Navigating HTI-4 Regulation with DAW Systems
In the quickly changing field of healthcare technology, keeping up with regulatory changes is essential for both compliance and strategic success. A significant development in this area is the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-4) Final Rule.
Released on July 31, 2025, by the Assistant Secretary for Technology Policy (ASTP) and the Office of the National Coordinator for Health Information Technology (ONC), the HTI-4 rule marks a major shift in how health information is exchanged among providers, payers, and pharmacies. It has the potential to save approximately $19 billion in labor costs over the next decade. This regulation aims to eliminate the administrative barriers that have long contributed to clinician burnout and delayed patient care.1
We will provide a detailed overview of the HTI-4 regulation, examine its impact on health IT platforms through key dates and requirements, and discuss how ScriptSure by D.A.W. Systems serves as the premier solution for navigating this transition.
Overview of the HTI-4 Regulation
The HTI-4 Final Rule is the fourth version in a series of "HTI" regulations designed to modernize the U.S. health IT infrastructure. Unlike earlier rules, such as HTI-1, which concentrated on predictive AI and transparency in decision support, HTI-4 focuses specifically on the critical final steps of the clinical workflow: medication management and administrative approvals.
The main objective of HTI-4 is to create a "real-time" healthcare ecosystem. In the past, clinicians have faced frustration with "black box" insurance requirements, prescribing medication only to discover days later that it needed prior authorization or that a more affordable alternative was available. HTI-4 seeks to provide these insights at the point of care.
HTI-4 Main Updates
- Modernized Electronic Prescribing:Updating the technical language used to transmit prescriptions, ensuring they are more detailed and accurate.2
- Real-Time Prescription Benefit:Requiring systems to display patient-specific out-of-pocket costs and formulary alternatives while the doctor is still with the patient.2
- Electronic Prior Authorization: Automating the process of obtaining insurance approval for medications and procedures through standardized APIs, effectively replacing fax machines with seamless digital communication.2
HTI-4 Impact: Key Dates and Requirements
For health information technology companies, HTI-4 isn't just a suggestion, it’s a mandatory roadmap for certification. Failure to meet these standards could mean losing "Certified Health IT" status, which is required for participation in major CMS programs. The regulation introduces several critical technical standards that platforms must adopt.
- NCPDP SCRIPT Standard v2023011: This is the new "gold standard" for electronic prescribing. It allows for more granular data sharing, such as better "Sig" (instructions) handling and improved medication history.3
- NCPDP RTPB Standard v13: This standard governs how a platform queries a payer for real-time drug pricing. It ensures that the "sticker price" a patient sees at the doctor’s office matches what they will pay at the pharmacy.3
- FHIR-Based APIs for Prior Authorization: HTI-4 adopts three new certification criteria based on HL7 Da Vinci specifications:1
- Coverage Requirements Discovery: Allows the system to automatically check if a PA is needed.
- Documentation Templates and Rules: Helps clinicians assemble the necessary clinical data for the PA.
- Prior Authorization Support: Facilitates the actual submission and status tracking of the request.
Important HTI-4 Compliance Dates:
- October 1, 2025: The Final Rule officially becomes effective.
- January 1, 2027: Platforms must support NCPDP RTPB version 13 and Formulary & Benefit version 60. Medicare MIPS reporting for electronic prior authorization begins this year.
- January 1, 2028: All certified electronic prescribing modules must also be certified for Real-Time Prescription Benefits and must use the NCPDP SCRIPT 2023011 standard exclusively.
For platforms, this means the clock is ticking. The complexity of moving from old standards to FHIR-based APIs and the newest NCPDP versions requires significant clinical workflow redesign.
How ScriptSure, D.A.W. Systems is Your Premier Solution
While health information technology companies are scrambling to interpret the final rule and plan their development cycles, D.A.W. Systems has already positioned its flagship product, ScriptSure, as a market leader in HTI-4 compliance.
In January 2025, ScriptSure Cloud ERX became the first E-prescribing company in the country to complete the upgrade to the NCPDP SCRIPT 2023011 standard. While the federal government is giving other vendors until 2028 to fully transition, ScriptSure users are already benefiting from the most advanced prescribing logic available today. This early adoption means that ScriptSure clients won't face the "deadline panic" that often accompanies major regulatory shifts.
How ScriptSure specifically addresses the HTI-4 mandates:
- Seamless Real-Time Benefits: ScriptSure integrates with PBMs (Pharmacy Benefit Managers) to provide instant cost transparency. Clinicians can see co-pays and alternatives immediately, reducing the likelihood of "sticker shock" at the pharmacy and increasing medication adherence.
- Automated ePA Workflows: By leveraging the latest standards, ScriptSure reduces the time spent on prior authorizations from days or weeks to mere minutes. It identifies PA requirements while prescribing, allowing staff to handle approvals before the patient even leaves the office.
- Award-Winning Accuracy: ScriptSure is a multi-year winner of the Surescripts White Coat Award for prescription accuracy. Having a platform that prioritizes clean, accurate data is essential for avoiding pharmacy callbacks and errors.
- Compliance & Security: ScriptSure is fully compliant with Information Blocking rules and is cloud-based, meaning updates are pushed automatically. Providers don't have to worry about manual installs or "patching" their software to stay compliant with new standards.
The HTI-4 regulation is more than just a list of technical requirements; it represents a vision for a seamless healthcare system where data benefits both patients and providers, rather than obstructing them.
By choosing a solution like ScriptSure, you are not just fulfilling a compliance requirement; you are providing your practice or platform with some of the most advanced, efficient, and user-friendly prescribing tools available. The future of health IT is characterized by real-time access, transparency, and automation. With D.A.W. Systems, you’re already positioned for that future.
Sources:
3 - https://www.ncpdp.org/Resources/CMS-Names-NCPDP-ePrescribing-Standards-in-Final-Ru