The HTI-4 Final Rule (.pdf), issued by the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC), marks an important milestone in advancing the nation’s health IT ecosystem. Building on the foundation of the 21st Century Cures Act, this rule introduces new certification requirements and updates to ensure that health IT systems are more interoperable, transparent, and patient-centered.

Most provisions take effect October 1, 2025 (some phased-in requirements may have longer compliance deadlines for vendors and payers).

1. Electronic Prescribing & Real-Time Benefit Tools
   • Certified health IT must support electronic prescribing of controlled and non-controlled substances.
   • New requirement for real-time prescription benefit (RTPB) tools, enabling prescribers to check patient-specific drug cost and coverage information at the point of care.
   • Real-time benefit checks could let psychiatrists see which antidepressants, antipsychotics, or mood stabilizers are covered under a patient’s plan — and at what cost — before sending the prescription.
2. Electronic Prior Authorization (ePA)
   • The final rule requires certified health IT systems to implement standards-based Application Programming Interface (APIs) that facilitate electronic prior authorization directly within clinicians’ workflows.
   • Health plans must respond within specified timeframes for prior authorization requests (beginning 2027).
   • With standards-based APIs, psychiatrists could submit PAs directly within their EHR workflow and get faster determinations.
3. Clinical Decision Support (CDS) & Decision Support Interventions (DSI)
   • Updates to the Clinical Decision Support criterion in the Health IT Certification Program.
   • Vendors must disclose key metadata (e.g., evidence source, developer, validation methods) to promote trustworthiness.
   • Prescribers may gain access to safer, more reliable guidance (e.g., drug-drug interaction alerts, evidence backing for treatment algorithms).
4. Standards & Interoperability Updates
   • Incorporates the latest USCDI v5 (United States Core Data for Interoperability) for certified systems.
   • Strengthens requirements for FHIR-based APIs to improve patient access to their health data and facilitate payer-provider data exchange.
   • Enhanced coordination with primary care
5. Certification Program Changes
   • HTI-4 updates the ONC Health IT Certification Program to align with statutory goals under the 21st Century Cures Act.
   • Developers must meet new certification requirements to ensure their products remain compliant.
   • Emphasis on usability, patient safety, and transparency in certified health IT modules.
   • Potentially more supportive of mental health workflows.

The HTI-4 Final Rule represents a significant step toward streamlining e-prescribing, prior authorization, and real-time benefit checks; enhancing clinical decision support transparency; and reinforcing interoperability through FHIR APIs and USCDI v5. It is aimed at reducing administrative burden, improving affordability, and ensuring patients and providers have timely access to needed information.