A Perfect Storm: What the CMS Proposed E-Prescribing Rule Means for EHR Vendors

Like the proverbial calm before the storm, the recent lull in the creation of new federal regulations for health IT has been both welcome and too brief. Now, a downpour is coming in the form of a Centers for Medicare & Medicaid Services (CMS) proposed rule that has new requirements for prior authorization and e-prescribing, plus an Office of the National Coordinator (ONC) HTI-1 final rule, which sets new standards for interoperability and patient access.

In a recent webinar, DrFirst experts Nick Barger, PharmD, and Caleb Dunn, PharmD, discussed the rules and their substantial implications for healthcare IT and EHR vendors. For those who missed the webinar, here are the key takeaways.

New E-Prescribing Standards

Why is the regulatory squall hitting now? During the COVID-19 emergency, most rulemaking that wasn’t pandemic-related was put on hold. Now, the pending rule is part of the Biden administration’s push to make up lost time.

The new rule, which is expected to land in the first half of the year, is a follow-on to previously proposed rules, but with a wider scope than the most recent version. It includes a broad uplift that will take us from CMS’ 2017 version of e-prescribing standards to a 2023 version.

“You might have missed that they reintroduced a new e-prescribing standard uplift because it’s literally buried deep inside a very large rule that encompasses many other things,” Barger said.

The proposed rule will affect how physicians will write, format, and transmit prescriptions; how pharmacies and payers gain access to medication history; and how providers and payers will complete prior authorizations (PAs). And, for the first time, the National Council for Prescription Drug Programs (NCPDP) standard for real-time prescription benefit tools will be required for Medicare Part D plan sponsors.

In technical terms, the rule will implement:

• NCPDP SCRIPT Standard Version 2023011 for prescribing, electronic PA, and medication history
• Real-Time Prescription Benefit Standard Version 13
• Formulary and Benefit Standard Version 60

In all, it will require a lot of work on behalf of EHR developers and IT vendors to meet the new requirements. The proposed rule includes these four major changes to e-prescribing:

• Modernized patient identifiers: This update will affect intake, documentation, scheduling, interoperability, and admission-discharge-transfer (ADT) workflows.
• New message types for electronic PA: This is in response to complaints from providers about payers’ PA requirements and refusals. Electronic PA will be faster and reduce the amount of duplicate work for providers.
• Revamped medication segments: E-prescribing has been adopting structured and codified sigs for years, but the new rule includes updated requirements, which will require additional coding.
• Additional requirements: Other refinements include workflow requirements for canceling prescriptions, receiving dispense notifications from pharmacies, and renewals.
  
  
  

Preparing for CMS and ONC Rules

In another change, the NCPDP standards for formulary and benefits (F&B) files will get their first update in more than 10 years. The F&B file outlines general plan-level prescription benefits of a patient relative to other medications in the prescription benefit. The NCPDP will release a transition guide for the new standard.

In the past, CMS and the ONC have worked independently when setting IT standards. But in this instance, they’re trying to align on objectives. In December, ONC finalized its HTI-1 rule, which sets new standards for interoperability and patient access. While the alignment is welcome, implementation of both rules is likely to occur at roughly the same time, meaning EHR developers will have to incorporate ONC and CMS changes simultaneously.

“This is like knowing the sky is cloudy, but not knowing if it’s raining outside at that moment,” says Dunn. “Up-to-date weather information lets us understand when it’s raining versus when it’s sleeting or snowing. This alignment is like upgrading our radar system and giving our clinicians a modern, high-resolution, color-coded map.”

The proposed rule sets a deadline of January 1, 2027, for development, certification, and provider adoption. With a rollout period that’s longer than normal, some vendors might be tempted to delay taking steps to comply—but that would be a mistake. The best thing EHR developers can do now is to take a methodical approach to compliance that includes:

• Undertaking a comprehensive rule review to identify your impacted workflows.
• Consolidating workflows to build flexibility into the roadmap to compliance. Flexibility is needed because further changes are likely to come this year.
• Incorporating continuous clinician feedback to make sure the changes work in a real-world setting.
• Weighing the benefits of bringing on a technology partner to accelerate compliance and workflow improvements.

One more thing to know is that telehealth waivers put into place during the pandemic have been extended through 2024. That includes the requirement for an in-person medical evaluation before prescribing a controlled substance. The uncertainty around what happens after the waivers expire adds to the cloudiness of the brewing storm.

Want to learn more about getting ready for the regulatory downpour? Watch the on-demand webinar here.