Uncertainty around several COVID-era regulations and unresolved legislative questions has precipitated real world-impacts on behavioral health operators, especially addiction treatment providers.
Specific questions around telehealth and the prescribing of controlled substances threaten the burgeoning crop of digital behavioral health operators that have thrived during the loosened regulations. Further, lingering questions about access to care via Medicaid hang over traditional addiction treatment providers as a potentially major threat to revenue and patient access.
Medicaid is the single largest payer for behavioral health services, according to the Centers for Medicare & Medicaid Services (CMS).
During the COVID-19 pandemic, the federal government temporarily lifted the Ryan Haight Act’s mandate that providers facilitate an in-person assessment before prescribing controlled substances as part of the public health emergency declaration (PHE).
Key medications in behavioral health are controlled substances. This list includes buprenorphine, a vital treatment in addiction treatment, for opioid use disorder (OUD); the brand-named ADHD drug Adderall, which is mixed amphetamine salts and a potent stimulant; and alprazolam, better known as Xanax. All are listed as controlled substances by the Drug Enforcement Administration (DEA).
Companies have prepared for the potential end of the PHE in different ways. San Francisco-based mental health startup Cerebral Inc., for example, canned nearly all of its controlled substances following a storm of criticism around its prescribing practices while citing concerns about the end of the PHE.
The end of the PHE opens several questions for telehealth which several executives in the space tell BHB has and will continue to define the behavioral health industry.
Virtual addiction treatment providers struggle with retail pharmacies
Major retail pharmacy operators including Walmart Inc. (NYSE: WMT) and CVS Health Inc. (NYSE: CVS) have tightened the reins on telehealth prescriptions for controlled substances.
These revelations, first reported by Fierce Healthcare, come at a time when several of these retail pharmacy operators find themselves on the wrong side of judgments and settlements over their handling of opioid painkillers.
On Sept. 20, West Virginia Attorney General Patrick Morrisey announced settlements with CVS Health and Walmart that total $147 million.
“There is a lot of concern and anxiety around what’s going to happen,” Emily Behar, vice president of clinical operations for Ophelia Health, told Behavioral Health Business.
The New York City-based virtual addiction treatment provider has always had a rocky experience with Walmart and discourages its patients from having prescriptions filled there, Behar said.
Ophelia Health is a digital MAT provider that operates in 14 states. It was founded in 2019 and that offers subscription services and works in-network with payers.
Recently, Ophelia Health has run into Walmart’s in-person assessment requirements for controlled substances.
“Walmart does not have a policy to refuse to fill telehealth prescriptions of controlled substances,” Walmart spokesperson Marilee McInnis told BHB. “Walmart requires in-person exams within two years for telehealth prescriptions for controlled substances. Walmart pharmacists are empowered to use their professional judgment when considering whether to fill any prescription.”
This is more stringent than is required presently by federal regulations, Behar points out. Virtual addiction treatment providers like Ophelia Health have thrived during the pandemic era regulations and garnered major venture-based investment rounds.
“There is a lot of concern and scrutiny of telehealth providers, which I understand and respect. It is good to make sure that … telehealth is not the Wild West,” Behar said. “But I think that there are undue fears that can also come with this because we and many other telehealth practitioners have been practicing for a number of years now with a tremendous amount of success.”
CVS Health pharmacies have become more selective over the last few months, especially in Pennsylvania, Behar said, even though they have not been able to get a specific answer on if this is the result of local policies or policies developed by corporate leadership.
A CVS Health spokesperson didn’t answer specific questions about if it has a policy on filling controlled substances prescriptions from virtual behavioral health providers.
CVS Health has previously decided whether to work with telehealth companies on an individual basis. CVS no longer accepts controlled substance prescriptions from Cerebral and the virtual mental health startups Done Global Inc. and Medvidi.
Mike DeAngelis, executive director of corporate communications for CVS, said it was “[a]s a result of our being unable to resolve concerns we had,” in an email.
Both Done and Medvidi market telehealth therapy and medication for ADHD. Done specializes in ADHD treatment while Medvidi treats other mental health conditions.
“We are committed to making mental health services as accessible and convenient as possible,” DeAngelis said. “At the same time, it is important that medications are prescribed appropriately.”
Both Done Global and Cerebral are reportedly under federal investigation.
Dealing with the uncertainty
Telehealth proponents argue that many patients who seek addiction treatment care virtually do not disclose their condition to primary care providers. About 80% of Ophelia Health’s OUD patients are either not engaged with the health care system or do not disclose their addiction to their provider, Behar said, adding that simply assuming that people will get in-person exams from a primary care provider is flawed.
“What we want is for pharmacists and pharmacies to be on the same team with us,” Behar said. “But they can also prove to be really strong barriers for us.”
The resumption of the Ryan Haight Act’s in-person requirements would require a fundamental shift in Ophelia Health’s operating and clinical model to accommodate office visits.
To deal with the uncertainty, Ophelia Health has focused on putting out as much data as possible to try to sway policymakers to enumerate COVID-era regulations and making contingency plans for if the PHE and related regulations end, Behar said.
This contingency planning includes plans to connect patients with in-person evaluations, Behar said. Ophelia Health CEO Zack Gray told BHB in a previous interview the company would likely partner with local providers, especially in rural areas, and consider opening offices in more densely populated areas.
Ophelia Health has had some regulatory near-misses at the state level.
“We’ve gone through two fire drills in Pennsylvania, where Pennsylvania has said that their ruling is going to expire twice now — requiring in-person exams again. Pennsylvania is one of our largest operating states,” Behar said. “We’ve gone up until the 11th hour where they say, ‘Oh no, we’re extending it.’”
Resolving the uncertainty requires enough political will and capital to get statutory changes to the Social Security Act through Congress and past Pres. Joe Biden, Christopher Eades, a shareholder with health care law firm Hall Render focused on virtual care and medical staffing, told BHB.
What telehealth changes have been enumerated by Congress and executive agencies at the federal level are largely tied to Medicaid and still aren’t permanent.
The Consolidated Appropriations Act 2022, enacted in March, allows for compensation for tele-behavioral health for Medicare patients and the origination of telehealth visits in their homes to extend 151 days, or about five months, after the end of the PHE.
The Advancing Telehealth Beyond COVID-19 Act of 2022, which has already passed the U.S. House of Representatives and is sponsored by outgoing Wyoming Republican Rep. Liz Chaney, would extend Medicare telehealth flexibilities to the end of 2024.
The uncertainty at the federal level spawns greater variability in regulation across the 50 states and territories, adding to the challenges of multi-state operators, Eades said.
“At the top of my list is where we will be with Medicare reimbursement across the board — that’s going to drive a lot of everything else we see in terms of reimbursement,” Eades said of specific concerns.
He also pointed to the potential problem of the DEA finally coming through with a special telehealth registry for providers that want to prescribe controlled substances that it was mandated to create by October 2019.
“Will the DEA special registration look anything like the current COVID-specific exception that the DEA has put in place for purposes of the pandemic?” Eades said, adding that the registry could send telehealth backward if it is based on a pre-COVID world. “That will create significant obstacles in terms of utilizing virtual care to the extent those encounters involve a controlled substance prescription.”
OTPs holding out hope for telehealth changes
While Scottsdale, Arizona-based Community Medical Services saw telehealth rates jump to as high as 90% during the onset of the pandemic for behavioral health services, it doesn’t have the same reliance on telehealth flexibilities of the virtual startups in the space.
The opioid treatment program (OTP) facility operator, a specific type of care provider recognized by the U.S. Substance and Mental Health Services Administration (SAMHSA), is legally required to have patients come into the office for certain services such as the administration of methadone, a highly regulated opioid used to treat OUD.
OTPs have also had some COVID-era flexibilities temporarily extended beyond the PHE.
“There was not much uncertainty around the telehealth piece [for Community Medical Services],” Nick Stavros, CEO of Community Medical Services, told BHB. “There are not many limitations on us doing telehealth.”
In June, SAMHSA announced that OTPs can continue prescribing buprenorphine through telemedicine without requiring patients to come in for an in-person medical visit for up to a year.
The federal government has also allowed OTPs to offer periodic assessments, counseling and therapy services via telehealth, specifically audio-visual chats, and allowed for audio-only chats during the PHE. Post-PHE, audio-only calls will no longer be allowed, according to the 2022 Physician Fee Schedule final rule.
The greater worry for Stavros is the potential for millions of patients that may be forced off Medicaid plans with the resumption of the Medicaid eligibility determinations the federal government mandated that states pause during the pandemic.
As many as 15 million people nationwide are projected to lose Medicaid coverage post-PHE, according to a report by the U.S. Health and Human Services Assistant Secretary for Planning and Evaluation.
“That’s our biggest fear,” Stavros said. “There’s no way to tell for us how many of our patients are at risk of falling off of Medicaid. That’s something we’re trying to understand and play an active role trying to make sure we’re doing our part communicating with patients and helping facilitate them getting coverage.”
For years, OTPs have sought clearance from the federal government to conduct initial exams and intakes for methadone via telehealth. Even during the pandemic, SAMHSA didn’t make that an option. Making this regulatory change is a top hope for Stavros.
Making it easier to start methadone treatment is especially relevant because of the rise of fentanyl overdose deaths. About two-thirds of the record-setting 108,000 drug overdose deaths in the 12 months ending in May involved synthetic opioids like fentanyl.
Methadone is the best understood and arguably the most effective medication in treating OUD, according to a study by the University of Washington. It is also the best medication for treating OUD patients using fentanyl, Stavros said.
However, it doesn’t typically see the same efficacy that it sees with less potent forms of opioids. Buprenorphine, another staple of treating OUD, also pales in treating fentanyl.
“The two most effective tools we have for fighting opioids are less effective for fighting and fentanyl right now,” Stavros said.
The greater worry for Stavros is the potential for millions of patients that may be forced off Medicaid plans with the resumption of the Medicaid eligibility determinations the federal government mandated that states pause during the pandemic.
As many as 15 million people nationwide are projected to lose Medicaid coverage post-PHE, according to a report by the U.S. Health and Human Services Assistant Secretary for Planning and Evaluation.
“That’s our biggest fear,” Stavros said. “There’s no way to tell for us how many of our patients are at risk of falling off of Medicaid. That’s something we’re trying to understand and play an active role trying to make sure we’re doing our part communicating with patients and helping facilitate them getting coverage.”
Companies featured in this article:
Community Medical Services, CVS Health, Hall Render, Ophelia Health, Walmart
