“We’re Putting Lives at Risk”: What the Proposed DEA Rules Mean for Behavioral Health

Disreputable, online pharmacies have been a thorn in the side of telehealth for a long time. Because both are internet-based transactions, they are often conflated, and some telehealth companies own their own pharmacy, so it is admittedly complicated.

The main fear regarding online prescribing is that unscrupulous prescribers and pharmacies may be able to distribute controlled substances illegally, at scale. To avoid this, in 2008, Congress passed the Ryan Haight Act, which requires a patient to have an in-person doctor exam in order to get a prescription for certain controlled substances.

During the Covid-19 public health emergency (PHE), the Drug Enforcement Agency (DEA) used enforcement discretion to allow practitioners to prescribe certain controlled substances based on telehealth visits alone.

The PHE is scheduled to end May 11, 2023. The DEA took this as a cue to reestablish the need for in-person visits originally enacted to create a relationship between a patient and their provider before any prescriptions could be given via telehealth as part of the Ryan Haight restrictions.

Why it’s important

Patients who have established a relationship with their treating clinician via telehealth are the individuals at risk. Towards the beginning of 2024, these patients will lose access to care unless they see a provider in person who is willing to refer to their treating telehealth provider.

As we know, many patients don’t have primary care physicians or any clinician they see in person for that matter. So, we would expect to see a large drop-off in patient access to care. While a well-meaning effort, the DEA’s proposed rules pose significant restrictions that have all of my behavioral health practitioner friends quite concerned that if we cannot ensure that patients maintain continuity of care, we are putting their lives at risk.

Many, including the American Telemedicine Association (ATA), where I serve as Immediate Past Chair of the Board, believe that mandatory in-person visits are clinically unnecessary barriers to appropriate care and could cause individuals needing access to clinically appropriate prescriptions of controlled substances to fall through the cracks of our healthcare system. Ultimately, this could lead to a potential public health crisis.

It’s important to note that in behavioral health care, including individuals with a wide variety of medical circumstances, including for mental health and substance use disorders, there is no clinical reason for an in-person visit. The evaluation of the patient is an interview — no physical exam required. Thus, it is an ideal use case for telehealth.

There is mounting evidence that telehealth is at least as effective as in-person care for mental health and substance use disorder treatment. In fact, a study published online in JAMA Psychiatry found that telehealth services helped to lower the odds of overdose and increased the use of medications for opioid use disorder among Medicare beneficiaries during the COVID-19 pandemic.

Ignoring key factors

However, another concerning aspect of the proposed rules allows for an initial 30-day prescription via telehealth, but then patients will be required to have an in-person visit with a provider. This would include prescriptions for medications to treat substance use disorder, such as buprenorphine, as well as common psychiatric drugs like Xanax, Ambien and Prozac. This new requirement ignores several important factors, including the fact that, during the pandemic, countless patients developed prescribing relationships with providers who are part of 50-state telehealth networks, seemingly the purpose of the in-person requirement. In addition, the wait time to see most behavioral health professionals is typically several months, making it almost impossible for patients to find an in-person prescriber within the 30-day requirement period.

Bottom line, these proposed rules put our patients at risk of not getting critical, clinically appropriate medications, which in turn puts their lives at risk. They also create a difficult dilemma for healthcare providers, who can start patients on needed treatment, but then must abruptly cut off their medication if they do not see a provider in-person within the next 30 days.

No doubt, our colleagues at the DEA are well-intentioned and have a real problem to solve. However, it is critical that the rules imposed by the DEA balance protections for patients with patient access to care without being overly restrictive. As the ATA, ATA Action, provider groups, and patient advocates have long stated, mandatory in-person visits are clinically unnecessary barriers to appropriate care.

How to help

The ATA and ATA Action, the ATA’s affiliated industry organization, are preparing comprehensive recommendations for the DEA. Likewise, we’re encouraging all interested parties to submit their feedback on the proposed rules to help ensure that practitioners can continue to prescribe certain controlled substances safely and appropriately via telemedicine without an in-person visit. You can submit your comments to the DEA by 11:59 pm EDT on March 31 (Docket No. DEA-407).

To learn more about the DEA’s proposed rulings, as well as additional information on submitting your comments, visit ataaction.org/remoterx. There is still time to make your voice heard.

This piece was written by Joseph Kvedar, MD, Senior Advisor for Mass General Brigham Center for Innovation in Digital HealthCare, and Professor of Dermatology at Harvard Medical School. It was originally published on his blog page, Reinventing Healthcare.