Impetus and Edict: What the Latest CMS Data Standards Mean for EHRs – Regulatory Talk Series

December 12, 2023

Impetus and Edict: What the Latest CMS Data Standards Mean for EHRs – Regulatory Talk Series

The following is a guest article by Nick Barger, PharmD, Vice President, Product at DrFirst.  This article is the second in the Healthcare Regulatory Talk series.

More regulatory churn is coming to shake up e-prescribing, this time with new data standards to step up clinical decision support at the point of care. The latest policy update from The Centers for Medicare and Medicaid Services (CMS) adds key provisions to the December 2022 proposed rule requiring adoption of a new NCPDP SCRIPT standard version. In the lead-up to a final rule, CMS is giving the industry impetus and edict to accelerate a new era in medication management.

Before I dive into the specifics of these new requirements from CMS, let’s consider what this means for EHR vendors: more work and increased investment on top of what’s waiting when the next regulatory shoe drops. The Office of the National Coordinator’s (ONC) final HTI-1 rule will bring major compliance hoops for EHR developers to jump through as they carry the next stage of interoperability forward. For more information on how to prepare for the ONC HTI-1 rule, read the first article in our Regulatory Talk series.

For anyone counting, those are two major regulatory rules from CMS and ONC. Both will require EHRs to redevelop different aspects of their roadmap simultaneously. Each standard opens new possibilities but brings its own set of quirks and challenges. With more regulation still to come and as adoption deadlines begin stacking up, the path to compliance can stretch into what will feel for some EHRs like a never-ending journey to the outer reaches of the healthcare ecosystem.

As something of a space nerd, I find the parallels between interoperability and space exploration striking. With missions that moved too slowly for too long, they both may feel impossibly far away despite being closer today than ever.

The trick may be to recalibrate how the industry talks about regulation. In an environment that tells those building the EHRs of the future that every looming deadline should be their top priority, let’s be realistic. If the regulatory environment was ever truly cyclical in nature, those days are long gone. The development platforms best able to withstand today’s compliance standards are those with enough strategic flexibility to pivot their technology innovation model for sustained performance in an ever-changing regulatory environment.

The proposed deadline for adopting the new CMS SCRIPT standards is January 1, 2027. That will come sooner than you may think, given the work it will take to be ready. To learn more about these standards, check out my blog on the initial e-prescribing updates announced by CMS in December 2022.

Let’s take a closer look at what’s coming as part of the latest CMS data standards for e-prescribing:

1. NCPDP SCRIPT Standard Version 2023011:

Creates a novel medication management framework to promote innovation between doctors and pharmacists. The new feature is a custom field extension that will improve data exchange for enhanced care coordination.

While many EHRs may welcome this new path to cutting through some of the administrative burden of prior authorizations, integrating the new standard may prove challenging for smaller EHRs and those that can’t easily adopt the technical updates the standard will require.

2. NCPDP Formulary and Benefits Standard Version 60:

Streamlines how doctors get information about drug coverage and alternative options based on a payer’s insurance plan. The standard has been updated several times since the industry’s last upgrade nearly a decade ago.

3. NCPDP Real-Time Prescription Benefit Standard Version 13:

Provides in-workflow clinical-decision support so doctors can access prescription benefit information, including drug coverage, out-of-pocket costs, and alternatives during the care visit in real-time.

EHRs already looking for ways to improve patient adherence to medication are more likely to approach development of the new standard as an investment in improved outcomes. That won’t be as easy for EHRs in the specialty space, where the standard’s one-size-fits-all approach to formulary updates may pose a burden for unique workflows.

For now, EHR developers may be focused on what it will take to adopt the new standards not as a series of separate design tasks, but as complete development of the standard as a seamless, integrated experience for clinicians. And then what? Getting ready to meet compliance standards is a survival tactic; important for today, but not a strategy for success in the long run.

While regulation has a reputation for stifling innovation, it can sometimes enable it. Having worked with over 300 EHRs over the years and seen platform challenges of every kind, the key is to plan for compliance that creates capacity for innovation downstream, right from the start. A compliance strategy, for example, enables clinicians to share information and provide ongoing feedback as the standard requires. An innovation strategy, on the other hand, creates a pipeline for progress that can leverage opportunities as they come.

Whether EHR vendors are focused solely on compliance or opportunities for future innovation, flexibility in design and development can help keep the regulatory cycle from feeling like a daily pressure test.


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 300 EHRs and health information systems they partner with, providing clinical, regulatory, and digital workflow solutions that make healthcare more efficient and effective across the continuum of care. Check out all the articles in the Healthcare Regulatory Talk series.