New federal initiatives signal digital health access as a key priority

Recent activity among lawmakers and federal agencies signal that the government may be poised to undertake meaningful legislative and administrative efforts to harness the potential of digital health innovation and to expand the accessibility of digital health tools for Medicare beneficiaries.

First, on May 8, 2025, the Access to Prescription Digital Therapeutics Act (PDT Act), originally introduced in 2022, was reintroduced in Congress in an effort to expand access to software-based treatments.

Just five days later, on May 13, 2025, the Centers for Medicare and Medicaid Services (CMS), in partnership with the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC), issued a Request for Information, titled “Health Technology Ecosystem” (HT RFI), seeking input from the public regarding “the market of digital health products for Medicare beneficiaries as well as the state of data interoperability and broader health technology infrastructure.”

These recent developments reflect the growing recognition within the healthcare industry of the potential for modern technology to expand access to care. While the development and deployment of digital health solutions in recent years has increased significantly, payor reimbursement for such products remains limited to date.

Below, we take a concise look at these developments and their implications.

Overview of the PDT Act

The PDT Act provides a pathway to Medicare and Medicaid reimbursement for “prescription-digital therapeutics” (PDTs), which are certain Food and Drug Administration (FDA)-approved products, devices, internet applications, or other technology that utilize software to treat chronic and behavioral health conditions.

Specifically, the PDT Act seeks to remove systemic barriers to care, and ensure equitable access to care, by establishing a Medicare- and Medicaid-covered benefit category for PDTs, to be effective January 1, 2026. The PDT Act tasks CMS with assigning specific Healthcare Common Procedure Coding System (HCPCS) codes to PDTs and developing a corresponding reimbursement framework.

To that end, within one year of enactment, CMS must establish a payment methodology for PDT manufacturers based on certain specific factors. Further, CMS must, within two years of enactment, establish permanent product-specific HCPCS codes. In the interim, CMS must create temporary HCPCS codes for the purpose of ensuring payment for PDTs.

Notably, a version of the PDT Act was first introduced in 2022 but failed to gain traction because legislators were concerned about potential costs to the Medicare program, and the Congressional Budget Office (CBO) declined to score the bill because it was unable to calculate the cost impact of the novel treatments.

With the latest version of the PDT Act, industry players have noted a renewed sense of optimism for enactment, in part because of Germany’s recently published reimbursement and usage information relating to PDTs, which Congress could utilize to help formulate an estimated budget impact.

Overview of the HT RFI

The HT RFI seeks input from patients, caregivers, providers, payors, technology developers, and other stakeholders, with the overarching goal of developing an innovative and accessible patient-centered digital health experience. Specifically, CMS and ASTP/ONC recognize within the HT RFI that the “necessary components to support a patient-centric digital health experience” exist, but that the current digital health experience can be difficult for patients, providers, and caregivers to navigate.

To that end, the HT RFI sets forth a list of questions for which CMS and ASTP/ONC are seeking comments, including but not limited to suggestions regarding (i) easing health data exchange through amending existing health information exchange laws; (ii) balancing patient privacy with convenience and access to digital health products and services; (iii) encouraging patient, caregiver, and provider engagement with digital health products; (iv) advancing value-based care initiatives; and (v) promoting innovation in consumer digital health products.

Trends and implications for the healthcare industry

The PDT Act and the HT RFI’s focus on digital health expansion and accessibility is consistent with several broader government initiatives to harness technology for advancement across the healthcare industry. For example, the Trump Administration’s initiative to Make America Healthy Again (MAHA) includes, in part, utilizing “digital technologies [to] make healthcare more accessible and personalized.” Further, on the same day that the HT RFI was introduced, the Department of Health and Human Services (HHS) submitted a request for information titled “Ensuring Lawful Regulation and Unleashing Innovation to Make America Healthy Again” (MAHA RFI) seeking input from all interested parties on how to “dramatically deregulate” the healthcare industry. Among other categories, HHS specifically seeks information regarding regulations “unjustifiably impeding technological innovation.”

Although the PDT Act has not yet been enacted, and the HT RFI and MAHA RFI are in their early stages, these developments, coupled with MAHA, represent an unprecedented push at the federal level to expand digital health access. These developments are significant, in part, because they indicate that digital health companies may be able to obtain Medicare and, in some cases, Medicaid reimbursement in a space that has traditionally been limited to remote therapeutic monitoring (RTM), remote patient monitoring (RPM), and complex care management (CCM). If Congress enacts the PDT Act, for example, digital health companies will be eligible for reimbursement of PDTs by the Medicare program – and, likely soon after, commercial payors, which often look to Medicare to determine items for which they will provide coverage and reimbursement – and will be able to increase both company profit and access to care.

Given the current legislative landscape, we encourage entities that offer PDTs to continue legislative outreach to convey the value and importance of the services they provide, and to demonstrate how such services further federal initiatives to promote access to care. We also encourage digital health companies and manufacturers to include as part of such outreach, to the extent applicable, information that may further contribute to the CBO’s ability to estimate budget and cost impacts of coverage for PDT and PDT-related treatment. Such information may include, for example, (i) proposed reimbursement amounts for PDTs, taking into account development, manufacturing, and distribution costs of such products; (ii) estimates of the potential market size for PDTs among Medicare beneficiaries; and (iii) projected cost offsets and returns on investment based on clinical data demonstrating the comparative effectiveness of PDTs as opposed to other treatments.

With regard to the HT RFI, we encourage stakeholders – particularly digital health technology companies – to take advantage of the opportunity to submit responses to CMS and, in so doing, identify gaps in current data privacy laws affecting operations and advocate for changes that will promote efficiencies. We likewise encourage developers of FDA-cleared digital health products that are not compatible or otherwise do not fit into the proper legislative bucket for RPM or RTM reimbursement to capitalize on the opportunity to submit comments to CMS and otherwise advocate for legislation that promotes reimbursement inclusive of such devices. Responses to the HT RFI are due June 16, 2025.

While we note digital health expansion is trending toward greater acceptance at the federal level, the government continues to focus on fraud and compliance in this space. For example, in September 2024, the Office of Inspector General (OIG) recommended additional oversight of RPM in the Medicare program, and, in recent months, the Medicare Learning Network (MLN) published several new materials to promote RPM billing compliance. We encourage healthcare entities to ensure they remain vigilant in meeting requirements necessary for the provision of services via digital platforms.

PDTs’ data privacy obligations could change if reimbursement is expanded because, if PDTs bill insurance and therefore engage in an electronic standard transaction, they will be required to comply with HIPAA as covered entities. Further, many states are proposing data privacy laws that may apply to PDTs and require stringent safeguards applicable to a broad range of consumer information (rather than only traditional “protected health information”), so it is important for PDT developers and manufacturers to continue to monitor state data privacy laws and assess the applicability of and compliance with any such new state data privacy laws. The HT RFI provides a key opportunity to provide comments to the federal government on data privacy considerations for PDTs, and states may also pay attention to HT RFI responses.

If you have any questions regarding the PDT Act, the HT RFI, the MAHA RFI, or related matters, please contact your DLA Piper relationship partner, the authors of this alert, or any member of our Healthcare industry group.