House · HR 3288 · 119th Congress
Access to Prescription Digital Therapeutics Act of 2025
Summary
This bill adds prescription digital therapeutics to Medicare and Medicaid coverage starting in 2026. These are FDA-cleared software apps used to prevent or treat medical conditions. It requires the government to set payment rates for makers of these products and makes companies report their private pricing data.
In Favor
Many patients cannot afford or access software-based treatments that doctors can already prescribe. This bill lets Medicare and Medicaid pay for these FDA-approved tools, so more patients can use them. Covering them could cut costs by helping people manage conditions before they get worse and require expensive care.
Against
The government must build an entirely new payment system for a new class of products, which takes time and money. Setting fair prices will be hard because software products do not age or run out like physical drugs. Taxpayers could end up overpaying if the pricing rules favor manufacturers over patients.
Additional Considerations
Purpose & Problem
Is the problem real and worth federal action?
The bill adds software-based medical tools, called prescription digital therapeutics, to Medicare and Medicaid coverage starting January 1, 2026. These tools must be FDA-cleared and use software to prevent, manage, or treat a medical condition.
Scope & Related Provisions
Does it stay focused, or carry unrelated add-ons?
The bill stays focused on adding prescription digital therapeutics to Medicare and Medicaid. All major provisions tie to defining, covering, paying for, and reporting on these products.
Who Is Affected
Who benefits, and who bears the cost?
Medicare and Medicaid patients gain access to covered FDA-cleared software treatments. Manufacturers must report pricing and user data to the federal government and may face fines for incomplete or wrong reports.
Cost & Funding
Is it affordable and responsibly funded?
The bill does not state a total dollar amount or include a CBO cost estimate. It directs federal Medicare and Medicaid spending to cover these products, and it authorizes fines of up to $10,000 per day for manufacturers that fail to report correctly.
Risks & Implementation
What could go wrong in practice?
The Secretary must build a new payment system and new billing codes within one to two years, which requires significant agency work on a new product category. Manufacturers must also set up annual reporting processes that did not previously exist under Medicare rules.
For the actual bill text, see congress.gov.
AI-generated · Published 7/22/2026