In our ongoing series about the HTI-2 proposed rule, we've previously provided a high-level overview, aspects related to API certification requirements, and information blocking. Today, we focus on the aspects related to the pharmacy services arena: ePrescribing, electronic prior authorization, and real-time prescription benefit (RTPB). These elements are pivotal in improving patient access to medication and enhancing the efficiency and transparency of the prescription delivery process.

ePrescribing and Electronic Prior Authorization Updates: Embracing the NCPDP SCRIPT Standard

The HTI-2 rule proposes aligning with the Centers for Medicare and Medicaid Services (CMS) final rule (CMS 4205-F, issued June 2024) by adopting mandatory and optional certification criteria for NCPDP SCRIPT version 2023011. This update continues to show the importance of evolving and modernizing systems that facilitate electronic prescribing and medication prior authorization. For system certification purposes, the current version, NCPDP SCRIPT 2017071, will remain valid until December 31, 2027, allowing health IT developers time to update their systems. By January 1, 2028, it will be mandatory for certified Health IT Modules to implement the updated version.

This update is crucial because:

• Enhanced Interoperability: The new version facilitates better communication and data exchange between different health IT systems, ensuring that prescriptions are transmitted, changed, or canceled expeditiously, accurately, and efficiently.
• Improved Patient Safety: By incorporating updated transaction sets and removing outdated ones, the standard helps reduce errors and ensures that critical prescription information is accurately conveyed to pharmacies.
• Streamlined Processes: The transition to and certification of the latest standard supports the seamless integration between systems, facilitating access for patients to needed therapies, including real-time electronic prior authorization transactions. Certification of these interoperable systems and processes will reduce the administrative burden for healthcare providers and health plans.

These changes will significantly impact healthcare providers, pharmacies, and health IT vendors. Providers and pharmacies will need to ensure their systems are updated and certified to meet the new standards. Health IT vendors, on the other hand, will need to develop and deploy compliant solutions within the stipulated timeframe.

Real-Time Prescription Benefit (RTPB): A New Certification Criterion

In alignment with CMS rulemaking, the HTI-2 proposed rule introduces a new certification criterion for real-time prescription benefit tools based on the NCPDP Real-Time Prescription Benefit standard version 13. This inclusion in the Base EHR definition aims to:

• Empower Providers and Patients: RTPB tools offer providers and patients instant access to crucial medication information such as suitable alternative medications, prior authorization requirements, and accurate out-of-pocket expenses at the patient's preferred pharmacy. This transparency helps in making informed decisions that can lead to cost savings.
• Enhance Medication Adherence: By providing detailed information about the patient’s out-of-pocket costs and whether prior authorization is required, RTPB tools can help patients avoid unexpected expenses and delays, thus improving primary adherence to prescribed therapies.
• Reduce Administrative Burden: The real-time data provided by RTPB tools streamlines the prescription process. It alleviates patient concerns about medication affordability, reduces the administrative load on providers by minimizing post-prescription follow-ups, and helps avoid situations where patients face unexpected rejections at the pharmacy counter due to unaddressed prior authorization requirements. By addressing these issues proactively, RTPB tools enhance the efficiency of healthcare delivery, improve patient satisfaction, and contribute to better primary medication adherence.

The integration of RTPB tools will impact multiple stakeholders. Healthcare providers will need to certify to the standard and adopt these tools, enabling them to offer more cost-effective and accessible options to their patients. Pharmacies will benefit from streamlined workflows and reduced prescription abandonment rates, potentially improving operational efficiency

Payers and insurers will play a crucial role in providing real-time benefit information, necessitating adjustments to their systems and processes. Patients stand to gain improved access to affordable medications and enhanced overall satisfaction with their healthcare experience.

The Evolution and Progress of ePrescribing and Real-Time Benefit Tools

A recent ONC blog post on the evolution of ePrescribing reminded me how far we’ve come. Over the past 20 years, the ePrescribing landscape has evolved significantly due to collaborative efforts and critical policy developments. Initially, only a few prescribers used stand-alone e-prescribing systems, relying on manual, paper-based methods for prescribing medications. Key milestones such as the Medicare Modernization Act of 2003, the Medicare Improvements for Patients and Providers Act of 2008, and the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009 have driven widespread adoption of e-prescribing.

Today, e-prescribing capabilities are integrated into most electronic health records (EHRs), with virtually all pharmacies accepting eprescriptions and 92% of prescribers eprescribing. This transformation has enhanced convenience, cost-effectiveness, and patient safety by reducing errors and automating drug interaction checks.

The introduction of electronic prescribing of controlled substances (EPCS) has further advanced patient safety and helped address the opioid epidemic by integrating with prescription drug monitoring programs (PDMPs). Federal mandates such as the SUPPORT for Patients and Communities Act of 2018 have reinforced the use of EPCS, resulting in widespread adoption and integration into clinical workflows. Looking ahead, the HTI-2 proposed rule represents a crucial step in continuing this progress.

The HTI-2 proposed rule's certification requirements for ePrescribing, electronic prior authorization, and the introduction of real-time prescription benefit tools are pivotal steps towards modernizing health IT infrastructure. By adopting and requiring certification to the latest NCPDP SCRIPT standard and implementing RTPB tools, the rule aims to improve interoperability, enhance patient safety, and empower patients and providers with transparent and real-time information.

POCP's Regulatory Resource Center team digs into the nitty gritty of policy and its impact on stakeholders. If your organization needs help understanding how aspects of this proposed rule may impact your strategic plans and interoperability roadmap, reach out to Kim Boyd at kim.boyd@pocp.com. Let us help you navigate the complexities of health IT regulations and ensure your organization is well-prepared for the future.

For more details, refer to the ONC HTI-2 Proposed Rule and the HHS Press Release.