Rules for prescribing controlled drugs via telemedicine: research roundup

Update: On May 9, 2023, the Drug Enforcement Administration and the Substance Abuse and Mental Health Services Administration issued a temporary rule, extending telemedicine flexibilities for six months through November 11, 2023. For patients who are already seeing a doctor via telemedicine, the temporary rule extends through Nov. 11, 2024. The flexibilities were established under the COVID-19 public health emergency and had been set to expire on May 11.

Under new federal regulations proposed to take effect in May, tens of thousands of patients across the U.S. will need to schedule in-person visits to continue obtaining prescriptions for controlled drugs via telemedicine.

Patients being treated remotely with buprenorphine for opioid use disorder, Ritalin for attention deficit disorders, ketamine for depression, or testosterone for gender-affirming care, among other controlled-drug treatments, will need to schedule an in-person exam, either with their telemedicine prescriber or a local provider who is registered with the federal Drug Enforcement Administration, according to the DEA’s proposed rules.

The draft regulations, which were first announced Feb. 24, allow telemedicine providers to initially prescribe 30 days’ worth of some medications, including buprenorphine, testosterone, or ketamine, before an in-person exam is required. Patients taking narcotic pain medication, or common ADD medicines, however, will need an in-person exam before any new prescriptions can be issued. Patients and providers who established treatment relationships remotely during the pandemic, when in-person exam requirements were temporarily waived, would have 180 days to comply with the new laws.

A brief history of online drug prescription regulations

The federal regulation of online prescribing started with the 2008 passage of The Ryan Haight Online Pharmacy Consumer Protection Act, which was meant to combat rogue internet pharmacies that started selling controlled drugs online in the 1990s. The law generally required in-person medical evaluations prior to prescribing controlled substances, but carved out seven exceptions, including one for public health emergencies, such as the COVID-19 pandemic. Thus, for the past three years, telemedicine practitioners have been prescribing controlled drugs without needing to conduct in-person exams. With the pandemic public health emergency ending in May, this exemption will no longer stand.

Another exception in the 2008 law envisioned the creation of a “special registration” process through which qualified telemedicine providers could prescribe controlled drugs without in-person visits. The DEA did not create the registration process at the time but was again directed to establish it in the SUPPORT Act of 2018. As a result, most stakeholders were expecting the DEA to enact the formal registry this year.

Instead, the DEA surprised the medical, telehealth, and health policy communities by proposing a narrow set of regulations aimed at improving access to buprenorphine, an effective medication used in opioid addiction treatment, while curtailing improper prescribing and illegal diversion of controlled drugs.

“What they proposed caught a lot of people off guard, because we were all thinking they were going to create the registry,” says Mei Kwong, executive director of the nonpartisan Center for Connected Health Policy.

In its release of the proposed rules, the DEA said it had deemed the registry approach “potentially burdensome for both prospective telemedicine providers and patients.” The two proposed rules included one targeting buprenorphine treatment for opioid use disorder and a broader telemedicine rule. DEA officials said they sought to balance the goal of expanding access to buprenorphine treatment by making permanent some pandemic-era flexibilities, such as allowing substance abuse treatment via audio-only telemedicine, with the desire to prevent drug-overdose deaths in the U.S., which increased 30% from 2019 to 2020, and another 15% in 2021.

“Medication for opioid use disorder helps those who are fighting to overcome substance use disorder by helping people achieve and sustain recovery, and also prevent drug poisonings,” said DEA Administrator Milgram in a press release.

Most overdose deaths involve synthetic opioids such as fentanyl and psychostimulants such as methamphetamine. A recent cross-sectional study of overdose deaths across the United States found that pandemic-era telemedicine flexibilities did not lead to an overall increase in buprenorphine-involved drug deaths, which accounted for 2.6% of all opioid-involved overdose deaths between July 2019 and June 2021.

What the proposed rules would do

The DEA’s proposed rules, which would be in addition to state-level regulations, affect people who have never had an in-person exam by the telemedicine provider who prescribes controlled substances to them.

Key aspects of the proposed rules include:

Limitations and requirements in the proposed rules do not apply if the telemedicine interaction meets one of the other exceptions under the Ryan Haight Act.
Telemedicine providers must keep more detailed records than previously required, including recording the address where the patient was during the visit. They must also check prescription monitoring databases to see whether other controlled drugs have been prescribed to patients.
Patients being treated for opioid use disorder are required to have an in-person visit within 30 days of receiving a prescription for buprenorphine (Suboxone, Zubsolv, and Sublocade) via telemedicine, to obtain refills.
Following the in-person exam, a patient can receive buprenorphine prescriptions via audio-only telemedicine (telephone), as an alternative to video calls.
Patients prescribed a non-narcotic Schedule III, IV, or V drug are required to have an in-person visit within 30 days of receiving a prescription via telemedicine, to obtain refills.
In lieu of an in-person exam by the remote provider, a local, DEA-registered health care provider, such as a primary care provider, can perform an in-person exam and then make a “qualified telemedicine referral” to a remote provider for a specific condition. Only one referral is needed for the remainder of the patient’s treatment for that condition.
Patients must have an in-person visit or a qualified telemedicine referral to receive a prescription for Schedule II controlled substances.

Schedule II controlled drugs include narcotic pain medications like oxycodone and fentanyl, and stimulants used to treat attention deficit disorder, like Adderall and Ritalin. Schedule III drugs include testosterone and ketamine, a former club drug that has become a popular off-label treatment for depression and other mental health conditions. Drugs classified as Schedule IV (Xanax and Ambien, for example) and Schedule V (Robitussin AC and Lyrica, for example) have a lower potential for abuse and low risk of dependence. Heroin, LSD and marijuana are examples of Schedule I drugs. In general, the DEA categorizes drugs based on their abuse rate and potential to create physical or psychological dependence.

At least two US Senators have asked the Biden administration to change testosterone to a Schedule IV or V drug. Meanwhile, debate about and government consideration of reclassifying marijuana has been ongoing for nearly a decade.

More than a dozen telehealth startups providing take-at-home ketamine emerged during the pandemic, and in-person ketamine clinics also grew in number and popularity. In March, however, Ketamine Wellness Centers, the largest provider of in-person ketamine treatment in the country — with 13 clinics in nine states — abruptly closed, reportedly due to financial issues stemming from its acquisition in 2021 by Canadian company Delic Holdings Corp. Field Trip Health, another in-person ketamine treatment provider, also ceased operations. These closures are likely to send local clinic patients scrambling for remote ketamine prescriptions before the new laws take effect in May.

Widespread opposition to the DEA proposal

The DEA’s proposed rules have drawn more than 35,000 public comments, the majority of them urging the DEA to rethink its stance on the in-person exam requirements, either by eliminating them or allowing more time for patients to schedule appointments. Several advocacy groups representing patients and medical professionals have pushed back against the proposal.

In a March 31 letter to Milgram, Dr. James Madara, CEO of the American Medical Association, expressed “grave concerns” that the new rules “would cause many patients who were started on buprenorphine to have their prescriptions lapse, leading to more overdose deaths instead of closing the treatment gap.” Kyle Zebley, senior vice president of public policy at the American Telemedicine Association, says there’s “no clinical need” for in-person exams. He calls the DEA’s proposed requirement “a clinically inappropriate barrier to care.”

“We have long been of the belief, going back prior to the pandemic, that we needed to have a regulatory regime in place that would allow for the remote prescription of clinically appropriate controlled substances” without an in-person requirement, Zebley says.

The changes come at a difficult time for the telehealth industry, when investment is already down amid rising interest rates, inflation and increased scrutiny of prescribing practices. Allowing local providers to refer patients for treatment via telemedicine represents “an improvement to the pre-pandemic status quo,” Zebley says. But, he adds, any in-person exam requirement creates a potentially life-threatening barrier, particularly for people in the early stages of opioid use disorder treatment.

Substance misuse treatment via telehealth

Research has shown that buprenorphine is a safe and effective treatment for people who suffer from opioid abuse disorder. Evidence to date does not suggest that remote prescribing of buprenorphine leads to more of the drug ending up on the street or more buprenorphine-involved overdose deaths. The DEA has acknowledged the need for increased access to buprenorphine, and in January, removed restrictions on the number of buprenorphine patients that prescribers could treat at a given time.

But the DEA also maintains its proposed rules are necessary to prevent diversion – a medical and legal term referring to the illegal transfer of a drug from the intended patient to someone else. This includes theft of prescription medications by health care providers as well as patients selling their own prescriptions of street drugs.

“Diversion of buprenorphine and other prescription opioids remains an issue across the country: in the past two years, DEA has seen Federal investigations of buprenorphine diversion across the country,” the DEA states in its proposed rule for buprenorphine telemedicine prescriptions. “Thus safeguards are necessary to mitigate the risk of diversion.”

Some researchers who study the use and efficacy of buprenorphine say the DEA’s proposed rules are “overly restrictive.” In a March 21 letter to the U.S. Attorney General, posted by the Brookings Institution, a group of top researchers write that the DEA’s proposal “fails to strike the right balance” and “would likely create more harm than benefit.”

“Specifically, the evidence to date does not support concerns about substantial medication diversion or misuse associated with prescribing of buprenorphine via telemedicine,” they write.

The letter’s signatories are Haiden Huskamp, Dr. Ateev Mehrotra, and Dr. Alisa Busch, of Harvard Medical School; Dr. Pushpa Raja of the David Geffen School of Medicine at University of California, Los Angeles; Richard Frank from the Brookings Institution; and Dr. Michael Barnet, of the Harvard T.H. Chan School of Public Health.

The researchers recommend eliminating the in-person requirement for patients being treated with buprenorphine for opioid abuse disorder. If that is not possible, then patients should have six months to schedule an in-person exam, rather than 30 days, they write, citing long waiting periods for in-person care.

“We need to take a public health perspective here, versus a criminal justice perspective,” Mehrotra, a professor of health care policy at Harvard Medical School, says. “The criminal justice perspective is to say, ‘Hey, look at these bad actors here. We need to do whatever we can to fix that problem.’ The public health perspective is to say, ‘Hey, there are bad actors, but let’s look at the net impact on society, because we don’t want to restrict access for everybody because of a couple of bad actors.’”

What does the research say?

Evidence on the efficacy of telehealth versus in-person care for various ailments is sparse, but a flood of research studies is widely anticipated over the next few years, as more data from the pandemic period become available for study. Additionally, because any negative health outcomes potentially resulting from receiving care via telehealth will take time to materialize, many researchers have only recently begun to analyze the effects of the rapid shift to remote care that has taken place during the COVID-19 pandemic.

“In 2019, we were studying many applications of telehealth and doing randomized, controlled trials of in-person versus telehealth for things for like depression, schizophrenia, anxiety and a couple of other areas, but we didn’t have a large body of research,” says Mehrotra. “Then, suddenly in 2020, [patients] started using telemedicine for everything. So, we’re still playing catch-up to try to answer the question of, ‘When is telemedicine viable and when is it not viable?’”

Patient usage and preference are other important factors that research is only beginning to investigate. A recent survey finds that people prefer to use telemedicine for minor health issues, as opposed to chronic illnesses. Research also suggests that healthcare providers themselves have not permanently adopted telemedicine at rates once predicted during the pandemic.

The DEA’s forthcoming laws on prescribing controlled substances via telemedicine will help shape the overall telehealth industry, especially given how much of it has been built around behavioral and mental health care over the past three years. Despite the economic downturn and current regulatory uncertainty, industry analysts expect continued growth for an industry that has demonstrated its ability to connect patients with care that they otherwise might not be able to access.

Research to Explore:

Trends and Characteristics of Buprenorphine-Involved Overdose Deaths Prior to and During the COVID-19 Pandemic
Lauren J. Tanz, et al. JAMA Network Open. January 2023.

The study: Using data from the State Unintentional Drug Overdose Reporting System, the researchers conducted a cross-sectional study to examine overdose deaths across the U.S. between July 2019 and June 2021. They looked into whether there was a change in the rate of deaths involving buprenorphine in the wake of the March 2020 COVID-19 public health emergency, when the federal government took actions allowing clinicians to prescribe buprenorphine without an in-person office visit.

The findings: Of the 74,474 opioid-involved deaths in the study, which included 48 states and the District of Columbia, buprenorphine was involved in 2.6% of them. More than 90% of the buprenorphine-involved deaths involved at least one other drug. While monthly overdose deaths from opioid use increased after March 2020, the percentage involving buprenorphine fluctuated but did not increase between July 2019 (3.6%) and June 2021 (2.1%).

In the authors’ words: “The findings of this cross-sectional study suggest that actions taken by the US federal government to facilitate access to buprenorphine-based medications for [opioid use disorder] during the pandemic were not associated with an increased proportion of overdose deaths involving buprenorphine, providing evidence to inform discussions on permanent adoption of COVID-19–related buprenorphine prescribing authorities. Nonetheless, although rare, overdose deaths involving buprenorphine highlight the importance of overdose prevention and support for those using buprenorphine both under medical supervision or outside of treatment for [substance use disorder] or pain.”

Initiating Opioid Use Disorder Medication via Telemedicine During COVID-19: Implications for Proposed Reforms to the Ryan Haight Act
Haiden A. Huskamp, et al. Journal of General Internal Medicine, January 2022.

The study: Between late November and mid-December 2020, the researchers conducted a national online survey to gauge whether clinicians who treat opioid use disorder considered telemedicine to be a safe and effective way to prescribe medications such as buprenorphine. Some 602 clinicians participated in the survey, 506 of whom reported having initiated opioid use disorder medication for a patient during the month preceding the survey.

The findings: Among those 506 clinicians, 303 had used telemedicine to initiate treatment for at least one patient in the past month, while 203 had only started their patients on opioid use disorder medication after an in-person visit.

When asked how they felt about using video visits to treat new patients for opioid use disorder, a little over one-third of respondents reported being “somewhat” or “very” comfortable, with the rest being “somewhat” or “very” uncomfortable. Clinicians who were treating more patients with opioid use disorder reported feeling more comfortable with treating patients via video.

In the authors’ words: “Findings suggest that a permanent relaxation of the Ryan Haight requirement may not result in widespread adoption of telemedicine for OUD medication initiation without additional supports or incentives.”

Receipt of Telehealth Services, Receipt and Retention of Medications for Opioid Use Disorder, and Medically Treated Overdose Among Medicare Beneficiaries Before and During the COVID-19 Pandemic
Christopher M. Jones, et al. JAMA Psychiatry, August 2022.

The study: The researchers compared telehealth treatment for opioid use disorder and medically-treated overdose before and after the onset of the COVID-19 pandemic. In a longitudinal study involving 175,778 Medicare and Medicaid beneficiaries, the researchers compared two cohorts of patients – one between September 2018 and February 2020, and one receiving treatment between September 2019 and February 2021.

The findings: Overall, access to telehealth services during the COVID-19 pandemic was associated with an increase in patients sticking with their treatment and a decrease in the risk of medically treated overdose. The researchers also found that some groups were less likely to receive telehealth services for opioid use disorder treatment, including non-Hispanic Black people and people living in the U.S. South. And they reported higher odds of medically treated overdose among non-Hispanic Black people, American Indian and Alaska Native people and Asian or Pacific Islanders.

In the authors’ words: “Use of telehealth during the pandemic was associated with improved retention in care and reduced odds of medically treated overdose, providing support for permanent adoption.”

Rules for prescribing controlled drugs via telemedicine: A research roundup and explainer