Latest Review Date: July 2024

Category: Medical

POLICY:

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

DESCRIPTION OF PROCEDURE OR SERVICE:

Digital health technologies is a broad term that includes categories such as mobile health, health information technology, wearable devices, telehealth and telemedicine, and personalized medicine. These technologies span a wide range of uses, from applications in general wellness to applications as a medical device, and include technologies intended for use as a medical product, in a medical product, as companion diagnostics, or as an adjunct to other medical products (devices, drugs, and biologics). The scope of this review includes only those digital technologies that are intended to be used for therapeutic application and meet the following 3 criteria: 1) Must meet the definition of "Software as a medical device" which states that software is intended to be used for a medical purpose, without being part of a hardware medical device or software that stores or transmits medical information. 2) Must have received marketing clearance or approval by the U.S. Food and Drug Administration (FDA) either through the de novo pre-market process or 510(k) process or pre-market approval and 3) Must be prescribed by a healthcare provider. This review will assess whether a digital therapy in the form of a computer game can improve attention in children with ADHD.

Scope of Review

Software has become an important part of product development and is integrated widely into digital platforms that serve both medical and non-medical purposes. The 3 broad categories of software use in medical devices are:

1. Software used in the manufacture or maintenance of a medical device (e.g., software that monitors x-ray tube performance to anticipate the need for replacement),
2. Software that is integral to a medical device or software in a medical device (e.g., software used to "drive or control" the motors and the pumping of medication in an infusion pump),
3. Software, which on its own is a medical device referred to as "Software as a Medical Device" (SaMD) (e.g., software that can track the size of a mole over time and determine the risk of melanoma).

The International Medical Device Regulators Forum, a consortium of medical device regulators from around the world led by the U.S. Food and Drug Administration (FDA) defines SaMD as "software that is intended to be used for one or more medical purposes that perform those purposes without being part of a hardware medical device". Such software was previously referred to by industry, international regulators, and health care providers as "standalone software," "medical device software," and/or “health software," and can sometimes be confused with other types of software.

The scope of this review includes only those digital technologies that are intended to be used for therapeutic application and meet the following 3 criteria:

1. Must meet the definition of "Software as a medical device" (SaMD) which states that software is intended to be used for a medical purpose, without being part of a hardware medical device or software that stores or transmits medical information.
2. Must have received marketing clearance or approval by the U.S. FDA either through the de novo pre-market process or 510(k) process or pre-market approval and,
3. Must be prescribed by a healthcare provider.

BCBSA Evaluation Framework for Digital Health Technologies

SaMDs, as defined by the FDA, are subject to the same evaluation standards as other devices. The Blue Cross and Blue Shield Association Technology Evaluation Criterion are as follows:

1. The technology must have final approval from the appropriate governmental 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.^a
4. The technology must be as beneficial as any established alternatives.
5. The improvement must be attainable outside the investigational settings.^b

 ^a The technology must assure protection of sensitive patient health information as per the requirements of The Health Insurance Portability and Accountability Act of 1996(HIPAA).

^b The technology must demonstrate usability in a real-world setting.

Other regulatory authorities such as the United Kingdom's National Institute for Health and Care Excellence (NICE) have proposed standards to evaluate SaMD.

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 5, 2024.

Summary of Evidence:

For individuals who are children ages 8 to 12 years with ADHD who receive Endeavor Rx, the evidence includes a pivotal randomized controlled trial (RCT) and an open label study. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The pivotal RCT compared outcomes of the EndeavorRx® with a word game that targeted different cognitive abilities (digital control intervention). 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 second open label study compared EndeavorRx plus stimulant medication with EndeavorRx alone. 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. 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 have recently been completed but not yet published. 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.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

EndeavorRx, ADD, ADHD, video game, Mightier Program

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. 

CURRENT CODING: 

CPT:

HCPCS:

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. International Medical Device Regulators Forum. Software as a Medical Device (SaMD): Key Definitions. 2013.http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-131209-samd-key-definitions-140901.pdf.
8. Kollins SH, Childress A, Heusser AC, et al. Effectiveness of a digital therapeutic as adjunct to treatment with medication in pediatric ADHD. NPJ Digit Med. Mar 26 2021; 4(1): 58.
9. 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.
10. National Institute for Health and Care Excellence (NICE). Evidence standards framework for digital health technologies.2021. nice.org.uk/corporate/ecd7/chapter/section-a-evidence-for-effectiveness-standards.
11. 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.
12. 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.
13. 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.

Medical Policy Panel, July 2022

Medical Policy Group, August 2022 (6): Updates to Key Points.

Medical Policy Group, November 2022 (6): 2023 Annual Coding Update. Added CPT 98978 to the Current Coding section. Moved CPT 0702T/0703T code from Current coding section. Created Previous Coding section to include code 0702T/0703T.

Medical Policy Panel, July 2023

Medical Policy Group, July 2023 (6): Updates to Description, Key Points, Practice Guidelines, Benefit Application and References.

Medical Policy Panel, July 2024

Medical Policy Group, July 2024 (6): Updates to Description, Key Points, Key Words and References.

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.