CMS Issues E-Prescribing Final Rule: Quick Takeaways in a No-Slowing-Down Reg Cycle – Regulatory Talk Series
The following is a guest article by Nick Barger, PharmD, Vice President, Product at DrFirst. This article is the fourth in the Healthcare Regulatory Talk series.
The Centers for Medicare & Medicaid Services (CMS) finalized new standards for electronic prescribing on June 13, concluding a complicated, 18-month regulatory process that came in fits and starts and went by without attracting much industry scrutiny.
Before the Office of the National Coordinator for Health Information Technology’s (ONCs) newly proposed HTI-2 rule, announced on July 10, becomes a primary focus for health IT developers, let’s explore what EHRs need to understand and implement to comply with CMS’ final rule for e-prescribing.
Key requirements include:
1. Formulary and benefit version 60
This update to the formulary and benefit standard is the first in nearly a decade. It allows prescribers to view on/off formulary designations from payers. Given the long gap since the last update, EHR vendors may need to make extensive upgrades, and IT teams will require extra time to adapt to both existing and new standards.
Date required: January 1, 2027
Key takeaway: Budget extra time for implementation.
2. Real-time prescription benefit (RTPB) version 13
This update requires patient-specific price and benefit information to include out-of-pocket costs, pharmacy pricing variations, and alternative drug pricing. While some EHRs already support this level of transparency, this marks the first time CMS has specified a standard for it.
Date required: January 1, 2027
Key takeaway: Even EHRs currently supporting real-time price and benefit information will need updates to comply with the new standard.
3. Electronic prior authorization
This standard requires using the NCPDP SCRIPT version 2023011 and allows electronic submission of information to payers for drug billing approval.
Date required: January 1, 2028
Key takeaway: Stay tuned in the months ahead as the ONC considers requiring electronic prior authorization as part of integrated e-prescribing workflows.
4. Medication history
Also upgraded to NCPDP SCRIPT 2023011, this standard enables clinicians to receive medication fill information from payers and pharmacies.
Date required: January 1, 2028
Key takeaway: This simple update will significantly enhance your roadmap.
5. E-prescribing routing transactions
All new prescriptions, refills, change requests, fill notifications, and cancellations must upgrade to NCPDP SCRIPT version 2023011.
Date required: January 1, 2028
Key takeaway: Start this transition earlier to get ahead of additional regulatory updates on the horizon.
6. Federal alignment and transition period
CMS and ONC will now require the same e-prescribing standards for EHRs and prescribers. This alignment eliminates the confusion from the last standards upgrade in 2020 when CMS and ONC had divergent requirements. Healthcare systems and IT vendors can start using the new standards as soon as they and their network partners are ready.
Date required: Compliance deadline to be determined by the HTI-2 final rule
Key takeaway: Use the flexibility in the transition period to upgrade functionality while minimizing impact on your customers.
You don’t have to wait until the deadline to push these changes into your development pipeline, and in fact, you shouldn’t. While 2027 and 2028 may seem far off, these regulations are part of an evolving healthcare regulatory landscape. Micky Tripathi, head of the ONC, has clearly outlined the industry’s future expectations.
“We are not slowing down,” Tripathi stated in March 2024. “Our work to support patients, assist providers in delivering care, and establish clear expectations for the entire care continuum regarding health IT is ongoing.”
Preparing for the new standards now and understanding how they fit into the broader regulatory roadmap will position you well for future compliance. Developing a proactive implementation plan and staying informed about ongoing regulatory changes will ensure smooth compliance in the months ahead.
Unsure how to reconstruct your roadmap to meet the new e-prescribing standards while trying to juggle multiple compliance deadlines? Register to attend Nick’s webinar on July 18, 2024.
About Nick Barger, PharmD
Nick is Vice President of Product at DrFirst, where he leads design and development of intelligent medication management solutions for the e-prescribing pioneer and the 300 EHRs and health information systems they partner with, providing clinical, regulatory, and digital workflow solutions that make healthcare more efficient and effective. Check out all thearticles in the Healthcare Regulatory Talk series.
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