Summary

Requires Medicare and Medicaid to cover "prescription digital therapeutics" and sets rules for how those products are paid, coded, and reported. Medicare coverage and manufacturer reporting begin January 1, 2026; the Secretary must establish a payment method within one year and product-specific HCPCS codes within two years. Manufacturers must report private-payor prices, sales volumes, and user counts, and false reporting can trigger civil money penalties. The law adds prescription digital therapeutics to the list of Medicaid-covered items and protects reported data under existing confidentiality rules while requiring reported prices to reflect discounts and rebates.

Key Points

• Medicare must cover prescription digital therapeutics starting January 1, 2026.
• Medicaid's statutory coverage list is amended to include prescription digital therapeutics.
• The Secretary must set a Medicare payment method within 1 year and assign product-specific HCPCS codes within 2 years.
• Manufacturers must report private-payor prices, volumes, and user counts beginning January 1, 2026, with prices reflecting discounts.
• Reported manufacturer data is protected under existing confidentiality rules, but false reports can trigger civil money penalties up to $10,000 per day.
• The law focuses on coverage rules, coding, payment method deadlines, and manufacturer transparency rather than setting specific dollar payment rates.
• Medicaid coverage is added by statutory amendment to the Social Security Act, which can affect state Medicaid programs.
• The law creates reporting and administrative duties for manufacturers and CMS, increasing regulatory and compliance requirements.

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