Access to Prescription Digital Therapeutics Act of 2025
- Bill Number
- S. 1702
- Origin Chamber
- Senate
- Congress
- 119th Congress, Session 1
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2025-05-08: Read twice and referred to the Committee on Finance.
- Last Updated
- 2026-06-17T11:03:25Z
AI-Generated Summary
Purpose
The Access to Prescription Digital Therapeutics Act of 2025 aims to expand health insurance coverage under Medicare and Medicaid to include prescription digital therapeutics (PDTs). PDTs are software-based tools, like apps or devices, that help prevent, manage, or treat medical conditions and are approved by the Food and Drug Administration (FDA). The goal is to make these innovative treatments accessible to more people by integrating them into federal health programs.
Key Provisions
- Definition of Prescription Digital Therapeutics: PDTs are defined as FDA-cleared or approved products (e.g., via 510(k) clearance, de novo classification, or premarket approval) that use software as the main mechanism to treat diseases or conditions. They must be exempt from certain drug labeling requirements under FDA rules.
- Medicare Coverage (Title XVIII):
- Starting January 1, 2026, PDTs are covered as a medical service under Medicare Part B (outpatient benefits).
- The Secretary of Health and Human Services (HHS) must create a payment system within one year, which could involve one-time fees or ongoing payments. This system considers factors like the product's list price, average payments from private insurers (weighted by sales volume), costs for continued use, and other relevant data.
- HHS must assign specific billing codes (HCPCS codes, which are standardized codes for medical services) for PDTs within two years; temporary codes will be used in the meantime for payments.
- Manufacturers must report annually starting January 1, 2026, on payments received from private insurers, sales volumes, and user numbers. Reports must account for discounts or rebates. Failure to report accurately can result in fines 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 covered services under Medicaid, making them reimbursable for eligible low-income individuals.
- Definitions: Includes terms like "actual list charge" (initial public price to private payers), "manufacturer" (FDA-defined producer), and "private payor" (non-government insurers).
Significant Changes to Existing Law
- Introduces PDTs as a new category of covered benefits under Medicare Part B and Medicaid, where they were previously not explicitly included. This amends the Social Security Act by adding subsections for definitions, coverage, and payment rules.
- Establishes novel reporting and payment requirements for manufacturers of digital therapeutics, mirroring some aspects of drug pricing transparency laws but tailored to software-based products.
- Shifts from no dedicated framework for PDTs to a structured system with FDA oversight integration, coding, and penalties, without altering core Medicare or Medicaid eligibility rules.
Potential Impacts
- On Government Agencies: HHS and the Centers for Medicare & Medicaid Services (CMS) will need to develop new payment and coding systems, potentially increasing administrative workload and costs. This could lead to better data on digital health pricing but may require additional resources for enforcement of reporting rules.
- On Citizens: Medicare and Medicaid beneficiaries (primarily seniors, disabled individuals, and low-income families) gain access to FDA-approved digital tools for conditions like mental health issues or chronic diseases, potentially improving treatment options without out-of-pocket costs beyond standard copays. This could enhance remote care, especially in underserved areas.
- On International Relations: Minimal direct impact, though it may influence global standards for digital health regulation by promoting U.S. FDA-approved PDTs in federal programs, potentially affecting trade in health tech with other countries.
Main Stakeholders Affected
- Beneficiaries and Patients: Medicare (over 65 million enrollees) and Medicaid (about 80 million enrollees) users, who benefit from expanded treatment access.
- Manufacturers and Developers: Companies producing PDTs, who gain reimbursement opportunities but face new reporting obligations and penalties.
- Healthcare Providers: Doctors and clinicians, who can prescribe PDTs more readily under covered benefits.
- Insurers and Payers: Private insurers, whose payment data will inform Medicare rates, and state Medicaid programs, which must implement coverage.
- Government Entities: HHS, CMS, and FDA, responsible for implementation, oversight, and enforcement.
Notable Legal, Constitutional, or Political Implications
- Legal: Builds on existing FDA authority for device approvals while adding enforcement tools like civil penalties under Medicare rules, potentially setting precedents for regulating software as medical devices. Ensures confidentiality of pricing data to protect trade secrets, aligning with antitrust considerations.
- Constitutional: No direct challenges anticipated, as it involves Congress's spending power under the Social Security Act; however, it could raise questions about federal overreach into state Medicaid programs if implementation varies.
- Political: Supports bipartisan interest in digital health innovation and telehealth expansion post-COVID, but may spark debates on program costs (e.g., adding to Medicare's $800+ billion annual budget) and equity in access to tech-based care. Could influence future legislation on health tech reimbursement.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Sen. Capito, Shelley Moore [R-WV]
Cosponsors (4)
Sen. Shaheen, Jeanne [D-NH], Sen. Booker, Cory A. [D-NJ], Sen. Budd, Ted [R-NC], Sen. Blackburn, Marsha [R-TN]
Recent Actions
- 2025-05-08: Read twice and referred to the Committee on Finance.
- 2025-05-08: Introduced in Senate
Bill Versions
- Access to Prescription Digital Therapeutics Act of 2025 — issued 2025-05-08 — PDF (8 pages)