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On May 11, the U.S. Department of Health and Human Services (HHS) ended its COVID-19 Public Health Emergency (PHE) declaration that had been in effect since January 2020. Along with it, a long list of pandemic-era policy changes and regulatory waivers that had been in place for more than three years expired.

However, not all pandemic-era policies ended on May 11. As a result of recent actions by either Congress or HHS, several key policies that were originally tied to the emergency declaration have continued. For many industry stakeholders, the most important of such policies is the ability of healthcare providers to prescribe controlled substances via telehealth.

End of the PHE & DEA proposed rules

Prior to the PHE, telehealth prescribing of controlled substances was only permitted following an in-person patient visit (per the Ryan Haight Online Pharmacy Consumer Protection Act of 2008). During the PHE, that in-person requirement was lifted, allowing for telehealth prescribing of medically necessary controlled substances without an in-person visit (assuming all other federal and state legal requirements for issuing a prescription were met).

As a result, many healthcare providers and patients (especially in the behavioral health and substance use recovery specialties) grew accustomed to this practice. In parallel, HHS and the U.S. Drug Enforcement Administration (DEA) came to recognize the benefits of it, so much so that on February 24, the DEA released two proposed rules that would have allowed providers in certain situations to continue to prescribe certain controlled substances via telehealth after May 11.

With these rules, the DEA proposed to establish new limited options for telehealth prescribing of controlled substances without an in-person visit that would have taken effect after the PHE ended on May 11. For telehealth visits where a patient had not previously been seen in person and was not a referral from a practitioner who conducted a prior in-person medical evaluation, the DEA proposed to create a narrow exception to allow the medical practitioner to prescribe:

  • a 30-day supply of Schedule III, IV, or V non-narcotic controlled medications, or
  • a 30-day supply of buprenorphine (Subutex, Suboxone) for the treatment of opioid use disorder.

In these limited circumstances, an in-person visit would have been required for an additional prescription (refill) beyond the initial 30-day supply. The DEA released this helpful summary chart that presents a visual look at how these rules would apply to different medications. 

The rules also tried to ease the transition to the post-PHE period by maintaining the prior PHE rules for existing patients for an additional 180 days beyond the PHE’s May 11 expiration. This would apply to telehealth prescribing of controlled substances for patients with whom a provider formed a telehealth relationship with during the PHE but had not seen in person.

Industry reaction & DEA reversal

The DEA released these proposed rules on February 24 and stated its plan to finalize them after the close of the public comment on March 31, but before the May 11 deadline. This plan changed, however, after the DEA received a record 38,000 public comments in response to its proposals. The comments largely communicated disappointment that the rules didn’t go further to permanently enable and expand the temporary pandemic policies. Many industry stakeholders questioned the need for an in-person visit for refills and were disappointed that the rules completely excluded popular Schedule II controlled substances such as Adderall and Vicodin.

In response, the DEA reversed course. First, on May 3, DEA Administrator Anne Milgram released a statement indicating that the agency would be soon issuing a regulation that would expand the circumstances in which the prescribing of controlled substances via telehealth would be allowed after May 11. Then, onMay 9,the DEA officially released a temporary rule titled, “Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications.” The rule took effect on May 11. According to the DEA, it “extends the full set of telemedicine flexibilities adopted during the COVID-19 public health emergency for six months – through November 11, 2023.”

Impact & next steps

As a result of this temporary rule, the pandemic-era rules regarding prescribing controlled substances via telehealth will remain in place for the next six months. Then, for the next year (November 11, 2023, through November 11, 2024), the full set of PHE telehealth flexibilities regarding prescribing controlled medications will remain in place for all established practitioner-patient relationships.

Separately, the DEA stated plans to issue a revised permanent rule on this topic later this year. Clearly, given its recent reversal, the intention of this revised rule will be to go further than the previous proposal did to permanently enable and expand these pandemic-era policies. Exactly to what extent and for which medications the DEA does so remains to be seen. Regardless, the key takeaway from all of this is that even though the pandemic is now officially over, telehealth and the ability to prescribe controlled substances during a telehealth encounter are here to stay.

Please note: these rules do not have any impact on telehealth prescriptions for non-controlled medications.

Watch the latest video about this topic here.

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Chris Emper

Government Affairs Advisor, NextGen Healthcare

Chris Emper, JD, MBA, is government affairs advisor at NextGen Healthcare and president of Emper Healthcare Advisors—a health IT industry advisory and consulting services firm in Washington, D.C. that specializes in helping healthcare providers and technology companies successfully navigate and comply with complex regulations and value-based reimbursement models. Prior to forming Emper Healthcare Advisors in 2016, Chris was vice president of Government Affairs at NextGen Healthcare (NASDAQ: NXGN) and Chair of the Electronic Health Record Association (EHRA) Public Policy committee.

An expert in The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), The Patient Protection and Affordable Care Act (ACA), and The 21st Century Cures Act, Chris is a frequent speaker at industry conferences and has written or appeared in articles in publications such as Politico, Health Data Management, Accountable Care News, and Medical Economics. From 2016-2019, Chris served as Chair of the HIMSS Government Relations Roundtable, a leading coalition of health IT government affairs professionals.

Prior to joining NextGen Healthcare in 2013, Chris served as a Domestic Policy Advisor for former Massachusetts Governor Mitt Romney’s 2012 Presidential Campaign, where he advised the campaign on policy issues including healthcare, technology, and innovation. He holds a law degree and an MBA from Villanova University and a BA from Boston College.