The Federal Public Health Emergency will end soon, and many states have already set their termination dates for State Public Health Emergencies. Prescribing controlled substances via telemedicine is allowed now during the Public Health Emergency. But what will happen once the Public Health Emergency ends in 2023? This issue spurred the American Hospital Association to write a letter to the DEA on behalf of its more than 5,000 member hospitals and health systems. They asked the DEA to act and implement a rule that was supposed to have been put into place almost fourteen years ago. So, some discussion about controlled substances and telemedicine is needed, and how this will work at the end of this year, if not sooner.
To further understand, a little history is in order here. In 2008, the Ryan Haight Online Pharmacy Consumer Protection Act sought to prevent the prescription of opioids over the internet via online questionnaire. Now they did carve out some safe harbors for legitimate professionals who are trying to practice in a way that will benefit patient care. At that time in 2008, the law required the DEA, to come up with a Special Telemedicine Registration process, along with rules and an application by April 2009. However, the DEA did not act. Fast forward to 2018, where after about a decade of waiting from the industry, Congress and the President signed a law that said the DEA shall issue the application instructions and come up with a final rule for the process to obtain what was the safe harbor called Special Telemedicine Registration under the Ryan Haight Act of 2008. Unfortunately, 2019 arrived, one year later, with the DEA still quiet on the subject. As all of you well know, at the beginning of 2020, we had a Public Health Emergency issued, and it, among other things, waived the in-person requirement before you can prescribe controlled substances, assuming you're acting in the ordinary course of your business, safely doing the right thing. (You're a good actor and not a bad egg, so to speak.)
Nearly a year ago, there was a letter in March of 2022, referenced in my book, The Practice of Telemedicine, among 100 or more stakeholders in the healthcare industry urging the DEA to come out with a solution for this for telemedicine only because they knew that the Public Health Emergency would not last forever.
Similarly, there was another letter, which I signed on behalf of Functional Lawyer and on behalf of all of you, by many industry stakeholders in fall of 2022, urging the DEA to come out with this Special Telemedicine Registration, which was then 13 years past due.
Today, we’re going on 14 years past due, and this most recent letter in December 2022 from the American Hospital Association vehemently asks the DEA to do what it said it would do or what it's required to do under both the Ryan Haight Act of 2008 and the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act of 2018. There’s still been nothing from the DEA, no response thus far.
So, here's what we know and here's what we'll look forward to as we move into 2023.
Right now, under the PHE, they have waived the in-person requirement prior to prescribing controlled substances, including testosterone. And what that means is when the PHE expires or ends, the default rule will go back into place. The default rule is prior to prescribing code-controlled substances. The prescriber must see the patient in-person for an evaluation before the prescriber can issue that prescription. I emphasize on prescriber because there have been some questions in the past about whether their PCP can do an in-person evaluation, and then a telemedicine provider issue the prescription. It's very clear under the rule that that is not allowed. The prescriber is the one that needs to be the one that conducts the in-person examination. So, unless the DEA acts, that role will fall back into place by the end of the year or whenever the PHE ends, whichever comes first.
Hopefully the DEA will, with the urging of the American Hospital Association and many, many other industry stakeholders, take some action because as they laid out in this most recent letter, there may be a gap in coverage here where patients, who whether it's mental health or whether it's hormonal health or anything in between, are relying on telemedicine to stay on their course of treatment, which includes controlled substances in this case. So, if nothing happens and the DEA declines to act, then there may be a gap there and the patient will have to scramble, or there may be some abandonment issues.
We're trying to make sure that providers don't get caught in this gap and that patient care ultimately comes first. Again, there is a safe harbor that's been carved out 13-14 years ago, but the rules for that have never been put into place. So, if nothing is done, the rule “you can't prescribe unless you see somebody in-person” will go back into effect once the public health emergency ends.
At Functional Lawyer, we want to make sure you are covered and protected, always.
Keep following along at Functional Lawyer. We will continue to monitor the situation and let you know when we hear anything from the DEA, if ever, or what are the best practices to do once the PHE expires if the DEA does nothing. We strive to keep you up to date, continually, in all areas.
As always, reach out to us with any questions via our website.