Issues in Regulating DTx

Access to evidence-based psychotherapies remains limited by time constraints, affordability, stigma, and other factors.¹ Digital therapeutics (DTx) represent a valuable addition to psychiatrists’ toolkits. But before they recommend DTx, psychiatrists should consider how these programs are being evaluated by regulators and delivered to patients.

Although existing DTx target a range of physical illnesses, those targeting mental health issues have received more funding in 2020 and 2021 than all other types.² This development will have a direct impact on the practice of psychiatry. The scope of this impact depends in large part on how regulatory oversight evolves, since regulation determines: which types of DTx are subject to oversight; whether a particular DTx is available via prescription or over the counter (OTC), and the required level of adjunctive care associated with it; and the evidence required for commercialization and reimbursement.

Given the unique set of applied uses and different risk profiles associated with DTx, oversight will require an updated regulatory model. The US Food and Drug Administration (FDA) has recognized this need as well, given the recent launch of their new Digital Health Center of Excellence (DHCoE). One of the 3 primary goals of the DHCoE is to “innovate regulatory approaches to provide efficient and least burdensome oversight while meeting the FDA standards for safe and effective products.”³ As progress on this front unfolds, 3 aspects of DTx are particularly important for psychiatrists and other mental health providers to consider: evaluation, delivery, and reimbursement.

Evaluation of DTx

The necessary amounts and types of evidence required by the FDA for DTx are controversial. Most commercially available DTx for behavioral health conditions qualify as wellness interventions (ie, they do not make treatment claims), and the FDA has stated that these DTx do not need regulatory clearance to be on market because they are low risk. In contrast, DTx that make treatment claims for specific psychiatric disorders do require traditional FDA clearance.

DTx cleared by the FDA have gone through both de novo classification and premarket notification (510k) regulatory pathways. The de novo classification permits device clearance when no marketed predicate device in the space exists and empirical evidence provides reasonable assurance of safety and efficacy for the intended use. Despite these standards, the clinical significance of FDA-cleared devices for mental health has been called into question.^4,5 Moreover, DTx pursuing the 510k pathway are required only to show equivalence to previously cleared devices. This has raised concerns that DTx will not have clinically significant effects, or that the results will not generalize to real-world psychiatric patients.⁵

In a March 2021 perspective on the FDA, Rathi et al noted that “breakthrough devices were approved primarily on the basis of studies that used short-term, surrogate end points for effectiveness, which may not translate into clinical benefits.”⁶ For example, a DTx product that uses the Apple Watch to send vibrations to interrupt nightmares in those with posttraumatic stress disorder was given breakthrough designation and permission to market based on a 30-day study of 70 patients.⁷ Rathi and colleagues continued: “The FDA authorized some breakthrough devices without supporting effectiveness data (ie, they were approved on the basis of safety data alone) and authorized other devices that carried important known safety risks.”⁶ As a result of these concerns, the Medicare Coverage of Innovative Technology (MCIT) rule, designed to grant an immediate Medicare coverage pathway for DTx once they are designated as a breakthrough by the FDA, has been delayed multiple times.⁸

To improve the utility of DTx for psychiatric practice, regulatory agencies need to reach greater consensus and clarity on what constitutes sufficient evidence for approvals—both for wellness and the treatment of psychiatric conditions. In the interim, it will be important for psychiatrists to evaluate the evidence for the DTx they would like to leverage in their practice, whether or not the FDA has cleared them.

Delivery of DTx

FDA regulatory classifications of DTx for psychiatric disorders have specified that these products should be distributed by prescription only. However, restricting access to DTx with particularly safe profiles contradicts many of the central goals behind DTx development. It is critical to consider which providers will be able to offer DTx to patients. With few exceptions (eg, the US Army), the only providers with prescription privileges are medical doctors and nurse practitioners. However, mental health care is provided by a broader range of professionals.

Most FDA-cleared DTx have been designated as adjunctive rather than stand-alone treatment, despite the fact that many DTx have been developed as stand-alone interventions and have shown clinical benefits without serving as an adjunct to in-person care. Requiring adjunctive care may be appropriate for some DTx, but denying individuals with low or moderate levels of psychiatric symptoms the opportunity to benefit from stand-alone DTx when risks are minimal seems misguided.

The majority of DTx have not been cleared by the FDA because they fall under other categories of oversight that do not require premarket clearance. In many cases, digital tools marketed as wellness products leverage the same clinical interventions (eg, CBT) that are simultaneously cleared by the FDA as prescription-only products. Given the large number of individuals who do not meet formal criteria for a diagnosis but experience clinical levels of distress nonetheless, a more granular approach to evaluation may be appropriate.

To provide additional guidance for psychiatrists and patients, it would be helpful for the FDA to establish a clearance status for DTx that is similar to an OTC designation. Although some DTx carry inherent risks, unnecessary restrictions on access to low-risk DTx are a bigger risk to consumers.

Reimbursement of DTx

Broadly speaking, there are 2 central challenges impacting the development of routine reimbursement pathways for DTx: reimbursement for the DTx itself and reimbursement for coordinating care.

There is currently no standard pathway for reimbursement for DTx; instead, DTx tend to be purchased by patients directly.⁹ If providers or patients cannot be reimbursed for the cost of DTx via the insurer, then the reach of DTx will be limited to patients who can pay out of pocket. The most comprehensive solution would be to establish a new DTx benefit category under Medicare; however, this change would require an act of Congress.

Reimbursement for coordinating care surrounding DTx is not straightforward. Under the current system, 4 Current Procedural Terminology (CPT) codes for remote physiologic monitoring treatment management services (99453-99458) have been used for some DTx. However, the October 2020 editorial meeting of the American Medical Association (AMA) seems to have established a new group of codes titled remote therapeutic monitoring services and remote therapeutic monitoring treatment management services. The change in a key word, from physiologicto therapeutic, may make these codes available to a broader scope of DTx, including those that target mental health and substance abuse.¹⁰

Concluding Thoughts

As we move into a new era of DTx for mental health, regulatory and reimbursement structures and processes must be modernized to reflect the treatments they oversee. As psychiatrists and other mental health providers learn to integrate DTx into patient care, it is critical to advocate for policies that broaden the accessibility and acceptability of these innovative and effective tools.

Dr Doss is a professor of psychology at the University of Miami. Dr Weingardt is chief executive officer of Audacious Digital Health. Dr Lindhiem is an associate professor of psychiatry at the University of Pittsburgh. Dr Timmons is an assistant professor of psychology at Florida International University. Dr Jones is a professor in the Department of Psychology and Neuroscience at the University of North Carolina at Chapel Hill. Dr Comer is a professor of psychology at the Center for Children and Families at Florida International University. Dr Carl is vice president of clinical development & medical affairs at Big Health Inc.

References

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8. Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘Reasonable and Necessary’; Delay of Effective Date. Fed Regist. 2021;86(94):26849-26854.

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