Bill > S1702

This bill seeks to establish a comprehensive framework for covering and reimbursing prescription digital therapeutics (PDTs) under Medicare and Medicaid. PDTs are defined as software-based medical technologies that are FDA-cleared or approved, used to prevent, manage, or treat medical conditions, and primarily operate through software. The bill requires the Secretary of Health and Human Services to create a payment methodology for PDT manufacturers within one year, considering factors like list pricing, median payment rates, and potential ongoing use costs. Manufacturers will be required to annually report payment rates, distribution volumes, and user numbers to the government, with potential civil monetary penalties of up to $10,000 per day for non-compliance or misreporting. The legislation also mandates the development of specific healthcare coding (HCPCS codes) for these digital therapeutics and ensures their coverage under both Medicare Part B and Medicaid starting January 1, 2026. By creating this regulatory structure, the bill aims to integrate innovative digital health technologies into mainstream healthcare coverage, providing patients with more treatment options and establishing clear guidelines for their reimbursement and reporting.

Budget and Finance

https://www.congress.gov/bill/119th-congress/senate-bill/1702/all-info