorders. Scores at least level 3 or evolving (to level 4..6) on the Rancho Los Amigos Level of Cognitive Function Scale (pages 3-4),. Specific short- and long-term goals and an anticipated discharge/completion date are documented. In adults aged 21 and over the injury occurred no more than six months from date of request. 1

2 Limitations: All other uses of cognitive rehabilitation are not medically necessary. Furthermore, cognitive rehabilitation in the following settings is not eligible for coverage of the following services whose effectiveness and medical necessity has not been established in the peer-reviewed literature: Transitional living. Day or community-based programs. Vocational rehab. Structured adult education. Community re-entry programs. Behavioral training. Employment counseling. Work hardening. Music, recreation or art therapies. Intelligence testing. Alternative Covered Services: Background Cognitive rehabilitation includes therapies (delivered by speech, occupational, or neuropsychological therapists) that are designed to improve intellectual, perceptual, and behavioral skills after damage to the central nervous system. These therapies intend ultimately to increase levels of self-management and independence. Interventions include retraining in abilities to think, use judgment, and make decisions. The focus is on correcting deficits in memory; concentration and attention; perception; learning, planning and sequencing of tasks. Interventions are further classified as restorative/remedial (using a variety of repetitive approaches); and compensatory/adaptive (adaptive devices and/or modification of the environment). Burden of disease Head injury is the most common cause of death in young adults in the Western world, accounting for up to two-thirds of in-hospital deaths and for a much larger proportion of lifelong disability after trauma. Outcome and potential for successful rehabilitation depend on the primary brain damage and on the quality of early management, adequate referral policy, prompt diagnosis and treatment of mass lesions, as well as preventing, limiting and treating processes leading to secondary damage. Evaluation Since its introduction in 1974, the Glasgow Coma Scale (GCS) has been widely adopted as an initial measure of the severity of brain injury. The GCS score summarizes responses in three domains: eye opening; verbal; and motor. GCS is established as a predictor of both immediate and long-term outcome after traumatic brain injury. TBI can be categorized as severe, moderate, or mild based on the presenting GCS. A GCS of 8 is considered representative of severe brain injury (3 8 indicating coma); 9 3 moderate brain injury, and mild brain injury or concussion. Patients presenting with severe brain injury have the highest mortality rate, typically reported in the range of 39% 51%. These patients are also at highest risk for the development of intracranial hypertension and thus are most likely to benefit from intervention to control intracranial pressure. Therefore, this group of patients wills most likely benefit from early 2

3 intervention to minimize secondary brain injury. The Rancho Los Amigos Cognitive Scale (below) further refines outcome prediction and monitoring for rehabilitation settings. Study types used in preparing this policy Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies, for cognitive rehabilitation are listed in Table 1, and other policies in Table 2. Systematic reviews use predetermined transparent methods to minimize bias, and are therefore rated highest in evidence- grading hierarchies. Economic analyses (cost-effectiveness, benefit or -utility studies, which report both costs and outcomes; but not simple cost studies), sometimes known as efficiency studies, also rank near the top of evidence hierarchies. Since searches for primary studies included in systematic reviews often cover several decades, a list of published reviews provides a snapshot of the literature along with gaps in the evidence base. Table 1 lists systematic reviews for cognitive rehabilitation along with diagnoses addressed in the reviews, years of literature covered, and major conclusions. Table 2 lists profession association guidelines and other clinical policies. Ranchos Los Amigos Cognitive Scale Describes and monitors a patient s level of functioning and progress over extended periods: Level Classification Definition I No response Unresponsive to all stimuli. II Generalized Inconsistent, non-purposeful reaction to stimuli. Responds to pain but may be delayed. III Localized Inconsistent reaction directly related to type of stimulus. Response to some commands. May respond to discomfort. IV Confused Disoriented and unaware of present. Occasional agitation with frequent bizarre or inappropriate responses. Short attention span and impaired information processing. V Confused, inappropriate, nonagitated Non-purposeful, fragmented, or random responses to complex tasks. Appears alert and responds to commands. Performs previous learned tasks but unable to learn new ones. VI Confused appropriate Goal-directed behavior. Responses to situation appropriate. Incorrect responses due to memory difficulties. VII Automatic appropriate Robot-like correct routine responses. Oriented to setting. Poor insight, judgment, problem-solving. VIII Purposeful appropriate (stand by assist) Consistent person, place, time orientation. Recalls and integrates past with present. Depressed, irritable, low frustration tolerance, angry and argumentative. 3

4 Level Classification Definition IX Purposeful appropriate (may request stand by assist) Independently shifts among tasks and completes accurately for at least two consecutive hours. May be agitated and depressed. X Purposeful and appropriate (modified independence) Self-monitors appropriateness. Multi-tasks regardless of environment. May need periodic breaks. Irritable and intolerant of frustration in case of illness, fatigue or stress. Table 1: Other guidelines/coverage Citation CMS ( NMP 129; 2013) Content/methods Cognitive rehabilitation post TBI: 3 hrs/day inpatient rehab following TBI AND all of the following: o Patient meets criteria for rehab admission. o Patient requires intensive interdisciplinary services 3 hrs/day 5-7 days/week of 2 different types of therapy (PT, OT, speech, cognitive, pulmonary). o Specific short- and long-term goals and anticipated discharge date are documented. o Injury occurred 6 months from date of request. o Patient is responsive to verbal or visual stimuli and demonstrates ability or potential to make progress and achieve goals. o Absence of substance abuse or acute psychiatric disorders. o Rancho Los Amigos Level of Cognitive Function Scale level 3 and evolving or Rancho 4 6. Outpatient: 3 hrs/day individualized neuro-cognitive rehab for diagnosed impairments when part of a multidisciplinary program with 2 types of therapy, no contraindications AND all following: o Documented specific short and long term goals, anticipated discharge date. o Cognitive interventions are structured, systematic, individualized and restorative. o Injury 6 months from date of request. o Active in home setting before injury. o Responsive to verbal or visual stimuli. o Ability or potential to progress and achieve goals. o No substance abuse or acute psychiatric disorders. Service setting exclusions: Transitional living. Day or community-based programs. Non-medical settings (e.g., clubhouses for socialization). Social skill development programs. 4

5 Citation Content/methods Supported living programs. Independent living centers. Service exclusions: Vocational rehab. Structured adult education. Community re-entry programs. Behavioral training. Compensatory devices (e.g., memory or date books, electronic paging, and computer-assisted training). Employment counseling. Work hardening. Music, recreation, and art therapies. Intelligence testing. Table 2: Glasgow Coma Scale (GCS) Published by the Centers for Disease Control May 9, 2003, Page 1 of 2 (last accessed August 2, 2013). Glasgow Coma Scale (GCS) Eye opening response: Spontaneous; open with blinking at baseline 4 points. To verbal stimuli, command, speech 3 points. To pain only (not applied to face) 2 points. No response 1 point. Verbal response: Oriented 5 points. Confused conversation, but able to answer questions 4 points. Inappropriate words 3 points. Incomprehensible speech 2 points. No response 1 point. Motor response: Obeys commands for movement 6 points. Purposeful movement to painful stimulus 5 points. Withdraws in response to pain 4 points. Flexion in response to pain (decorticate posturing) 3 points. Extension response in response to pain (decerebrate posturing) 2 points. No response 1 point. Categorization: Coma No eye opening, no ability to follow commands, no word verbalizations (3-8). 5

6 Head Injury Classification: Severe head injury GCS score of 8 or less; Moderate head injury GCS score of 9 to 12; Mild head injury GCS score of 13 to 15. (Adapted from Advanced Trauma Life Support: Course for Physicians, American College of Surgeons, 1993). Methods Searches: 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. Searches were conducted on July 9, 2014, using the terms traumatic, brain, injury, cognitive, and rehabilitation. 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 evidencegrading 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 Summary of clinical evidence Citation SIGN (2013) Brasure (AHRQ; 2012) Hayes (annotated Content, Methods, Recommendations Brain injury rehabilitation in adults: RCTs or systematic reviews, Memory impairment after TBI compensatory memory strategies with clear focus on daily functioning: o Mild-moderate impairment; external aids and internal strategies (visual imagery). o Severe impairment; external compensation focused on function. Attention deficits post TBI strategies relevant to personal function. Executive functioning meta-cognitive strategies focused on personally relevant problems with planning, problem-solving, and goal management. Comprehensive/holistic programs should involve multidisciplinary team using goal-focused cognitive, emotional, and behavioral therapies. Multidisciplinary post-acute rehab for moderate to severe TBI in adults: Prospective cohort studies and RCTs, Productivity outcomes; heterogeneity among studies precluded overall summary. Community integration outcomes one RCT with moderate risk of bias and one cohort with unadjusted results no summary feasible. Key overall finding complexity of TBIs and incompletely defined interventions; heterogeneity of populations precluded pooling results. No clear benefit of one approach over another. Cognitive rehabilitation for TBI: , study types not specified. 6

7 bibliography; 2012) Marshall (2012) Cincinnati Children s Hospital (2011) WLDI (2011) Lane-Brown 2009) VA/DoD (2009) Goliscz (2009) Kumar (Cochrane protocol; 2009) Turner-Stokes (2006) Chesnut (AHRQ; 1999) Archived, full text no longer available Cha (2013) Chung 2013) Some evidence for efficacy in memory or social skills. Comprehensive-holistic cognitive rehab may improve community integration vs. standard neurorehabilitation. No studies report safety. Variation among studies in targeted domains and rehab protocols; for TBI firm conclusions are difficult. CPGs for mtbi with persistent symptoms: Systematic review of available guidelines with consensus recommendations; published guidelines in English or French, Persisting cognitive complaints: Screen for: attention and concentration; processing speed; and memory (Rivermead Post-concussion Symptoms Questionnaire; provided in appendix to full-text article). Assess for co-morbid conditions that may influence cognition (anxiety, depression, PTSD, pain, fatigue, sleep disturbance, acute stress disorder). Refer to neuropsychologist experienced with TBI. Spontaneous cognitive improvement can be expected in most cases of MTBI. Cognitive rehabilitation should be initiated when: o Cognitive impairments persist on formal evaluation. o Compensatory strategies are needed for resumption of functional activities/work or safety concerns (self and/or others). o Electronic external memory devices (computers, paging devices, organizers) are effective for improving function post-mtbi. Speech therapist-directed computer assisted cognitive rehabilitation for acquired brain injury, ages 3 21 years: TBI; tumors; AVMs; seizure disorders; meningitis; encephalitis; CVAs; hydrocephalus. Systematic reviews or analytic primary studies, Recommended for impairments in processing speed; attention; memory/working memory; inhibition; problem solving. Head (trauma, headaches, not including stress and mental disorders): Study types not specified. Recommendations for physical therapy but cognitive rehab not specifically addressed. Interventions for apathy after TBI Management of concussion/mtbi: Does not include cognitive rehab. Occupational therapy for adults with TBI: Does not specifically include cognitive rehab. Occupational outcomes after TBI Specialist rehabilitation for reducing dependency and costs for adults with complex acquired brain injuries: Before-and-after data from 297 patients admitted to UK rehab service, Changes in dependency status were associated with substantial savings in direct costs of ongoing care, especially for high-dependency patients. Rehabilitation for TBI: Controlled studies, Key question 3: Cognitive rehab Mixed results, but best evidence supported prosthetic aids for memory. o One study indicates cognitive rehabilitation reduces anxiety; improves self-concept and relationships. o Two studies support use of computer-assisted cognitive rehab in improving immediate recall. Computer-based cognitive rehab for stroke. Executive dysfunction in stroke or other adult non-progressive acquired brain damage. 7

8 Loetscher 2013) Arends 2012) Hoffmann 2010) Thomas 2009) O Brien (2008) Attention deficits following stroke. Return to work in adults with adjustment disorders. Cognitive impairment in stroke. Multiple sclerosis. Multiple sclerosis. Glossary Aneurysm Section in the wall of a blood vessel weakened, bulging, or otherwise at risk of rupture and bleeding into surrounding tissues. Anoxia Lack of oxygen. Coma State of profound unconsciousness caused by disease, injury, or poison. Traumatic brain injury (TBI) TBI is an alteration in function or other evidence of brain pathology caused by external force. References Professional society guidelines: Care of the patient with mild traumatic brain injury. Glenview (IL): American Association of Neuroscience Nurses, Association of Rehabilitation Nurses; p.35. Colorado Division of Workers' Compensation. Traumatic brain injury medical treatment guidelines. Denver (CO): Colorado Division of Workers' Compensation; 2012 Nov 26. p.119. Department of Veterans Affairs, Department of Defense. VA/DoD clinical practice guideline for management of concussion/mild traumatic brain injury (mtbi). Washington (DC): Department of Veteran Affairs, Department of Defense; 2009 Apr. p.112. Golisz K. Occupational therapy practice guidelines for adults with traumatic brain injury. Bethesda (MD): American Occupational Therapy Association (AOTA); p

9 Peer-reviewed references: Arends I, Bruinvels DJ, Rebergen DS, Nieuwenhuijsen K, Madan I, Neumeyer-Gromen A, Bültmann U, Verbeek JH. Interventions to facilitate return to work in adults with adjustment disorders. Cochrane Database of Systematic Reviews Issue 12. Borg J, Holm L, Cassidy JD, Peloso PM, Carroll LJ, von Holst H, Ericson K. Diagnostic procedures in mild traumatic brain injury. Results of the WHO Collaborating Centre Task Force on mild traumatic brain injury. Journal of Rehabilitation Medicine, 2004a; 43(Suppl): Brasure M, Lamberty GJ, Sayer NA, Nelson NW, MacDonald R, Ouelette J, Tacklind J, Grove M, Rutks IR, Butler ME, Kane RL, Wilt TJ. Multidisciplinary postacute rehabilitation for moderate to severe traumatic brain injury in adults. Comparative effectiveness review number 72. AHRQ Publication No. 12-EHC101-EF. June Bulger EM, Nathens AB, Rivara FP, Moore M, MacKenzie EJ, Jurkovich GJ. Management of severe head injury: Institutional variations in care and effect on outcome. Critical Care Medicine, 2002;30(8): Cha YJ, Kim H. Effects of computer-based cognitive rehabilitation (CBCR) for people with stroke: A systematic review and meta-analysis. Neurorehabilitation.2013;32(2): Chung CSY. Pollock A, Campbell T, Durward BR, Hagen S. Cognitive rehabilitation for executive dysfunction in adults with stroke or other adult non-progressive acquired brain damage. Cochrane Database of Systematic Reviews Issue 4. Dunning J, Stratford-Smith P, Lecky F, Batchelor J, Hogg K, Browne Sharpin C, Mackway-Jones K, for the Emergency Medicine Research Group. A meta-analysis of clinical correlates that predict significant intracranial injury in adults with minor head trauma. Journal of Neurotrauma, 2004;21(7): Hayes, Inc. Cognitive rehabilitation for traumatic brain injury (TBI). Medical Technology Directory Pocket Summary. June Hoffmann T, Bennett S, Koh CL, McKenna KT. Occupational therapy for cognitive impairment in stroke patients. Cochrane Database of Systematic Reviews Issue 9. Kumar KS, Kamalesh KS, Macadan AS. Cognitive rehabilitation for occupational outcomes after traumatic brain injury. Cochrane Database of Systematic Reviews (protocol) Issue 3. Lane-Brown A, Tate R. Interventions for apathy after traumatic brain injury. Cochrane Database of Systematic Reviews Issue 2. Loetscher T., Lincoln NB. Cognitive rehabilitation for attention deficits following stroke. Cochrane Database of Systematic Reviews Issue 5. Marshall S, Bayley M, McCullagh S, Velikonja D, Berrigan L. Clinical practice guidelines for mild traumatic brain injury and persistent symptoms. Canadian Family Physician.2012;58:

10 Mower WR, Hoffman JR, Herbert M, Wolfson AB, Pollack CV, Zucker MI, for the NEXUS II Investigators. Developing a clinical decision instrument to rule out intracranial injuries in patients with minor head trauma: methodology of the NEXUS II investigation. Annals of Emergency Medicine, 2002;40(5): O Brien AR, Chiaravalloti N, Groverover Y, DeLuca J. Evidence-based cognitive rehabilitation for persons with multiple sclerosis: a review of the literature. Archives of Physical Medicine and Rehabilitation.2008;89(4): Sommer JB, Norup A, Poulsen I, et al. Cognitive activity limitations one year post-trauma in patients admitted to sub-acute rehabilitation after severe traumatic brain injury. Journal of Rehabilitation Medicine. June 2013; 45(8) Thomas PW, Thomas S, Hilier C, Galvin K, Baker R. Psychological interventions for multiple sclerosis. Cochrane Database of Systematic Reviews Issue 1. Turner-Stokes L, Paul S, Williams H. Efficiency of specialist rehabilitation in reducing dependency and costs of continuing care for adults with complex acquired brain injuries. Journal of Neurology, Neurosurgery, and Psychiatry (5): Clinical trials: Name of Trial: The Study of Cognitive Rehabilitation Effectiveness for Mild Traumatic Brain Injury (SCORE). Cognitive Rehabilitation of Blast Traumatic Brain Injury (TBI) (CRbTBI). Neural Markers and Rehabilitation of Executive Functioning in Veterans With Traumatic Brain Injury and Posttraumatic Stress Disorder. Brain Stimulation for Traumatic Brain Injury (TMS/DAI). Behavioral and Neuroimaging Changes After Cognitive Rehab in Traumatic Brain Injuries (TBI) and Mild Cognitive Impairment (MCI). ClinicalTrials.gov Identifier: NCT NCT NCT NCT NCT Centers for Medicare & Medicaid Services (CMS) National Coverage Determination There is no National Coverage Determination. There Are Medicare Benefit Policy Manuals for cognitive rehabilitation post traumatic brain injury. National medical policy NMP129. Effective 4/2004. Updated 2/2013. Medicare Benefit Policy Manual, Chapter 12 - Comprehensive Outpatient Rehabilitation Facility (CORF) Coverage: Medicare Benefit Policy Manual, Chapter 1 - Inpatient Hospital Services Covered Under Part A: Local Coverage Determinations There are no LCDs for this condition. 10

11 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 Code Description Development of cognitive skills: attention, memory, problem solving each 15 minutes one-on-one patient contact. Comment S9056 Coma stimulation per diem Rehabilitation not otherwise specified. ICD-9 Code Description Comment Cognitive deficits Traumatic brain injury Other and unspecified injury to head, face and neck. ICD-10 Code Description Comment S06.x Intracranial injury. S07.x S08.x S09.x Crushing injury of head. Avulsion and traumatic amputation of part of head. Other and unspecified injuries of head. HCPCS Level II S9056 Coma stimulation per diem. Description Comment 11