Arlington, VA: In June, the Digital Therapeutics Alliance (DTA) submitted formal comments in response to the United States Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Lamar Alexander’s call for recommendations on pandemic preparedness. These recommendations are part of DTA’s ongoing global 2020 initiative to break down obstacles to patient access to digital therapeutics (DTx).

As part of our comments, the Digital Therapeutics Alliance highlighted how in the United States private insurers and employers are increasingly embracing digital therapeutic technologies to improve patient outcomes. Unfortunately, traditional Medicare and most Medicaid programs do not currently recognize and reimburse for these clinically validated therapies. Due to their flexible delivery platforms and ability to treat underserved populations, DTx products offer critical solutions for the three following lessons that we’ve learned during the Covid-19 pandemic:

  • Lesson #1: Underlying health disparities result in unequal pandemic impacts. Minority populations in the United States have suffered disproportionately from the Covid-19 pandemic. Nationally, U.S. counties with predominantly Black populations are experiencing a three-fold higher infection rate and a six-fold higher death rate than other counties. Native American communities have also been greatly affected during this pandemic, with New Mexico reporting that Native Americans are 19 times more likely to die from Covid-19 than the rest of the population. This unacceptable impact of Covid-19 on minority populations is still surprising despite the longstanding health disparities that continue to be well-documented.
  • Lesson #2: Mental health shortages have long persisted and may worsen during and after this national emergency. Prior to Covid-19, 115 million Americans lived in a mental healthcare shortage area. This number is expected to increase as Americans continue adjusting to unfamiliar new normals, while already overburdened healthcare providers face new demands on their time and work to address outstanding patient backlogs. Research by the Well Being Trust indicates the aftermath of the Covid-19 pandemic is likely to trigger another 75,000 deaths of despair from drug abuse, alcohol misuse, or suicide. The United States will be unable to meet this heightened need for mental health services if we solely rely on traditional sources of counseling and treatment.
  • Lesson #3: Technology adoption is essential to a healthcare system in duress. During the coronavirus isolation period, Americans of all ages and backgrounds quickly adopted the use of a wide range of technologies to continue working, maintain connections to friends and family, and connect with healthcare services. Many clinicians embraced telehealth and other technologies for the first time to meet with and serve patients, to the extent that telehealth visits in the United States increased 4,347% in March 2020, compared to March 2019. While the immediate scaling of telehealth has been very successful, further benefits will likely result as additional technologies such as remote monitoring products and digital therapeutics are layered into the broader telehealth ecosystem.

The Digital Therapeutics Alliance recommends that policymakers take this opportunity to curate a cohesive, efficient healthcare system that includes the necessary spectrum of available digital technologies, including telehealth platforms, remote patient monitoring, and digital therapeutics. In particular, DTx products can begin helping the nation break down some of the health disparities that are experienced by minority populations, rural residents, and patients with chronic and mental health conditions, while additionally addressing other significant policy issues.

Digital therapeutics have clinically demonstrated reliable patient outcomes for numerous health conditions. DTx products for chronic diseases have demonstrated a 63% increase in asthma control, increased symptom free days for COPD patients by 35%, and decreased A1c levels in patients with diabetes by 1.7 to 2.0 points. DTx products have also demonstrated that 60% of patients with a depression-only diagnosis can achieve recovery criteria, 50% of PTSD patients can achieve remission, and the abstinence rate of substance abusers can double. This represents a fraction of the clinical outcomes that are being demonstrated by DTx products for physical, mental, and behavioral health conditions.

“We will have an unbalanced ecosystem in the United States until Medicare and Medicaid begin providing patients with access to remotely delivered digital therapies and enable the formal reimbursement of DTx products,” shared Megan Coder, DTA Executive Director. “While many patients who receive insurance coverage through private payors and employers have access to DTx products, low income and aging populations covered by Medicare, Medicaid, and other publicly funded programs are generally prevented from accessing these important therapies. Given that DTx products may be accessible via patient-owned devices, they can become important treatment options for many underserved and rural populations who require care but may not always have access to it.”

Digital therapeutics deliver therapeutic interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad spectrum of behavioral, mental, and physical diseases and disorders. These products differ from health and wellness apps, telehealth platforms, or tools solely designed for monitoring, diagnostic, and adherence purposes. DTx products comply with rigorous patient-centered core principles and best practices to ensure product integrity, user-centered designs, patient privacy through HIPAA (in the US), and validated clinical outcomes via randomized controlled trials (RCT) and real world evidence (RWE).

About DTA
The Digital Therapeutics Alliance (DTA) is a global non-profit trade association of industry leaders and stakeholders with the mission of broadening the understanding and adoption of digital therapeutics into healthcare. DTA works to enable expanded access to high quality, evidence-based digital therapeutics for patients, clinicians, and payors in order to improve clinical and health economic outcomes. To learn more please visit: www.dtxalliance.org.