| Coverage Policy Manual | |
| Policy #: | 2021038 |
| Category: | Medicine |
| Initiated: | August 2021 |
| Last Review: | August 2023 |
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| Digital Health Therapies for Attention Deficit/Hyperactivity Disorder | |
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| Description: |
Attention-deficit/hyperactivity disorder (ADHD) is a chronic condition characterized by symptoms of hyperactivity, impulsivity, and inattention, which are considered excessive for the person’s age. Both the International Classification of Mental and Behavioral Disorders 10th edition (ICD-10) and the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) require that the symptoms are reported or observed in several settings and that the symptoms of ADHD affect psychological, social, and/or educational/occupational functioning. Prevalence estimates for ADHD vary from 7.2% to 15.5% of children (Wolraich, 2019).
For children younger than 17 years of age, the DSM-5 requires at least 6 symptoms of hyperactivity-impulsivity or at least 6 symptoms of inattention. The combined type requires a minimum of 6 symptoms of hyperactivity-impulsivity plus at least 6 symptoms of inattention. The symptoms must; 1) occur often, 2) be present in more than 1 setting, 3) persist for at least 6 months, 4) be present before 12 years of age, 5) impair function in academic, social, or occupational activities, and 6) be excessive for the developmental level of the child.
Established treatments for ADHD in children include educational, environmental, psychological, and behavioral interventions, and medication. Almost two-thirds of children with ADHD take medication, and about one half receive behavioral treatment (Wolraich, 2019).
Regulatory Status
In April 2020, EndeavorRx (Akili Interactive Labs) received marketing clearance by the U.S. Food and Drug Administration (FDA) through the De Novo premarket review process (DEN200026). EndeavorRx is a prescription device that is indicated to “improve attention function as measured by computer-based testing in children ages 8-12 years old with primarily inattentive or combined type ADHD, who have a demonstrated attention issue. Patients who engage with EndeavorRx demonstrate improvements in a digitally assessed measure Test of Variables of Attention (TOVA) of sustained and selective attention and may not display benefits in typical behavioral symptoms, such as hyperactivity.” EndeavorRx is intended to be used as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs.
EndeavorRx is a digital therapy (software-as-a-medical device) in the form of an interactive video game that requires the child to navigate a character through a game-like space while collecting objects. It is designed to be played on a mobile device at home for approximately 25 minutes a day, 5 days a week, and has reminders to both the child and parent to encourage compliance. Typical treatment would be for a period of 1 month, with extension up to 3 months allowed per license.
EndeavorRx uses a proprietary technology platform that adjusts the difficulty level based on the user’s prior performance. The adaptive algorithm is intended to encourage the patients to surpass their previous performance, so that the user would gradually increase their ability to focus attention. No claims are made for behavioral symptoms such as hyperactivity.
Earlier non-prescription versions were called ProjectEvo and AKL-T01, which was released under the Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders During the COVID-19 Public Health Emergency.
EndeavorRx is intended to be used as part of a therapeutic program. EndeavorRx is not intended to be used as a stand-alone treatment
Coding
There are no specific CPT or HCPCS codes for this service. The following codes may be billed:
CPT
99199 Unlisted special service, procedure or report [when specified as a mobile-based health management software application]
HCPCS
E1399 Durable medical equipment, miscellaneous [when specified as a mobile-based health management software application]
T1505 Electronic medication compliance management device, includes all components and accessories, not otherwise classified [when specified as a mobile-based health management software application]
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Policy/ Coverage: |
Effective July 2023
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Prescription digital therapy for the treatment of attention-deficit/hyperactivity disorder, including but not limited to EndeavorRx, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, prescription digital therapy, including but not limited to EndeavorRx, for the treatment of attention-deficit/hyperactivity disorder is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective December 2021 through June 2023
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Prescription digital therapy for the treatment of attention-deficit/hyperactivity disorder does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, prescription digital therapy for the treatment of attention-deficit/hyperactivity disorder is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
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| Rationale: |
This evidence review was created in July 2021 with a search of the PubMed database. The most recent literature update was performed through June 9, 2021.
Digital Therapies for Attention-Deficit/Hyperactivity Disorder
The purpose of digital therapies is to provide a treatment option that is an alternative to or an improvement on existing therapies for patients with attention-deficit/hyperactivity disorder (ADHD). Attention-deficit/hyperactivity disorder is a syndrome that can include hyperactivity, impulsivity, and/or inattention, which in turn can affect cognitive, academic, behavioral, emotional, and social functioning.
The symptoms of the hyperactive-impulsive presentation typically occur together and are characterized by the inability to sit still or inhibit behavior. The inattentive presentation is characterized by reduced ability to focus attention and reduced speed of cognitive processing, which is exhibited by difficulty with maintaining attention, lack of follow through and organization, distraction, and forgetfulness. The combined presentation includes symptoms of both the hyperactive-impulsive presentation and the inattentive presentation.
Treatment may include environmental adjustments, behavioral and psychological interventions, and medications. In some children, these treatments do not sufficiently address symptoms. In others, there may be resistance by the parents to treat children with medications, or there may be other barriers to obtaining established therapies. EndeavorRx is proposed to address these barriers with improved access to care and minimal side effects. The therapy is based on research showing that impairments in attention and cognitive control are associated with lower activation of frontal, frontoparietal, and ventral attention networks. Previously, a game-like intervention was shown to improve cognitive performance and alter the electroencephalogram in the prefrontal cortex in older adults (Anguera, 2013). The similarity between cognitive control in older adults and attention deficits in ADHD led to the development of EndeavorRx for the treatment of ADHD in children.
Kollins et al reported results of the STARS-ADHD (Software Treatment for Actively Reducing Severity of ADHD) randomized double blind trial, which compared treatment with AKL-T01 to a game (EVO Words) that targets cognitive domains other than those targeted by AKL-T01 (Kollins, 2020). AKL-T01 is a digital game played on a mobile device. EVO Words requires the child to spell as many words as possible by connecting letters in a grid in a fixed amount of time. Parents and children were informed that the study was evaluating 2 different investigational interventions for ADHD, and only the study coordinator was aware of which video game that the children received. Compliance was monitored by study coordinators, who notified parents by email if the game was not played for more than 48 hours. After 4 weeks, patients were reassessed for attentional functioning, ADHD symptoms, and impairment. The primary outcome was the change in the test of variable of attention, attention performance index (TOVA API). Secondary outcomes included a number of clinician and parent reported measures such as the ADHD rating scale, Impairment Rating Scale, and Clinical Global Impressions-Improvement. Out of 348 patients who were randomly assigned, 5 were lost to follow-up, 4 were withdrawn by the parent or investigator, and 10 had invalid test results, resulting in a final sample of 329 children for the primary outcome measure. The 2 children who received the incorrect allocation were included in the intention-to-treat population. The mean change from baseline on the TOVA API was 0.93 in the AKL-T01 group and 0.03 in the control group (p<.05). However, there were no between-group differences for secondary measures, which included the clinician and parent ratings of ADHD symptoms; both groups showed improvement in ADHD ratings from baseline to post-treatment. Treatment-related adverse events AKL-T01 group included frustration (5 [3%] of 180) and headache (3 [2%] of 180) with a mean number of completed sessions of 83%, compared to 96% compliance in the EVO Words group. The study was well-designed and conducted, but there are a number of limitations in study relevance due to the limited age range, limited follow-up, and most importantly the uncertainty of the association of computerized tests with observable behavior. There are also questions regarding what might be the most effective treatment schedule and characteristics of the patients who might benefit from this intervention. As was also noted by the trial authors "the results of the current trial are not sufficient to suggest that AKL-T01 should be used as an alternative to established and recommended treatments for ADHD."
The single RCT that has been identified compared outcomes of the predecessor of the FDA-cleared EndeavorRx (AKL-T01) to a word game that targeted different cognitive abilities. Although the experimental treatment group had significantly greater improvement on a computerized test of attention, both the experimental and control groups improved to a similar extent on parent and clinician assessments. The clinical significance of an improvement in a computerized test of attention without a detectable improvement in behavior by parents and clinicians is uncertain.
For individuals with ADHD who receive a prescription digital therapy, the evidence includes an RCT. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The single RCT that has been identified compared outcomes of the predecessor of the FDA-cleared EndeavorRx (AKL-T01) to a word game that targeted different cognitive abilities. Although the experimental treatment group had significantly greater improvement on a computerized test of attention, both the experimental and control groups improved to a similar extent on parent and clinician assessments. The clinical significance of an improvement in a computerized test of attention without a detectable improvement in behavior by parents and clinicians is uncertain. A number of questions remain concerning the efficacy of this treatment, and additional studies to assess the effect of the digital therapy in adolescents and in children on stimulant medication are ongoing or have recently been completed. At this time, the digital therapy is not recommended as an alternative or adjunct to established treatments. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
Practice Guidelines and Position Statements
Guidelines or position statements will be considered for inclusion in ‘Supplemental Information' if they were issued by, or jointly by, a US professional society, an international society with US representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.
American Academy of Pediatrics
In 2019, the American Academy of Pediatrics (AAP) updated their 2011 clinical practice guideline on the diagnosis, evaluation, and treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents (Wolraich, 2019).
The guidelines were based on a systematic evidence review by the Agency for Healthcare Research and Quality. The AAP gave strong recommendations based on level A evidence for medications and training and behavioral treatment for ADHD implemented with the family and school.
Society for Developmental and Behavioral Pediatrics
In 2020, the Society for Developmental and Behavioral Pediatrics published a clinical practice guideline for the assessment and treatment of children and adolescents with complex ADHD (Barbaresi, 2020). Complex ADHD is defined by age (<4 years or presentation >12 years), presence of coexisting conditions, moderate to severe functional impairment, diagnostic uncertainty, or inadequate response to treatment. The society gave a strong recommendation based on grade B evidence for psychoeducation and evidence-based behavioral and educational interventions (eg, parent training, classroom management, behavioral peer interventions, organizational skills training). The society gave a recommendation based on grade C to B evidence for the frequent need to combine behavioral approaches with pharmacological treatments, and that "treatment should focus on areas of functional impairment and not just symptom reduction, by incorporating developmentally appropriate strategies for self-management, skill building, and prevention of adverse outcomes.
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this review are listed below.
Ongoing
NCT 04897074a
A Single Arm Pivotal Trial to Assess the Efficacy of AKL-T01, a Novel Digital Intervention Designed to Improve Attention, in Adolescents, Aged 13-17 Years Old, Diagnosed With Attention Deficit Hyperactive Disorder (ADHD)
Planned Enrollment: 165 Completion Date: Dec 2022
Unpublished
NCT03649074a
Software Treatment for Actively Reducing Severity of ADHD as Adjunctive Treatment to Stimulant (STARS-ADHD Adjunctive)
Planned Enrollment: 203 Completion Date: Sept 2019 (results submitted)
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through July 2022. No new literature was identified that would prompt a change in the coverage statement.
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through July 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Kollins et al reported results of the STARS-Adjunct study, a multicenter, open-label study of EndeavorRx as an adjunct to pharmacotherapy in children 8 to 14 years of age with ADHD on stimulant medication (n= 130) or EndeavorRx alone (n = 76) (Kollins, 2021). This study design does not permit conclusions about the adjunctive treatment effect of EndeavorRx as both study arms received EndeavorRx. An appropriate study design would be comparing EndeavorRx plus stimulant medication versus stimulant medication alone.
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| References: |
Anguera JA, Boccanfuso J, Rintoul JL, et al.(2013) Video game training enhances cognitive control in older adults. Nature. Sep 05 2013; 501(7465): 97-101. PMID 24005416 Barbaresi WJ, Campbell L, Diekroger EA, et al.(2020) Society for Developmental and Behavioral Pediatrics Clinical Practice Guideline for the Assessment and Treatment of Children and Adolescents with Complex Attention-Deficit/Hyperactivity Disorder. J Dev Behav Pediatr. Feb/Mar 2020; 41 Suppl 2S: S35-S57. PMID 31996577 Conners CK.(2008) Conners 3rd Edition. Toronto, Multi-Health Systems, Inc., 2008. DuPaul GJ.(1991) Parent and teacher ratings of ADHD symptoms: Psychometric properties in a community based sample. J Clin Child Psychol 1991; 20:242. Forbes GB.(1998) Clinical utility of the Test of Variables of Attention (TOVA) in the diagnosis of attention-deficit/hyperactivity disorder. J Clin Psychol. Jun 1998; 54(4): 461-76. PMID 9623751 Guy W, editor.(1976) ECDEU Assessment Manual for Psychopharmacology. Rockville, MD: US Department of Heath, Education, and Welfare Public Health Service Alcohol, Drug Abuse, and Mental Health Administration; 1976. Kollins SH, Childress A, Heusser AC, et al.(2021) Effectiveness of a digital therapeutic as adjunct to treatment with medication in pediatric ADHD. NPJ Digit Med. Mar 26 2021; 4(1): 58. PMID 33772095 Kollins SH, DeLoss DJ, Canadas E, et al.(2020) Kollins SH, DeLoss DJ, Canadas E, et al. Lancet Digit Health. Apr 2020; 2(4): e168-e178. PMID 33334505 Wolraich ML, Feurer ID, Hannah JN, et al.(1998) Obtaining systematic teacher reports of disruptive behavior disorders utilizing DSM-IV. J Abnorm Child Psychol. Apr 1998; 26(2): 141-52. PMID 9634136 Wolraich ML, Hagan JF, Allan C, et al.(2019) Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents. Pediatrics. Oct 2019; 144(4). PMID 31570648 Wolraich ML, Lambert W, Doffing MA, et al.(2003) Psychometric properties of the Vanderbilt ADHD diagnostic parent rating scale in a referred population. J Pediatr Psychol. Dec 2003; 28(8): 559-67. PMID 14602846 |
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Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2024 American Medical Association. |
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