On May 8, 2025, U.S. lawmakers reintroduced the Access to Prescription Digital Therapeutics Act of 2025 (H.R. 3288), placing prescription digital therapeutics (PDTs) squarely on the federal health policy agenda.1 PDTs are software interventions prescribed by clinicians to prevent, manage, or treat specific conditions. Over the past several years, they have gained traction in clinical programs and attracted increasing regulatory and payer attention.
The PDT Act would create a formal Medicare and Medicaid coverage pathway by directing the Centers for Medicare and Medicaid Services (CMS) to establish coding and payment approaches for these products.1 For health technology developers and provider organizations, that shift matters because reimbursement ambiguity has been one of the largest barriers to operational adoption at scale, particularly in settings where patients depend on government coverage for access.
The reintroduction also aligns with broader federal activity aimed at modernizing digital health access and interoperability. In mid-May 2025, CMS and federal health IT leadership sought public input on the market for digital health products for Medicare beneficiaries and on interoperability infrastructure, underscoring an intent to shape a more coherent, technology-enabled care ecosystem.23
Healthcare stakeholders often describe efforts like H.R. 3288 as part of a longer transition, moving digital health products from “innovation” pilots into covered benefits that can be ordered, documented, and reimbursed with the same discipline as more traditional modalities. If implemented carefully, this kind of policy can reduce inequities created by out-of-pocket payment models and improve access for patients with chronic, behavioral, or high-friction conditions that benefit from sustained engagement.
At its core, the Access to Prescription Digital Therapeutics Act seeks to create Medicare and Medicaid coverage for certain software-based therapeutic interventions by amending titles XVIII and XIX of the Social Security Act.1 The bill is designed to translate regulatory authorization and clinical value into a reimbursable care pathway that providers can operationalize through established billing and coverage mechanics.
A central practical issue for PDTs has been the gap between clinical adoption and sustainable reimbursement. Even when a PDT is clinically credible and fits a care model, health systems still need a consistent way to code, bill, and justify payment. The Act addresses that friction by directing CMS to establish Medicare payment methodology and coverage-related processes for PDTs, with implications that could extend into Medicaid policy and managed care administration.1
If a tailored reimbursement framework emerges, it could reshape care delivery patterns by aligning software-enabled interventions with payment streams already used for chronic condition management, behavioral health support, and longitudinal engagement programs. This is especially relevant for conditions where outcomes depend on sustained adherence, education, coaching, and behavior change, such as diabetes management, substance use disorder support, insomnia programs, or smoking cessation. A covered PDT pathway can also reduce reliance on out-of-pocket purchasing and narrow employer-only access, helping providers offer consistent options across payer mixes.
From a healthcare IT and compliance standpoint, the “how” of reimbursement matters as much as the “whether.” New reimbursable modalities typically create new documentation expectations, ordering workflows, coding rules, and audit risks. If PDTs become a covered benefit category, provider organizations should expect to build or refine:
The bill’s broader signal to the market is also meaningful. Clearer federal reimbursement pathways can influence product strategy, investment, and partnerships. Vendors are more likely to invest in robust clinical studies, integration work, and enterprise-grade implementation capabilities when payment is not limited to niche pilots. Likewise, payers and providers are more likely to engage in scaled deployments when billing rules and coverage criteria are defined in a predictable way.
Finally, federal policy signals around digital health infrastructure and interoperability provide important context. The 2025 federal request for information on the health technology ecosystem specifically asked for input on the digital health product market for Medicare beneficiaries and on interoperability and broader infrastructure needs.3 If reimbursement expands while interoperability expectations mature, PDTs that can integrate cleanly into EHR and care management workflows will have a practical advantage over tools that remain operationally siloed.
The PDT Act intersects with wider federal priorities related to digital health access, responsible innovation, and interoperability modernization. In May 2025, CMS highlighted efforts to improve technology that empowers Medicare beneficiaries, alongside collaboration with federal health IT leadership.2 In parallel, federal agencies sought input on the current market for digital health products and on the state of interoperability and health technology infrastructure.3
By calling for a defined reimbursement pathway, the Act challenges a historically fragmented payment environment. Medicare fee-for-service has limited precedent for treating software therapeutics as distinct, reimbursable interventions. If H.R. 3288 advances, CMS would need to translate legislative direction into benefit design decisions, including utilization controls, evidence expectations, and operational requirements that reduce fraud and waste while preserving access.1
For Medicare Advantage and other value-based arrangements, a PDT benefit category could also influence care management strategy. Plans and ACO-aligned organizations tend to prioritize tools that improve engagement and outcomes while reducing downstream utilization. A structured PDT pathway could accelerate adoption where the total cost of care model rewards effective longitudinal interventions.
On the Medicaid side, the Act’s coverage implications could cascade into state plan updates, managed care contract language, and new administrative guidance. In practice, Medicaid adoption often depends on whether states can map coverage into existing benefit categories, define medical necessity criteria, and set consistent prior authorization expectations for managed care entities. Those operational details can determine whether a federal policy change becomes meaningful access at the state level.
As this evolves, policymakers and implementers will likely focus on guardrails. A workable reimbursement approach typically requires clarity around which PDTs qualify, what evidence is sufficient, how outcomes are measured, and what ongoing monitoring is needed. This emphasis aligns with broader federal interest in interoperability and infrastructure maturity, which influences how reliably PDT data can be captured and exchanged across care settings.3
If the PDT Act’s framework is implemented, providers, payers, and developers will face concrete operational changes. Providers would need to update clinical workflows to prescribe, document, and bill for PDTs according to CMS-established processes and any related guidance.1 That work typically spans clinical informatics, revenue cycle, compliance, and EHR integration teams because prescribing and billing for software is structurally different from billing for a test, procedure, or in-person visit.
For provider organizations, the most common friction points tend to show up in day-to-day workflow design:
Payers, including Medicare Advantage plans and state Medicaid agencies, would need to determine how PDTs fit into benefit design. That includes decisions about coverage criteria, step therapy analogs (where clinically appropriate), prior authorization, and re-authorization rules tied to engagement or outcome thresholds. Plans may also seek to align PDT use with quality measures and care management programs.
Regulatory posture also matters. Many PDTs are regulated as medical devices and may require FDA clearance or approval before broad clinical use. When reimbursement eligibility is tied to regulatory status, developers face a two-track timeline: regulatory authorization plus payer-ready evidence and operational readiness. That reality affects product planning, clinical study design, and real-world evidence strategies, especially when payers seek proof of effectiveness in populations similar to Medicare and Medicaid beneficiaries.
Interoperability and data standards are another make-or-break factor for real-world implementation. For PDTs to integrate into clinical practice without adding administrative burden, they need to exchange relevant data with EHRs, care management platforms, and population health tools. Federal interoperability initiatives, including ongoing development of the United States Core Data for Interoperability (USCDI), are part of the backbone that can enable these data flows over time.4
For healthcare IT and compliance leaders, preparation should focus on building a repeatable governance model for PDT intake and scaling. That typically includes security and privacy review, vendor risk management, integration validation, clinical ownership, documentation standards, and billing compliance controls. Organizations that treat PDTs as enterprise clinical products, rather than standalone apps, will be better positioned to absorb new coverage pathways without creating fragmented workflows or unmanaged risk.
The reintroduction of the Access to Prescription Digital Therapeutics Act of 2025 represents more than incremental legislative action. It signals a potential evolution in how healthcare systems conceptualize, evaluate, and pay for software-driven care interventions.1 If Congress advances the bill, the downstream impact will likely be felt in provider workflow design, payer coverage policy, and developer investment in evidence and integration.
Stakeholders should monitor not only legislative movement, but also federal signals about digital health market expectations and infrastructure priorities. CMS’s emphasis on empowering Medicare beneficiaries through modernized technology, along with requests for public input on the health technology ecosystem, provides context for how agencies may shape implementation and guardrails.23
For operational readiness, the near-term “no-regrets” work is largely the same across provider and payer organizations: strengthen documentation standards, formalize governance for software-based clinical products, validate interoperability assumptions, and ensure security and privacy controls are adequate for new data flows. As interoperability initiatives mature, including continued development of USCDI, organizations will be better positioned to integrate PDT data into longitudinal records and quality reporting processes.4
If enacted and implemented effectively, H.R. 3288 could become a reference point for future coverage models for other forms of software-enabled care, including remote monitoring enhancements, digital care pathways, and certain AI-supported clinical tools. The lasting outcome will depend on how well payment policy aligns with clinical value, operational feasibility, and responsible oversight.
