As the Regulatory Cycle Revs Up, Are You Ready?

April 3, 2023

Nick Barger, PharmD

As the Regulatory Cycle Revs Up, Are You Ready?

At last, the emergency phase of the COVID pandemic is beginning to wind down in the United States. As the public health crisis eases, the lull in healthcare policy changes is also coming to an end.   

So what can you expect as the regulatory engine cranks up again? For electronic health record (EHR) and healthcare technology systems vendors, recent proposals reveal important changes that will impact your development roadmap. The best time to get ready? Right now.


Rewriting the SCRIPT Standard 

In December 2022, The Centers for Medicare and Medicaid Services (CMS) proposed a rule that would require the adoption of new e-prescribing standards as part of the Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Program for Contract Year 2024. An upgrade from the NCPDP SCRIPT 2017 standard to a newer version would impact many aspects of medication management, including: 

  • E-prescribing technology for formatting prescriptions, transmitting prescriptions to pharmacies, and receiving medication history from pharmacies and payers 
  • Patient safety improvements, including an upgrade to codification of patient instructions that will allow for safer ways to communicate a prescriber’s intentions to pharmacists and vice versa 
  • Real-time prescription benefits transactions that put out-of-pocket costs in front of providers while they are having conversations with patients about drug therapies 
  • Clinical workflows for providers to support electronic prior authorization on a broad scale and reduce the duplicate work that sometimes occurs between pharmacies and prescribers  

The proposed upgrade to the SCRIPT standard could be adopted soon, with a proposed deadline of January 1, 2025.  


Training and Certification to Prescribe Controlled Substances 

The Consolidated Appropriations Act (known as the Omnibus bill) will change training and certification requirements for providers who treat patients with opioid abuse disorder (OUD). Notably, the bill removed the federal requirement for providers to submit a notice of intent to prescribe medications such as buprenorphine via the Data 2000 Waiver Program, commonly referred to as the X-Waiver. (This does not affect existing state laws.) 

By June 2023, the Drug Enforcement Agency (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) will identify and implement training requirements for prescribers of these medications. DrFirst worked with our DEA auditor to update our attestation to remove the application requirement that forces the X-Waiver to be in place prior to prescribing. If your applications are certified for e-prescribing of controlled substances, you should be working with your auditor to determine if recertification is required. 


Ending the Public Health Emergency  

Congressional legislation and an executive order will soon end the COVID-19 Public Health Emergency that was declared in January 2020. This is big news with wide-reaching implications for the country, but the major change related to medication management involves restoring the requirement for an in-person visit before starting controlled substance therapy. The restoration of the in-person visit requirements is subject to final rules issued by the DEA, which are expected to be released imminently. 

The legislation also restores multistate DEA license registration for prescribers who practice and prescribe controlled substances in multiple states, as well as the requirement for a follow-up prescription for controlled substance prescriptions that are given verbally from a prescriber to a pharmacist over the phone.

Between now and the end of May, regulatory agencies are evaluating their Public Health Emergency responses to determine if any should be carried forward after the expected deadline of May 11, 2023. 


Getting Ready  

These changes—and others that are sure to follow—will affect your business and your customers. Stay tuned for future regulatory updates to be sure your platform is compliant and reach out to us if you need a partner to help you navigate the complex issues surrounding e-prescribing policy and regulation. 

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About Nick Barger, PharmD
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Nick Barger, PharmD, is Vice President, Core E-Prescribing at DrFirst.