Access to Prescription Digital Therapeutics Act of 2025
- Bill Number
- H.R. 3288
- Origin Chamber
- House
- Congress
- 119th Congress, Session 1
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2025-05-08: Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- Last Updated
- 2026-06-23T08:05:45Z
AI-Generated Summary
Purpose
The Access to Prescription Digital Therapeutics Act of 2025 aims to expand health coverage by requiring Medicare and Medicaid to include prescription digital therapeutics (PDTs). PDTs are software-based tools, like apps or devices, approved by the Food and Drug Administration (FDA) to help prevent, manage, or treat medical conditions. This legislation seeks to make these innovative digital health solutions accessible to low-income and elderly Americans through public insurance programs.
Key Provisions
- Definition of Prescription Digital Therapeutics: PDTs are defined as FDA-cleared or approved products (e.g., devices, apps, or software) that use digital technology as their main mechanism to treat or manage diseases. They must be exempt from certain drug labeling rules under FDA regulations.
- Medicare Coverage (Title XVIII):
- Starting January 1, 2026, PDTs will be covered as a medical service under Medicare Part B (outpatient care).
- The Secretary of Health and Human Services (HHS) must create a payment system within one year of enactment, which could involve one-time fees or ongoing payments to manufacturers. Factors considered include the product's list price, average payments from private insurers (weighted by usage volume), costs for continuous use, and other relevant elements.
- Healthcare Common Procedure Coding System (HCPCS) codes—standard codes used for billing medical services—must be established for PDTs within two years, with temporary codes available immediately for payments.
- Manufacturers must report annually (starting January 1, 2026) details like payments from private insurers, distribution volumes, user numbers, and any discounts or rebates. Failure to report accurately can result in civil penalties up to $10,000 per day. Reported data will be kept confidential, similar to drug pricing information.
- Medicaid Coverage (Title XIX): PDTs are added to the list of mandatory covered services for state Medicaid programs, ensuring low-income individuals can access them without states opting out of this category.
Significant Changes to Existing Law
- New Coverage Category: Prior to this bill, Medicare and Medicaid did not explicitly cover digital therapeutics as a distinct benefit. This adds PDTs to Medicare Part B's list of covered outpatient services and Medicaid's mandatory benefits, filling a gap for software-driven treatments.
- Payment and Reporting Framework: Introduces a tailored payment methodology for PDTs, distinct from traditional drugs or devices, and mandates manufacturer transparency on pricing—similar to existing rules for outpatient drugs but applied newly to digital products.
- Timeline and Enforcement: Establishes specific deadlines (e.g., payments within one year, coding within two years) and penalties for non-compliance, which were not previously required for this category of health technology.
Potential Impacts
- On Government Agencies: The Centers for Medicare & Medicaid Services (CMS) will need to develop new administrative processes for payments, coding, and data collection, potentially increasing short-term workload and costs. States managing Medicaid may face higher expenditures but could see long-term savings from better disease management.
- On Citizens: Medicare (primarily seniors) and Medicaid (low-income individuals) beneficiaries gain access to FDA-approved digital tools for conditions like chronic pain or mental health, potentially improving health outcomes and reducing the need for in-person care. This could enhance equity in digital health access but may raise program costs if usage grows.
- On International Relations: Minimal direct impact, though it could encourage global standards for digital therapeutics by signaling U.S. government endorsement, indirectly benefiting U.S. manufacturers in international markets.
Main Stakeholders Affected
- Beneficiaries: Elderly and low-income Americans enrolled in Medicare or Medicaid, who may use PDTs for ongoing health management.
- Manufacturers: Companies producing FDA-approved digital therapeutics, required to report pricing data and adapt to new payment structures, which could boost market entry and revenue from public programs.
- Healthcare Providers: Doctors and clinicians who prescribe PDTs, benefiting from expanded treatment options but needing to integrate digital tools into care plans.
- Government Entities: CMS for federal oversight; state Medicaid agencies for implementation; HHS and FDA for regulatory alignment.
- Private Insurers: Indirectly affected through required data reporting, which may influence pricing negotiations.
Notable Legal, Constitutional, or Political Implications
- Legal Implications: Strengthens FDA's role in defining eligible PDTs while imposing CMS enforcement via civil penalties, modeled on existing drug reporting laws (e.g., under the Social Security Act). This could lead to litigation over payment methodologies or data confidentiality if disputes arise between manufacturers and regulators.
- Constitutional Implications: None significant; the bill operates within Congress's authority to regulate interstate commerce and public welfare programs, without raising free speech, privacy, or federalism concerns beyond standard administrative rulemaking.
- Political Implications: Promotes innovation in digital health, appealing to bipartisan interests in cost-effective care, but may spark debates over federal spending increases (estimated impacts not specified in the bill) and the balance between public coverage expansion and fiscal responsibility. Referred to key committees (Energy and Commerce, Ways and Means), it highlights growing focus on technology in healthcare policy.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Cosponsors (10)
Rep. Thompson, Mike [D-CA-4], Rep. Craig, Angie [D-MN-2], Rep. Balderson, Troy [R-OH-12], Rep. Van Duyne, Beth [R-TX-24], Rep. Wittman, Robert J. [R-VA-1], Rep. Panetta, Jimmy [D-CA-19], Rep. DelBene, Suzan K. [D-WA-1], Rep. Sewell, Terri A. [D-AL-7], Rep. Ross, Deborah K. [D-NC-2], Rep. Fitzpatrick, Brian K. [R-PA-1]
Recent Actions
- 2025-05-08: Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- 2025-05-08: Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- 2025-05-08: Introduced in House
- 2025-05-08: Introduced in House
Bill Versions
- Access to Prescription Digital Therapeutics Act of 2025 — issued 2025-05-08 — PDF (8 pages)