New Rule Boosts Prescription Drug Transparency and Streamlines Patient Access

This document describes the final rule for “Prescription Benefit and electronic Prior Authorization,” also known as the HTI-4 final rule.

Here’s a breakdown of what’s in the HTI-4 final rule:

Real-time Prescription Benefit Checks: A new certification criterion has been adopted to allow prescribers to access prescription benefit data at the point of care. This enables patients and prescribers to compare drug prices and find cheaper alternatives, fulfilling requirements from the Consolidated Appropriations act (CAA) of 2021. This policy is based on common standards for real-time prescription benefit exchange developed by the National council for Prescription Drug Programs (NCPDP).

Standardized Electronic Prior Authorization: New HL7® Fast Healthcare Interoperability Resources® (FHIR®) certification criteria have been adopted to support standardized, electronic prior authorization. These criteria leverage standards from the HL7 Da Vinci Project and enable providers to:
Request coverage requirement information from payers.
Gather necessary information for prior authorization requests.
Submit requests directly from their certified health IT systems.
Monitor the status of these requests.These criteria align with the prior authorization API requirements from the 2024 CMS Interoperability and Prior Authorization final Rule and will support new Electronic Prior Authorization measures in the Medicare Promoting Interoperability program and the MIPS Promoting Interoperability performance category starting in 2027.

* Updated Electronic Prescribing Standard: The baseline standard for electronic prescribing has been updated for the first time in five years. The “electronic prescribing” certification criterion now includes an improved version of the NCPDP SCRIPT standard. Additionally, prescriber systems are now required to support electronic prior authorization for prescriptions, which was previously optional.

The HTI-4 final rule is part of HHS’s FY26 Hospital Inpatient Prospective Payment System (IPPS) final rule and aims to support the goal of processing prior authorizations in real time during patient care encounters, thereby easing administrative burdens for patients, providers, and payers.

how will the new rule regarding real-time benefit data impact a patient’s out-of-pocket prescription drug costs?

Understanding the New Regulations

As of August 1st, 2025, a significant new rule is taking effect, designed to dramatically improve prescription drug transparency and simplify the process for patients to access the medications they need. this initiative addresses long-standing concerns about hidden fees, complex prior authorization processes, and a lack of clear information regarding drug pricing. the core of the rule focuses on empowering patients with more control over their healthcare costs and ensuring a smoother experience when filling a prescription.

“Carelessness in filling a prescription could cost a life,” highlighting the critical importance of accuracy in the pharmacy dispensing process.This new rule aims to reduce errors and improve patient safety alongside increased access. (WordReference Forums, 2025)

Key Provisions of the Rule

The new regulations encompass several key areas:

Real-Time Benefit Information: Insurers are now required to provide patients with real-time, accurate information about their prescription drug costs before they go to the pharmacy.This includes copays, deductibles, and any potential alternative, lower-cost options. This is a major step towards price transparency in healthcare.

Standardized Prior Authorization: The rule introduces standardized electronic prior authorization forms.This will reduce administrative burdens for both healthcare providers and pharmacies, leading to faster approvals and fewer delays in treatment. Prior authorization, a common hurdle for many patients needing specialty medications, will become considerably more efficient.

Increased Transparency in Pharmacy Benefit Manager (PBM) Practices: PBMs, which negotiate drug prices with manufacturers, will be subject to greater scrutiny and required to disclose more information about their pricing practices and rebates. This aims to address concerns about hidden markups and ensure that savings are passed on to patients.

Simplified Appeals Process: Patients will have a clearer and more streamlined process for appealing denied claims or prior authorization requests. This includes defined timelines for responses and clear explanations for denials.

Electronic Prescribing (e-prescribing) mandate: While e-prescribing has been encouraged for years, the new rule strengthens the mandate, aiming to reduce errors associated with handwritten prescriptions and improve medication safety.

How This Impacts patients

These changes translate to tangible benefits for patients:

lower Healthcare Costs: Access to real-time benefit information allows patients to make informed decisions about their medications, potentially choosing more affordable alternatives.

Faster Access to Medications: Streamlined prior authorization and e-prescribing reduce delays in treatment,ensuring patients receive the medications they need promptly.

Greater Control Over Healthcare: Increased transparency empowers patients to understand their healthcare costs and advocate for their needs.

Reduced Administrative Burden: simplified processes reduce the paperwork and hassle associated with managing prescriptions.

Improved Medication Adherence: Easier access and lower costs can lead to better medication adherence, improving health outcomes.

The Role of Pharmacies and Providers

Pharmacies play a crucial role in implementing these changes. They will need to integrate new systems to access real-time benefit information and process standardized prior authorization requests. Pharmacists will also be key in communicating cost-saving options to patients.

Healthcare providers will benefit from reduced administrative burdens and faster prior authorization approvals. They will also need to embrace e-prescribing and utilize the new tools to provide patients with accurate cost information. Continuing medical education (CME) on the new regulations will be vital for providers.

Addressing Potential Challenges

while the new rule is a positive step, some challenges may arise:

System Integration: Integrating new systems across the healthcare landscape will require significant investment and coordination.

Data Security: Protecting patient data is paramount. Robust security measures must be in place to prevent breaches and ensure privacy.

PBM Resistance: Some PBMs may resist increased transparency, potentially leading to legal challenges.

Patient Education: Patients need to be educated about their rights and how to utilize the new tools available to them.

Resources for Patients and professionals

Centers for Medicare & Medicaid Services (CMS): https://www.cms.gov/ – Provides detailed information about the rule and its implementation.

National Association of Boards of Pharmacy (NABP): https://nabp.pharmacy/ – Offers resources for pharmacies and pharmacists.

American Medical Association (AMA): https://www.ama-assn.org/ – Provides guidance for healthcare providers.

Patient Advocacy Groups: Numerous patient advocacy groups offer support and information about prescription drug access and affordability.

References:

WordReference Forums. (2025).filling a prescription. Retrieved from https://forum.wordreference.com/threads/filling-a-prescription.85240/