Clinical Policy Title: Ambulatory and Video Electroencephalogram (AEEG, VEEG) Clinical Policy Number: 09.01.05 Effective Date: Initial Review Date: Most Recent Review Date: Next Review Date: Oct. 1, 2014 March 19, 2014 April 16, 2014 March, 2014 Policy contains: • Ambulatory EEG. • Video EEG. • Epilepsy, seizure disorder. See Also: Telemedicine Policy #18.02.01 ABOUT THIS POLICY: AmeriHealth Caritas has developed clinical policies to assist with making coverage determinations. AmeriHealth Caritas’ 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 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’ 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’ clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, AmeriHealth Caritas will update its clinical policies as necessary. AmeriHealth Caritas’ clinical policies are not guarantees of payment. Coverage Policy: AmeriHealth Caritas considers the use of Ambulatory EEG and Video EEG to be clinically proven and therefore, medically necessary when the following criteria are met: A. Ambulatory Electroencephalography (AEEG): 1. A seizure disorder is suspected but not defined by history, physical examination or resting EEG.—OR-2. Used in the differential diagnosis of syncope or transient ischemic attack where history, physical examination and resting EEG do not elucidate the diagnosis B. Video Electroencephalography (VEEG or Video EEG) a. When ordered by a pediatric or adult neurologist or neurosurgeon. –AND— b. In children or adults with a seizure disorder of uncertain diagnosis only after history, physical examination, and resting EEG have failed to establish the diagnosis.—AND— c. Non-neurologic conditions such as cardiovascular, chemical or metabolic etiologies have been considered and excluded. --AND--d. The Video EEG is necessary for one of the following indications: 1 i. Establish the initial diagnosis of a seizure disorder not evident from history, physical exam and standard EEG. –OR-ii. Establish the specific diagnostic category of seizure disorder that has not been determined through history, physical examination and other EEG. –OR-iii. Establish a diagnosis of psychogenic seizure. –OR-iv. For identification of seizure focus in children or adults being considered for seizure surgery. Limitations: • AmeriHealth Caritas considers the use of AEEG and VEEG to be investigational and therefore, not medically necessary for monitoring medication adjustments or treatments. • VEEG and AEEG are not supported by clinical evidence for evaluation of classic febrile seizures. • Video EEG monitoring exceeding 72 hours does not generally improve diagnostic capability and is not medically necessary. • Repeat VEEG are not commonly indicated. • VEEG is not covered to establish a diagnosis of brain death. • NOTE in Pennsylvania the following codes are not included on the Medicaid Fee Schedule: o 95824 - ELECTROENCEPHALOGRAM (EEG); CEREBRAL DEATH EVALUATION ONLY o 3650F - ELECTROENCEPHALOGRAM (EEG) ORDERED, REVIEWED OR REQUESTED (EPI) All other uses of AEEG and VEEG are not medically necessary. Alternative Covered Services: Primary care and specialist evaluations within the network are covered alternative services. Diagnostic tests such as resting EEG, standard laboratory and imaging services may be covered in the evaluation of a patient with an apparent seizure disorder. Background: According to the American Academy of Neurology (AAN), annually 150,000 adults present with an initial seizure. Some 45,000 children under the age of 15 have a new diagnosis of epilepsy made each year. In total there are approximately 3,000,000 people in the country with a diagnosis of a seizure disorder, representing early 1% of the US population. Accurate diagnosis is important to treatment. Seizures may be the result of non-neurologic causes such as arrhythmias, transient ischemic attacks, migraine, hypoglycemia, cocaine use, or other cardiovascular, chemical or metabolic causes. Psychogenic seizures are relatively common but may be difficult to diagnose. Epilepsy itself may be defined in terms of classifications such as partial or focal seizure or generalized ones. This latter classification includes absence or petit mal seizures, myoclonic seizures, atonic seizures and grand mal type of tonic-clonic seizure. These different seizure types have distinct clinical presentations and respond to different classes of anti-epileptic drugs (AEDs). The goal of treatment is prevent or reduce the frequency of the occurrence of the specific seizure. Reports indicate that the incidence of a second seizure after an initial unprovoked episode is 30 to 50% in the next two years. (Pohlmann-Eden) The American Academy of Neurology has disseminated an evidence-based practice parameter for the evaluation of patients with an initial unprovoked seizure that recommends detailed history and physical examination inclusive of a neurologic evaluation as the initial step. The AAN recommends from Class I and Class II evidence that a routine resting EEG should be included in the neurodiagnostic evaluation. Neuroimaging with MRI or CT has a diagnostic yield of 10% so is of value in the 2 evaluation of the initial epileptic seizure of unknown etiology. Routine laboratory blood work, lumbar puncture and toxicology should be performed if history and physical examination are suggestive. When routine EEG does not help diagnose the type of seizure, additional studies may be necessary. The British guidelines include a sleep-deprived EEG before proceeding to longer-duration studies. Ambulatory EEG provides the opportunity for up to 72 hours of continuous recording of an electroencephalogram in the ambulatory setting. Standardization of instrumentation has allowed AEEG to become much more common. As with all forms of EEG, there may be significant variation in interpretation as the inter-rater reliability may vary. AEEG is useful for its extended recording period increasing the opportunity to capture ictal and postictal events. While most AEEG systems include an event recording capability, many forms of epilepsy do not always provide symptoms recognizable to the patient. Video electroencephalography (VEEG) also allows simultaneous recording of EEG patterns and of videographic capture of patient activity. This allows the interpreting physician the ability to link physical activity to the EEG recording. Typically there are two cameras: one trained on the face and the other on the entire body. VEEG may be performed in the hospital setting or in an ambulatory environment. Video EEGs are especially helpful in the diagnosis of psychogenic seizures. That diagnosis is made when there is the visual recording of a seizure-like event but at the time when no epileptiform changes could be demonstrated on the EEG. Such a sequence demonstrates that the apparent seizure is not epilepsy. Further evaluation with provocation techniques and/or psychotherapy can elucidate the diagnosis. The typical duration for use of VEEG is 48 hours but there is no literature to standardize a longer duration of use. Methods Searches: AmeriHealth Caritas 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 March 1st, 2004, using the terms “Ambulatory EEG” and “Video EEG.”. 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 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 The studies and guidelines listed in this Clinical Policy demonstrate that both Ambulatory EEG and Video EEG can be useful tests for the initial diagnosis of epilepsy. They are both considered to be secondary tests. History, physical examination and careful neurologic evaluation are the cornerstones of diagnoses. These should not be performed in a perfunctory fashion as this classical assessment in children or adults, does guide further evaluation. The use of routine, resting EEG and imaging studies are considered the next appropriate evaluation of an initial seizure in a child or adult in whom history, physical and neurologic 3 evaluation does not suggest a non-neurologic etiology of the seizure activity. Laboratory studies including toxicology and spinal fluid analysis are guided by the initial assessment. If there is still areas lacking clarity of diagnosis, the either Ambulatory EEG or Video EEG may be performed to help establish the diagnosis, type of seizure and to exclude psychogenic seizures. Video EEG and Ambulatory EEG are not helpful in medication management. Their utility declines significantly with utilization beyond 72 hours for AEEG, and beyond 48 hours for VEEG. Summary of Clinical Evidence Citation Content, Methods, Recommendations Am Academy of Neurology 2007 Key Point • From the Quality Standards Subcommittee of the AAN, used evidencebased standards for literature review to develop practice parameters • .Life-time cumulative risk of recurrent seizures by age 80 yrs. is 1.4% to 3.3% • Evaluation after initial unprovoked seizure for Class I evidence is history, physical examination, neurologic examination and routine resting EEG. • Class I and II evidence is for neuroimaging with MRI preferred over CT • Class II evidence for selective use of laboratory studies, toxicology, and spinal fluid assessment. Alving (2009) Key Point • • • Asano (2005) Key Points • • • • Elgavish (2011) Evaluated 234 consecutive video EEG-sessions (221 patients) over a 2year period. In 44% of the cases the video EEG was diagnostically useful regardless whether it was used to diagnose or classify a seizure Average duration of study was 2.4 days. Evaluation of clinical utility of video EEG on 1000 children age 1.7 years to 17 years (mean 7) A total of 315 studies were considered 'useful-epileptic'; 219 'usefulnonepileptic'; 224 'uneventful'; 242 'inconclusive' Average duration of study was 1.5 days. Found maximal impact on diagnosis occurred within the first 3 days for most patients. Key Points • • 3,727 patients completing scalp VEEG at the University of Alabama at Birmingham Epilepsy Center from 2002 to 2009 82.4% were diagnosed on the first admission (2,622 of 3,183), with 54% 4 • of the remainder on the second admission. Conclusion: Repeat video-EEG (VEEG) may increase diagnostic yield, but the test is resource intensive, time-consuming, and expensive and poses some potential risks to patients Glossary: Ambulatory Electroencephalogram –An electroencephalogram obtained in the ambulatory environment, which allows up to 72 hours of continuous recording of electrical activity from the brain and may include an event monitoring device so the patient may mark the time of any unusual event. Electroencephalogram –A recording generally from the scalp with small attached wires. Electrical activity for the surface of the brain may be recorded. The pattern of those electrical activities is altered during a seizure allowing the interpreter to make a diagnosis. Epilepsy –According to the National Epilepsy Foundation “Epilepsy is a medical condition that produces seizures affecting a variety of mental and physical functions. It is also called a seizure disorder. When a person has two or more unprovoked seizures, they are considered to have epilepsy. Seizures happen when clusters of nerve cells in the brain signal abnormally, which may briefly alter a person's consciousness, movements or actions.” (http://www.epilepsyfoundation.org/aboutepilepsy/index.cfm ) Last accessed March 2nd, 2014. Ictal Period—The Ictal Period is the same as the time of a seizure. Medically Necessary- A service or benefit is Medically Necessary if it is compensable under the MA Program and if it meets any one of the following standards: • • • The service or benefit will, or is reasonably expected to, prevent the onset of an illness, condition or disability. The service or benefit will, or is reasonably expected to, reduce or ameliorate the physical, mental or developmental effects of an illness, condition, injury or disability. The service or benefit will assist the Member to achieve or maintain maximum functional capacity in performing daily activities, taking into account both the functional capacity of the Member and those functional capacities that are appropriate for Members of the same age. Post-Ictal Period – The post-seizure period may reflect abnormal electrical activity as recorded in an EEG although the body is no longer showing physical evidence of a seizure response. Video Electroencephalogram –An EEG obtained with simultaneous recording of a video display of the motor function of that individual. Related Policies: AmeriHealth Caritas Utilization Management program description. 5 References Professional society guidelines/other: Hirtz D, Berg A, Bettis D, Camfield C, Camfield P, Crumrine P, Gaillard WD, Schneider S, Shinnar S; Quality Standards Subcommittee of the American Academy of Neurology; Practice Committee of the Child Neurology Society. Practice parameter: treatment of the child with a first unprovoked seizure: Report of the Quality Standards Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society. Neurology. 2003 Jan 28; 60(2):166-75. Krumholz A, Wiebe S, Gronseth G, Shinnar S, Levisohn P, Ting T, Hopp J, Shafer P, Morris H, Seiden L, Barkley G, French J; Quality Standards Subcommittee of the American Academy of Neurology; American Epilepsy Society. Practice Parameter: evaluating an apparent unprovoked first seizure in adults (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Epilepsy Society. Neurology. 2007 Nov 20; 69(21):1996-2007. Peer-reviewed references: Alving J, Beniczky S. Diagnostic usefulness and duration of the inpatient long-term video-EEG monitoring: findings in patients extensively investigated before the monitoring. Seizure. 2009 Sep; 18(7):470-3. Asano E, Pawlak C, Shah A, Shah J, Luat AF, Ahn-Ewing J, Chugani HT. The diagnostic value of initial video-EEG monitoring in children--review of 1000 cases. Epilepsy Res. 2005 Aug-Sep; 66(1-3):129-35. Benbadis SR, LaFrance WC Jr, Papandonatos GD, Korabathina K, Lin K, Kraemer HC; NES Treatment Workshop. Interrater reliability of EEG-video monitoring. Neurology. 2009 Sep 15; 73(11):843-6. Chapell R, Reston J, Snyder D, Treadwell J, Treager S, Turkelson C. Management of treatment-resistant epilepsy. Evid Rep Technol Assess (Summ). 2003 Apr ;( 77):1-8. Elgavish RA, Cabaniss WW. What is the diagnostic value of repeating a nondiagnostic video-EEG study? J Clin Neurophysiol. 2011 Jun;28(3):311-3. Pichon RA, Augustovski F, Garcia MS, Glujovski D, et al. [Usefulness of video EEG for the assessment of patients with refractory epilepsy] Buenos Aires; Institute for Clinical Effectiveness and Health Policy (IECS). Informe de Respuestra Rapida No 220. 2011 Pohlmann-Eden B, Beghi E, Camfield C, Camfield P. The first seizure and its management in adults and children. BMJ. 2006 Feb 11; 332(7537):339-42. Clinical Trials: • Brain Infusion of Muscimol to Treat Epilepsy, National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ) NCT00005925 This study will examine the safety and effectiveness of infusing a chemical called muscimol into the brain to control seizures in patients with intractable epilepsy (frequent seizures that persist despite therapy). Muscimol, which is similar to a naturally occurring brain chemical called GABA, has been 6 shown to reduce seizures in rats. After the infusion study, patients will undergo a standard surgical procedure for controlling seizures. Patients 18 years of age or older with intractable epilepsy may be eligible for this study. Before entering protocol 00-N-0158, candidates will be screened under protocol 01-N-0139, Evaluation and Treatment of Patients with Epilepsy, with a medical history, physical and neurologic examination, chest X-ray, electrocardiogram, blood and urine tests, electroencephalographic (EEG) monitoring and magnetic resonance imaging (MRI) of the head • Seizure Detection and Warning System for Epilepsy Patients, Brain Sentinel, NCT01874600 The seizure detection and warning system is an ambulatory system designed to monitor and analyze EMG data to detect the onset of GTC seizures and to provide a warning signal to alert caregivers that a seizure is occurring using a night-watch seizure detection device and warning system • Evaluation and Treatment of Patients With Epilepsy, National Institutes of Health Clinical Center (CC) NCT00013845 This protocol has three purposes: 1) to screen patients with seizures for participation in research studies of NINDS s Clinical Epilepsy Section (CES), 2) to follow the natural course of seizure disorders, and 3) to train CES fellows in evaluating and treating epilepsy. Only standard diagnostic tests and treatments will be used in this study. Patients of any age with seizures who are referred to CES may participate in this study. At the end of the study, patients may be discharged to the care of their referring physician, offered participation in another NINDS research protocol, or followed for teaching purposes. Participants will undergo standard diagnostic procedures used to determine the type of their seizures, what part of the brain they are coming from, what is causing them, and whether standard drug treatments can help them Centers for Medicare and Medicaid Services (CMS) National Coverage Determination National Coverage Determination (NCD) for Ambulatory EEG Monitoring (160.22) http://www.cms.gov/medicare-coverage-database/details/ncddetails.aspx?NCDId=215&ncdver=1&DocID=160.22&bc=gAAAAAgAAAAAAA%3d%3d& (last accessed March 2, 2014) National Coverage Determination (NCD) for Electroencephalographic (EEG) Monitoring during Open-Heart Surgery (160.9) http://www.cms.gov/medicare-coverage-database/details/ncddetails.aspx?NCDId=78&ncdver=1&DocID=160.9&bc=gAAAAAgAAAAAAA%3d%3d& (last accessed March 9, 2014) National Coverage Determination (NCD) for Telephone Transmission of EEGs (160.21) http://www.cms.gov/medicare-coverage-database/details/ncddetails.aspx?NCDId=214&ncdver=1&DocID=160.21&bc=gAAAAAgAAAAAAA%3d%3d& (last accessed March 9, 2014) Local Coverage Determinations No LCD for Ambulatory or Video EEG monitoring could be found. 7 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 in accordance with those manuals. CPT Code 3650f 95813 95816 95819 95822 95824 95827 95830 95950 95951 95953 95954 95955 95956 95957 Icd-9 Code 300.11 345.00 345.00 345.00 345.00 345.01 345.10 345.10 345.10 345.11 345.11 345.2 345.3 345.3 345.40 345.40 345.41 Description Electroencephalogram (Eeg) Ordered, Reviewed Or Requested (Epi). Electroencephalogram (Eeg) Extended Monitoring; Greater Than 1 Hour. Electroencephalogram (Eeg); Including Recording Awake And Drowsy. Electroencephalogram (Eeg); Including Recording Awake And Asleep. Electroencephalogram (Eeg); Recording In Coma Or Sleep Only. Electroencephalogram (Eeg); Cerebral Death Evaluation Only. Electroencephalogram (Eeg); All Night Recording. Insertion By Physician Or Other Qualified Health Care Professional Of Sphenoidal Electrodes For Electroencephalographic (Eeg) Recording. Monitoring For Identification And Lateralization Of Cerebral Seizure Focus, Electroencephalographic (Eg, 8 Channel Eeg) Recording And Interpretation, Each 24 Hours. Monitoring For Localization Of Cerebral Seizure Focus By Cable Or Radio, 16 Or More Channel Telemetry, Combined Electroencephalographic (Eeg) And Video Recording And Interpretation (Eg, For Presurgical Localization), Each 24 Hours. Monitoring For Localization Of Cerebral Seizure Focus By Computerized Portable 16 Or More Channel Eeg, Electroencephalographic (Eeg) Recording And Interpretation, Each 24 Hours, Unattended. Pharmacological Or Physical Activation Requiring Physician Or Other Qualified Health Care Professional Attendance During Eeg Recording Of Activation Phase (Eg, Thiopental Activation Test.) Electroencephalogram (Eeg) During Nonintracranial Surgery (Eg, Carotid Surgery). Monitoring For Localization Of Cerebral Seizure Focus By Cable Or Radio, 16 Or More Channel Telemetry, Electroencephalographic (Eeg) Recording And Interpretation, Each 24 Hours, Attended By A Technologist Or Nurse. Digital Analysis Of Electroencephalogram (Eeg) (Eg, For Epileptic Spike Analysis). Description Conversion Disorder. Epilepsy, Generalized Nonconvulsive. Petit Mal Seizure. Absence Seizure. Generalized Nonconvulsive Epilepsy Without Mention Of Intractable Epilepsy. Generalized Nonconvulsive Epilepsy With Intractable Epilepsy. Seizure, Grand Mal. Grand Mal Seizure. Generalized Convulsive Epilepsy Without Mention Of Intractable Epilepsy. Generalized Convulsive Epilepsy With Intractable Epilepsy. Seizure Disorder, Intractable. Epileptic Petit Mal Status. Seizure Disorder, Status Epilepticus. Epileptic Grand Mal Status. Localization-Related (Focal) (Partial) Epilepsy And Epileptic Syndromes With Complex Partial Seizures, Without Mention Of Intractable Epilepsy. Psychomotor Seizure. Localization-Related (Focal) (Partial) Epilepsy And Epileptic Syndromes With Complex Partial Seizures, With Intractable 8 345.50 345.50 345.50 345.51 345.80 345.81 345.90 345.91 649.40 649.41 649.42 649.43 649.44 780.32 780.33 780.39 780.39 780.39 780.39 794.01 794.01 794.02 V12.49 V12.49 Icd-10 Code F44.5 G40.90 R56.1 R56.9 Hcpcs Level II Epilepsy. Seizure Disorder, Frontal Lobe. Seizure Disorder, Partial. Localization-Related (Focal) (Partial) Epilepsy And Epileptic Syndromes With Simple Partial Seizures, Without Mention Of Intractable Epilepsy. Localization-Related (Focal) (Partial) Epilepsy And Epileptic Syndromes With Simple Partial Seizures, With Intractable Epilepsy. Other Forms Of Epilepsy And Recurrent Seizures, Without Mention Of Intractable Epilepsy. Other Forms Of Epilepsy And Recurrent Seizures, With Intractable Epilepsy. Unspecified Epilepsy Without Mention Of Intractable Epilepsy. Unspecified Epilepsy With Intractable Epilepsy. Epilepsy Complicating Pregnancy, Childbirth, Or The Puerperium, Unspecified As To Episode Of Care Or Not Applicable. Epilepsy Complicating Pregnancy, Childbirth, Or The Puerperium, Delivered, With Or Without Mention Of Antepartum Condition. Epilepsy Complicating Pregnancy, Childbirth, Or The Puerperium, Delivered, With Mention Of Postpartum Complication. Epilepsy Complicating Pregnancy, Childbirth, Or The Puerperium, Antepartum Condition Or Complication. Epilepsy Complicating Pregnancy, Childbirth, Or The Puerperium, Postpartum Condition Or Complication. Complex Febrile Convulsions. Post Traumatic Seizures. Seizure Disorder, Generalized. Seizure Disorder. Seizure Disorder, Complex Partial. Other Convulsions. Nonspecific Abnormal Echoencephalogram. Electroencephalogram, Abnormal. Nonspecific Abnormal Electroencephalogram (Eeg). Seizures, Hx Of Seizure Disorder, Hx Of. Description Conversion Disorders With Seizures. Epilepsy, Unspecified, Not Intractable. Post Traumatic Seizures. Seizures (Convulsive Disorders) Nos. Description N/A 9