New Solutions Are Gaining Traction as Demand for Help Increases in the U.S.

As you are reading this, roughly half of the United States population lives in what's called a ‘designated mental health provider shortage area’, according to the U.S. Health Resources and Services Administration. And the shortage is only getting worse.

Yet there are an array of untapped tools just waiting for dynamics to shift, which would make them more widely accessible. Despite the hype and overestimation by a few early companies, there is a simple truth: when utilized intentionally and appropriately, prescription digital therapeutics (PDT) for behavioral health can deliver personalized, convenient, and cost-effective care.

The PDT sector has endured early overzealous investors and some high-profile bankruptcies due to lagging reimbursement policies. Our current legacy system need not be totally abandoned; rather, we should adapt it to support the clear benefits of digital therapeutics in partnership with clinicians, health systems, payers, and all mental health stakeholders.

Clinicians and patients have long awaited evidence-based, regulated technologies to treat or manage conditions like diabetes and substance use disorder. Now, these solutions are finally within reach. All major stakeholders—including large health systems, employers, and life science companies—want improvements in outcomes alongside cost-of-care reductions. However, healthcare moves slowly and progresses iteratively. Simply wanting change does not ensure it will happen, or happen as quickly as desired.

So why is a behavioral healthcare system strained by widening access gaps driven by workforce shortages and rising costs, and reluctant to adopt technology?

Reimbursement is the largest obstacle that remains. PDTs are somewhere in the mix of medical devices, pharmaceuticals, and digital health apps. They’re within some existing frameworks, but reimbursement and adoption by health plans in general are inconsistent.

Enter the Access to Prescription Digital Therapeutics Act, which was recently reintroduced to Congress by a group of bipartisan lawmakers and helped bring renewed attention to the issue. It’s driven recent policy changes—such as new HCPCS codes and CMS’s physician fee schedule for digital mental health treatment. These are bold moves forward, but more work remains. Without sustainable payment, innovations will be lost. The cause of the collapse of several early PDT pioneers wasn’t clinical failure; it was financial, due to the lethargic pace with which we adopt new remedies in our health care ecosystem.

Health plans want clearer evidence linking PDTs to measurable cost savings and improved outcomes. Early studies have been promising, but payers remain cautious. They want real-world data across diverse populations that are consistent with the pivotal trial outcomes.

Among behavioral health providers, acceptance is far from universal.

Many mental health practitioners welcome tools that can reinforce therapy between sessions, extend their reach, and give patients structured support. Digital CBT programs, for example, can help standardize care and offer immediate interventions while clinicians manage more complex cases.

In contrast, PDT developers are fighting two battles. Early adoption syndrome and legacy treatment paradigms. This is the first time technology has entered the mental health treatment space. Cardiology and other health disciplines are accustomed to regular technological advances. But not mental health. Some therapists worry about being replaced by technology or overwhelmed by yet another data stream they don’t have time to monitor.

Additional questions persist that PDTs may hinder therapeutic alliance—the collaborative bond between clinician and patient at the heart of mental health care. Many clinicians feel digital therapeutics might erode that connection.

Freespira and other digital mental health companies with FDA clearance are responding by emphasizing clinician-controlled prescribing, offering training, and generating stronger evidence for outcomes in real-world settings. In essence, these treatments operate as an extension of the provider and enhance the care pathway for many patients. These tools are not replacing clinical judgement and acceptance among mental health professionals is steadily growing.

Where PDTs will have a demonstrable impact is the efficiencies within the clinicians’ office, allowing them more time to focus on patient-facing activities and reducing back-office administrative duties by prescribing digital therapeutics when appropriate, as these companies will often take the lead on patient onboarding to provide enhanced patient experience.   Even the most brilliant technology fails when it adds friction to a clinician’s day. Adoption hinges on seamless integration.

The next generation of PDTs is increasingly being embedded into mental health care pathways, enabling easier prescribing, automated data flows, and simplified monitoring. AI is accelerating this shift by reducing administrative steps and surfacing clinically relevant insights rather than raw data.

To their credit, many developers are investing in stronger trials, longitudinal tracking, and tighter integration into electronic health records. Partnerships with academic medical centers and pharmaceutical companies are helping move PDTs from “interesting add-ons” to clinically validated interventions.

To that end,  studies indicate that only about 20 percent of clinicians are actively doing measurement-based care on a routine basis. The data we provide insurers and clinicians is based on using PCL-5 and PDSS surveys with information gathered before and after treatment to determine the clinical outcome analysis. This data inspires more confidence in the treatment and creates a pathway for increased PDT use in the mental health space. Healthcare providers are far more likely to use a tool that gives them time back rather than steals more of it.

The question now isn’t whether PDTs belong in modern mental health care—they do. The question is whether the industry can build the infrastructure, trust, and reimbursement stability needed for them to deliver on their potential.

Remember, almost 50% of individuals in the United States live in what's called a designated mental health provider shortage area. But progress is viable and PDTs could meet the demands for mental health care as routinely as prescribing a medication, by recognizing it as another tool in the clinician’s toolkit.

The next few years will be defining. PDTs are growing up. The healthcare system simply needs to give them a fair chance to prove their value.

Joseph Perekupka is the CEO of Freespira, Inc., an emerging growth company shifting the paradigm for behavioral healthcare solutions. Freespira’s clinically validated solution combines a medical device with high-touch support to deliver rapid and lasting symptom relief in just 28 days.