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Shaheen, Capito Reintroduce 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 Kevin Hern (OK-01) and Mike Thompson (CA-04) reintroduced bipartisan, bicameral legislation to increase access to Prescription Digital Therapeutics (PDTs).

The Access to Prescription Digital Therapeutics Act of 2023 would expand Medicare coverage to include PDTs, which are software-based disease treatments designed to directly treat disease. 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. The treatments are 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.

“Prescription Digital Therapeutics are tested and regulated like traditional prescription medication, so it’s commonsense that we remove barriers to care for those who respond positively to this kind of treatment,” said Shaheen. “Prescription digital therapeutics can help treat a range of diseases, including substance use disorders and mental health challenges, but many who need this treatment currently lack access. Our bipartisan, bicameral bill would remedy that issue by bringing this innovative care in line with traditional treatment so Medicare patients have control over their access to the therapies that work best for them.”

“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,” Capito said. “Prescription Digital Therapeutics are an excellent example of how innovative technology can address some of the health challenges providers and patients continue to face. I’m proud to join my colleagues and reintroduce this important legislation.”

“Technology has tremendously improved our lives in so many ways, it’s time we apply that to our medical care. Prescription digital therapeutics will provide important benefits to patients - such as mental health resources for veterans - while unlocking untold potential in new technologies. I’m proud to introduce this legislation in the House to ensure Americans have access to cutting-edge care,” said Hern.

“Prescription digital therapeutics – software-based health care treatments – present significant benefits to patients and provide a new tool to help improve peoples' lives,” said 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 Hern to ensure that seniors on Medicare have access to these innovative treatments.”

“Healthcare access is one of the hardest pain points to overcome, but innovation cannot be stifled simply because of how complex our healthcare system is to navigate. Patients covered by Medicare and Medicaid deserve equitable access to DTx therapies,” shares Andy Molnar, DTA Chief Executive Officer. “Additionally, commercial insurers look to federal leadership for coding and reimbursement, so it is of utmost importance that our government leadership does everything possible to pass the Access to Prescription Digital Therapeutics Act this year.”

For the full bill text, click here.

During the pandemic, Shaheen led Senate initiatives to strengthen and expand access to telehealth in New Hampshire and across the country. In June 2021, Shaheen helped lead bipartisan legislation, the Protecting Rural Telehealth Access Act, which would make a variety of Medicare’s pandemic-era 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 2021, 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. 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.