Revisiting a Groundbreaking Prescribing Regulation

More than a decade ago, the U.S. Drug Enforcement Administration (DEA) published its Electronic Prescribing for Controlled Substances (EPCS) Interim Final Rule (IFR). Surescripts applauded this regulation, which took effect on June 1, 2010. 

Subsequently, on August 4, 2011, a new era in e-prescribing began when the first legal EPCS was transmitted by a prescriber to a pharmacy via the Surescripts network. Since then, Surescripts has processed just over half a billion e-prescriptions for controlled substances. Clearly, the core EPCS process has worked well within the parameters published by the DEA, and overall, our electronic health record (EHR) vendor and pharmacy customers are comfortable with the EPCS processes that they have implemented.

Implicit in the term Interim Final Rule is the notion that eventually there will be a Final Rule. Originally, the DEA’s intent was to allow the industry to implement EPCS within the guardrails of the IFR and then revisit the rule within a few years to determine if amendments were necessary or desirable. Yet five years passed before the agency began to reevaluate the rule in the summer of 2015, and soon thereafter the effort dissipated. Then, in the fall of 2018, Congress passed the SUPPORT for Patients and Communities Act, which mandates that EPCS be used for the Medicare Part D program beginning January 1, 2021. This mandate also obligated the Attorney General (via the DEA) to update the IFR regarding the biometric authentication processes allowed for EPCS. It also spurred the DEA to act, and on April 21, 2020, the agency reopened its EPCS IFR for 60 days for additional comment.

In reopening the rule, the DEA has shown that it is primarily interested in meeting its charge from the SUPPORT Act, which meant that the agency had a need to collect the healthcare industry’s thoughts about biometric authentication. Such authentication is by and large the responsibility of EHR companies. However, the agency solicited other types of feedback as well.

Surescripts has garnered a wealth of experience regarding EPCS since adopting the technology, not only by implementing the e-prescribing intermediary requirements of the IFR, but also by assisting our EHR and pharmacy customers to adopt and make available EPCS capabilities. Given that our experience shows that EPCS is working quite well, our high-level recommendation to the DEA was that the agency refrain from making major changes to the rule. We believe, however, that there might be room for improvement in these areas of the rule:

• Third-party EPCS application audits
• EHR EPCS module policies
• Telemedicine implications of EPCS
• Strategies for handling failed EPCS transmissions

So, what’s next? Now that the recent IFR comment period is closed, DEA staff will review all comments received, consider their merits, and, in many cases, incorporate what they have learned into what we hope will be a final EPCS rule. This process normally takes several months or more but given that the federal EPCS mandate takes effect in January, we expect that the DEA will publish the resulting EPCS rulemaking sometime in late fall. We’ll be watching for it, and you can count on seeing our assessment of the rule’s noteworthy changes shortly thereafter.

Learn more about how the Surescripts Network Alliance is enhancing prescribing, through the use of EPCS and other technologies. Visit our blog, Intelligence in Action, for smart dialogue on the opioid crisis, price transparency, specialty medications and more.