What does Preamble of HR 3288 do?

This bill, formally titled 'To amend titles XVIII and XIX of the Social Security Act to provide for coverage of prescription digital therapeutics under the Medicare and Medicaid programs, and for other purposes,' aims to amend the Social Security Act. The bill intends to provide coverage for prescription digital therapeutics under the Medicare and Medicaid programs. The bill was introduced in the House of Representatives on May 8, 2025.

What does SHORT TITLE. of HR 3288 do?

This bill is formally titled the Access to Prescription Digital Therapeutics Act of 2025.

What does COVERAGE AND PAYMENT OF PRESCRIPTION DIGITAL THERAPEUTICS UNDER of HR 3288 do?

This section amends the Social Security Act to define 'prescription digital therapeutic' as a product cleared or approved by the FDA that primarily uses software to achieve its intended result. It expands Medicare coverage to include prescription digital therapeutics furnished on or after January 1, 2026. The Secretary of Health and Human Services must establish a payment methodology for manufacturers of prescription digital therapeutics within one year of enactment, considering factors like list charge, weighted median, and ongoing use costs. The Secretary must establish product-specific HCPCS codes for these therapeutics within two years of enactment, utilizing temporary codes until permanent codes are available. Manufacturers are required to report payment rates, volume distributed, and user numbers to the Secretary annually, starting January 1, 2026. Failure to accurately report this information may result in a civil monetary penalty of up to $10,000 per day. Information reported by manufacturers will be treated with the same confidentiality as information disclosed for covered outpatient drugs.

What does COVERAGE OF PRESCRIPTION DIGITAL THERAPEUTICS UNDER THE of HR 3288 do?

This section amends Section 1905(a) of the Social Security Act. Paragraph (31) of Section 1905(a) is modified by replacing ``; and'' with a semicolon. Paragraph (32) of Section 1905(a) is redesignated as paragraph (33). A new paragraph (32) is inserted into Section 1905(a) to include prescription digital therapeutics. Prescription digital therapeutics are defined as those in section 1861(nnn).

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Access to Prescription Digital Therapeutics Act of 2025 — HR. 3288

Last updated: 5/8/2025 · Introduced: 5/8/2025

Author: Kevin Hern (R-OK)

TL;DR (AI)

This bill expands Medicare and Medicaid coverage to include prescription digital therapeutics, defined as FDA-cleared or approved software-based products.
The bill requires the Secretary of Health and Human Services to establish payment methodologies and product-specific codes for prescription digital therapeutics.
Manufacturers of these therapeutics must annually report payment rates and usage data to the Secretary, facing potential penalties for inaccurate reporting.

119th Congressin committeeOfficial page

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Other Sections

Includes provisions on preamble, short title., and 2 more.

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