Lack of action by DEA could replace one public health emergency with another
WASHINGTON, DC, Oct. 20, 2022 – The founder of Done. Global Inc., a leading telehealth provider of services for people with attention-deficit/hyperactivity disorder (ADHD), joined renowned medical experts, patients, and a former member of Congress during a policy briefing to advocate for regulatory relief that would permanently allow some clinicians to prescribe medications online without the need to meet in person.
The “special registration” designation, a provision for providers seeking to prescribe controlled substances via telehealth, falls under the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 and has yet to be effectuated by the Drug Enforcement Administration (DEA) through the promulgation of implementing regulations. Generally, to prescribe controlled substances via telehealth a provider has to first have had an in-person encounter with the patient. However, the in-person requirement has been suspended during the declared federal Public Health Emergency but could be changed at any time. After 14 years of inaction, DEA submitted a draft regulation to the White House Office of Management and Budget on March 17, 2022, and no action has yet to be taken.
The briefing panelists included former Rep. Bart Stupak (D-Mich.), who represented Michigan’s 1st District from 1993-2011 and is now a Partner at Venable LLP; two congressional staffers; Dr. Zoe Martinez, Clinical Director for Done Health P.C. and board-certified psychiatrist from UCLA who previously worked at institutions like Kaiser Permanente; and the Founder of Done. Global Inc., Ruthia He.
“With more than 17 million people with ADHD in the U.S. and less than 30,000 psychiatrists to treat them, we hope to bridge the gap by providing a patient-first, technology-powered ADHD management platform that connects patients with psychiatric board-certified clinicians for services, including clinical consultations, chronic care management, and 24/7 care team support,” said He during her opening remarks. “As Americans and providers continue to see the benefits of telehealth, we are pleased to participate in this discussion about the vital role that platforms like Done have played in bridging gaps in access to high-quality care for patients across the United States. However, it would be disheartening to see that these patients we have helped would not be able to continue their care after the PHE [public health emergency] expires.”
The ability to prescribe medications without seeing someone in person is particularly critical for people living in remote parts of the country where medical access is difficult or even non-existent and for anyone who lives with physical disabilities or additional diseases, disorders, or behaviors that make it virtually impossible to leave their home and travel to a medical facility. He and others also referenced the fact that adults with ADHD are five times more likely to die by suicide in the absence of proper treatment.
“Telehealth has been groundbreaking for many patients who do not have easy access to doctors, never mind specialty providers,” said Dr. Martinez. “COVID may have provided a reason to loosen some restrictions, but the need for increased access was there long before that particular health crisis.”
Participants in the briefing also referenced a letter from May 2022 addressed to Anne Milgram, DEA Administrator, and signed by the bipartisan leaders of the Health, Communications & Technology, and Consumer Protection & Commerce Subcommittees of the House Energy and Commerce Committee. The letter implores the DEA to develop the requisite framework for designation of “special registration” and deems its inaction “unacceptable.”
Done. executives will also submit a letter to President Joe Biden to request immediate attention on this issue and present findings and testimonials from patients – in-person – that underscored the pressing need for the DEA to take action.
Silvia S., who works in healthcare, in her remarks at the briefing shared her experience with how difficult it is to find ADHD treatment. And Dave W., a working professional and briefing panelist, said that he struggled to find adult ADHD care in his state. When he learned that his daughter also has ADHD he described much of the medical advice they received as subpar before discovering Done.
Throughout its existence, Done. has adhered to stringent standards to ensure the safety of patients. Before seeing a clinician, all patients must complete screenings for current controlled substance use and clinically significant depression and/or anxiety. It is crucial for the potential patient to go on to the initial assessment by a board-certified or eligible psychiatrist or psychiatric mental health board-certified nurse practitioner.
If that clinician decides the potential patient can benefit from treatment, the clinician will prepare a treatment plan and may issue prescriptions (enough for 30 days) in accordance with state/federal regulations. Throughout their treatment, patients complete symptom reports and health tracking and go through regular monthly check-ins on the platform.
October is ADHD Awareness Month – the same month in which World Mental Health Day takes place. The message at this time from Done. and others is clear: the White House should release the draft regulation so the DEA can move forward with finalizing a “special registration” process so Americans can continue to receive fundamental access to mental-health treatment.
Done. is a digital health platform dedicated to empowering everyone living with attention deficit and hyperactivity disorder (ADHD) to reach their fullest potential. Through a patient-first, technology-powered ADHD treatment platform, industry-leading digital health company, Done. is making high quality psychiatric chronic care management more accessible and affordable for patients. To learn more about the platform, visit: DoneFirst.com.