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The temporary rules for prescribing controlled substances

Floating pills

by Beju Shah, PharmD, MBA

Key takeaways

  • The Ryan Haight Act requires initial in-person evaluations before prescribing controlled substances.
  • The Public Health Emergency created an exception to this requirement.
  • Now there is a temporary extension of flexibilities that will offer a one-year grace period.
  • The proposed rules are yet to be finalized and may end up being more complex and limited than the current flexibilities.

Staying up to date with telehealth regulations

I recently had a conversation with a physician—and user—at an academic medical center. One of their frustrations was about regulations: How do they stay up to date with telemedicine prescribing rules while running a busy practice? There’s no time, or they don’t know where to look. Or both. 

It left me wondering, how many other providers feel the same way? 

There have been many changes to state-to-state prescribing laws since the pandemic began. Some of these laws have slipped under the radar for many providers across the country. With that in mind, here’s a detailed breakdown of everything you need to know about telemedicine prescribing laws on controlled medications.

Along the way, I'll provide context for the current laws by describing: how we got here, what the laws cover now, and what will happen to these laws in the near future.

Why we have regulations for controlled substance prescriptions 

Federal laws always aim to strike a balance between protecting the public interest and upholding individual rights. The Ryan Haight Act Online Pharmacy Consumer Protection Act of 2008 illustrates this protection. 

You might be familiar with the story of Ryan Haight, an 18-year-old honor student whose life was tragically cut short due to the inappropriate prescribing of narcotics. This event was a call to action that led to the creation of the Ryan Haight Act. The law regulates the prescription of controlled substances online to prevent similar occurrences. Additionally, the act further restricted the scope of the Controlled Substances Act (CSA), requiring patients to undergo at least one in-person medical evaluation before receiving a prescription for controlled medications.

The Ryan Haight Act successfully cracked down on "rogue internet pharmacy sites" that illegally sold controlled substances online. Many of these illegal sales were facilitated by providers, who signed blanket prescriptions without seeing their patients. But there was also a downside to the Act: an unintended consequence was that legitimate providers had more difficulty prescribing controlled substances using telemedicine. 

There are exceptions to the Act though.

The exceptions to these rules in telemedicine

There are now exceptions to the required in-person evaluation if you plan to conduct a telemedicine visit. These include treatment:

  1. In a hospital or clinic
  2. In the presence of a DEA-registered practitioner
  3. By Indian Health Service or Tribal practitioners
  4. During a public health emergency declared by the Secretary of Health and Human Services (such as the COVID-19 pandemic)
  5. By a practitioner with a "special registration"
  6. By Department of Veterans Affairs practitioners during a medical emergency
  7. With other circumstances specified by regulation

Most of these exceptions are specific and have limited use in practice. But one exception is clear cut to many providers: treating patients during a public health emergency (PHE). During the pandemic, we temporarily waived the requirement in the Controlled Substances Act for in-person evaluations to ensure continued access to care.

While this flexibility cleared many of the hurdles around prescribing medications to patients, it also unleashed rampant misuse and abuse in the industry. You might recall telemedicine startups that gained the media spotlight, raising concerns about them writing prescriptions without adhering to the usual standard of care. Though different from the problems mentioned earlier (i.e., rogue internet pharmacy), the widespread abuse cases have raised questions about achieving the right balance between the benefits and risks to society.

There’s also a broader question we must ask ourselves. Should the in-person exam requirement be a proxy for establishing the standard of care and patient-provider relationship?

What happens to these laws now that the Public Health Emergency has ended?

As the federal COVID-19 Public Health Emergency (PHE) declaration ended on May 11, 2023, many wondered if telehealth flexibilities introduced during the pandemic would disappear. The question on everyone's minds was: Do we go back to the old rules, or implement new ones based on lessons learned? 

Federal agencies are actively proposing changes to the prescribing laws to address this question. Although the rules are still being finalized, the Drug Enforcement Administration (DEA) and Substance Abuse and Mental Health Services Administration (SAMHSA) have implemented their interim plan. The agencies issued a temporary rule for extensions on all telemedicine flexibilities related to the prescription of controlled medications that went into effect during the pandemic. 

As a result, the extension will remain in place until November 11, 2023. Additionally, for patient-provider telemedicine relationships established on or before this date, all telemedicine flexibilities will continue until November 11, 2024.

Updates as of October 2023

This was recently superseded by a second extension, which allows providers to use telehealth visits to prescribe Schedule II to V medications through December 31, 2024. Without this update, the telemedicine flexibilities for treating patients without an established provider-patient relationship would have expired on November 11, 2023. The DEA expects to establish a final set of permanent rules by the fall of 2024. 

How these proposed changes to telemedicine prescribing will affect you

The temporary flexibility grants a one-year grace period from in-person visit requirements. According to the DEA, the interim rule aims to ensure uninterrupted patient care and prevent any backlogs in the healthcare system. 

In turn, the existing rules of the Ryan Haight Act will continue to apply if you (or another referring provider) have conducted at least one in-person examination or meet the criteria in the exceptions outlined earlier. After the first in-person visit to prescribe controlled substances, the legislation doesn’t mandate any more in-person visits.

One important thing to remember though, you need to comply with both state and federal laws. That means you may still be required to adhere to the most restrictive rules. For instance, while federal law may not require additional in-person visits, some states might have their own rules. 

Additional resources

Hopefully this article clears up some questions you may have on prescribing laws. For quick reference, visit the Center of Connected Health Policy (CCHP) for detailed updates that apply to your state and practice. 

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