HR3288-119

What This Bill Does

The Access to Prescription Digital Therapeutics Act creates federal coverage and payment rules for software-based prescription digital therapeutics. A covered therapeutic must be FDA cleared or approved under 510(k), De Novo, or PMA pathways, have a cleared or approved indication for preventing, managing, or treating a disease, condition, or disorder, primarily use software to achieve its result, and qualify as a prescription device exempt from certain labeling requirements. Medicare Part B would cover prescription digital therapeutics furnished on or after January 1, 2026. CMS must establish a payment methodology for manufacturers within one year, considering actual list charge, weighted median private-payor payment rates by volume, ongoing-use amounts, and other factors. CMS must establish product-specific HCPCS codes within two years and temporary codes before permanent codes. Manufacturers must report private-payor payment rates, distribution volume, user counts, discounts, rebates, coupons, and concessions annually starting January 1, 2026, with confidentiality protections and civil money penalties up to $10,000 per day for failures or misrepresentations. Medicaid would also add prescription digital therapeutics to covered medical assistance.

Who Benefits and How

Medicare beneficiaries benefit because covered prescription digital therapeutics become Part B benefits starting January 1, 2026. Medicaid beneficiaries benefit because state Medicaid medical assistance would include prescription digital therapeutics. Digital therapeutic manufacturers benefit from Medicare payment methodology and product-specific HCPCS coding. Clinicians prescribing digital therapeutics benefit from clearer federal coverage and payment pathways.

Who Bears the Burden and How

CMS payment staff must build payment methodology, temporary and permanent HCPCS coding, confidentiality systems, and manufacturer reporting enforcement. Digital therapeutic manufacturers must report private-payor rates, distribution volume, user counts, and price concessions annually. Manufacturers making reporting omissions or misrepresentations face civil money penalties up to $10,000 per day. State Medicaid agencies must update coverage systems to include prescription digital therapeutics.

Key Provisions

• Adds prescription digital therapeutics to Medicare Part B coverage for products furnished on or after January 1, 2026.
• Requires CMS payment methodology, product-specific HCPCS codes, and temporary codes for covered digital therapeutics.
• Requires annual manufacturer reporting of private-payor rates, volumes, user counts, discounts, rebates, coupons, and concessions.
• Extends Medicaid coverage and authorizes penalties up to $10,000 per day for reporting failures or misrepresentations.