DTA engaging in policy discussions to advocate for greater recognition of digital therapeutics in US policies

DTA engaging in policy discussions to advocate for greater recognition of digital therapeutics in national policies in the United States

With recent comments on proposed rules and regulations, DTA is ensuring members and the patients they serve are considered in policy decisions

March 24, 2022 – Arlington, VA – The Digital Therapeutics Alliance (DTA) is leading policy and advocacy efforts to expand adoption, coverage, and access to clinically validated digital therapeutics (DTx). During a critical time, this innovative category of medicine is addressing unmet needs and major gaps in healthcare. The pandemic and subsequent challenges have resulted in many patients unable to access much needed care – either due to geographic limitations, cultural and language barriers, well-documented disparities, health condition severity, or demand far exceeding the supply of qualified clinicians.

DTA is working with policymakers to support the wider integration of DTx therapies across the healthcare ecosystem to ensure these evidence-based treatments get into the hands of those who need them most. 

DTA’s current advocacy efforts in the United States are focused on:

• Formal recognition of DTx products: Officially define and recognize DTx products in legislation and regulation so Medicare and Medicaid patients can access these critical therapies.
• Codifying DTx product coverage: Require CMS to assure that Medicare and Medicaid cover technologies that meet the definition of a digital therapeutic.
• Expanding clinician coding and payment: Direct CMS to ensure that adequate payment mechanisms exist to pay primary care providers and clinicians engaged in the authorization and clinical use of DTx products.

By engaging directly with federal agency officials and submitting comments on proposed rules and regulations, DTA is working to ensure members and the patients they serve are considered in policy decisions. 

As a part of these efforts, this week DTA submitted comments related to two Food and Drug Administration draft guidances:

1. DTA response to ‘Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency’ (FDA-2021-D-1118), published in December 23, 2021.
2. DTA response to ‘Digital Health Technologies for Remote Data Acquisition in Clinical Investigations’ (FDA-2021-D-1128), published December 21, 2021.

Additional recent responses from DTA include:

February 28, 2022 – DTA responds to the White House Office of Science and Technology Policy (OSTP) Request for Information (RFI) on Strengthening Community Health Through Technology (87 FR 492), published January 5, 2022.

February 28, 2022 – DTA responds to the Food and Drug Administration’s ‘Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products,’ (FDA-2021-D-1214) published December 9, 2021.

February 28, 2022 – DTA responds to the Food and Drug Administration’s ‘Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products,’ (FDA-2021-D-1146) published November 30, 2021.

January 15, 2022 – DTA responds providing an overview of efforts to ensure product safety and reliability for the White House Office of Science and Technology Policy (OSTP) Request for Information on public and private uses of biometric technologies (86 FR 56300), published October 8, 2021.

November 29 , 2021- DTA responds to the Agency for Healthcare Research and Quality’s (AHRQ) draft technical brief “Evaluation of Mental Health Mobile Applications.” (86 FR 28601), published October 20, 2021.

November 26, 2021 – DTA responds to Food and Drug Administration’s ‘Notice to Public of Website Location of CDRH Fiscal Year 2022 Proposed Guidance Development,’ (FDA-2012-N-1021), published October 26, 2021.

DTA keeps members informed about all relevant federal actions in the U.S. as well as provides opportunities for members to directly engage in advocacy efforts through its US Policy Task Group, member newsletter, and Slack community. Connect with us if you would like to be involved in these efforts.