The Public Health Emergency is ending — now what?
The rollback of telemedicine flexibilities for controlled substances and what that means for digital health startups
In a statement made on January 30, the Biden administration announced that the COVID-19 public health emergency (PHE) will officially end in May. For many, this signals the termination of a period that we can’t wait to put behind us. However, for some who work in healthcare, May 11 might mark the beginning of the end.
Without question, COVID wreaked havoc on the economy and took a devastating toll on families everywhere — particularly those who lost jobs and loved ones to the virus. But it also forced the world to innovate.
In particular, the healthcare sector underwent a perceptible transformation.
Although there were initial efforts to digitize the healthcare industry prior to COVID, heavy regulations and a lack of infrastructure readiness (read: tech adoption) prevented healthcare companies from achieving meaningful transformation. The pandemic changed this overnight.
In addition to patients and doctors becoming more comfortable with at-home diagnostics, new regulations were put in place to increase awareness and adoption of telemedicine, making it easier for practitioners to provide care remotely. An ancillary benefit, this change made healthcare more accessible and affordable than ever before.
While some of these telehealth flexibilities have been made permanent, others are temporary and set to expire on May 11, when the Public Health Emergency officially comes to an end. These changes, some argue, will pose existential threats to the behavioral health system and the many startups that have since been founded to support it.
The Ryan Haight Act
Among the most transformational flexibilities set to expire include the relaxation of the 2008 Ryan Haight Act, temporarily waiving the in-person exam requirement needed for practitioners to prescribe controlled substances. This change spawned a new wave of innovation in 2020+ as D2C telemedicine startups began cropping up to service patients with depression and anxiety (via oral Ketamine and Xanax), ADHD (via Adderall, Ritalin, and Vyvanse), Opioid Use Disorder (via Buprenorphine), insomnia (via Ambien), and hormone replacement therapy/gender-affirming hormone therapy (via Testosterone).
Under the new proposed rules, Schedule II drugs will require an in-person prescription, while Schedule III or higher medications can be prescribed for an initial 30 days via telehealth, but would require an in-person evaluation before a refill. Public comment about these proposed rules will remain open for 30 days (due March 31), after which point the DEA will make a final decision about adopting them.
A secondary, albeit preventable, public health crisis
Should these rules take effect, doctors estimate that they will not be able to take on new patients for six to nine months as they catch up with having to see existing patients who they’ve never seen face to face, explained Dr. Joel Young, medical director of the Rochester Center for Behavioral Medicine, in a recent interview. “This is going to be devastating and the cost will be significant, particularly for adolescent mental health.”
Like Young, the PHE flexibilities enabled clinicians nationwide to expand their services to rural areas and take on greater caseloads made possible by more flexible working hours. These changes did wonders for improving access, affordability, and quality of care for patients while also improving the quality of life for doctors.
In light of these benefits, a number of industry groups, including the American Hospital Association (AHA) and American Telemedicine Association (ATA), have spoken out against the proposed rules, calling them unnecessarily restrictive and counter-progressive.
“Our concern lies with the potential public health crisis this could cause for individuals needing access to clinically appropriate prescriptions of controlled substances for a wide variety of medical circumstances, including for mental health and substance use disorders,” said ATA’s senior vice president Kyle Zebley in a press release. “The continuity of care for countless Americans will be severed, potentially leaving these patients to fall through the cracks of our healthcare system without access to needed medications.”
To paint the picture more clearly, in addition to expanding access to patients in rural “care deserts,” these telehealth flexibilities have also benefitted low-income Americans, many of whom work hourly jobs and cannot sacrifice time off for in-person appointments during regular business hours.
Flexibilities have also benefitted college students — the fastest growing population diagnosed with mental and behavioral health disorders — who have taken advantage of telehealth’s ability to offer greater care continuity regardless if they are at home or at a school out of state.
Serving this important need, Caraway is a Gen Z-focused virtual care platform providing mental, physical, and reproductive care for teen and college-aged patients, including prescription psychiatry services. However, they have not yet dipped their toes into controlled substances (e.g., stimulants for learning differences, testosterone for gender-affirming, or otherwise) due to the looming need for in-person examinations.
In short, the PHE flexibilities leveled the playing field for people who didn’t have specialists in their area or whose schedules or occupations didn’t allow them to visit such specialists during normal business hours. Not to mention, added travel can be dangerous, costly, and generally burdensome for people with comorbidities, who live far away, or who don’t own a car (as with many college students and low-income Americans).
In line with these concerns, the Drug Enforcement Agency is rumored to be issuing a rule outlining how practitioners can register to waive the in-person requirement. But this proposal has been stuck in regulatory review since March 2022, according to the Office of Management and Budget.
Why backpedal progress?
According to the DEA, the new rule aims to provide safeguards to prevent online over-prescribing of controlled medications, which has been a greater concern as of late — particularly within the behavioral and mental health sectors.
Recent exposés on Ketamine assisted therapy in the Washington Post and the New York Times outline concerning potential side effects of prolonged use, including bladder issues and addiction, to name a few.
While these risks are often not discussed by doctors and scientists (given they are typically associated with unregulated, recreational usage of the drug), more stories about their prevalence in legitimate cases are making their way to headlines.
I found The Times’ piece particularly enlightening in this regard, as it recounted a variety of perspectives from more than 40 patients who received access to the drug through telehealth, two dozen medical professionals, and a handful of scientific studies, case reports, and data from researchers, government agencies, and private analytic firms.
Notably, one of the doctors interviewed said that of the roughly 3,000 patients he has treated with Ketamine across 44 states, only two or three have misused the drug and that he was able to get them help.
Patient interviews, on the other hand, showcased a different perspective. Most interestingly, three patients of the same doctor told The Times that they abused their prescriptions and concealed it from their doctor for fear of having their Ketamine revoked. Two of them had issues so severe that they required care from a urologist.
Other stories outlined in the article present similar examples of patient deception for fear of losing access to the only treatment that had ever helped. In one story, a Utah-based man said that his using a catheter every day was a small price to pay for a drug that saved his life.
Although this story speaks volumes to the efficacy of Ketamine in treating depression, it also shines a wary light on the less-discussed potential downsides and the difficulty in monitoring patient symptoms from afar, especially without access to a complete care continuum.
All said, who’s to say patients won’t continue to conceal adverse side effects when meeting with a medical practitioner in person or after receiving a referral? If people are truly becoming addicted to controlled substances, the channel through which the evaluation takes place seems irrelevant so long as the patient maintains that they are functioning normally.
Will pulling back telehealth flexibilities really move the needle in stopping this behavior, or should the solution be more about remote patient monitoring and creating a patient-centered medical home (PCMH)? I.e., Delivering high-quality, cost-effective care using a patient-centered, culturally appropriate, and team-based approach?
What’s Next?
As providing care becomes more restrictive and in-person examinations become necessary for receiving treatment, telehealth startups will face existential questions about their future. Some include: How will we incorporate in-person evaluations or build the referral network necessary to maintain our core value propositions (access, affordability, and convenience)? And does this mean our core value proposition will change?
Resilient operators — who have been working with referral practitioners from the beginning, who have always taken the time to conduct a detailed intake, who keep copious notes about their patients’ medical journeys, and/or who have incorporated four-wall into their long-term business strategy — might be able to circumvent the changes enough to stay afloat.
Others, including defamed Cerebral, are already admitting defeat. Cerebral recently announced that it will be closing doors on its Opioid Use Disorder (OUD) program and laid off another 15% of staff. This news comes shortly after the business was put on blast for prescribing depression medication to an under-aged patient who later committed suicide and spending heavily on social-media ads for stimulant prescriptions for ADHD.
Other businesses in the OUD category remain hopeful. Zack Gray, CEO and co-founder of Ophelia Health, said the company believes the government will make the Ryan Haight waiver permanent beyond the public health emergency for buprenorphine, which is a Schedule III substance used for opioid use disorder. It could also tie the waiver to the open-ended opioid public health emergency rather than the COVID public health emergency, which expires this May, Gray said in an interview.
Another promising signal, a new collaboration between Bicycle Health, Wellpath, and the Federal Bureau of Prisons will provide virtual OUD services to incarcerated patients in 42 states, further proving that the digitally-native medication-assisted treatment (MAT) model for OUD is here to stay.
Ketamine Assisted Psychotherapy (KAP) and testosterone therapy for gender-affirming care and/or general hormone replacement may not be as lucky.
Regardless of the regulatory outcome, one thing is for sure — telehealth companies everywhere are taking a hard look at their business models and reassessing how to move forward with critical speed.
Moving into the future, it will be essential for clinics, startups, and providers across the country to monitor their patients closely (looking for warning signs), mind recommended protocols, incorporate a more fulsome care continuum with relevant doctors, and prioritize patient well-being over profits.
All opinions and views expressed are my own and are current as of the date of this writing. My content is for informational purposes only, and does not constitute or imply endorsement of any third party’s products or services, nor should it be considered investment advice.
