Bill > HR3288

This bill seeks to establish a comprehensive framework for the coverage and payment of prescription digital therapeutics (PDTs) under Medicare and Medicaid programs. PDTs are defined as software-based medical technologies cleared by the FDA that are used to prevent, manage, or treat medical conditions. Under the bill, Medicare would require the Secretary of Health and Human Services to develop a payment methodology for PDT manufacturers within one year, considering factors like list price, median payment rates, and ongoing usage costs. The bill mandates the creation of specific healthcare coding (HCPCS codes) for these technologies and requires manufacturers to annually report payment rates, distribution volumes, and user numbers to the government. Manufacturers who fail to report accurately could face civil monetary penalties of up to $10,000 per day. For Medicaid, the bill adds PDTs to the list of covered medical services, ensuring patients in both Medicare and Medicaid programs can access these innovative digital health technologies starting January 1, 2026. This legislation represents a significant step in recognizing and integrating digital therapeutic technologies into mainstream healthcare coverage, potentially improving treatment options for patients across the United States.

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https://www.congress.gov/bill/119th-congress/house-bill/3288/all-info