Policy and reimbursement strategies to improve patient access to prescription digital therapeutics - Summary - MDSpire

Policy and reimbursement strategies to improve patient access to prescription digital therapeutics

  • By

  • Lani Reilly

  • Andrew Molnar

  • December 3, 2025

  • 0 min

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Objective:

To address the specific outdated U.S. reimbursement structures that restrict access to Prescription Digital Therapeutics (PDTs) and propose strategies for their modernization.

Key Findings:
  • PDTs are FDA-cleared but face significant reimbursement challenges in the U.S., limiting patient access.
  • The Access to Prescription Digital Therapeutics Act aims to create a new benefit category for PDTs, potentially transforming patient care.
  • International models like Germany's DiGA program demonstrate the potential for expanded access and cost savings, serving as a blueprint for U.S. policy.
Interpretation:

Modernizing reimbursement frameworks for PDTs is essential to enhance patient access, improve health outcomes, and align with global practices, ultimately benefiting the healthcare system.

Limitations:
  • Current U.S. reimbursement structures are outdated and do not accommodate the unique nature of PDTs, hindering innovation.
  • The Access to PDT Act is still pending evaluation by the Congressional Budget Office, delaying potential improvements in access.
Conclusion:

Timely action is critical to modernize reimbursement pathways for PDTs, ensuring that patients benefit from innovative digital health solutions and urging stakeholders to prioritize this issue.

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