HHS Finalizes Rule to Boost E-Prior Auth, Real-Time Rx Checks

The Department of Health and Human Services’ health IT division finalized the HTI-4 rule this week, aimed at reducing administrative barriers and enabling faster prior authorization and real-time prescription benefit checks. This update also improves electronic prescribing standards and was included as part of the Centers for Medicare and Medicaid Services’ (CMS) Inpatient Prospective Payment System (IPPS) rule.

The rule supports CMS’s 2024 Interoperability and Prior Authorization regulation, allowing certified electronic health records (EHRs) to submit prior authorizations, select drugs consistent with a patient’s insurance coverage, and exchange prescription information with pharmacies and insurers. ASTP/ONC, the federal agency overseeing health IT certification, is shifting focus toward API certification and interoperability enforcement rather than traditional EHR certification.

HTI-4 updates the electronic prescribing certification to require the latest NCPDP SCRIPT standard, making electronic prior authorization transactions mandatory rather than optional. It also adds a new real-time prescription benefit certification criterion based on the NCPDP Real-Time Prescription Benefit standard, enabling providers and patients to compare drug prices and identify lower-cost alternatives at the point of care.

The rule introduces three new FHIR-based certification criteria developed with the HL7 Da Vinci project to streamline electronic prior authorization. These allow providers to request payer coverage requirements, assemble documentation templates according to payer rules, submit prior authorization requests electronically, and track their status. These criteria align with CMS payer requirements and will support healthcare providers participating in Medicare’s Promoting Interoperability program starting in 2027.

Additional certification criteria support API functionality, including workflow triggers for clinical decision support and subscription notifications for data updates. HTI-4 also advances implementation specifications for exchanging clinical and administrative data with payers, along with sharing formulary and provider directory information, furthering CMS interoperability goals.

According to ASTP, these updates will improve workflow automation, reduce manual administrative effort, and promote timely, transparent clinical decision-making. The agency estimates these efficiencies could save millions of clinician hours annually, amounting to $19 billion in labor cost savings over ten years, allowing providers to focus more on patient care and less on paperwork.

Overall, the HTI-4 final rule represents a targeted but significant update to health IT certification, enhancing technical capabilities to improve efficiency, reduce administrative burdens, and support CMS priorities in electronic prior authorization and data interoperability.