Access to Prescription Digital Therapeutics Act of 2025

Key Points

• This bill would require Medicare (Part B) and Medicaid to cover prescription digital therapeutics, which are FDA-cleared software-based products used to prevent, manage, or treat medical conditions. Coverage would begin on January 1, 2026.
• To qualify for coverage, a digital therapeutic must be cleared or approved by the FDA, have an approved indication for treating a disease or condition, primarily use software to achieve its results, and meet certain federal labeling exemptions.
• The government would create a payment system for manufacturers within one year, considering the list price, the weighted median of private insurer payment rates, and costs for ongoing use. This aims to set fair reimbursement rates.
• Manufacturers must report pricing data, distribution volume, and user counts to the government annually starting January 1, 2026. Failing to report or misrepresenting data could result in penalties of up to $10,000 per day.

Votes

No votes have been recorded for this legislation yet.