CurrentBaylor Scott & White Health PlanPolicy N/A

Digital Cognitive Behavioral Therapy (prescription mobile software applications)

Policy governing coverage and prior authorization requirements for practitioner‑prescribed mobile software applications intended to evaluate, diagnose, or treat medical conditions using cognitive or behavioral therapy; applies to Baylor Scott & White Health Plan lines of business unless plan documents state otherwise.

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyDigital Cognitive Behavioral Therapy (prescription mobile software applications)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMay 1, 2025

Next Review DateApr 14, 2026

Key ActionObtain prior authorization and document that the prescribed mobile software application was ordered for a covered medical purpose.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Prior auth requiredAuthorization stance

Somryst listedNamed therapy

FDA requiredRegulatory

A9291Billing code

Medicare/Medicaid guidance appliesPlan notes

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Coverage and Medical Necessity

Medical Necessity Criteria

BSWHP may consider digital cognitive behavioral therapy medically necessary when ALL of the following criteria are met:

MSA regulatory and evidence criteria: The MSA has been approved or cleared by the Food and Drug Administration (FDA); there is credible scientific evidence permitting reasonable conclusions regarding the impact of the MSA on health outcomes; and the MSA has been proven to materially improve net health outcome or be as beneficial as any established alternative.

From policy section A: criteria for the mobile software application (MSA).

Member and ordering criteria: The MSA has been prescribed by a healthcare practitioner; there is documentation that the MSA was ordered for a covered purpose (preventing, evaluating, diagnosing or treating an illness, injury, disease or its symptoms) in accordance with generally accepted standards of medical practice; and the requested MSA is not primarily for the convenience of the individual, caregiver, or healthcare provider.

From policy section B: member criteria.

This policy does not apply to mobile-based software applications that are available to the general public for download (direct‑to‑consumer or “over‑the‑counter” apps). It also excludes applications that promote general wellness, applications operated by a healthcare practitioner in a clinical setting for remote health monitoring, and mobile software used in the management of a separate FDA‑cleared or approved standalone hardware medical device. For specific member coverage, review the plan Evidence of Coverage (EOC) or Summary Plan Description (SPD) as plan terms supersede this policy.

All digital therapy applications not specifically evaluated and named in this policy are considered experimental, investigational, or unproven due to a paucity of well‑designed, controlled clinical trials demonstrating clinical efficacy, and may be denied for lack of evidence.

Billing and Coding

CPT Codes (listed)CPT

98978

Remote therapeutic monitoring (eg, therapy adherence, therapy response); device(s)_ supply with scheduled (eg, daily) recording(s) and/or programmed alert(s) transmission to monitor cognitive behavioral therapy_each 30 days.

HCPCS Codes (covered)HCPCSCovered

A9291

Prescription digital cognitive and/or behavioral therapy, FDA-cleared, per course of treatment.

HCPCS Codes (not covered)HCPCSNot Covered

T1505

Electronic medication compliance management device, includes all components and accessories, not otherwise classified.

ICD-10ICD-10

No codes listed

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Digital Cognitive or Behavioral Therapy. Review the plan Evidence of Coverage (EOC) / Summary Plan Description (SPD) for member coverage details and to determine if the specific plan covers this therapy.

Step Therapy

No explicit step therapy rules are provided in this policy. Providers should verify plan-specific requirements in the member's EOC/SPD or prior authorization instructions, as payers may implement step therapies outside this policy.

Documentation Required

Required Documentation for Medical Purpose and Prescription

Documentation supporting medical purpose and prescription is required. Medical records must show that the MSA was prescribed by a healthcare practitioner and ordered for a covered purpose (preventing, evaluating, diagnosing, or treating an illness, injury, disease, or its symptoms) and consistent with generally accepted standards of medical practice. Documentation should also show the MSA is not prescribed primarily for convenience.

Key Terms

Mobile Software Application (MSA) / Prescription Digital Therapeutic

DefinitionPractitioner‑prescribed software applications for health management on mobile devices intended to evaluate, diagnose, or treat a medical condition; excludes direct‑to‑consumer/over‑the‑counter wellness apps and apps integrated with a separate FDA‑cleared standalone hardware device.

Scope of useIntended for prescription by a healthcare practitioner for clinical purposes (preventing, evaluating, diagnosing, or treating an illness, injury, disease, or its symptoms).

Regulatory requirementTreated like drugs/devices: digital therapies may be evaluated and approved or cleared by the U.S. Food and Drug Administration (FDA).

ExclusionsDoes NOT include mobile apps available to the general public for download (direct‑to‑consumer/over‑the‑counter), general wellness apps, or apps used in management of another FDA‑cleared standalone hardware medical device.

Documentation/prescription requirementMust be prescribed by a healthcare practitioner and ordered for a covered clinical purpose consistent with generally accepted standards of medical practice.

Named Prescription Digital Therapeutics

Prescription Digital Therapeutic (e.g., Somryst)

Somryst indication: Somryst is identified as a prescription digital therapeutic for chronic insomnia using a 9-week cognitive behavioral therapy methodology and is considered medically necessary if the policy criteria are met.

Named example of a covered prescription digital therapeutic.

Background and Scope

Digital therapy refers to practitioner‑prescribed software programs (mobile software applications) intended to prevent, manage, evaluate, diagnose, or treat medical disorders or diseases using therapeutic methods such as cognitive or behavioral therapy. Like drugs and devices, these mobile software applications may require FDA clearance or approval and are evaluated for credible scientific evidence demonstrating meaningful improvements in net health outcomes versus established alternatives.