DTA Releases & Statements

DTA Applauds the Reintroduction of Bipartisan Legislation to Enable Public Coverage of Prescription Digital Therapeutics

March 9, 2023

Digital Therapeutics Alliance Applauds the Reintroduction of Bipartisan Legislation to Enable Public Coverage of Prescription Digital Therapeutics

Creating Medicare and Medicaid benefit categories for digital therapeutics (DTx) is a critical step toward expanded patient access and appropriate reimbursement.

March 9, 2023 — Arlington, VA — As the leading international organization on digital therapeutic (DTx) thought leadership and education, the Digital Therapeutics Alliance (DTA) welcomes the reintroduction of the
Access to Prescription Digital Therapeutics Act (S. 723 and H.R. 1458). Upon passage, this bill will enable public coverage of prescription digital therapeutics, defined in this bill as a product that uses software to achieve its intended result, is cleared or approved by the Food and Drug Administration (FDA) for the prevention, management, or treatment of a medical condition, and is authorized by a qualified, licensed clinician. 

If passed, the Access to Prescription Digital Therapeutics Act will establish a payment methodology for manufacturers of prescription digital therapeutics, product-specific Healthcare Common Procedure Coding System (HCPCS) codes, and a DTx manufacturer reporting process to the Centers for Medicare and Medicaid Services (CMS).

Championed by a bipartisan group of Congressional lawmakers under the leadership of Senators Jeanne Shaheen (D-NH) and Shelly Moore Capito (R-WV) and Representatives Kevin Hern (R-OK) and Mike Thompson (D-CA), the reintroduction of this legislation reflects the growing recognition of the clinical and health economic value that DTx products provide to patients, caregivers, and clinicians.

“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.”

This legislation comes at a critical moment for patients and marks an important step toward expanded patient access to DTx therapies for chronic and mental health conditions. Creating a DTx benefit category and access pathway for Medicare and Medicaid-covered populations will provide patients with remote access to therapies that can tremendously impact quality of life and healthcare outcomes. Expanded coverage for DTx products will also assist health systems and clinicians to better manage capacity, drive value, and serve communities.

Insights from the bill’s four co-sponsors include:

“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.”


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