Editor’s Note: There is no doubt that the improved access to high quality, virtual care in the post COVID era has provided numerous benefits for patients. Patients that previously struggled to access specialty care due to geographic or other logistical challenges no longer face such barriers. In fact, those struggling with complex health conditions in search of innovative treatments to improve their quality of life can now access them conveniently from manufacturers' websites or the numerous, novel digital healthcare access channels. The shift from a healthcare delivery model in the United States that was largely in-person to one that mixes in-person with virtual care based on individual preferences isn’t going away anytime soon. However, as this new modality of care delivery has taken off, many gray areas have also surfaced that have caused uncertainty and concern, particularly around issues like the prescribing of controlled substances. Providers and pharmacies need to operate with the highest standards to ensure that they are both adhering to the appropriate regulations and promoting the health of their patients. At PHIL, we are excited about the potential that digital health offers patients and doctors and we operate with the highest standards. To learn more about how we support manufacturers seeking to open new, digital access channels, read this telemedicine case study.
Just two days before the COVID-19 public health emergency expires, the Drug Enforcement Administration said Tuesday it will extend telehealth flexibilities that enabled clinicians to virtually prescribe controlled medications to their patients for another six months.
Facing major backlash to its proposed rules released in February, the DEA last week announced it planned to extend the flexibilities without offering a timeline. The agency is looking to buy some time to reconsider whether it should enforce stricter limits around the prescribing of controlled substances via telehealth.
For any practitioner-patient telemedicine relationships that have been or will be established up to November 11, 2023, the full set of telemedicine flexibilities regarding the prescription of controlled medications established during the COVID-19 PHE will be extended for one year – through November 11, 2024, the agency said.
The agency received a record 38,000 comments on its proposed telemedicine rules, according to DEA Administrator Anne Milgram.
"We take those comments seriously and are considering them carefully,” Milgram said in a statement. “We recognize the importance of telemedicine in providing Americans with access to needed medications, and we have decided to extend the current flexibilities for six months while we work to find a way forward to give Americans that access with appropriate safeguards.”
“Access to evidence-based treatment is a pillar of the HHS Overdose Prevention Strategy,” said Miriam E. Delphin-Rittmon, the HHS Assistant Secretary for Mental Health and Substance Use and the leader of SAMHSA in a statement. “We strongly support policies that promote access to effective and safe treatment for opioid use disorder, including through telemedicine platforms, and ensuring continued access to necessary controlled medications past the COVID-PHE.”
The DEA issued proposed rules three months ago that would reinstate strict limitations on the virtual prescribing of controlled substances and would roll back telehealth flexibilities extended during the COVID-19 pandemic. The proposed rules would once again require patients to be evaluated in person by a doctor to receive prescriptions for some controlled substances (PDF) including stimulants like Adderall and opioids such as oxycodone and buprenorphine used to treat opioid use disorder.
The Biden administration said at the time that the new rule seeks to provide safeguards to prevent online over-prescribing of controlled medications. Teleprescribing has been touted as a robust tool for bringing medications for opioid use disorder (MOUDs) to rural areas in the ongoing treatment of the opioid epidemic.
Provider groups, telehealth advocates and patients submitted comments largely panning the proposal, arguing that it would create barriers to care.
Under the proposed rule, Schedule 2 medications or narcotics would require (PDF) an in-person prescription. Schedule 3 or higher medications, including buprenorphine, can be prescribed for 30 days via telehealth but would require an in-person visit before a refill. Non-narcotic drugs like Ambien, Valium, Xanax and ketamine also fall into this category. If a patient is referred to a provider, an in-person appointment is not required as long as one took place with the referring physician.
If a telemedicine relationship was established during the COVID-19 public health emergency, the DEA will extend the in-person exam waiver for an additional 180 days.
The Ryan Haight Act of 2008 required a prior in-person examination of a patient to get a controlled substance prescription. The law provides some exemptions, one of which is a federal public health emergency
Telehealth providers are cheering the DEA's decision to extend the COVID rules for telemedicine, at least temporarily.
"We saw that the Office of Management and Budget and the DEA put out a statement to extend the COVID rules for telemedicine. We don’t know for how long, or to what end," Ankit Gupta, Bicycle Health's CEO and co-founder, said. "However, what we’re hearing is that the overwhelming response from the healthcare community to the DEA’s proposed rules is causing them to rethink their approach to the in-person requirement for telemedicine—particularly when it comes to prescribing buprenorphine for opioid use disorder—because of the overwhelming clinical evidence that shows their approach would be catastrophic to patient health, and extremely costly to the healthcare system at large."
Bicycle Health is an online medication-assisted treatment provider for opioid dependence. Gupta said the DEA is "doing the right thing by delaying the implementation of this rule."
The expanded use of telehealth services during the pandemic was shown to reduce the risk of opioid overdoses, according to a 2022 study published in JAMA Psychiatry. The study, conducted by the National Institute on Drug Abuse, followed 175,000 Medicaid beneficiaries and found that telehealth services led to an increase in OUD treatment access and adherence.
The American Academy of Family Physicians (AAFP) also reacted positively to the DEA's announcement.
"We are hopeful this will minimize care disruptions for family physicians and their patients when the PHE ends next week. We look forward to continuing to work with DEA on final regulations that advance equitable, timely access to care and protect patient safety,' the AAFP said in a statement.
But it still remains unclear to providers how long the temporary telehealth flexibilities will be extended and when the DEA will issue its final rule.
“We are glad to see the DEA taking the comments seriously and are relieved to know that our patients aren’t going to be unnecessarily limited in accessing care," said Geoffrey Boyce, CEO and co-founder of Array Behavioral Care, an online therapy company. "We’d be even more pleased if we knew when to expect clarity and what to tell our patients and clinicians to expect.”
The DEA was mandated to create a special registration process for remote prescribing in 2008, something it has yet to do. The recent omnibus bill requested once again that the DEA finalize the changes to the Controlled Substances Act. January was expected to bring word about the agency’s response, yet the month came and went without news. Without a top-down plan, providers are remaining hopeful while preparing for the worst.
"Our hope is that they use the time to collaborate with experts in healthcare to create an effective special registration process for telehealth-based buprenorphine treatment programs, per their original mandate from Congress," Gupta said. "OUD is one of those rare illnesses that has a well-defined cure—which is medication for opioid use disorder (MOUD) with buprenorphine—that people simply could not access before telehealth."
He added, "For nearly two decades, the country was losing this battle against opioid use disorder because treatment wasn’t accessible. The problem was getting appreciably worse every year and there was no plan to address it. The pandemic created this opportunity to use telehealth, and it actually worked—far better than anyone expected. Now is not the time to reverse course."
Mindbloom, a psychedelic telemedicine company that offers at-home ketamine therapy for mental health, also welcomed the DEA's decision to delay the release of a final rule.
“Over 35,000 comments were submitted in response to the U.S. Drug Enforcement Administration's proposed rules for the prescribing of controlled medications via telemedicine because of the immense impact that they would have on patients' access to care, especially for mental and behavioral health," said Michael Petegorsky, general counsel of Mindbloom, in a statement.
"As the mental health crisis in America continues to worsen—with nearly 1 in 4 adults suffering from mental illness in the past year and less than 50% receiving treatment—the federal government must expand access to clinically-appropriate treatments and commit to supporting telehealth so that individuals suffering from depression, anxiety, and other conditions can access evidence-based treatment options, like ketamine therapy, that work well for them. We are grateful that the DEA is taking the time to consider the comments from patients and providers across the healthcare spectrum.”
This article was written by Heather Landi from FierceHealthcare and was legally licensed through the Industry Dive Content Marketplace. Please direct all licensing questions to email@example.com.
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