H.R.3288 - Access to Prescription Digital Therapeutics Act of 2025 (119th Congress)
Summary
H.R.3288, the Access to Prescription Digital Therapeutics Act of 2025, aims to amend the Social Security Act to include prescription digital therapeutics (PDTs) under Medicare and Medicaid coverage. This bill defines PDTs as software-driven products approved by the FDA for the prevention, management, or treatment of medical conditions.
The bill outlines payment methodologies, coding requirements, and manufacturer reporting obligations to ensure appropriate reimbursement and oversight. It directs the Secretary of Health and Human Services to establish payment methodologies and HCPCS codes for PDTs.
Ultimately, this act seeks to expand access to innovative digital health technologies for Medicare and Medicaid beneficiaries.
Expected Effects
The passage of H.R.3288 would lead to the integration of prescription digital therapeutics into mainstream healthcare by making them accessible to a broader population through Medicare and Medicaid. This would incentivize the development and adoption of these technologies.
It would also establish a framework for regulating and reimbursing PDTs, including reporting requirements for manufacturers and coding systems for healthcare providers. This framework will likely influence the future of digital health regulation and reimbursement.
This bill could also lead to increased healthcare costs, depending on the payment methodologies established by the Secretary and the utilization rates of PDTs.
Potential Benefits
- Increased access to innovative healthcare technologies for Medicare and Medicaid beneficiaries.
- Potential for improved patient outcomes through personalized and accessible digital therapies.
- Incentivizes innovation and investment in the digital health sector.
- Creates a framework for the regulation and reimbursement of prescription digital therapeutics.
- May lead to more efficient and cost-effective healthcare delivery in certain cases.
Potential Disadvantages
- Potential for increased healthcare costs if payment methodologies are not carefully managed.
- Risk of fraud and abuse if oversight and reporting mechanisms are inadequate.
- Concerns about data privacy and security related to the use of digital health technologies.
- Uneven access to technology and digital literacy among beneficiaries.
- Potential for over-reliance on digital therapeutics and neglect of traditional healthcare approaches.
Constitutional Alignment
The bill's expansion of Medicare and Medicaid aligns with the general welfare clause of the Constitution, as it aims to improve healthcare access for vulnerable populations. Specifically, the preamble states the goal to "promote the general Welfare".
However, the bill's delegation of authority to the Secretary of Health and Human Services to establish payment methodologies and coding systems raises questions about the non-delegation doctrine, which prevents Congress from delegating its legislative powers to administrative agencies without clear standards.
Furthermore, the Commerce Clause (Article I, Section 8) provides Congress with the power to regulate interstate commerce, which could be used to justify the regulation of digital therapeutics that cross state lines.
Impact Assessment: Things You Care About ⓘ
This action has been evaluated across 19 key areas that matter to you. Scores range from 1 (highly disadvantageous) to 5 (highly beneficial).