November is fast approaching, and with it comes the Drug Enforcement Administration’s (DEA) proposed rule on telehealth and controlled substance prescribing.
After a six-month delay, the federal law enforcement and regulatory body will release regulations that will shape the future of telehealth within behavioral health in the post-COVID era. It also has the potential to redirect the evolution of telehealth in the behavioral health industry.
Companies that exclusively or heavily focus on providing care via telehealth have had to prepare for the potential snapback to a regulatory environment where in-person exams were required before a telehealth provider could prescribe certain controlled substances.
During the flexibility of the pandemic public health emergency (PHE), a legal posture by the federal government meant to allow greater flexibility for providers to work through crises, several addiction treatment providers focused on using telehealth to address opioid use disorder (OUD) flourished in terms of new patients and funding from investors.
Digital health has long been a magnet for venture capital. But the pandemic and the loosened regulatory environment goaded on heightened activity. In 2021, investors poured $29.3 billion into digital health companies. While that number plummeted in 2022 to $15.3 billion, investor interest in the digital health space has rebounded back to pre-pandemic levels. In the first half of 2023, digital health company investments totaled $6.1 billion.
Part of the pitch for any digital health company is increasing convenience or expanding access to care. Given several regional behavioral health provider shortages, this is an essential need for many patients. About 164 million Americans, or roughly 49% of the population, live in areas that qualify as mental health service provider shortage areas, according to the federal government.
Despite population needs, digital-focused behavioral health companies have had to anticipate and prepare for a possible regulatory environment that requires in-person operations, several executives at such companies tell Behavioral Health Business. This includes establishing or reopening in-person offices or strengthening partnerships with primary care providers near their clients. Still, some providers are holding out and hoping the DEA has a change of heart.
Hope the DEA changes its mind
There is an expectation that the DEA will heed the public commentary on treating behavioral health conditions via telehealth and controlled substances without an in-person exam. So far, the DEA has signaled that capitulation is possible.
“The federal government has shown that they understand the vital role that telehealth plays in mental health care, and we’re confident that they won’t rip telehealth away from the millions of Americans who depend on it,” Dylan Beynon, CEO and founder of Mindbloom, told Behavioral Health Business.
Mindbloom offers virtual ketamine-assisted therapy. Benyon previously told BHB that he believes that his company can operate under the DEA’s proposed rule as presented. The rule includes a provision that allows for a 30-day supply of certain drugs to be prescribed without an in-person examination, giving enough time to complete one course of treatment.
A flood of overwhelmingly negative feedback during the comment period for the DEA’s proposed rule released on Feb. 24 led the DEA to delay its action on telehealth and controlled substance prescribing.
Telehealth proponents hold up the DEA’s delay as a victory for public advocacy on the matter.
The DEA has also signaled that it might be willing to end its opposition to creating a special registration process for telehealth-only prescribing. It held public comment listening sessions on Sept. 12 and 13 about a special registration process and related public safety considerations. Many providers in the SUD space see movement on the special registration process as a win.
Still, for persistent and critical treatment, such as medication-assisted treatment (MAT) for opioid use disorder (OUD), the requirement to get an in-person exam may present a major delay at best and an insurmountable hurdle at worst to accessing care.
Emily Behar, vice president of clinical operations at Ophelia Health, a virtual OUD treatment company, told BHB that as many as 79% of its patients did not have a primary care provider when seeking care from Ophelia.
“If the DEA reinstates the in-person exam mandate, it will be a significant deterrent for OUD patients to seek treatment and further exacerbate the opioid crisis,” Behar said.
Similarly, the Medicaid-focused virtual behavioral health provider Boulder Care previously told BHB that about 60% of its patients do not have an established primary care provider.
Try to plan for everything
Many virtual behavioral health providers offering services before the pandemic had already established the infrastructure to conduct in-person examinations in-house or through community partners.
Workit Health, founded in 2014, provided in-person exams for years before the pandemic; care was initiated in person and then continued virtually. The company maintained office locations, leaving it prepared for the in-person exam requirement.
Bicycle Health, a virtual OUD treatment company, launched with an in-person element too. It opened in 2017 with office visits as its main way of seeing patients.
Apart from having clinics, providers must consider several aspects of patients’ lives to ensure uninterrupted care.
“It’s vital for us to ensure an in-person visit is as painless as possible for our members, which might mean assisting with transportation coordination, offering childcare onsite, creating pop-up clinics, or offering more flexible appointment scheduling,” Robin McIntosh, co-founder and CEO of Workit Health, told BHB. “Our provider partners, like health systems and hospitals, will also play a critical role in ensuring we’re able to coordinate care for members who may not be able to travel to a Workit Health location.”
The potential for regulatory change has inspired a need to change technology infrastructure to account for referrals.
Bicycle Health has reworked its app to help patients get an in-person examination to get or continue treatment, Bicycle Health CEO Ankit Gupta told BHB.
Still, planning in the midst of uncertainty can only go so far. Ophelia Health has explored several strategic options but will wait to see how the DEA decides before enacting a new strategy, Behar said.
Build partnerships with clinicians close to patients
Providers that took a B2B or partnership approach to funneling in patients appear somewhat shielded from the DEA’s proposed rule. These partnerships baked in at least the opportunity for an in-person exam as part of the company’s strategy and structure.
On the whole, these types of business models can only grow as fast as partnerships with dozens of community partners can be built, putting a damper on the speed of a company’s growth, as was the case with Boulder Care.
“Our go-to-market approach has always relied on planting deep roots in the communities we serve and cementing relationships with health systems, primary care providers, and community-based organizations,” Stephanie Strong, CEO of Boulder Care, told BHB. “We built Boulder as a value-based virtual provider in order to play a key role: stitching fragmented parts of the local ecosystem together so that patients with SUD stop slipping through the cracks of the safety net.
More than 80% of Boulder Care’s new patients are referred via local partnerships or existing patient referrals, Strong said.
For Workit Health, health system and hospital partners will be vital in ensuring care continues for those unable to travel to a company location.
To boost the volume of opposition to the DEA rule, several companies intend to push the DEA and other policymakers to ensure the proposed rule isn’t finalized, at least as it was originally presented.
Much of that advocacy will center around the safety and effectiveness of virtual behavioral health care involving controlled substances. Previous research has found that the use of virtual OUD treatment led to a lower likelihood of fatal overdose and had similar benefits to in-person care.
Other research finds that virtual services are associated with higher care retention and lower overdose rates. Further, there was no associated increase in overdoses related to the controlled substances used in OUD treatment with the increased access to those substances created by the PHE, federal government research found.
“Today, we are focused on advocating for the voices of our patients, clinicians, and [medications for opioid use disorder via telemedicine] treatment to help shape strong solutions,” Gupta said. “Bicycle Health plans to join others across the telehealth space and healthcare continuum at the DEA listening sessions in D.C. in September. Our patients deserve access to safe, easily accessible, effective treatment.”
Talkiatry, a virtual psychiatry company, will seek to present information to the DEA during its listening sessions. It intends to share its proprietary data and other proposals related to the special registration process. Those proposals will include strategies to prevent drug diversion and increase access to treatment.
The company’s CEO and co-founder, Robert Krayn, told BHB that controlled substances represent a minority of the medications Talkiatry’s providers have so far prescribed. Still, he said it’s essential that providers have the flexibility to act in the best medical interest of their patients.