WASHINGTON, D.C. — Today, U.S. Senators Shelley Moore Capito (R-W.Va.) and Jeanne Shaheen (D-N.H.), along with U.S. Representatives David McKinley (R-W.Va.-01) and Mike Thompson (D-Calif.-05), introduced bipartisan legislation to increase access to Prescription Digital Therapeutics (PDTs).

The legislation, known as the Access to Prescription Digital Therapeutics Act of 2022, would expand Medicare coverage to include PDTs, which are software-based disease treatments designed to directly treat disease, tested for safety and efficacy in randomized clinical trials, evaluated by the U.S. Food and Drug Administration (FDA), and prescribed by health care providers. PDTs are designed and tested much like traditional prescription drugs but rather than swallowing a pill or taking an injection, patients receive cognitive therapy through software.

“Prescription Digital Therapeutics are an excellent example of how innovative technology can address some of the health challenges providers and patients continue to face,” Senator Capito said. “The Access to Prescription Digital Therapeutics Act would allow more patients living with a broad variety of diseases and conditions – from Substance and Opioid Use Disorders and mental and behavioral health issues to diabetes and Parkinson’s disease – to more efficiently access the care and support they need and deserve.”

“We must harness the power of innovation in medicine to improve access and treatment options for patients. That’s why I’m helping to introduce bipartisan, bicameral legislation to expand access to cognitive therapies that are proven to treat a range of diseases, including substance use disorders and mental health challenges,” Senator Shaheen said. “Our bill ensures these prescription digital therapeutics are covered by Medicare so more patients, including seniors, have access to the cutting-edge care they deserve.”

“West Virginia has the highest overdose death rate in the country and we know all too well the loss families touched by this crisis have endured. It is essential that we do more to treat mental health and substance abuse and look to new approaches that can improve people’s lives,” Congressman McKinley said. “This legislation will ensure that innovative and effective treatments, like Prescription Digital Therapeutics, are more broadly available to help fight this scourge."

“Living in the modern age requires medicine to adapt to address the needs and challenges of accessing quality care. Prescription digital therapeutics, software-based health care treatments, present significant benefits to patients and provide a new tool to help improve peoples’ lives,” Congressman Thompson said. “PDTs have been shown to benefit those with mental health issues like depression and substance abuse, providing an alternative to traditional medicine. I am proud to introduce this bipartisan bill alongside Senators Shaheen and Capito and Congressman McKinley to ensure that seniors on Medicare have access to these innovative treatments."

“Digital therapeutics are revolutionizing healthcare, addressing many unmet medical needs, and most importantly improving the health of many Americans,” Andy Molnar, Digital Therapeutics Alliance Chief Executive Officer, said. “Introduction of this legislation to establish new Medicare and Medicaid benefit categories for Prescription Digital Therapeutics is a critical step toward ensuring that these evidence-based treatments get into the hands of those who need them most. We are grateful for the work of the bill sponsors and look forward to working with a broad coalition of patients, providers, and others to pass this into law.”

"Providing patient-centered health care means supporting people ‘where they are.’ We stand with the bill sponsors and for all of the individuals who will benefit from increased access to prescription digital therapeutics. We can’t think of a more practical, effective healing modality than people literally having access to support at their fingertips,” Dr. Dawn Nickel, Founder of the SHE RECOVERS Foundation, said.

The legislation is supported by national patient advocacy organizations such as the Kennedy Forum, Shatterproof, SHE RECOVERS Foundation, and Young People in Recovery, as well as the Digital Therapeutics Alliance.


For the full bill text, please click here.

For a one-pager on the bill, please click here.
 

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