Congress Must Act Now to Make Digital Therapeutics Accessible to All Americans

Since the start of the pandemic, which has driven a sharp increase in drug overdose deaths, life expectancy has dropped significantly, especially among Native Americans, African Americans, and Hispanic Americans. This frightening trend has been exacerbated by a massive and growing mental health crisis. Throughout history, America has harnessed the power of science and innovation to overcome such daunting challenges.

Today, our scientists, physicians, software engineers, and other innovators are developing a new field of FDA-authorized medicines called prescription digital therapeutics, or PDTs. PDTs are in the early stages of revolutionizing health care, but Congress must take immediate action to turn their potential into reality. PDTs are one of many scientific advances promising to improve the lives of Americans and increase their life expectancies. Clinical trial and real-world data compiled through the use of PDTs strongly supports improved outcomes and reduced costs to the health care system. Failure to act this year could be devastating for such a promising industry and for the patients, providers, and payers who will benefit from the emergence of this new class of medicine. 

Why PDTs Are an Important Innovation

PDTs treat serious diseases with cutting-edge software. Patients access them on their own time, when needed, on their smartphones. PDTs are developed under Good Manufacturing Practices and tested in randomized controlled clinical trials, much like pharmaceuticals. They also receive market authorization from the FDA, are prescribed by clinicians based on a label from the FDA, and they work on their own as well and in combination with pharmaceuticals. Importantly, PDTs can improve clinical outcomes—saving our healthcare system time and expense. Their 24/7 availability make them very convenient for patients, no matter where they live or work. Various published studies support that including:

  • A study showed 40% of patients’ use of a PDT for addiction occurred outside normal office hours when patients could not see a physician.
  • A study of an isolated population of Native Americans in Alaska, who often struggle to get equal access to care, showed strong engagement from a PDT to treat addiction.
  • A study of African-American women showed they benefitted significantly from a PDT to treat chronic insomnia.
  • A study of children showed marked improvement resulting from a PDT to treat ADHD, which could help reduce reliance on pharmaceutical interventions.

PDTs also show great promise in treating panic attack disorders and pediatric eye diseases—and specific models for treating Alzheimer’s disease and stroke are already in the pipeline.

Barriers to PDT Adoption

Given their effectiveness in treating a wide range of conditions, including addiction, it should come as no surprise that many state leaders have begun to deploy PDTs to help Americans seeking recovery. No new approaches to treating addiction had been authorized by the FDA in over a decade until two PDTs to treat substance use disorder and opioid use disorder became the first two PDTs ever to receive FDA market authorization. Since then, a small but growing number of other innovative PDT companies have secured market authorizations for their first PDTs addressing a range of diseases. We anticipate more PDT companies will seek FDA authorization to bring additional treatments to the market soon. But all this progress could come to a halt—and these new innovative PDTs may not be manufactured in the U.S. and available to all Americans—if Congress fails to pass legislation this year to ensure Medicare and Medicaid coverage.

Historically, private insurers have followed Medicare’s lead in covering new innovative therapeutics. As there is no defined Medicare benefit category for PDTs, very few Americans have public or private health insurance coverage for PDTs. Since PDTs do not fit into any current Medicaid reimbursement category, there is a lack of clarity on if and how state Medicaid can cover PDTs—a significant market access barrier, with just two of 50 states currently providing Medicaid coverage of any PDTs. 

What Needs to be Done Now

To fix this problem and unleash American medical innovation, Congress must pass the bipartisan Access to Prescription Digital Therapeutics Act of 2022 (S. 3791, H.R. 7051), which will give CMS the authority to cover PDTs. This will ensure that millions of Medicare and Medicaid beneficiaries have access to these innovative treatments. And it will drive a rapid expansion of private insurance coverage.

America has long been a global leader in health care innovation. In the late 1980s, a number of small companies pioneered large molecule monoclonal antibodies to treat disease in ways that had never been done before. More than 30 years later, these pioneers are part of the global biotech industry, which has saved countless lives and created jobs across this great country. The PDT industry has the potential to be the next biotech industry if the products created by a growing number of small, innovative PDT companies can become more available to patients, of all backgrounds, races, geography, and socioeconomic status—through Medicare, Medicaid, and private sector payers. While we sit on different sides of the aisle politically, we recognize transformational public policy opportunities when we see them. We encourage Congress to pass this historic legislation this year.

Former Congressman Patrick J. Kennedy (D-R.I.) is a lifelong mental health advocate and a former member of the President’s Commission on Combating Drug Addiction and the Opioid Crisis.

Paul Mango, was the Deputy Chief of Staff for Policy at Department of Health and Human Services from 2019-2021, and serves on the Board of Directors of Pear Therapeutics, Inc.