Several behavioral health executives shared their thoughts on the Drug Enforcement Administration’s (DEA) proposed rules for controlled substances and telehealth on Tuesday, with most going to bat for virtual-prescribing practices in front of agency officials.
Tuesday brought the first of two listening sessions to discuss what potential post-COVID regulations for telehealth prescribing could and should look like.
The DEA posted notice of the two-day listening session at the beginning of August and solicited comments about how the agency should resume regulating telehealth and the prescribing of certain controlled substances.
The discussion launched a novel approach for the DEA. It has, for the first time, reversed its stonewalling of a special registration process for telehealth prescribing of controlled substances. Further, the DEA doesn’t typically engage in public forums in its policymaking process.
“This listening session is novel for the DEA in that we have not generally held public meetings to inform our regulatory drafting efforts,” Matthew Strait, deputy assistant administrator for the DEA, said at the outset of the session. “I hope that this effort underscores our desire to improve upon our information gathering capabilities to better inform this important work. At no time has this novel approach been more logical and more appropriate.”
Broadly, he said, this is because these regulations will impact the delivery of health care for “every American in the United States.”
“And frankly, we do need to make sure we get it right,” Strait continued.
In total, the DEA lined up 61 commentators to present. Commenters presented to DEA Administrator Anne Milgram and Deputy Assistant Administrator Tom Prevoznik, who also asked follow-up questions.
The DEA will also hold another written comment period in the fall of 2023 regarding telehealth and controlled substance prescribing.
In February, the DEA released a proposed final rule that would, in part, mandate in-person exams prior to controlled substances being prescribed by telehealth providers. The DEA delayed that rule following a tide of negative reactions from the public, especially from behavioral health providers.
Here’s a collection of comments from the first day of the listening session:
We received over 30,000 public comments in response to those proposed regulations, and we read every single one. We believe that is among the highest number of comments we have gotten in the DEA’s history.
A significant majority of those comments expressed concerns that the proposed regulations place limitations on the supply of controlled substances that could be prescribed prior to an in-person evaluation. After evaluating these comments, the DEA wanted to reopen this conversation about telemedicine prescribing and allow for a public listening session.
We are now holding these listening sessions to gather information from stakeholders in this space, including patients, practitioners, pharmacies and others.
— DEA Administrator Anne Milgram
In 2016, I was the subject of a brutal home invasion. A friend suggested I go and speak to someone. Their wife is a psychiatrist. In the largest city in our country, with the highest number of psychiatrists, I couldn’t find anybody. You email 20 doctors, and whoever responds is the doctor you go and see. There’s a very high likelihood that that’s not the right doctor for you, and an even higher likelihood that you’re not the right patient for that doctor. For me, it was a basement office with eight doorbells on the side of the wall with tape underneath each one. I assume it was linked to a bell in the doctor’s office to let them know I’m here.
In-person visits do not equal quality care. The flexibilities that Administrator Milgram has afforded America for the last three years have fundamentally changed access for millions of Americans. You should be incredibly honored and proud of the work that your team has done. Make no doubt, we’re on the precipice of history. I think that we have the opportunity to resolve a special registration process under this administration, that’s been evading multiple administrations for decades.
— Robert Krayn, CEO and co-founder of Talkiatry
The special registration should not be limited to a particular diagnosis or condition in the long term. We believe that the DEA should enhance collaboration with health care agencies to integrate data sources and develop better algorithms and access to identify bad actors.
DEA should convene clinical subject matter experts at the subspecialty level to develop appropriate enforcement frameworks by subspecialty, patient population and other clinical considerations.
Any DEA audit should also incorporate appropriate clinical expertise to assess appropriate prescribing practices. DEA should also work with federal health agencies and state prescription drug monitoring programs (PDMPs) to create a national database for PDMPs in electronic prescribing of controlled substances (EPCs data) for population-level monitoring and enforcement.
— Dr. Shabana Khan, representing the American Psychiatric Association and the American Academy of Child and Adolescent Psychiatry
We believe that a requirement that a patient see a clinician in person is not an effective control against diversion and instead simply limits access to legitimate health care. … Mandating an in-person evaluation prior to prescribing a controlled substance via telemedicine only results in reduced access to care and does not enhance the DEA’s ability to do its job of limiting drug diversion or pursuing illegal actors.
Every state allows a clinician and a patient to establish a valid patient-provider relationship via telehealth, and that relationship is just as legitimate as one established in person. While in-person requirements may be intended to reduce diversion and illegal activity, they will likely, in fact, do the opposite. As access to legitimate health care is restricted, illegal online drug sellers will fill the void.
— Kyle Zebley; senior vice president of public policy for the American Telemedicine Association, executive director of ATA Action
This care represents over half of outpatient care during the early months of the pandemic and 13% of outpatient care over the last 12 months at our institution. And this care spans a wide variety of specialties, including psychiatry, genetics, neurology, surgery and oncology. This rate has been steady over the past one-and-a-half years, with about 30,000 visits per month.
And we consider this to be our new normal. We found it particularly impactful in increasing access to mental health care.
At Johns Hopkins Medicine, 65% of our outpatient psychiatry visits were conducted via telemedicine in 2022, and 40% of the provider-patient relationships in psychiatry were maintained exclusively via telemedicine over the past three years – with no in person visits.
Leveraging telemedicine, in our view, is the only realistic pathway to achieve the goals of President Biden’s mental health strategy seeking to connect more Americans to mental health care. We feel strongly that the Drug Enforcement Agency should not interfere with reasonable clinical decision-making. Telemedicine controlled substance prescribing happens in a variety of settings across Johns Hopkins Medicine often without a previous in person encounter
— Dr. Helen Hughes, medical director for the Office of Telemedicine, at Johns Hopkins Medicine