Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Medical Evaluation and Management for Attention-Deficit Hyperactivity Disorder (ADHD)

Policy #:07.03.03g

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

MEDICALLY NECESSARY

Services listed below are the most frequently used components in the medical evaluation of attention-deficit hyperactivity disorder (ADHD). These medical evaluation services are considered medically necessary and, therefore, covered:
  • Review and interpretation of screening tools for ADHD with standardized behavioral rating scales or questionnaires are considered part of the evaluation and management, and include, but are not limited to, the following:
    • ADHD Rating Scale-IV
    • Brown ADD Rating Scales for Children, Adolescents, and Adults
    • Conners Parent Rating Scale-Revised
    • Conners Teacher Rating Scale-Revised
    • School Situations Questionnare-Revised
    • National Institute for Children’s Health Quality (NICHQ) Vanderbilt
    Assessment Scale
    • Child Behavior Checklist
    • Swanson, Nolan and Pelham version IV (SNAP)
  • A complete physical examination if not conducted within the last 12 months
    • Blood lead levels
    • Quantitative plasma amino acid assays to detect phenylketonuria
    • Thyroid hormone blood levels and thyroid-stimulating hormone (TSH) blood levels
      • If the individual has clinical symptoms suggesting a comorbid condition such as hyperthyroidism (e.g., palpitations, heat intolerance, sudden weight loss, nervousness)
    • Neurologic evaluation studies as indicated, if the individual has clinical symptoms suggesting a comorbid condition (e.g., focal signs, degenerative neurological condition, seizure)
      • Electroencephalogram (EEG)
      • Magnetic resonance imaging (MRI)
      • Single-photon emission computed tomography (SPECT)
      • Positron emission tomography (PET)
  • Clinical interviews are considered part of the evaluation and management and include the following:
    • Establishment of problematic patterns of behavior (i.e., inattention and/or impulsivity and hyperactivity) that cause functional impairment in two or more settings (e.g., school, work, home), or severe impairment in one setting
    • Collection of information about school or day care functioning (if child or adolescent)
    • Evaluation for comorbid psychiatric disorders (e.g., depression, mania, anxiety disorders, tic disorders, substance abuse, psychosis)
    • Evaluation for evidence of a learning disability
    • Review of medical, social, and family histories

Medical management of ADHD through professional provider office visits are covered under the member's medical benefit.

Pharmacological therapy in the management of ADHD may be covered under the prescription plan when the member has a pharmacy benefit.

NOT MEDICALLY NECESSARY

NONTRADITIONAL TREATMENTS
Nontraditional treatments for ADHD such as, but not limited to, the following are considered not medically necessary and, therefore, not covered:
  • Elimination diets (e.g., Feingold diet)
  • Nutritional supplements (e.g., megadoses of vitamins)
  • Antifungal therapy
  • Electroencephalogram (EEG) biofeedback
  • Anti-motion sickness medication

NEUROPSYCHOLOGICAL TESTING
Unless an associated neurologically based condition exists (e.g., seizure disorder, intracranial neoplasm), neuropsychological testing is considered not medically necessary for the evaluation and management of ADHD and, therefore, not covered because the available published peer-reviewed literature does not support its use in the diagnosis or treatment of illness or injury.

REHABILITATIVE THERAPIES (OCCUPATIONAL, PHYSICAL, AND/OR SPEECH)
Occupational, physical, and/or speech therapy are considered not medically necessary and, therefore, not covered for the treatment of ADHD, unless the individual has a neurological or physical deficit that requires such therapy.

EXPERIMENTAL/INVESTIGATIONAL

NONTRADITIONAL TREATMENTS
Nontraditional treatments for ADHD such as, but not limited to, the following, lack validation and scientific support, and are considered experimental/investigational and, therefore, not covered:
  • Sensory integration therapy
  • Optometric vision training (orthoptic/pleoptic)
  • Interactive metronome training (a computerized version of keeping the beat, which provides auditory feedback)
  • Chiropractic manipulation

EXTERNAL TRIGEMINAL NERVE STIMULATION SYSTEM FOR ADHD
Although the US Food and Drug Administration (FDA) has approved external trigeminal nerve stimulation (eTNS) system for the treatment of ADHD, the Company has determined that the safety and/or effectiveness of eTNS cannot be established by review of the available published peer-reviewed literature. Therefore, eTNS system for the treatment of ADHD is considered experimental/investigational by the Company and not covered.

TRANSCRANIAL MAGNETIC STIMULATION FOR ADHD
Transcranial magnetic stimulation for ADHD is considered experimental/investigational and, therefore, not covered because the
safety and/or
effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

QUANTITATIVE ELECTROENCEPHALOGRAPHY
Although the US Food and Drug Administration (FDA) has approved devices for quantitative electroencephalography, the Company has determined that the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature. Therefore, quantitative electroencephalography (QEEG)--based assessment that reports the strength, pattern, and/or ratios of brain waves is considered experimental/investigational by the Company and, therefore, not covered as a diagnostic aid for neuropsychiatric disorders, including, but not limited to, ADHD.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Guidelines

The federal Individuals with Disabilities Education Act (IDEA) mandates educational testing for learning disabilities; therefore, treating health care professionals might recommend that the school district conduct psychoeducational testing if learning disabilities are suspected.

For psychotherapies used in the treatment of attention-deficit hyperactivity disorder (ADHD), please refer to the behavioral health vendor.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, the medical evaluation for ADHD is covered under the medical benefits of the Company's products when medical necessity criteria listed in this medical policy are met.

The Company has delegated the responsibility for utilization management activities for professional behavioral health services to the contracted behavioral health vendor.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Monarch® external Trigeminal Nerve Stimulation (eTNS®) System was approved by the FDA on April 19, 2019 for the treatment of ADHD in individuals ages 7 to 12 years old.

Description

Attention-deficit hyperactivity disorder (ADHD), also known as attention-deficit disorder (ADD), is one of the most common psychiatric disorders of childhood and adolescence. Signs and symptoms of ADHD may appear over the course of several months, frequently with symptoms of impulsiveness and hyperactivity or inattention. ADHD affects boys more often than girls, with symptoms usually present before the age of 12. ADHD causes clinically significant impairment in social, academic, or occupational functioning in settings such as school, work, and/or home. New research linking genetics, brain development, and functioning are providing scientists with a new understanding of how ADHD develops. While there is no specific test to confirm a diagnosis of ADHD, the diagnosis is applied to children and adults who display certain characteristic behaviors over a period of time. The American Academy of Pediatrics (AAP) recommends the initiation of an evaluation for any child starting at age four who presents with academic or behavioral problems and any of the following most common three types of behaviors:
  • Inattention (more common in females): It may be difficult for the individual to stay focused or to pay attention to detail. The individual is easily distracted and has difficulty learning something new or completing a task.
  • Hyperactivity (more common in males): The individual is unable to sit still, appears to be always in motion, and may talk incessantly. Children may squirm in their seats, wiggle their feet, or touch everything. Adults and teens might feel restless, try to do several tasks at the same time, or bounce from one activity to another.
  • Impulsivity: The individual has difficulty curbing immediate reactions and acts without thinking. In addition, symptoms of inattention and hyperactivity are manifested equally.

CHILDREN

Children with ADHD have functional impairments when interacting with peers, at school, and at home. School problems may include:
  • Lower than expected or erratic grades
  • Poor organization and study skills
  • Gaps in learning
  • Difficulty with test taking
  • Failure to complete assignments and/or turn in homework.

Behavior problems at school often lead to continuous friction among peers, teachers, and parents and/or caregivers. This pattern of behavior often leads to suspension, placement in special classes, or expulsion.

Research shows that ADHD tends to run in families, suggesting that there is a considerable genetic component to the etiology of ADHD. The risk of ADHD in siblings of children diagnosed with ADHD is increased by two to three times, compared with the general pediatric population. Up to 80 percent of children diagnosed with ADHD continue to have symptoms of ADHD into adolescence, and up to 65 percent exhibit symptoms into adulthood. Some literature suggests that children with ADHD are more likely to experiment with drugs and may develop a significant substance abuse problem.

A therapeutic alliance between the parents and/or caregivers, the child, and the school to allow specific treatment interventions is the most crucial aspect of the treatment plan for a professional provider (e.g., therapist, physician). Treatment plans need to be individualized according to the strengths identified during an evaluation and the pattern of target symptoms.

The AAP (2011) recommends for preschool-aged children (i.e., four to five years of age) evidence-based parent- and/or teacher-administered behavior therapy as the first line of treatment, as well as the provision of pharmacotherapy if behavior interventions do not offer significant improvement and there continues to be moderate-to-severe disturbance in the child's function. In geographic areas where evidence-based behavioral treatments are not available, the professional provider needs to weigh the risks of starting pharmacotherapy at an early age against the potential harm of delaying diagnosis and treatment.

For elementary school-age children, psychological interventions alone, such as behavior modification, are less effective than medication. Most controlled studies showed minimal benefit when behavior modification was added to pharmacotherapy. Parent and/or caregiver training consists of teaching parents and/or caregivers to give clear instructions, give positive reinforcement, and reprimand effectively. For parents and/or caregivers and other family members, education is essential in the treatment of ADHD. Parents and/or caregivers need to understand their child's developmental needs and to develop practical strategies to meet educational and social goals. Family therapy might be appropriate to address family dysfunction related to the raising and managing the child with ADHD or for primary parental or marital pathology resulting from living with a child with ADHD.

ADOLESCENTS

Adolescents with ADHD show a different clinical picture. These children tend to be restless instead of hyperactive. Adolescents diagnosed with ADHD tend to have low self-esteem, poor peer relations, and diminished school performance. Children who start on medication at an earlier age may or may not require a change in medication at puberty. Pharmacotherapy may be prescribed for newly diagnosed adolescents. In addition to pharmacotherapy, evidence-based behavior therapy may also be prescribed.

ADULTS

ADHD in adults tends to be missed. Most often adults seek evaluation and treatment after their child is diagnosed with ADHD. Some of the symptoms/comorbidities observed in adults include:
  • Agitated depression
  • Borderline or antisocial personality disorder
  • Dissociative disorders
  • Hypomania
  • Alcohol and/or drug abuse
  • Cognitive brain syndromes

Education about ADHD is very important in the treatment plan. The same medications used for children are used in adults. Family therapy can be helpful in addressing the chaotic relationships that often result from ADHD symptoms.

SCREENING TOOLS

Screening tools are a component of a comprehensive evaluation that also includes medical examination and interviews. Screening tools include standardized behavior rating scales and questionnaires that assist professional providers in obtaining information from parents and/or caregivers, teachers, and others about symptoms and functioning in various settings. For example, if a parent and/or caregiver reports that the child or adolescent suffers from any symptoms of ADHD that induce impairment, or if the child or adolescent scores in the clinical range for ADHD symptoms of a rating scale, then a full evaluation for ADHD is indicated.

Common standardized behavior rating scales and questionnaires used in the screening, assessment, and monitoring of treatment for ADHD include the following:
  • ADHD Rating Scale-IV
  • Brown ADD Rating Scales for Children Adolescents, and Adults
  • Conners Parent Rating Scale-Revised
  • Conners Teacher Rating Scale-Revised
  • School Situations Questionnaire-Revised
  • National Institute for Children’s Health Quality (NICHQ) Vanderbilt
    Assessment Scale
  • Child Behavior Checklist
  • Swanson, Nolan and Pelham version IV (SNAP)

LABORATORY TESTING

Several laboratory tests have been used to evaluate individuals with suspected ADHD. There are a few medical conditions that can resemble symptoms of ADHD. For example, hyperthyroidism can be associated with hyperactivity and agitation, but hyperthyroidism is also associated with additional signs and symptoms of excessive thyroid hormone levels. Elevated blood lead levels can also be associated with neurocognitive impairment, including inattention. The American Psychiatric Association notes that there are no laboratory tests that are diagnostic indicators for ADHD.

NEUROLOGIC EVALUATION STUDIES

Electroencephalograms (EEGs), magnetic resonance imaging (MRI), single-photon emission computed tomography (SPECT), and positron emission tomography (PET) are only indicated in the presence of clinical suggestions of a comorbid condition such as a seizure disorder or a degenerative condition.

Quantitative electroencephalography (QEEG) measuring strength, pattern, and/or ratios of brain waves has been proposed for use as a diagnostic aid for ADHD. Individuals with ADHD may have altered brain wave patterns on EEG compared to individuals without ADHD. While an increased theta/beta ratio is the most common wave pattern, not all studies have found this association, and some report other brain wave patterns in individuals with ADHD. Additional study is needed to determine how strongly the theta/beta ratio is associated with ADHD.

In 2011, the US food and Drug Administration (FDA) approved a de novo 510k classification for the generic device: Neuropsychiatric Interpretive Electroencephalograph Assessment Aid. According to the FDA documentation, this device utilizes an individual's EEG to provide an interpretation of a neuropsychiatric condition.

In 2013, the FDA cleared the Neuropsychiatric EEG-based Assessment Aid (NEBA®) as a de novo device indicated to measure the theta/beta ratio of the EEG, in individuals six to seventeen years of age, and to aid in the diagnosis of ADHD. When used as part of a complete medical and psychological examination it is proposed that the NEBA can help confirm an ADHD diagnosis or a professional provider's decision that further diagnostic testing should focus on ADHD or other medical or behavioral conditions that produce symptoms similar to ADHD.

Further research is needed to evaluate the potential impact of QEEG such as NEBA®, on the evaluation and management of ADHD. In addition, further research on the effect of the test on individual outcomes, such as the rate of medication use, would allow greater certainty regarding the usefulness of NEBA®.

CLINICAL BEHAVIORS

The use of specific criteria in The Diagnostic and Statistical Manual of Mental Disorders,Fifth edition, (DSM-5), assists professional providers in establishing a diagnosis of ADHD in the context of their clinical assessment of an individual. The DSM-5 criteria defines the three subtypes of ADHD as inattentive type, hyperactive-impulsive type, and combined type. The criteria items in DSM-5 include examples to facilitate application across the lifespan; the onset criterion include several inattentive or hyperactive-impulsive symptoms were present prior to age 12. Six symptoms persisting for at least six months in one domain are required for an ADHD diagnosis in children and adolescents under the age of 17, while only five symptoms in either of the major domains are required for older adolescents and adults. A persistent pattern of inattention and/or hyperactivity-impulsivity must be present in two or more settings (such as home or school), and must interfere with or reduce the quality of social, academic or occupational functioning (American Psychiatric Association, 2013).


Clinical Behaviors of ADHD
    ADHD Inattentive Type Behaviors
    ADHD Hyperactivity-Impulsivity Type Behaviors
    • Failure to pay close attention to details or demonstrates careless mistakes in schoolwork, work, or other activities
    • Difficulty with sustaining attention in tasks or play activities
    • Does not appear to hear or respond when spoken to directly
    • Failure to follow through on instructions and failure to finish school work, chores, or duties in the workplace (not due to oppositional behavior or failure to understand instructions)
    • Difficulty organizing tasks and activities
    • Difficulty with tasks that require sustained mental effort
    • Misplaces items necessary for tasks or activities
    • Easily distracted by extraneous stimuli
    • Demonstrates forgetfulness during daily activities
    Hyperactivity:
    • Demonstrates fidgeting behaviors
    • Difficulty with remaining seated in situations when it is expected to remain largely immobile
    • Demonstrates excessive behaviors of running or climbing in situations in which it is inappropriate; reports feelings of restlessness.
    • Difficulty with engaging in quiet activities
    • Demonstrates "on the go" behaviors
    • Demonstrates excessive talking

    Impulsivity:
    • Failure to wait before questions have been completed before answering
    • Demonstrates difficulty awaiting turn
    • Demonstrates interruptive or intrusive behaviors


PHARMACOTHERAPY

The decision to use pharmacotherapy is based on an ADHD diagnosis and sufficiently severe symptoms to cause functional impairment at school, at work, at home, and/or with peers. The American Academy of Child and Adolescent Psychiatry (AACAP) recommends that the pharmacological treatment of ADHD be a trial with an agent approved by the US Food and Drug Administration (FDA) for this purpose. FDA-approved agents include the psychostimulants and non-stimulants. Stimulants include dextroamphetamine and methylphenidate; mixed amphetamine salts; lisdexamfetamine; dexmethylphenidate; and methylphenidate hydrochloride. Non-stimulants include atomoxetine, extended release guanfacine, and extended release clonidine. A stimulant (e.g., methylphenidate) is the first medication of choice as recommended by AACAP and American Academy of Pediatrics (AAP), particularly when no comorbidity is present. Stimulants are fast-acting, easily titrated, and have mostly mild and easily reversed side effects. However, medication should not be a substitute for appropriate educational curricula. Children and adolescents should not be responsible for administering their own medication, due to the fact that they are impulsive, disorganized, and usually dislike taking medication.

The American Academy of Pediatrics and the American Heart Association (2008) in a joint statement agree that it may be reasonable to consider an electrocardiogram (EKG or ECG) as part of a complete cardiac evaluation for children being considered for stimulant medication for ADHD. They are no longer recommending it be done for all children who may need treatment with stimulant medication for ADHD, and are allowing the professional provider's clinical judgment when deciding if an electrocardiogram is necessary. Current practice guidelines and consensus statements are reaffirmed in available published peer-reviewed literature (Hammerness 2011).

PSYCHOTHERAPIES

Psychotherapies may be used to address secondary problems and disorders. Behavior modification is a psychological intervention that relies on rewarding positive behavior to increase the frequency of such behavior. Such positive rewards can be as simple as praising a child on the little things accomplished and complimenting a child about a job well done several times throughout the day.

NEUROPSYCHOLOGICAL TESTING

Neuropsychological testing (which tests the functional integrity of the brain) may be helpful in evaluating suspected neurological comorbidities in an individual with suspected ADHD; however, there is no evidence for the use of neuropsychological testing in the evaluation of ADHD where such comorbidities are not suspected. Psychological testing should not be used for educational purposes, only for diagnostic reasons. Psychoeducational testing to evaluate for learning disabilities often associated with ADHD should be performed by the child's school under the federal mandate, Individuals with Disabilities Education Act (IDEA).

REHABILITATIVE THERAPIES (OCCUPATIONAL, PHYSICAL, AND/OR SPEECH)

Rehabilitative therapies should not be considered routine treatment for ADHD. Occupational, physical, and/or speech therapy are only appropriate when there is evidence of a physical or neurological condition where rehabilitative therapy(ies) may be useful in treating such a condition. There is no available published literature that validates these therapies in the treatment of an individual with ADHD.

NONTRADITIONAL TREATMENTS

The AACAP identifies the following as examples of nontraditional treatments:
  • Elimination diets (e.g., Feingold diet)
  • Anti-motion sickness medication
  • Nutritional supplementation (e.g., megadoses of vitamins)
  • Antifungal therapy
  • Biofeedback (e.g. electroencephalogram (EEG) biofeedback)
  • Interactive metronome training
  • Sensory integration
  • Optometric vision training (orthoptic/pleoptic)
  • Chiropractic manipulation

However, the AACAP also warns that these treatments are based on uncontrolled studies and are therefore lacking efficacy and scientific support.

ELIMINATION DIETS
One of the most common dietary interventions is the adherence to the Feingold diet. This diet focuses on the theory that children are sensitive to dietary salicylates, artificially added colors, flavors, and preservatives, and that eliminating these offenders from the diet could potentially improve a child's learning disability and behavioral problems.

ANTI-MOTION SICKNESS MEDICATION
The theory behind antimotion sickness medicine is that a relationship exists between ADHD and the inner ear system. The inner ear system plays a key role in balance and coordination. This treatment includes a combination of medications such as meclizine and/or cyclizine, sometimes mixed with stimulants.

NUTRITIONAL SUPPLEMENTATION
Nutritional supplementation takes the opposite position of dietary elimination. This theory is based on the assumption that something is missing from the diet and that what is determined to be missing should be added in optimum amounts. This theory includes such things as megadoses of vitamin(s), zinc, iron, amino acids, and herbal supplements.

ANTIFUNGAL THERAPY
The belief behind this treatment is that toxins produced by overgrown yeast weaken the immune system and make the body susceptible to ADHD and other psychiatric disorders. Proponents recommend the use of antifungal agents such as nystatin while restricting sugar intake. At the present time, there is no data to support the use of antifungal medications in the treatment of ADHD.

ELECTROENCEPHALOGRAM (EEG) BIOFEEDBACK
Electroencephalogram (EEG) biofeedback (also known as neurofeedback) is based on the findings that some individuals with ADHD show lower levels of arousal in the frontal brain area. The goal of biofeedback is to teach these individuals to tolerate increased arousal levels. This improves attention and reduces impulsive behavior and hyperactivity. Although there have been encouraging studies in the use of neurofeedback in the treatment of ADHD, there are no definitive studies to support neurofeedback in the treatment of ADHD at this time.

INTERACTIVE METRONOME TRAINING
An interactive metronome is a computerized version of a simple metronome. The goal of this therapy is to have the individual attempt to match the rhythmic beat with hand or foot tapping. This improves motor planning and timing skills.

SENSORY INTEGRATION
Sensory integration (SI) dysfunction is a condition where the brain is overloaded by too many sensory messages and is not able to respond. There are some pediatricians who postulate that SI dysfunction and ADHD are associated. SI is based on the theory that this dysfunction can be bypassed by organizing information and presenting it through multiple sensory modalities. There have been some controlled and uncontrolled studies conducted using various strategies; however, the state of the empirical evidence regarding these interventions is uneven, ranging from no data to well-controlled trials.

CHIROPRACTIC MANIPULATION
There are several theories about chiropractic treatment for ADHD based on the belief that spinal problems are the cause of health problems. Advocates believe that spinal adjustment can effectively treat ADHD and learning disabilities. The theory behind this approach is that learning disabilities are caused by the misalignment of the sphenoid bone (at the base of the skull) and the temporal bones. This misalignment is purported to create unequal pressure on different areas of the brain, causing brain dysfunction. There are no definitive studies to support chiropractic use in the treatment of ADHD.

OPTOMETRIC VISION TRAINING (ORTHOPTIC/PLEOPTIC)
Advocates of this treatment (e.g., eye exercises, perceptual training) believe that visual problems such as faulty eye movement, sensitivity to certain light frequencies, and focus problems create reading disorders. However, there are no definitive studies available to support this claim.

EXTERNAL TRIGEMINAL NERVE STIMULATION SYSTEM

External trigeminal nerve stimulation system device connects via a wire to a small patch that adheres to an individual's forehead, just above the eyebrows. The system delivers the low-level electrical stimulation to the branches of the trigeminal nerve, which sends signals to the parts of the brain thought to be involved in ADHD. While the exact mechanism of eTNS is not yet known, neuroimaging studies reportedly have shown that eTNS increases activity in the brain regions that are known to be important in regulating attention, emotion and behavior.

In April 2019, the Monarch® eTNS® System (NeuroSigma, Inc., Los Angeles, California) received approval by the US Food and Drug Administration (FDA) for the treatment. Approval was based on a double- blind, sham-controlled trial to access the efficacy of TNS for ADHD (McGough et al 2019). The researchers randomized sixty-two children ages 8 to 12 years old into either active TNS (n=32) or sham TNS group (no electrical current; n=30). The participants were followed for a period of four weeks, followed by one week without intervention to access potential benefit persistence after discontinuation. The primary outcome measure was the clinical administrated ADHD- IV Rating Scale (ADHD-RS). Secondary behavioral outcomes were: clinical global impression-severity (CGI-I), weekly Behavioral Rating Inventory of Executive Functioning (BRIEF) scales, Conner Global Index, and Children’s Sleep Habits Questionnaire (CSHQ). General linear mixed model with treatment group (active versus sham), time (in weeks), and group-by-time interactions to access treatment effects differences as primary predictors. Researchers measured effect size differences between groups. Plotted ADHS-RS total scores over time suggested a nonlinear pattern, with decreasing scores in the two groups during the first week. Followed by the active group treatment improvement diminishing in subsequent weeks while the improvement response flattened in the sham group. The researchers report an estimated ADHD-RS effect size of 0.50, suggesting 50 percent of the participants responded to treatment. CGI-I scores suggest greater results for active group compared to sham (p =.003). No significant differences were reported between group and time interactive effects for Conner’s index scores, BRIEF, CSHQ scales and ARI scales. Despite FDA approval, current published peer-reviewed literature does not support the use of TNS for the treatment of ADHD. The study presented with serious limitations, such as: small sample size, short follow-up, and potential for placebo biases and type 1 error (false positive) were observed even after blinding. Due to the limitations in the study, no firm conclusions can be drawn. There is a need for larger long-term data to be published, preferably from randomized controlled trials along with competitive effectiveness trials to assess TNS to standard ADHD medications.

TRANSCRANIAL MAGNETIC STIMULATION FOR ADHD

In a randomized, sham-controlled crossover study, researchers tested the safety and efficacy of transcranial magnetic stimulation (TMS) in the treatment of young adults and adolescents aged 14-21 (n=9) with ADHD (Weaver et al., 2012). During the study, individuals were randomized in the first treatment phase to receive active TMS or sham and were crossed over to the other treatment modality in the second phase. Results showed significant improvement in Clinical Global Impression-Improvement Scale (CGI-I) in those randomized to active TMS first as well as to those randomized first to Sham TMS. Although both groups improved during the first phase of treatment, only those assigned to active TMS improved during the second phase, suggesting that placebo-type effects were washed out with completion of the first phase. No serious adverse effects, including seizures and EEG changes, resulted from the treatment (the study excluded individuals with increased risk of seizure). Researchers in this study concluded that this exploratory study shows encouraging results of the potential efficacy of TMS for ADHD. Although the sham controlled crossover study design was well conceived, the number of study subjects was far too small to allow for any conclusions regarding efficacy of TMS for ADHD treatment.
References


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https://www.uptodate.com/contents/attention-deficit-hyperactivity-disorder-in-children-and-adolescents-overview-of-treatment-and-prognosis?search=adhd&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1 [via subscription only]. Accessed April 25, 2019.

Liechti MD, Valko L, Muller UC, et al. Diagnostic value of resting electroencephalogram in attention-deficit/hyperactivity disorder across the lifespan. Brain Topogr. 2013;26(1):135-151.

McGough JJ, Sturm A, Cowen J, et al. Double-blind, sham-controlled, pilot study of trigeminal nerve stimulation for attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2019;58(4):403-411.

Monastra VJ, Lubar JF, Linden M. The development of a quantitative electroencephalographic scanning process for attention deficit-hyperactivity disorder: reliability and validity studies. Neuropsychology. 2001;15(1):136-144.

National Institutes of Health. Clinical trials: Transcranial magnetic stimulation for attention deficit/hyperactivity disorder (ADHD)
(NCT03663179). [NIH Web site]. Available at:https://clinicaltrials.gov/ct2/show/record/NCT03663179. Accessed April 25, 2019.

National Institutes of Health. Clinical trials: Trigeminal nerve stimulation for ADHD (TNS for ADHD) (NCT02155608). [ClinicalTrials Web site]. 04/12/2019. Available at:https://clinicaltrials.gov/ct2/show/results/NCT02155608 . Accessed April 25, 2019.

National Institute of Mental Health (NIMH). Attention Deficit Hyperactivity Disorder. [NIMH Web site]. March 2016. Available at: http://www.nimh.nih.gov/topics/topic-page-adhd.shtml. Accessed April 25, 2019.

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NeuroSigma.The Monarch® eTNS® System is the First FDA Cleared Device for Treating Pediatric ADHD. [NeuroSigma Web site]. 04/23/2019. Available at: http://www.neurosigma.com/company.html. Accessed April 25, 2019.
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Rappley MD. Clinical practice. Attention deficit-hyperactivity disorder. N Engl J Med.2005;352(2):165-173.

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Snyder SM, Hall JR. A meta-analysis of quantitative EEG power associated with attention-deficit hyperactivity disorder. J Clin Neurophysiol. 2006; 23(5):440-455.

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Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

F90.0 Attention-deficit hyperactivity disorder, predominantly inattentive type

F90.1 Attention-deficit hyperactivity disorder, predominantly hyperactive type

F90.2 Attention-deficit hyperactivity disorder, combined type

F90.8 Attention-deficit hyperactivity disorder, other type

F90.9 Attention-deficit hyperactivity disorder, unspecified type



HCPCS Level II Code Number(s)

N/A


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

07.03.03g:
07/15/2019This version of the policy will become effective 07/15/2019.

This policy has been updated to communicate the Company’s coverage position for external trigeminal nerve stimulation (eTNS) for the treatment of attention-deficit hyperactivity disorder (ADHD) as experimental/investigational.

Policy statement was added to address transcranial magnetic stimulation (TMS) for the behavioral health condition of ADHD as experimental/investigational. In addition, clarified current benefit application that the Company has delegated the responsibility for utilization management activities for professional behavioral health services to the contracted behavioral health vendor.

The following ICD-10 CM codes have been removed from this policy:
Z79.899 Other long term (current) drug therapy

Z51.81 Encounter for therapeutic drug level monitoring

Revisions from 07.03.03f:
06/06/2018The policy has been reviewed and reissued to communicate the Company’s continuing position on Medical Evaluation and Management for Attention-Deficit Hyperactivity Disorder (ADHD).


Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 07/15/2019
Version Issued Date: 07/15/2019
Version Reissued Date: N/A

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