Exploring Digital Mental Health Treatment Devices

The healthcare ecosystem has been evolving to support patients and practitioners since the earliest days of human medicine. Innovations in how we examine, treat, and record medical interactions have helped increase life expectancy from roughly 32 years in 1900 to just over 70 years by 2021.

While the patient-provider relationship remains the foundation of any medical practice, effectively using new technologies is essential to delivering more efficient, high-quality care and maintaining long-term practice health.

On January 1st, 2026, the new CMS Medicare Physician Fee Schedule Final Rule will come into effect. The changes encompass many updates that will help practices better serve patients, including new policies guiding the use and coding of digital mental health treatment (DMHT) devices.

These devices offer meaningful opportunities for physicians and behavioral healthcare providers to expand their treatment capacity when used independently or alongside psychotherapy or medications as part of a patient’s treatment plan. However, knowing the strengths and limitations of these devices is critical to ensure they are used most effectively and coded correctly.

Today, let’s spend some time talking about these devices – what they are, how they can be used to treat patients, and how you can get the technical support you need to start using these devices in your practice.

What are digital mental health treatment devices?🔗

Digital mental health treatment devices, often shortened as DMHT devices, are a type of digital health tool. The category of digital health is defined by the APA as a “broad category that includes “mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine.”

We’ve been using many tools within the broader classification of health IT for decades now – EHRs, secure patient-provider messaging, telehealth, and even encrypted email fall into this category. Additionally, several types of therapeutic monitoring devices that convey patient data to providers (coded under CPT code 98978) have been included in Medicare and Medicaid since CY 2023.

In contrast, digital mental health treatment devices are software or apps that have been medically validated to help treat, diagnose, or prevent mental or behavioral health conditions, such as generalized anxiety disorder or major depressive disorder.

While there are many direct-to-consumer apps and programs available that are purported to promote better mental health, DMHT devices are unique because they:

• Are evidence-based
• Are regulated by the FDA
• Require a prescription or order from a licensed provider
• Must be included as part of a plan of care

Providers seeking to use DMHT devices must code them specifically, using:

• G0552 – supplying and onboarding of the device and initial patient education
• G0553 – First 20 minutes of monthly treatment management services directly related to the provider’s professional time
• G0554 – Each additional 20 minutes of monthly treatment management services that are directly related to the patient’s use of the DMHT device.

Both G0553 and G0554 would also include time spent reviewing patient observations and require interaction with the patient during the relevant calendar month.

Since these unique new DMHT devices are available in the form of either software or an app, the algorithm within the software is actually the device being used for patient care. Because of the rapid innovation of this type of software, agencies including the FDA, the Veterans Health Administration (VHA), and the Substance Abuse and Mental Health Services Administration (SAMHSA) are watching closely as use of these devices develops and expands across the country.

Treating behavioral health conditions with digital mental health treatment devices🔗

There have been several evidence-based uses for these devices established by the FDA and CMS. So far, the devices that have been approved for wider use include:

• EndeavorRX: A digital therapeutic device developed for pediatric patients in treatment for primarily inattentive or combined-type ADHD.
• DaylightRX: A DMHT device designed for patients with generalized anxiety disorder, which helps teach CBT-based techniques to reduce anxiety and worry.
• Rejoyn: A prescription-only smartphone app intended to help adult patients with major depressive disorder who are not fully responding to antidepressants.
• SparkRX: The first digital therapeutic device intended to help treat adolescent depression through CBT and behavioral activation protocols.

By integrating FDA-regulated digital treatments into existing plans of care, practices can extend therapeutic support beyond the traditional visit, improve patient engagement between appointments, and serve populations that may otherwise face access barriers.

The impact of generative AI on digital mental health treatment devices🔗

As digital mental health treatment devices continue to evolve, generative artificial intelligence (gen AI) is increasingly playing a visible role in how these tools are designed, personalized, and scaled.

In many cases, large language models are being used to adapt therapeutic content in real time based on data such as patient engagement, symptom reporting, or usage patterns. When used appropriately, this personalization can reinforce evidence-based interventions such as CBT and support more consistent patient participation between visits. At the same time, the use of generative AI introduces significant new concerns around safety, transparency, and regulatory oversight.

As of now, none of the FDA-approved DMHT devices like Rejoyn, EndeavorRX, SparkRX, or DaylightRX report the use of generative AI. Because the software itself is considered a medical device, any AI-driven functionality must meet the FDA’s rigorous expectations for clinical validation, risk management, and ongoing performance monitoring.

The FDA has already signaled its intent to take a lifecycle-based approach to regulating AI-enabled medical software, with an emphasis on ongoing surveillance and clear documentation of how algorithms are trained, updated, and governed over time. This is particularly important in behavioral health, where clinical nuance and patient trust are central to effective care.

Explore DMHT devices in your practice🔗

Digital mental health treatment devices represent a new horizon in how we think about behavioral health conditions, particularly those that do not respond well to treatment or affect those who do not have regular access to care.

These devices also represent a meaningful opportunity to expand service offerings without proportionally increasing staff burden. When implemented thoughtfully and coded correctly, DMHT devices can support more consistent patient touchpoints, more precise documentation of treatment management time, and new, reimbursable workflows that align with evolving CMS policies.

Keep reading our blog for more updates on this emerging technology and other clinical innovations that can help boost your practice’s RCM.