Senators push DEA to permanently extend telehealth prescribing ability

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Six U.S. Senators have penned a letter to the Drug Enforcement Agency imploring it to make permanent the flexibilities allowing physicians to prescribe controlled substances through telehealth without a face-to-face evaluation.

The senators – Edward Markey, Ron Wyden, Elizabeth Warren, Jeffrey Merkley, Martin Heinrich and Sheldon Whitehouse – focused specifically on buprenorphine, a medication used to treat opioid use disorder (OUD). 

The Public Health Emergency, declared in March 2020 in response to the COVID-19 pandemic, prompted the DEA to allow people to access the medication through telehealth, and while the agency has proposed regulations to make some of those flexibilities permanent, the lawmakers contend that these regulations are "overly restrictive" for people trying to access the drug.

Buprenorphine is one of three medications approved to treat OUD, and because it's one of only two medications for OUD that's not restricted to an opioid treatment program, it's one of the more accessible medications in outpatient settings and pharmacies, the senators said.

"Along with methadone, buprenorphine is considered a treatment of choice for people who are pregnant and breastfeeding, and is associated with decreased risks for HIV, Hepatitis C infections, unemployment, and imprisonment," they wrote.

But they expressed concern that the DEA's plan to roll back some of these flexibilities could make the medication more difficult to obtain – what they described as an "avoidable retrenchment."

WHAT'S THE IMPACT?

With the COVID-19 Public Health Emergency set to expire on May 11, the U.S. Drug Enforcement Agency said it would temporarily extend telemedicine flexibilities around prescription of certain controlled medications as it sifts through comments on its proposed plans for post-PHE remote prescribing guardrails.

Before March 2020, individuals were required to have at least one in-person medical examination before being prescribed buprenorphine through telehealth. The flexibility brought by the PHE resulted in more people enrolling in treatment, remaining in treatment longer and reducing their risks for overdose, the lawmakers said.

New proposed rules will now require any new OUD patient who starts buprenorphine treatment through telehealth to find and see a provider in person to renew their prescription beyond an initial 30-day supply.

"Receiving a limited 30-day prescription of buprenorphine with no guarantee of continued treatment poses significant risks for individuals experiencing OUD and may result in a return to illicit drug use, overdose, or even death," the senators wrote.

The in-person appointment requirement is especially problematic, they said, because some people may face barriers in attempting to secure an appointment with a provider, including a lack of availability, transportation challenges and the stigma associated with OUD. These problems are especially acute in rural areas and medically underserved communities, the senators wrote.

"With fentanyl-related overdoses now the leading cause of death for people under age 50 and the majority of people who need OUD treatment not receiving it, any gap between OUD prevalence and the availability of treatment has adverse and, in some cases, catastrophic consequences," they wrote.

According to the Centers for Disease Control and Prevention, telehealth has increased access to care in medically underserved areas and is often seen as a more efficient way to provide care in rural areas where medical services are limited.

Citing research from the Harvard T.H. Chan School of Public Health, the senators said the challenges experienced during the COVID-19 pandemic have exacerbated the opioid epidemic, making the case for the DEA expanding, not limiting, access to buprenorphine. 

"The DEA should continue to allow audio-video real-time interactive examination, rather than an in-person visit," lawmakers wrote. "This would permit medical providers to both see and hear the patients they are evaluating, without reintroducing barriers to care such as limited provider availability, poor transportation accessibility, and long travel times – all exacerbating rural health disparities."

THE LARGER TREND

Prior to the COVID-19 pandemic, the Ryan Haight Act of 2008 amended the Controlled Substances Act to prohibit prescribing of controlled substances via online forms and outlined requirements for in-person evaluations prior to the prescribing of controlled substances. There are certain exceptions to the in-person visit requirement, including when there are public health emergencies.

During the COVID-19 PHE, the DEA enacted flexibilities to certain requirements to ensure patients could continue to receive medications virtually while minimizing exposure and preserving provider capacity. Flexibilities, including waiving the required initial in-person visit prior to prescribing controlled substances via telehealth, and allowing the use of telephone evaluations to initiate buprenorphine prescribing, have proved critical, according to the American Hospital Association.

In February the American Telemedicine Association and its ATA Action group issued a statement outlining their opposition to the DEA's proposed permanent changes to rules around the prescribing of controlled medications via telehealth.

The DEA says it is expanding patient access to critical therapies beyond the scheduled end of the COVID-19 public health emergency – except for the remote prescription of controlled substances.

"The proposed rules from the DEA are significantly more restrictive than is warranted," said Kyle Zebley, the ATA's senior vice president of public policy and executive director of ATA Action, in a statement.
 

Twitter: @JELagasse
Email the writer: Jeff.Lagasse@himssmedia.com