What does Preamble of Access to Prescription Digital Therapeutics Act of 2025 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 such titles, and for other purposes,' aims to modify the Social Security Act. The proposed changes relate to titles XVIII and XIX of the Social Security Act.

What does SHORT TITLE. of Access to Prescription Digital Therapeutics Act of 2025 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 Access to Prescription Digital Therapeutics Act of 2025 do?

This section amends the Social Security Act to define 'prescription digital therapeutic' as a product cleared or approved by the FDA, primarily using software, and having a cleared or approved indication for a medical condition. 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 these 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 prescription digital therapeutics within two years of enactment, initially using temporary codes. Manufacturers are required to annually report payment rates, volume distributed, and number of users to the Secretary, starting January 1, 2026. Failure to report or misrepresentation of information can result in a civil monetary penalty of up to $10,000 per day. Reported information will be treated with the same confidentiality as information related to covered outpatient drugs.

What does COVERAGE OF PRESCRIPTION DIGITAL THERAPEUTICS UNDER THE of Access to Prescription Digital Therapeutics Act of 2025 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 after paragraph (31) 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

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

Author: Shelley Capito (R-WV)

TL;DR (AI)

This bill expands Medicare coverage to include prescription digital therapeutics cleared or approved by the FDA, starting January 1, 2026.
The bill requires the Secretary of Health and Human Services to establish a payment methodology and product-specific codes for prescription digital therapeutics.
Manufacturers of prescription digital therapeutics must annually report data on payment rates, distribution volume, and user numbers, facing potential penalties for non-compliance or misrepresentation.

119th Congressin committeeHR. 3288(In Committee)Official page

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

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