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Senators Shaheen, Capito, Reps. McKinley, Thompson Introduce Bipartisan Access to Prescription Digital Therapeutics Act

(Washington, DC) – U.S. Senators Jeanne Shaheen (D-NH) and Shelley Moore Capito (R-WV) and U.S. Representatives David McKinley (WV-01) and Mike Thompson (CA-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.

“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,” said Senator Shaheen. “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.”  

“Prescription Digital Therapeutics are an excellent example of how innovative technology can address some of the health challenges providers and patients continue to face,” said Senator Capito. “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.”

“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,” said Congressman McKinley. “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,” said Congressman Thompson. “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.”

For the full bill text, click here.

Throughout the pandemic, Shaheen has been a leader in strengthening and expanding access to telehealth in New Hampshire and across the country. Shaheen helps lead bipartisan legislation, the Protecting Rural Telehealth Access Act, which would make a variety of Medicare’s current telehealth flexibilities permanent, including flexibilities to provide audio-only forms of telehealth services. This would ensure that Medicare patients are able to continue to have access to the services and consultations that they need and patients in rural areas without access to broadband will still be able to utilize audio-only and phone-based visits with their doctors. In April 2020, Shaheen, Manchin and Moran led a bipartisan group of Senators in urging the U.S. Department of Health and Human Services (HHS) and Centers for Medicare & Medicaid Services (CMS) to increase telephone-based, or audio-only, telehealth reimbursements to equal other audio-visual telehealth reimbursements. The next month, CMS heeded Shaheen’s call and updated guidelines to bring Medicare reimbursement for telephone-based health services in line with Medicare reimbursement for video telehealth. Shaheen also helped introduce the bipartisan Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act, which would expand coverage of telehealth services through Medicare, make permanent COVID-19 telehealth flexibilities, improve health outcomes, and make it easier for patients to safely connect with their doctors. Last April, Shaheen also introduced legislation that would provide Medicare reimbursement for audio and video telehealth services furnished by home health agencies during the COVID-19 public health crisis and future public health emergencies.