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.”
Digital therapeutics (DTx) have the potential to fill gaps in care for people and their families across the world. As a new category of medicine, DTx face numerous barriers in becoming fully integrated into traditional healthcare systems. To enable patients to receive access to DTx products that are convenient and effective, DTA and NCPDP co-hosted a workshop with stakeholders from across the U.S. healthcare system to map existing DTx integration and workflow pathways, while simultaneously identifying areas of improvement.
Workshop stakeholders included policymakers, clinicians, health systems, health plans, pharmacies, DTx product manufacturers, and patients.
Over the course of six months, between August 2022–January 2023, DTA and NCPDP brought together subject matter experts from relevant stakeholder groups to contribute to the development of this report which outlines the integration and workflow of DTx products in the healthcare system, using the patient journey – from diagnosis through DTx treatment – as the primary focal point.
DTA and NCPDP are committed to providing patients with access to healthcare and ensuring that clinicians have the ability to utilize and deliver innovative products like digital therapeutics to patients. This effort, led by Jessica Hauflaire, DTA Chief Operating Officer, will collaborate with stakeholders on addressing the next steps outlined in this report to optimize the healthcare system to meet the needs of clinicians and patients.
Preliminary findings (Feb 2023): DTx Integration & Workflow Workshop Report
In alignment with our mission to broaden the understanding, adoption, and integration of digital therapeutics (DTx) across the global healthcare system, the Digital Therapeutics Alliance (DTA) is hosting its first annual summit at the Washington Marriott Metro Center. As the leading international DTx industry organization, DTA is convening leaders in Washington, D.C. on June 7-9 from across the healthcare ecosystem to address the industry’s most pertinent challenges and opportunities.
Who should attend?
Clinicians, policymakers, payors, healthcare decision makers, patients, caregivers, product manufacturers, and other ecosystem leaders
Learn more about the event details and registration.
ARLINGTON, VA – December 14, 2022 – As the leading international organization on digital therapeutic (DTx) thought leadership and education, the Digital Therapeutics Alliance (DTA) welcomes the introduction of the ‘‘Medicaid and CHIP Access to Prescription Digital Therapeutics Act’’. This bipartisan legislation would provide guidance regarding coverage of prescription digital therapeutics under Medicaid and the State Children’s Health Insurance Program (CHIP).
This bipartisan legislation is championed by Senators Shelly Moore Capito (R-WV) and Jeanne Shaheen (D-NH) and reflects the growing recognition of the clinical and health economic value that digital therapeutics provide to patients, caregivers, and clinicians – especially given the increased barriers to care that Medicaid beneficiaries continue to face during and beyond the Covid-19 pandemic.
While Massachusetts and Oklahoma are already covering prescription digital therapeutics through their state Medicaid programs, this legislation provides much-needed clarity for other states intending to provide access to digital therapeutics and comes at a critical moment for patients, when many are unable to access other forms of necessary therapies. Using this guidance to leverage existing pathways to expand access to DTx products for Medicaid-covered populations will enable those with chronic and mental health conditions to access expanded care options that can make a tremendous difference in their quality of life and healthcare outcomes.
In addition to providing critical guidance to enable more standardized coverage decisions across the country, the Medicaid and CHIP Access to Prescription Digital Therapeutics Act (S.5238) would also allow the Secretary of Health and Human Services (HHS) to provide technical assistance to states considering coverage of FDA-approved or cleared prescription digital therapeutic products, and would define ‘prescription digital therapeutic’ within the context of Medicaid.
“Digital therapeutics hold particular value for Medicaid populations with convenient, accessible, and personalized treatment options to address many unmet medical needs,” says Andy Molnar, DTA Chief Executive Officer. “This legislation would establish more clarity and uniformity in how prescription digital therapeutics are covered by public programs from state to state and is a critical step toward ensuring that these evidence-based treatments get into the hands of those who need them most. We are grateful for the work of the bill sponsors and look forward to working with a broad coalition of patients, clinicians, and others to pass this into law.”
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About DTA
The Digital Therapeutics Alliance (DTA) is a global non-profit trade association of industry leaders and stakeholders with the mission of broadening the understanding, adoption, and integration of digital therapeutics into healthcare. DTA works to enable expanded access to high quality, evidence-based digital therapeutics for patients, clinicians, and payors to improve clinical and health economic outcomes. To learn more, please visit: www.dtxalliance.org or follow us on LinkedIn and Twitter.
Media Contact:
Hannah Fairman
Digital Therapeutics Alliance
hfairman@dtxalliance.org