Mental health care in the United States has reached a crisis point. Approximately one in five U.S. adults – or 57.8 million Americans in 2021 – are living with a mental illness.1 Concerningly, less than half (47.2%) of those living with a mental health condition receive professional help, signaling widespread unmet need.2 Profound demographic disparities also exist: young adults are disproportionately impacted but less likely to receive help, while fewer people identifying as Black or African American, Hispanic or Latino, or Asian receive care compared to Whites.3 Despite the availability of treatment options, financial, geographic, cultural, and educational barriers have made it impossible to adequately and effectively deliver care, particularly among communities at the margins.4
This gap between the demand for and receipt of mental health care bears considerable costs. Mental health diagnoses are associated with lower school attendance and poorer academic performance, as well as lower productivity and $193 billion in lost earnings.5, 6, 7, 8 Mental health conditions also have a bilateral tie to incarceration and houselessness, with associated societal costs.9, 10 Intergenerational costs should also not be ignored: children whose parents experienced mental health issues were nearly twice as likely to also have poor mental health.11 Arguably the greatest cost of mental health conditions is suicide, which led to 49,449 in 2022 – a 2.6% increase from 2021 and a 36% increase from the year 2000.12
The 2020-21 COVID-19 pandemic was a pivotal turning point for US mental health. Not only was care harder to access, but mental illness rose steeply due to widespread social isolation, personal loss, unemployment, upended lifestyles, and the fears of viral contagion. Approximately half of women and a third of men have experienced worsened mental health due to the pandemic.13 Communities subject to systemic barriers like Hispanic and Black people, the unemployed, mothers, and essential workers were especially affected by pandemic-related mental health challenges.14
In response, the Biden administration’s Unity Agenda has identified improved mental health care as a key issue to address through increased coverage and lowered treatment costs, expanded access to providers and community programs, and enhancements to the suicide prevention lifeline and Veterans Crisis Line.15 The Department of Health and Human Services and its agencies have also initiated mental health and substance abuse programs, with $300M+ in funding from the Biden administration. Another government entity, the Substance Abuse and Mental Health Services Administration (SAMHSA) has provided numerous programs, initiatives, and grants to help patients access mental health services, including digital health products.16
This expanded federal investment in mental health has translated into major legislative changes. Originally introduced in 2008, the Mental Health Parity and Addiction Equity Act (MHPAEA) prohibits group health plans from providing poorer benefits for mental health and substance use disorder than for medical and surgical care. This act was poorly enforced, having minimal impact until the Consolidations Appropriations Act (CAA) of 2021, which required group health plans to analyze their compliance with MHPAEA, and plans have since faced fines for noncompliance. The Biden Administration’s 2023 Budget also gave the MHPAEA a $275M boost to support enforcement. It seems these steps have motivated employers and insurers to enhance and prioritize their mental health benefits, whetting appetites for innovative and cost-saving mental health services.
How Digital Therapeutics Could Help Patients
The nation’s mental health landscape appears defined by high unmet need, gaping disparities, and a broad awareness that action is urgently needed. A promising solution is the introduction of digital health therapeutics: innovative technologies that enhance the accessibility, convenience, and effectiveness of mental health care.
SAMHSA has issued a detailed advisory on digital therapeutics.17 In addition to improved health outcomes, SAMSHA stressed the utility of digital therapeutics (DTx) in expanding access and overcoming major barriers to behavioral healthcare in traditionally underserved communities. The remote nature of DTx and the reduced need for in-person treatment can overcome provider shortages and geographic barriers. This is urgently needed, considering that 37% of the overall population and two-thirds of the rural population live in an area with a shortage of mental health practitioners.18, 19
Digital tools that help diagnosis or treatment may reduce the bias that exists within care received by BIPOC and LGBTQIA+ communities.20 Remote care can provide a sense of anonymity and therefore reduce the experience of stigma, enhancing patient willingness to seek treatment. Further, the personalized nature of DTx can overcome cultural barriers and create more effective care for traditionally underserved populations, presenting an important opportunity to improve health equity.21 For example, a culturally tailored digital therapeutic for substance use disorders in urban American Indians/Alaska Natives was shown to significantly improve post-treatment abstinence and social connectedness.22
Certain disease areas can see significant patient benefits and enhanced recovery rates from the adoption of technology, particularly diseases where the response time of a clinician to a psychiatric emergency is crucial (e.g. Psychotic Illnesses, Early Psychosis).23 To that end, digital health offers a promising intervention to affect patient outcomes and recovery rates by allowing clinicians to assess patient condition on a daily basis.24 Community-based studies have shown individuals with early psychosis showed clinical benefit and improved clinician engagement through the use of mobile health apps to assess and manage the disease.
Broadly speaking, DTx have demonstrated benefits in improving access, engagement, and outcomes all while reducing care costs according to a SAMHSA Advisory report.25 A DTx developed by the Center for Technology and Behavioral Health (CTBH) within the National Institutes of Health (NIH) resulted in double abstinence rates when offered as part of substance use disorder treatment, greatly increased substance use disorder treatment retention, and reduced costly emergency department visits and inpatient hospitalizations.26 Cost-effective mental health care is critical since primary care has had 23.8% higher reimbursement rates than behavioral health care.27 A 2023 meta-analysis found that 17 out of the 18 digital therapeutics studied were either cost-effective or cost-saving.28
What Access Looks Like Today
Clearly, digital therapeutics hold promise in helping address the US mental health crisis, and a number of innovative tools already exist for depression, PTSD, bipolar disorder, and substance use disorders, among others. However, the adoption of these technologies has lagged in the US compared to other nations, stifled by tenuous policy, and insufficient provider reimbursement.29
Coverage and provider reimbursement barriers are the chief barriers imposed by insurance plans, where coverage refers to the range of medical services and products that an insurance plan will pay for, and provider reimbursement, is the actual payment made by the insurance company to the healthcare provider for that covered service. Without coverage, patients would need to cover the cost entirely out-of-pocket, and without reimbursement, no provider would likely be willing to prescribe DTx. Insurance plans and DTx companies have been locked in a stalemate, with insurance plans deciding not to cover and reimburse, leaving patients without access to this new technology.
In the studies assessing mobile health among Early Psychosis patients, lack of insurance reimbursement for clinician work was the primary barrier to greater adoption. This lack of reimbursement stems from the lack of available billing codes resulting in an inability for providers to bill and subsequently receive payment for hours spent treating patients via the mobile health platform.30 After years of reimbursement uncertainty, however, digital therapeutics may be beginning to see a change in coverage and reimbursement policies.
Providing evidence that insurance companies demand – for a fee.
Highmark Healthcare, a regional Pittsburgh-based integrated delivery network (IDN) and insurance company was one of the first and most exciting examples of digital health adoption and reimbursement success. Highmark’s VITAL Innovation program provides DTx companies a platform for evidence development in exchange for an assessment fee to facilitate coverage and reimbursement from Highmark and other payers. In 2016 Freespira partnered with VITAL and leveraged patients in the Highmark system to build out a body of clinical data. Other companies have worked with VITAL since. These companies have the opportunity to maintain close contact with both the providers and plan members, allowing for accurate tracking of the products’ efficacy and how they are being used.
Last fall, Highmark expanded its insurance coverage and reimbursement for some prescription digital therapeutics on the basis of approval by the FDA becoming the first large regional organization to offer payment coverage when prescribed by a licensed healthcare professional within the appropriate indication. Products like Freespira™, reSET®, reSET-O®, NightWare™, Somryst®, Mahana™ for IBS, RelieVRx™, EndeavorRx®, and Luminopia™ One are now available to Highmark’s 6,000,000 patient lives. While Highmark’s new policy offers a blueprint for one approach to covering DTx, there are other examples.
Innovative partnerships to build access pathways.
In an effort to develop patient access and provider reimbursement, DTx developer Orexo formed an important partnership with the IDN Trinity Health North Dakota.31 An essential feature of implementation in the Trinity Health network was the integration of products into a collaborative care model, an innovative model of patient care connecting primary care providers, progress monitoring, and psychiatrist oversight. Within this interdisciplinary system, Orexo worked with Trinity to ensure coverage of Vorvida® and Deprexis$reg; products by establishing reimbursement pathways and administrative procedures that facilitated patient access to these products.
Orexo’s approach concurrently overcame two challenges to adoption by 1) addressing uncertainty through real-world patient outcomes data, and 2) establishing a reliable benefits infrastructure through the reimbursement pathway and administrative support to providers.32 Contextual factors also boosted integration. For example, many Trinity providers had first-hand experience with Deprexis®, which was offered to Trinity employees free of charge in a post-COVID pilot program.33, 34 Additionally, Trinity Health covers rural communities experiencing a high prevalence of binge drinking (23% of adults) and major depressive disorder symptoms (25% of adults), creating a strong motivation to implement remote, innovative mental health solutions. Partnerships with IDNs such as Trinity allow the DTx to seamlessly integrate with existing collaborative care models to more easily build reimbursement pathways for providers, and access pathways for patients.
Longer-Term Adoption Hinges on Legislative Measures
While the payer landscape is showing preliminary signals of access, such movement is likely too slow to meet the unmet needs of patients. Directive legislation would undoubtedly bring access to an even greater number of patients and in a swifter fashion. While robust mental health resources are expressly supported at the federal level, digital health itself has been met with more ambivalence. The Food and Drug Administration (FDA), the regulatory body responsible for assessing safety and efficacy has welcomed and approved digital health products, however, these approvals and the guidance issued have minimally influenced other stakeholders. Medicare, the nation’s public and largest health insurer coverage has thus far refused coverage, citing a lack of legislative authority to cover software-only products. Because commercial insurers look to CMS for direction, coverage in the private sector has largely faltered in turn.
The Access to Prescription Digital Therapeutics Act of 2023 could resolve this issue entirely by expanding Medicare coverage to include prescription digital therapeutics (PDTs) and directing CMS to develop payment methods and product-specific billing codes.35 However, the act’s recent reintroduction in early 2023 means it faces a lengthy process of bureaucratic consensus ahead.
Recommendations for the Future
Most patients with mental health challenges do not receive help.36 Digital therapeutics are a promising strategy to address the pressing unmet needs and equity issues in mental health. With a strong national awareness about mental health needs in the wake of the pandemic, and rising interest in enhancing workplace mental health benefits, a receptive market is in place for effective and accessible solutions. The landscape may be signaling a shift in coverage and reimbursement policies as Highmark became the first large commercial insurer to pay for the use of apps that help treat psychiatric disorders and other complex conditions.37 While this was an encouraging sign, ambiguities in policy and skepticism among the broader payer and provider communities must be overcome to gain traction. At the federal level, widespread support for the Access to Prescription Digital Therapeutics Act will be key to unlocking coverage for the publicly insured and encouraging commercial payers to take the leap in DTx coverage. Broader engagement with patients and individual physicians will also be critical, with comprehensive education on the efficacy, cost-savings, and applications of DTx.
Until legislative action is taken, there are promising opportunities to acquire evidence and gain patient exposure in select healthcare settings. DTx companies should leverage the large patient networks, collaborative care models, and integrated nature of IDNs to develop high-quality evidence and test specialized reimbursement pathways through mutually beneficial partnerships. The evidence and ensuing coverage from these partnerships can support a product’s value and promulgate the broader adoption of DTx. The ultimate goal of these partnerships should be a standardized DTx evidence generation framework: a “gold standard” that payers, manufacturers, and policy-decision makers must commit to avoid extensive, repetitive piloting for each payer or health system. This will require increased transparency on piloting programs and publication of all clinical and financial outcomes. By identifying cost savings within a value-based setting, utilizing integrated health records to track progress across stages of care, and working with providers to establish the most efficient delivery, the evidence base for DTx will only become stronger and its integration more feasible through IDN partnerships. The urgent need to address the US mental health crisis has set the stage for DTx to revolutionize care and offer hope to the under-resourced, underserved, and under-acknowledged.
The potential and pressing need for digital mental health tools in reshaping the mental health landscape is evident. Evidence-based tools offer unprecedented opportunities for individuals to access high-quality mental health care, irrespective of personal, geographic, or other limitations. However, the journey to fully realize this potential is fraught with challenges. We need to continue the establishment of gold-standard evidentiary requirements while also reimagining financing and access for patients to ensure everyone has access to dependable, efficacious, and accessible mental health resources.
Author List: Ernie Lee1, Heidi C. Waters PhD2, Megan Johnston1, Grace Danon1, Junko Saber MBA1
Affiliations: 1 – Innopiphany LLC, 2 – Otsuka Pharmaceutical Development & Commercialization, Inc.
Partnership statement:
This white paper was prepared by Innopiphany LLC. and supported by Otsuka.
Otsuka and its affiliates oversee research and development and commercialization activities for innovative products in North America. Their driving philosophy is to defy limitation, so others can too. Otsuka seeks to serve those with unmet medical needs in three important treatment areas: nephrology, central nervous system, and digital therapeutics. Otsuka is proud to be at the forefront of the research and development of new therapies designed to help patients with Alzheimer’s disease, mental illness, and chronic kidney disease. Otsuka respects the value within every mind—whether it’s a grand idea that changes the world, a simple human connection that changes someone’s life, or something in between.
In partnership with One Mind, Otsuka and Innopiphany captures the positive change digital therapeutics can bring in closing critical gaps in mental healthcare to improve health equity.
Footnotes
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[22] Campbell AN, Rieckmann T, Pavlicova M, Choo TH, Molina K, McDonell M, West AE, Daw R, Marsch LA, Venner KL. Culturally tailored digital therapeutic for substance use disorders with urban Indigenous people in the United States: A randomized controlled study. Journal of Substance Use and Addiction Treatment. 2023 Sep 9:209159.
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