The United States continues to face a pervasive public health challenge: lack of access to behavioral health providers and resources. Behavioral health conditions have been significantly increasing in prevalence, but despite the widespread need, there continues to be a large gap between demand and availability of behavioral health resources. Persistent shortages within the behavioral health workforce often result in lengthy wait times for a behavioral health appointment and delayed patient care, which ultimately lead to worse outcomes.
To help address this challenge, the Centers for Medicare & Medicaid Services (CMS) has prioritized increasing access to behavioral health services. Most recently, CMS collaborated with the Food and Drug Administration on a novel approach in the calendar year 2025 Physician Fee Schedule (PFS) final rule on coding and Medicare payment policies to improve access to behavioral health services through innovative, safe, and effective digital mental health treatments (DMHT). In general, DMHTs are software devices intended to treat or alleviate behavioral health conditions. These devices hold tremendous promise to help bridge the gap in availability and access to mental health services and providers.
The FDA’s Office of Neurological Devices and Physical Medicine (OHT 5) authorized the first of these devices in 2016 for mental health treatment for substance use disorder. Since then, the FDA has authorized several digital products under the regulation “Computerized behavioral therapy device for psychiatric disorders,” including devices for insomnia, depression, postpartum depression, and generalized anxiety disorder.
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