HTI-4 Final Rule Summary

1. Rule Overview & Effective Date

  • Finalized July 31, 2025, incorporated into CMS’s FY 2026 Inpatient Prospective Payment System rule — effective October 1, 2025 .

  • Issued by the Office of the National Coordinator for Health IT (ONC/ASTP) to update health IT certification criteria and advance interoperability in e-prescribing, benefits transparency, and prior authorization .

2. Goals & Rationale

  • Streamline clinical workflows, reduce administrative burden, mitigate clinician burnout, and accelerate patient care .

  • Projected to yield $19 billion in labor cost savings over 10 years .

  • Promotes real-time, point-of-care decision-making for prescribers and patients .

3. Key Components

a) Electronic Prescribing (eRx)

  • Updates criterion 45 CFR 170.315(b)(3) to mandate using an improved version of the NCPDP SCRIPT standard (2023011) and the December 4, 2023 RxNorm release .

  • Transition period: Until December 31, 2027, health IT may support either the older or new SCRIPT versions; after January 1, 2028, only 2023011 is acceptable .

  • Optional ePA (electronic prior authorization) components become required, replacing prior optional inclusion .

b) Real-Time Prescription Benefit (RTPB)

  • Establishes a new certification criterion for real-time benefit checks using NCPDP RTPB Standard version 13 .

  • Effective January 1, 2028, any health IT certified under eRx must also meet RTPB requirements .

  • Enables prescribers and patients to view drug costs and alternative therapies at the point of care .

c) Electronic Prior Authorization (ePA)

  • Introduces three FHIR-based certification criteria (under § 170.315) following HL7 Da Vinci specifications :

    1. Coverage Requirements Discovery – query payer for coverage rules.

    2. Documentation Templates & Rules – retrieve payer-specific documentation using FHIR Questionnaires.

    3. Submission & Status Tracking – submit ePA requests and monitor status via certified systems.

  • Supports clinical workflows by reducing fax and phone-based exchange and expediting authorization .

  • Aligns with CMS’s Interoperability and Prior Authorization regulation and supports future MIPS/ePA measure starting 2027 .

d) API & Workflow Enhancements

  • Adds two modular API criteria:

    • CDS Hooks Triggering (170.315(j)(20)) – integrates decision support workflows via API.

    • Subscriptions – Data Notifications (170.315(j)(21)) – enables notifications when key clinical events occur .

  • Designed to facilitate more seamless IT-enabled decision support and notification workflows.

4. Physician Implications & Takeaways

  • Reduce administrative load: ePA and RTPB built into EHR workflows, eliminating manual processes and enhancing prescribing efficiency.

  • Enhance point-of-care decision-making: Access to medication costs and formulary guidance improves shared decision-making and affordability.

  • Stay compliant: Providers and vendors should monitor adoption timelines—especially the 2027 deadlines for ePA reporting and SCRIPT upgrade.

  • Prepare for MIPS: Starting 2027, ePA functionality may factor into Promoting Interoperability performance metrics.

  • Workflow modernization: CDS Hooks and subscription APIs can enable smarter alerts and notifications integrated into physician workflow.