Prescription Digital Therapeutics (PDTs) Legislation Introduced
The Access to Prescription Digital Therapeutics Act of 2022 has been introduced by Reps. Mike Thompson (D-CA) and David McKinley (R-WV) and Sens. Jeanne Shaheen (D-NH) and Shelly Moore Capito (R-WV).
“According to the bill’s release, it would expand Medicare coverage to include PDTs, which are software-based 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.”
The bill sponsors released a one page fact sheet about the bill and PDTs itself.
“Prescription Digital Therapeutics (PDTs) are software-based disease treatments designed to directly treat disease, tested for safety and efficacy in randomized clinical trials, evaluated by the FDA, and prescribed by healthcare providers. These therapies are designed and tested much like traditional prescription drugs with one distinction: rather than swallowing a pill or taking an injection, patients are treated with software.
The COVID-19 pandemic and public health emergency rapidly accelerated the pace of innovation to address some of the most pressing challenges in health care. New tools are being rapidly deployed and adopted, particularly in the case of digital health, which are increasingly being used, PDTs provide clinicians and patients with evidence-based remote treatment modalities to treat substance and opioid use disorders, mental health, diabetes and other diseases and conditions. However, there is no clear statutory benefit category to allow for Medicare and Medicaid coverage for PDTs.”
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