The Access to Prescription Digital Therapeutics Act of 2022 aims to officially define prescription digital therapeutics (PDTs) at the federal level and establish new Medicare and Medicaid benefit categories for PDTs. The bill was introduced on March 10, 2022 by Senator Capito and co-sponsored by Senator Shaheen, and, if passed, could improve healthcare access for more than 148 million Americans.
What are Digital Therapeutics and Why do Some Need a Prescription?
Digital Therapeutics (DTx) are software-based interventions intended to prevent, manage, or treat mental or physical conditions and while many DTx are available to consumers directly, PDTs differ in that they require a prescription for use, following a thorough consultation with a physician.
PDTs are subject to the same stringent requirements as pharmacotherapy or medical devices, and must demonstrate evidence of clinical effectiveness, safety, and quality through clinical trials in order to be approved by the FDA and be made available to patients.
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 Shelley Moore Capito (co-sponsor of the Access to Prescription Digital Therapeutics Act of 2022)
What are the Benefits of PDTs?
With the same functional benefits as DTx, PDTs offer access to healthcare that may otherwise be hindered by accessibility barriers to traditional treatment such as stigma, lack of daily support, or logistics. This is particularly the case for those of racial or ethnic minorities or those on low income, who are disproportionately affected by the diseases that PDTs can help to manage, such as diabetes, depression, and substance abuse disorders. Through access to sustained clinical support and monitoring, these patients can be treated more effectively and experience better outcomes than with traditional therapy alone.
According to a recent survey by Pear and Avalere, 80% of payers believe PDTs would be effective complementary therapy, but 67.5% felt that FDA authorization of the PDTs to be ‘very important’ when deciding to cover it in claims. The lack of clear regulation and slow approval of the FDA for DTx may explain why only 40% of payers are currently covering PDTs.
Making PDTs available through national health insurance provisions like Medicare and Medicaid would not only allow greater access to a wider range of supportive therapy for more than 44% of Americans receiving state healthcare support, it would also set a precedent for private insurance companies to increase their coverage of PDTs too, opening up digital therapeutic solutions as a mainstream tool in healthcare nationwide.
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.
Senator Jeanne Shaheen (sponsor of the Access to Prescription Digital Therapeutics Act of 2022)
What Does the Access to Prescription Digital Therapeutics Act Aim to Achieve?
The bill is a bipartisan piece of legislation aimed at establishing PDTs as federally-recognized therapeutics, ensuring that reimbursement from payers can be achieved more easily so that patients can benefit from the unique support these digital healthcare solutions can provide.
Core Components of the Bill:
- To establish an official definition for PDTs at the federal level.
- To establish a new Medicare and Medicaid benefit category for PDTs.