Some leaders in the virtual medication-assisted treatment (MAT) space see the opportune regulatory environment of the moment continuing post-COVID.
However, virtual MAT providers were disappointed in the past by a regulatory flub at the federal level that could have secured them key flexibilities, leaving them to at least think about what might happen if current flexibilities ended.
During the pandemic, the federal government and state governments relaxed regulations, allowing telehealth across behavioral health to proliferate.
The Drug Enforcement Administration in March 2020 waived a key provision to the Ryan Haight Act, which requires an in-person visit before a patient is prescribed a controlled substance and then another in-person visit once every 24 months.
This made it easier for MAT providers to see patients and get them connected to needed medications — of which buprenorphine is considered the gold-standard treatment in opioid use disorder — and for those providers to expand across the country. Early research suggests virtual MAT, which marries several services of in-person MAT with a telehealth experience, increased access to the treatment.
But while there is widespread support for increased access to MAT, the COVID-related public health emergency (PHE) — and related waivers — will not last forever. Providers and advocates are therefore calling for more permanent action and mulling possible paths forward as the nation moves away from a pandemic footing.
In-person waiver set up virtual MAT for success
The onset of the pandemic pushed Boston-based Bicycle Health from a hybrid model of in-person and in-office visits to all telehealth, which was possible because of the regulatory environment. And the move has been a boon for Bicycle, according to Founder and CEO Ankit Gupta.
“We were able to provide almost a significantly higher quality of care through telemedicine,” Gupta said, adding telehealth overcomes the potential barriers of transportation, convenience and stigma, making the care more accessible. “Our treatment actually fits into your life. it becomes more accessible and also becomes less expensive.”
Under then-President Donald Trump, the U.S. Department of Health and Human Services (HHS) declared the PHE, creating the legal grounds for many federal agencies to operate differently to better respond to the pandemic. HHS Secretary Xavier Bacerra renewed the PHE for another 90 days, effective April 16, setting the expiration date for the loosened regulatory framework in July.
About 15 states have laws on the books that are similar to the Ryan Haight Act that companies must comply with. Some states also added temporary flexibilities in response to the pandemic. Recently, Florida changed its state code to allow telehealth providers to prescribe controlled substances without an in-person visit.
The end of the federal PHE may have an impact on telehealth. But it won’t directly impact the DEA waiver, Gupta said. While the expiration of the PHE would mark an end of many Covid-era regulations, the DEA’s waiver of the in-person visits for prescribing controlled substances, which include medications related to MAT, won’t necessarily end with the PHE.
And the DEA has sent a fairly clear signal that it appreciates the potential to bring treatment to more people, especially as the nation faces its worst drug overdose death wave ever with the spreading of illicit fentanyl through the black market drug supply. The Centers for Disease Control and Prevention estimates that about 107,000 people have died from drug overdoses in the 12 months ending in November.
On March 23, the DEA released a statement meant to demonstrate the agency’s commitment to MAT and point out its accomplishments on the issue.
“In this moment, when the United States is suffering tens of thousands of opioid-related overdose deaths every year, the DEA’s top priority is doing everything in our power to save lives,” DEA Administrator Anne Milgram said in the statement. “Medication-assisted treatment helps those who are fighting to overcome substance use disorder by sustaining recovery and preventing overdoses.
“At DEA, our goal is simple: we want medication-assisted treatment to be readily and safely available to anyone in the country who needs it.”
However, the DEA is almost three years late in promulgating rules allowing MAT providers to prescribe controlled substances via telehealth, as Zack Gray, the CEO of New York City-based virtual MAT provider Ophelia Health, points out.
In October 2018, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act became law. Among other things, it mandates the creation of the special registration process, which would allow qualified providers to tele-prescribe controlled substances to patients they haven’t seen in person, precisely the regulation that is enabling the MAT segment today.
That registration process was supposed to come out in October 2019. Advocates and organizations in the space have made it clear they want the DEA to follow through on its congressional mandate.
“There’s good reason to believe that, for medication-assisted treatment specifically, the environment will remain favorable for the long term,” Gray said. “The Ryan Haight act is widely known to be an outdated law from an era in which telemedicine wasn’t what it is today.”
Even if the DEA were to end its pandemic-era waiver, Gray said the HHS secretary could theoretically tie the in-person waiver to the PHE that the Trump administration declared for the opioid epidemic in October 2017, which has so far seemed durable — at least until the opioid crisis abates.
There is also an apparent interest on the part of lawmakers in ensuring that widened access to MAT is a key part of the congressional response to the behavioral health crisis highlighted and made worse by the pandemic, another potential reason to hope for a favorable outcome in MAT regulation.
Planning for uncertainty in the regulatory process
Ophelia Health is contingency planning in case the regulatory environment doesn’t go the way that MAT providers in the virtual space would like.
“Worst case scenario, we think we would have sufficient time to make investments,” Gray said.
But if the DEA does come out with the registration process, there is the prospect that the process is onerous and/or not grounded in the latest science, Gray said. Even if the process were based on solid footing, businesses could face the prospect of government backlogs and sluggish processes that could hurt the virtual MAT space.
Gray believes that the Ryan Haight Act rules for in-person — which applies to all controlled substances — might come back and impact some virtual behavioral health providers’ ability to prescribe medication.
“There have been a number of high-growth telehealth companies making their way prescribing lots and lots of Adderall, which is a Schedule II controlled substance — it’s more controlled than buprenorphine,” Gray said. “And I’m not sure how the government feels about that. … If we’re talking about providers who are dealing with other medications and other disorders, then the calculus is very different than the situation that we are particularly in.”
Ophelia Health focuses on treating opioid use disorder with Suboxone, a combination of the medications buprenorphine and naloxone, which is a Schedule III drug.
On the chance that the Ryan Haight Act waiver, or waivers to similar state laws end, Gray says companies would need to figure out how to accommodate the in-person visit.
For Ophelia, it wouldn’t make sense to try to establish an office in rural areas, where the need for greater MAT access is the highest, Gray said. There is a severe dearth of providers who can prescribe controlled substances via telehealth nationally, which is much worse in rural areas.
The company would need to partner with local providers to reach rural patients. It would make more sense to establish offices in urban areas. But if that were to happen, Ophelia Health would need to accelerate its potential products on its development roadmap to get the most out of the overhead that offices would bring. This could include offering long-acting injections and primary care services, Gray said.
“If you read [the Ryan Haight Act,] there are ways to work with providers that are co-located with patients: This is not a secret,” Gray said.
Bicycle Health, which was founded in 2017, has a legacy of operating in-person locations: It got its start as a clinic in Redwood City, California. And Gupta said the company has a location in all of the 23 states that it operates in and would be able to comply with the in-person requirement “tomorrow” if it came back.
Both Gupta and Gray pointed out that the desire for expanded access to virtual MAT goes all the way to the top. President Joe Biden said in his State of the Union address that the No. 1 priority of his “Unity Agenda” was beating the opioid epidemic.
“It takes time for things to move at the federal level,” Gupta said about the federal government’s interest in expanding MAT all levels. “All these signs that are coming out are quite positive in that direction.”
Companies featured in this article:
Bicycle Health, Department of Health and Human Services, Drug Enforcement Administration, Ophelia, Ophelia Health, U.S. Department of Health and Human Services, U.S. Health and Human Services Department
