Digital Cognitive or Behavioral Therapy Form

MEDICAL COVERAGE POLICY SERVICE: Digital Cognitive Behavioral Therapy Policy Number: 302 Effective Date: 05/01/2026 Last Review: 04/23/2026 Next Review: 04/23/2027 Page 1 of 3 Important note: Unless otherwise indicated, medical policies will apply to all lines of business. Medical necessity as defined by this policy does not ensure the benefit is covered. This medical policy does not replace existing federal or state rules and regulations for the applicable service or supply. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan documents. See the member plan specific benefit plan document for a complete description of plan benefits, exclusions, limitations, and conditions of coverage. In the event of a discrepancy, the plan document always supersedes the information in this policy. SERVICE: Digital Cognitive or Behavioral Therapy PRIOR AUTHORIZATION: Required. POLICY: Please review the plan’s EOC (Evidence of Coverage) or Summary Plan Description (SPD) for details. Not all plans cover this therapy. This policy addresses practitioner-prescribed digital therapeutic software applications used for health management on a mobile or computing device, including a mobile phone, tablet, laptop, or smartwatch, with the intent to evaluate, diagnose, or treat a medical condition. This policy does not apply to software applications that are integral to or used in conjunction with a separate U.S. Food and Drug Administration cleared or approved medical device. This policy also does not apply to:  Applications available directly to consumers without a prescription, including over the counter or direct to consumer products  Applications intended solely for general wellness purposes  Applications used by a healthcare practitioner within a clinical setting, including those used for remote physiological monitoring or telehealth service delivery Note: Unless otherwise indicated (see below), this policy will apply to all lines of business. For Medicare plans, please refer to appropriate Medicare NCD (National Coverage Determination) or LCD (Local Coverage Determination). If there are no applicable NCD or LCD criteria, use the criteria set forth below. For Medicaid plans, please confirm coverage as outlined in the Texas Medicaid Provider Procedures Manual | TMHP (TMPPM). If there are no applicable criteria to guide medical necessity decision making in the TMPPM, use the criteria set forth below. BSWHP may consider digital cognitive behavioral therapy medically necessary when ALL of the following criteria are met:

MEDICAL COVERAGE POLICY SERVICE: Digital Cognitive Behavioral Therapy Policy Number: 302 Effective Date: 05/01/2026 Last Review: 04/23/2026 Next Review: 04/23/2027 Page 2 of 3 A. Criteria for the mobile software application (MSA) (See table below):

1. The MSA has been approved or cleared by the Food and Drug Administration (FDA) when such clearance or approval is required; and
2. There is credible scientific evidence which permits reasonable conclusions regarding the impact of the MSA on health outcomes; AND
3. The MSA has been proven materially to improve the net health outcome or be as beneficial as any established alternative B. Member criteria to evaluate the appropriateness of the MSA for the individual:
4. The MSA is prescribed by a licensed healthcare practitioner acting within the scope of their practice; AND
5. There is documentation supporting that the MSA was ordered for a covered purpose such as preventing, evaluating, diagnosing or treating an illness, injury, disease or its symptoms, and in accordance with generally accepted standards of medical practice; AND
6. The requested MSA is not primarily for the convenience of the individual, caregiver, or healthcare provider
7. The MSA is used as part of a comprehensive treatment plan, when clinically appropriate The following mobile software applications (MSAs) have been evaluated and determined to have demonstrated medical benefit when all medical necessity criteria (see Section A) are met. All other digital therapy applications are considered experimental, investigational, or unproven due to insufficient evidence from well-designed, controlled clinical trials demonstrating efficacy. Digital Therapeutic Intervention or Treatment Methodology BSW Health Plan Status Somryst Chronic Insomnia Cognitive behavioral therapy
   9-week Prescription Digital Therapeutic Medically necessary if criteria met reSET Substance Use Disorder Cognitive behavioral therapy with contingency management (prescription digital th ti ) Medically necessary if criteria met reSET-O Opioid Use Disorder Cognitive behavioral therapy with contingency management (prescription digital th ti ) Medically necessary if criteria met SleepioRx Chronic Insomnia Cognitive behavioral therapy for insomnia (digital therapeutic) Medically necessary if criteria met BACKGROUND: Digital therapeutics are software-based interventions designed to prevent, manage, or treat a specific medical condition or disease. Unlike general wellness or lifestyle applications, digital therapeutics intended for clinical use may undergo evaluation and, when required, clearance or approval by the U.S. Food and Drug Administration (FDA).

MEDICAL COVERAGE POLICY SERVICE: Digital Cognitive Behavioral Therapy Policy Number: 302 Effective Date: 05/01/2026 Last Review: 04/23/2026 Next Review: 04/23/2027 Page 3 of 3 These therapies are prescribed by a licensed healthcare practitioner and are intended to improve clinically meaningful health outcomes, similar to other evidence-based medical interventions. Not all digital therapy applications are FDA-cleared or clinically validated; therefore, only applications meeting the medical necessity criteria outlined in this policy are considered for coverage. CODES: Important note: Due to the wide range of applicable diagnosis codes and potential changes to codes, an inclusive list may not be presented, but the following codes may apply. Inclusion of a code in this section does not guarantee that it will be reimbursed, and patient must meet the criteria set forth in the policy language. Covered Codes Code Description Notes A9291 Prescription digital cognitive and/or behavioral therapy Coverage requires all medical necessity criteria to be met Note: This list of non-covered codes is not exhaustive. Any other codes billed for digital cognitive or behavioral therapy that do not meet the medical necessity criteria outlined in this policy are also considered not covered. Not Covered / Excluded Codes Code Description Notes 98978 Remote therapeutic monitoring (e.g., therapy adherence, therapy response); device(s) supply with scheduled recordings and/or programmed alert transmission to monitor cognitive behavioral therapy, each 30 days Not covered under this policy T1505 Electronic medication compliance management device, includes all components and accessories, not otherwise classified Not covered under this policy POLICY HISTORY: Status Date Action New 03/30/2023 New policy Reviewed 04/08/2024 Formatting changes, added hyperlinks to TMPPM, beginning and ending note sections updated to align with CMS requirements and business entity changes; added references to align with current evidence. Reviewed 04/14/2025 No changes Updated 08/11/2025 Removed, “Medicare NCD or LCD specific InterQual criteria may be used when available.”

MEDICAL COVERAGE POLICY SERVICE: Digital Cognitive Behavioral Therapy Policy Number: 302 Effective Date: 05/01/2026 Last Review: 04/23/2026 Next Review: 04/23/2027 Page 4 of 3 Updated 03/17/2026 Revised policy scope and definitions to clarify practitioner-prescribed digital therapeutics and explicitly exclude consumer, wellness, and provider-operated applications; strengthened regulatory alignment language for Medicare and Texas Medicaid; updated medical necessity criteria to include FDA clearance “when required,” added requirement for credible evidence and net health benefit, clarified provider prescription requirements, and added use as part of a comprehensive treatment plan; expanded and refined evaluated digital therapeutics table to include reSET, reSET-O, and SleepioRx; revised background to distinguish digital therapeutics from general wellness applications and clarify FDA oversight; updated codes section to add A9291 as covered, designate 98978 and T1505 as not covered, restructure code tables, and clarify that non-covered code list is not exhaustive; updated references to reflect current evidence. REFERENCES: The following scientific references were utilized in the formulation of this medical policy. BSWHP will continue to review clinical evidence related to this policy and may modify it at a later date based upon the evolution of the published clinical evidence. Should additional scientific studies become available, and they are not included in the list, please forward the reference(s) to BSWHP so the information can be reviewed by the Medical Coverage Policy Committee (MCPC) and the Quality Improvement Committee (QIC) to determine if a modification of the policy is in order.

1. Digital Health Center of Excellence. Available from FDA.
2. Food and Drug Administration. Policy for device software functions and mobile medical applications: guidance for industry and Food and Drug Administration staff.
3. International Medical Device Regulators Forum. Software as a Medical Device (SaMD): key definitions.
4. Morin CM. Profile of Somryst prescription digital therapeutic for chronic insomnia: overview of safety and efficacy. Expert Rev Med Devices. 2020;17(12):1239-1248. doi:10.1080/17434440.2020.1852929
5. Steven W. Evans, Theodore P. Beauchaine, Andrea Chronis-Tuscano, Stephen P. Becker, Anil Chacko, Richard Gallagher, Cynthia M. Hartung, Michael J. Kofler, Brandon K. Schultz, Leanne Tamm & Eric A. Youngstrom (2021) The Efficacy of Cognitive Videogame Training for ADHD and What FDA Clearance Means for Clinicians, Evidence-Based Practice in Child and Adolescent Mental Health, 6:1, 116-130, DOI: 10.1080/23794925.2020.1859960
6. Hayes Reviews. Available at https://evidence.hayesinc.com/. Requires subscription.
7. Maricich YA, Bickel WK, Marsch LA, et al. Safety and Efficacy of a Prescription Digital Therapeutic as an Adjunct to Buprenorphine for Treatment of Opioid Use Disorder. Current Medical Research and Opinion. 2021;37(2):167- 173.
8. Xiong X, Braun S, Stitzer M, et al. Evaluation of Real-World Outcomes Associated With Use of a Prescription Digital Therapeutic to Treat Substance Use Disorders. The American Journal on Addictions. 2023;32(1):24-31.
9. Kwan I, Burchett HED, Macdowall W, et al. How Effective Are Remote and/or Digital Interventions as Part of Alcohol and Drug Treatment and Recovery Support? A Systematic Review and Meta-Analysis. Addiction. 2025;120(8):1531-1550.
10. Espie CA, Emsley R, Kyle SD, et al. Effect of Digital Cognitive Behavioral Therapy for Insomnia on Health, Psychological Well-Being, and Sleep-Related Quality of Life: A Randomized Clinical Trial. JAMA Psychiatry. 2019;76(1):21-30

MEDICAL COVERAGE POLICY SERVICE: Digital Cognitive Behavioral Therapy Policy Number: 302 Effective Date: 05/01/2026 Last Review: 04/23/2026 Next Review: 04/23/2027 Page 5 of 3

11. Soh HL, Ho RC, Ho CS, Tam WW. Efficacy of Digital Cognitive Behavioural Therapy for Insomnia: A Meta- Analysis of Randomised Controlled Trials. Sleep Medicine. 2020;75:315-325. Note: Health Maintenance Organization (HMO) products are offered through Scott and White Health Plan dba Baylor Scott & White Health Plan, and Scott & White Care Plans dba Baylor Scott & White Care Plan. Insured PPO and EPO products are offered through Baylor Scott & White Insurance Company. Scott and White Health Plan dba Baylor Scott & White Health Plan serves as a third-party administrator for self-funded employer-sponsored plans. Baylor Scott & White Care Plan and Baylor Scott & White Insurance Company are wholly owned subsidiaries of Scott and White Health Plan. These companies are referred to collectively in this document as Baylor Scott & White Health Plan. RightCare STAR Medicaid plans are offered through Scott and White Health Plan in the Central Managed Care Service Area (MRSA) and STAR and CHIP plans are offered through SHA LLC dba FirstCare Health Plans (FirstCare) in the Lubbock and West MRSAs.