mp-742
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Digital Health Therapies for Attention Deficit/Hyperactivity Disorder

Policy Number: MP-742

Latest Review Date: July 2021

Category: Medical

Policy Grade:  A

POLICY:

Prescription digital therapy is considered investigational for the treatment of attention deficit/hyperactivity disorder.

DESCRIPTION OF PROCEDURE OR SERVICE:

Attention-deficit/hyperactivity disorder (ADHD) is characterized by symptoms of hyperactivity, impulsivity, and inattention, which are considered excessive for the person’s age. Established treatments for ADHD in children include educational, environmental, psychological, and behavioral interventions, and medication. This review will assess whether a digital therapy in the form of a computer game can improve attention in children with ADHD.

Attention-Deficit/Hyperactivity Disorder

Attention-deficit/hyperactivity disorder (ADHD) is a chronic condition characterized by core 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.

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

Treatment

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.

Educational intervention involves discussion with parents about symptoms and access to services, environmental modifications such as seating arrangements, changes to lighting and noise, reducing distractions, and the benefit of having movement breaks and teaching assistants at school.

Parent-child behavioral therapy teaches parenting techniques within the principles of behavior therapy. The therapy programs typically last 2 to 3 months and includes rewarding positive behavior, identifying unintentional reinforcement of negative behaviors, limiting choices, and using calm discipline.

Medication with stimulants, such as methylphenidate, are considered first-line therapy for ADHD in school-age children. However, adverse effects of stimulants may include sleep disturbance, decreased appetite, and weight changes. Combination therapy with medication and behavioral interventions can improve both core ADHD symptoms and non-ADHD symptoms such as social skills and parent-child relations.

Table 1. ADHD Rating Scales

Rating Scale

Description

Scoring

ADHD Rating Scale

 

The ADHD-RS-IV is an 18-item, clinician-administered questionnaire for which a parent respondent rates the frequency of occurrence of ADHD symptoms and behaviors as defined by criteria outlined for ADHD in the DSM-IV. Each item is scored on a 4-point scale ranging from 0 (rarely or never) to 3 (very often) with total scores ranging from 0 to 54.The 18 items are grouped into 2 subscales: hyperactivity/impulsivity and inattentiveness.

Each subscale produces a subscale score ranging from 0 to 27. A higher score indicates more severe ADHD symptoms and behaviors and a negative change in total score indicates improvement.

The Clinical Global Impression Scale -Improvement

The CGI-I is a clinician's comparison of the participant’s overall clinical condition at follow-up to the overall clinical condition at baseline. It includes an assessment of the change from the initiation of treatment with a rating from 1 to7.

The 7-point scale is: 1 = Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, and7=Very much worse. A score of 1, 2, or 3 would indicate overall improvement of ADHD severity.

Conner’s Comprehensive Behavior Rating Scales

Parent and teacher forms are available in full (90-item, 59-item) and abbreviated (27-item, 28-item) versions.

Normative values are provided separately by gender and age.

The Vanderbilt Assessment Scales for parents and teachers

The Vanderbilt Assessment Scales are based on DSM-IV scales. The scale for parents has 55 questions that rate symptoms and their impact on family and school. The teacher scale includes 43 questions on symptoms and school performance.

Normative data and percentile ranks are provided for each subscale by grade and gender.

Test of Variables of Attention, Attention performance index

TOVA® is a validated computerized continuous performance test that presents targets and non-targets as squares that either appear at the top or bottom of the screen. The task consists of two halves: the first half has a target-to-non-target ratio assessed sustained attention; the second half assesses inhibitory control. The program assesses attention consistency, attentional lapses, and processing speed.

Clinical meaningfulness for the pivotal trial was defined as: TOVA API improvement greater than 1.4 points, and post-test API score 0 or more (normative range), ADHD-RS improvement of 2 points or more, CGI-I post-score of 1 (very much improved) or 2 or less (very much or much improved), and any improvement in an Impairment Rating Scale.

ADHD: attention-deficit/hyperactivity disorder; ADHD-RS-IV: ADHD rating scale, version 4; CGI-I: clinical global impression scale-improvement; DSM-IV: Diagnostic and Statistical Manual of Mental Disorders 4th edition; TOVA (API): test of variables of attention (attention performance index).

KEY POINTS:

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.

Author, year, country

Study Design

Population Characteristics

Interventions

Comparators

Kollins et al (2020);STARS-ADHD, US

RCT

348 pediatric patients aged 8 to 12 years, with confirmed ADHD, TOVA API scores -1.8 and below, without or with washout of disorder-related medication.

AKL-T01 (EndeavorRx) for25 min a day on 5 days per week for 4 weeks (n=180)

EVO Words for 25 min a day on 5 days per week for 4 weeks (n=168)

 

ADHD: attention-deficit/hyperactivity disorder; RCT: randomized controlled trial; STARS-ADHD:

Software Treatment for Actively Reducing Severity of ADHD;

TOVA API: test of variables of attention, attention performance index.

Study

TOVA API mean improve-ment (SD)

TOVA API Improvement >1.4points n/N (%)

ADHD-Rating Scale Improvement

>

2points n/N (%)

Impairment Rating Scale

n/N (%)

Clinical Global Impressions

<

2 n/N (%)

Kollins et al (2020);STARS-ADHD

 

N

329

329

337

332

339

AKL-T01

0·93 (3.15)

79/169 (47%)

128/173 (74%)

82/171 (48%)

29/175 (17%)

EVO Words

0·03 (3.16)

51/160 (32%)

119/164 (73%)

60/161 (37%)

26/164 (16%)

p-value

<.05

.006

.77

.049

.86

ADHD: attention deficit/hyperactivity disorder; RCT: randomized controlled trial; SD: standard deviation; STARS-ADHD:

Software Treatment for Actively Reducing Severity of ADHD;

TOVA API: test of variables of attention, attention performance index.

Study Limitations

  • The study population was limited to children 8 to 12 years of age.
  • Improvement on computerized tests of attention is weakly associated with classroom attention.
  • There was no follow-up after the 4 week intervention period.
  • Missing data was not included in the intention-to-treat analysis.

Summary of Evidence:

For individuals with ADHD who receive a prescription digital therapy, the evidence includes an randomized controlled trial (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) with 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 cannot be 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

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.

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.

Complex ADHD is defined by age (<4 years or presentation >12years), 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 (e.g., parent training, classroom management, behavioral peer interventions, and 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."

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

EndeavorRx, ADD, ADHD, video game

APPROVED BY GOVERNING BODIES:

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.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: Special benefit consideration may apply.  Refer to member’s benefit plan.  FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

CURRENT CODING: 

CPT:

0702T

Remote therapeutic monitoring of a standardized online digital cognitive behavioral therapy program ordered by a physician or other qualified health care professional; supply and technical support, per 30 days (Effective 01/01/2022)

0703T

Remote therapeutic monitoring of a standardized online digital cognitive behavioral therapy program ordered by a physician or other qualified health care professional; management services by physician or other qualified health care professional, per calendar month (Effective 01/01/2022)

 

HCPCS:

E1399

Durable Medical Equipment Miscellaneous

 

REFERENCES:

  1. Anguera JA, Boccanfuso J, Rintoul JL, et al. Video game training enhances cognitive control in older adults. Nature. Sep 052013; 501(7465): 97-101.
  2. Barbaresi WJ, Campbell L, Diekroger EA, et al. 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 DevBehav Pediatr. Feb/Mar 2020; 41 Suppl 2S: S35-S57.
  3. Conners CK. Conners 3rd Edition. Toronto, Multi-Health Systems, Inc., 2008.
  4. DuPaul GJ. Parent and teacher ratings of ADHD symptoms: Psychometric properties in a community based sample. J ClinChild Psychol 1991; 20:242.
  5. Forbes GB. 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
  6. Guy W, editor. ECDEU Assessment Manual for Psychopharmacology. Rockville, MD: US Department of Heath, Education, andWelfare Public Health Service Alcohol, Drug Abuse, and Mental Health Administration; 1976.
  7. Kollins SH, DeLoss DJ, Canadas E, et al. A novel digital intervention for actively reducing severity of paediatric ADHD (STARS-ADHD): a randomised controlled trial. Lancet Digit Health. Apr 2020; 2(4): e168-e178.
  8. Wolraich ML, Feurer ID, Hannah JN, et al. Obtaining systematic teacher reports of disruptive behavior disorders utilizing DSM-IV. J Abnorm Child Psychol. Apr 1998; 26(2): 141-52.
  9. Wolraich ML, Lambert W, Doffing MA, et al. Psychometric properties of the Vanderbilt ADHD diagnostic parent rating scale in a referred population. J Pediatr Psychol. Dec 2003; 28(8): 559-67.
  10. Wolraich ML, Hagan JF, Allan C, et al. Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents. Pediatrics. Oct 2019; 144(4).

POLICY HISTORY:

Medical Policy Panel July 2021

Medical Policy Group, July 2021 (6) New Medical Policy based on previous non-coverage per internal guidelines. On Draft through August 29, 2021.

Medical Policy Group, November 2021: 2022 Annual Coding Update. Added CPT 0702T-0703T.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.