Proposed new limits on telehealth prescribing in connection with the end of the Covid public health emergency may be on hold for now, experts say.
Telemedicine prescribing of medications during the pandemic was expanded, allowing people to get medications without physically seeing a provider. But that expansion had been scheduled to expire with the end of the Covid public health emergency, expected on May 11. The Drug Enforcement Administration posted new proposed rules, allowing some telemedicine prescribing but with more restrictions than the pandemic rules, to go into effect with the end of the emergency. But people watching the situation closely say they expect the new rules may be put on hold or otherwise delayed because of widespread opposition and fear of dire consequences.
[Update, May 3: D.E.A. Administrator Anne Milgram issued a statement saying: “The Drug Enforcement Administration received a record 38,000 comments on its proposed telemedicine rules. We take those comments seriously and are considering them carefully. We recognize the importance of telemedicine in providing Americans with access to needed medications, and we have decided to extend the current flexibilities while we work to find a way forward to give Americans that access with appropriate safeguards.
“For this reason, last week, D.E.A., in concert with the Department of Health and Human Services, submitted a draft Temporary Rule to the Office of Management and Budget entitled ‘Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications.’ Further details about the rule will become public after its full publication in the Federal Register.”]
At issue is especially the D.E.A.’s proposed new requirement for some in-person component for all prescriptions of controlled medications like the attention hyperactivity disorder drug Adderall, painkillers like Oxycontin, the steroid testosterone, non-narcotic medications such as ketamine, the opioid withdrawal medication buprenorphine, Tylenol with codeine, benzodiazepines, Xanax and other medications. During the pandemic, providers were allowed to prescribe by telemedicine, and that practice was expected to expire with the pandemic public health emergency on May 11.
The new rules set off alarm bells among patients, doctors and advocacy groups predicting that the restrictions would result in people who couldn’t get their medications.
The new regulations were set forth for a 30-day period of public comment, which ended on March 31, with the D.E.A. receiving around 30,000 comments, overwhelmingly critical. The D.E.A. was then to review comments and draft final regulations for the May 11 end of the emergency, the agency said in a statement. (The original rule restricting online prescribing of controlled substances was called the Ryan Haight Online Consumer Protection Pharmacy Act of 2008. It was those rules that were relaxed for the pandemic.)
Under the proposed new post-health emergency rules, announced Feb. 24, patients who get controlled prescriptions from a provider they have never seen in person would need to have at least one in-person appointment after the public health emergency ends if they want to continue getting their medications. This raises the possibility that people with ADHD using Adderall will have to stop until they can find a doctor’s appointment, or that transgender people transitioning will lose immediate access to testosterone, or that people with anxiety will lose access to Xanax, that people using buprenorphine for substance abuse disorders will lose access, that people using gabapentin will lose the ability to control seizures and nerve pain, and a host of other scenarios.
Harmful to patients
The D.E.A. must come up with a new plan by May 11, the end of the emergency, or the old rules will come back into play, experts said.
Nathaniel M. Lacktman, partner at the law firm Foley & Lardner and chair of the telemedicine and digital health industry team at the firm, said comments on the D.E.A.’s new plan revealed “the concerns were significant about limiting access to medically necessary medications, and the potential that Americans will just die as a result of D.E.A. turning off the ability to get access to these meds overnight.”
“What we believe, and what stakeholders in the industry believe, is that the D.E.A. is going to seek permission to extend the controlled substance prescribing waivers even after a public health emergency ends,” he said in a phone interview. “That would give the D.E.A. time to complete its review of the public comments, and then make some changes to the proposed rule before it’s finalized.”
He said he and others believe the federal government, including the D.E.A., will not allow this practice to immediately expire without a solution. “The solution will either be a an extension of these prescribing waivers even after the public health emergency, or be the final rule as proposed, which would create the new process for patients to get prescriptions via telemedicine, and in connection with that it would have a grace period of about 120 days or so, through the beginning of November.
“But nobody knows outside of government exactly what it is, because it hasn’t been published.”
Lacktman wrote a thorough piece titled “D.E.A.’s Proposed Rules on Telemedicine Controlled Substances Prescribing after the P.H.E. Ends” about the ins and outs of the proposal. He wrote:
“The two new options introduced in the proposed rule are:
“1. A virtual first process where a practitioner can issue an initial prescription for a controlled substance without having conducted an in-person exam of the patient, but only if: 1) the medication is a non-narcotic Schedule III, IV, or V controlled substance (or buprenorphine for treatment of OUD); and 2) the prescribed amount does not exceed 30 days. This is called a ‘telemedicine prescription.’ Before any additional prescribing can occur, the patient must undergo an in-person exam.
“2. A ‘qualified telemedicine referral’ process where a patient has an initial in-person exam with a practitioner, who subsequently refers the patient to a second practitioner. The second practitioner can have a telemedicine exam of the patient and prescribe a controlled substance without personally conducting an in-person exam of the patient. Under this referral process, the telemedicine practitioner can prescribe Schedule II-V and narcotic controlled substances.
The D.E.A. is part of the Department of Justice, though it’s possible to imagine that a final decision is up to the White House.
Return to past prescribing rules
Returning to past pre-pandemic prescribing rules would be harmful to patients, said Dr. Owen Muir, a New York psychiatrist.
“If D.E.A. does not act, the world goes back to its prior-to-Covid state, in which every single controlled substance of any drug must be prescribed with an in-person visit with a prescriber, and that’s just not the world we live in,” he said. “And this is a ton of drugs.
“Most importantly, for my purposes, as a child psychiatrist, we’re talking about Schedule II drugs, which are stimulant medications. But there are additional controlled substances. There’s testosterone, for people with hormone deficiencies or transitioning their gender. There is Gabapentin, which is controlled in some states and not in others. It’s a wide array of medicines. It is just logistically impossible for us to come back to the state of the world, pre-Covid.”
D.E.A. proposed that prescriptions should have an in-person component, “and there just aren’t enough people who can prescribe medicines to do that,” he said. Lacktman also noted that many people lack access to doctors.
Muir is a dual board-certified child and adult psychiatrist who is a curator of the national educational module on ADHD through the American Academy of Child and Adolescent Psychiatry. Disclosure: Muir and I are acquainted via an online message board of healthcare people. He treats children and adults at Fermata Health and writes about healthcare at TheFrontierPsychiatrists.
As he and I discussed before, prescription medications for ADHD and similar conditions are already sometimes hard for people to get for other reasons — a settlement with prescription distributors over an opioid case, plus supply-chain shortages, have made it difficult for many people to obtain Adderall, Ritalin, Vyvanse, Concerta and other meds.
Telehealth exploded
Telehealth prescribing exploded during the pandemic. While many millions of people benefited, by being able to get prescriptions without friction and without physically visiting their doctors, there were also widespread criticisms of such companies as Cerebral, which came under heavy criticism and is now under federal investigation for prescribing medications online. Patients said Cerebral had mishandled their cases, and the president of the company was removed a year ago. Another A.D.H.D. health teleprovider, Done, is also under federal investigation.
D.E.A. said its motivation in reining in the practice of telehealth prescribing was to protect patients who may be getting inappropriate prescriptions.
“It’s just not logistically plausible to go out and change all of how everyone prescribes medicines with no systems to do so by May 11,” Muir said. He said he had learned that the D.E.A. had reached out to the White House to ask for an extension of the public health emergency as it related to controlled substances “to allow the D.E.A. to appropriately consider what the regulation should be.”
“I don’t foresee a world which the D.E.A. decides to become the most hated agency on Earth by removing everyone’s access overnight to life-saving buprenorphine,” Muir said in a phone interview. “And every child on stimulants is going to go running wild because almost everybody prescribes by telehealth through a psychiatrist. It’s hundreds of thousands of people, millions of people, now getting their medicines that way. If you don’t, you can have a seizure, or an opiate relapse, or your kid destroys your home. And so I imagine what’s going to happen is going to be probably the extension.”
Lacktman said he also hopes that the D.E.A. will “pick up its work on drafting special telemedicine rules and registration” as mandated by the Ryan Haight Act. That work was mandated under the act but never completed, he said. “We’ve been waiting 15 years for the D.E.A. to publish it,” he said. “It already exists in the statute, they just did not put out a regulation.”
Effects on patients
In an opinion piece on the topic for The Washington Post, Kate Woodsome wrote: “Even before the pandemic, 130 million Americans — a third of the population — lived in areas with a shortage of mental health providers, and more than half of U.S. counties didn’t have a single psychiatrist. Getting an appointment in remote locations could mean waiting months, to say nothing of the travel time.”
“But for people who sought treatment for ADHD or opioid addiction for the first time online during the lockdown — or are thinking about it now — they’ll go back to needing an in-person evaluation to get medication. DEA and Health and Human Services officials say they are taking this step because the pandemic created a dynamic where some people were being pushed drugs they do not need.”
In a Health Affairs article titled “Maintaining telehealth care for opioid use disorder Is critical,” Stephen A. Martin and Arthur Robin Williams write that deaths from opioid-involved overdoses rose dramatically during the pandemic, fueled in part by fentanyl.
The two are involved in opioid use disorder treatment at Boulder Care and Ophelia. They write of the proposed D.E.A. in-person visit requirement: “Obtaining a primary care visit within 30 days — perhaps as a new patient, perhaps with Medicaid, is nearly impossible due to lack of available practices and is an undue burden for someone working hard to improve their life, especially in rural and frontier areas.
“Should this proposal become a rule, people will lose their lives and be harmed as a direct result. Ironically, one of the legal exemptions for a mandated in-person visit is in the case of a [public health emergency]. Sadly, there is no sign of the opioid crisis waning and losing its own P.H.E., first announced October 2017.”
People in rural areas and areas short of prescribers — including inner-city areas, where providers may be few — would be extensively affected.
Black and gray market drugs
Muir also said he had suggested that the D.E.A. consider illegal drug dealers’ assessment of the proposed new rule, since they would benefit if supplies of prescriptions like Adderall, buprenorphine and other medications became scarce and people seek to buy illegally.
“The most interesting conversation we had was ‘Have you checked with drug dealers? The party who’s not in the room? They are the people who are going to make money off of the fact that it’s hard.’ The actual crisis that we’re going to be facing is that there are going to be entrepreneurs in black or gray markets, who are going to be meeting a need generated by regulatory ineptness. And what they think about this law is as important if not more important than what everyone who’s anxious to comply thinks about the law.
“So I’m hoping we’ll be reaching out to any contacts in illegal drug dealing, so they can find out, are they enthusiastic or not? That’s a pretty good indication that we have a public health problem, right? If drug dealers are on board with the D.E.A., you know you’re doing it wrong.”
Black-market drugs are often laced with fentanyl, Lacktman pointed out, meaning that black-market purchases can easily be fatal.
Beyond that, Muir said: “The illegal sector, with buprenorphine, has long been providing access to a drug that was inappropriately regulated. Buprenorphine is a life-saving treatment. Street buprenorphine is so much safer than the street anything else.
“If you pull the rug out from underneath us on this, it will lead to death of some of the most vulnerable people on Earth.”
D.E.A. regulation or F.D.A. regulation?
Lacktman said the issue has brought to the fore the question of whether an enforcement agency like the D.E.A. should be in charge of decisions relating to people’s health.
“There have been a number of opinion articles in The New York Times and The Washington Post about how this has just been a complete failure, about how the existence of D.E.A. did not prevent the opioid crisis and has not been helpful,” he said.
“Just questioning even its role: Using a policing agency to have oversight over health care. Some people are already asking to switch that responsibility to an entity like the F.D.A.,
which is a health organization and not a policing organization.
“So I do think that public sentiment is certainly not supportive of this proposed rule and the way this has been handled.”
What you can do
People with telehealth-only prescriptions should be aware of the potential rule change and follow the news. Some people may not be in close touch with their providers, or may not realize that some change in prescribing is likely to take place — though no one can say right now what that change will be or when it will be instituted.
Muir said this is a really good time to make an appointment with your primary-care doctor. That doctor can prescribe, or make a referral to a telehealth provider. In the proposed new plan, Muir noted, the trail of recording these events does not currently exist in record-keeping systems, which has been an obstacle to the change. Suggestions for updating the trail of recording have been made in the 30,000 comments, Muir said (he made one) to smooth the path of primary-doc-to-telehealth-providing under a new regulation.
