MedCity Influencers, Legal

Reading Between the Lines of the DEA’s Proposed Rules on Telemedicine

In some ways, the Drug Enforcement Agency’s (DEA) proposed rules for prescribing controlled substances via telemedicine are a sign of progress. Behavioral health could be getting some much-needed clarity, but at what cost?

The unprecedented expansion of telehealth and mental health care during the pandemic was a monumental shift for behavioral health care in more ways than one.

The flexibilities for behavioral health visits that resulted from the government’s Covid-19 public health emergency (PHE) declaration meant patients could more easily meet remotely with licensed clinicians at their convenience. These telehealth flexibilities enabled millions of virtual psychiatry and therapy sessions that have been an essential lifeline for adults and children.

These changes, fortunately, came at a time of tremendous need for individuals struggling during the pandemic, and unfortunately, that need is still very present today. According to a Kaiser Family Foundation and CNN survey, as many as 90% of adults believe the country is suffering from a mental health crisis. People identified the opioid epidemic, mental health issues in children and teenagers, and severe mental illness as crisis-level concerns.

And yet, the behavioral health community and patients are bracing for the re-introduction of requirements that will hinder treatment and present significant barriers to being legitimately prescribed essential medications.

In February, the DEA proposed permanent rules for the prescribing of controlled medications via telemedicine. A significant concern is that the rules will require an in-person exam in addition to telemedicine exams for any prescribing of controlled substances, including medications commonly used to treat substance use disorder, anxiety, and ADHD in children. With a continuing psychiatrist shortage and more than 150 million Americans living in federally designated mental health professional shortage areas, this change means the stakes couldn’t be higher for mental health clinicians and patients everywhere.

Removing barriers for clinicians and patients

The in-person requirement will limit access for rural and underserved communities with inadequate access to in-person providers without the substantive burden of distance, financial status, health insurance, childcare, and transportation. These rules are contrary to the recommendations of the bodies that create the clinical best practices for psychiatry, the American Psychiatric Association and the American Academy of Child and Adolescent Psychiatry.

The comment period is now closed, and the consensus in behavioral health circles is that there is a high likelihood that these proposed rules will become final. On one hand, it is essential to recognize that these rules represent progress: the DEA is giving mental health prescribers a clearer pathway for approved teleprescribing. The proposed rules provide greater clarity amid a gray area the industry has been operating in since 2008.

The Ryan Haight Online Pharmacy Consumer Protection Act was passed by Congress in 2008 to stymie the growth of rogue online pharmacies. At that time, unsafe and irresponsible prescribing was on the rise, and the legislation limited prescribing of controlled substances without an in-person examination first. The Ryan Haight Act largely accomplished the primary goal of curtailing the activities of rogue internet pharmacies, but it also brought unintended consequences that inhibited the adoption of telemedicine. Between 2008 and the beginning of the PHE in 2020, legitimate mental health prescribers were extremely limited in how they could work via telemedicine because they had no clarity from DEA on how to legally prescribe via telemedicine and were forced to operate in a legal gray area, despite following best practices and clinical standards from their professions.

The good news today is that these recently proposed regulations clarify that gray area, but they do it in a way that unnecessarily limits some clinical best practices. And to make matters worse, the proposed rules also make compliance more complicated, requiring clinicians to complete multiple redundant state registrations with the DEA. At a time of significant shortages of licensed psychiatrists and prescribers, why is the agency choosing to implement processes that will make access to treatment more difficult?

Telehealth adoption has expanded rapidly and proven to be effective. In addition to the thousands of public comments that have been submitted to the DEA, more than 70 organizations have previously asked to permanently remove the prior in-person requirement and restrictions on the location of the patient being treated. Despite this unified front, and data showing telehealth expanding patient access, the DEA is still choosing an overly conservative approach that will put up more barriers and potentially do more harm than good.

Proposed rules may limit mental health care for youth

The recent proposal by the DEA is particularly limiting to the practice of child psychiatry. It places a unique and heavy requirement that the in-person examination must occur before prescribing stimulants to children and adolescents through telehealth. This requirement is very impractical because of how scarce qualified child psychiatric specialists are. It is not uncommon for families to wait up to six months to secure an initial appointment with a child psychiatrist. Telemedicine can reduce that wait significantly. However, under this new rule, a fully remote child psychiatrist cannot initiate standard treatment in that first session and must instead refer the patient for an in-person exam, which likely just results in a referral back to the original remote psychiatrist, and a hope that another appointment is available.

Beyond being impractical and a poor use of a very scarce resource, this proposed requirement will also exacerbate existing health disparities. Children and adolescents from marginalized communities, who are already less likely to have access to mental health care, will be disproportionately affected by this requirement. Families who lack transportation or live in rural areas may struggle to find a clinician who can perform the necessary examination, leading to delays in treatment and potentially long-term negative consequences for their mental health.

The Covid-19 pandemic has highlighted the importance of telehealth in providing access to care, particularly for individuals who live in areas with limited resources. While likely well intended, as currently proposed, the in-person examination requirement is a step backward in expanding access to telehealth for mental health care, particularly for children and adolescents. We urge the DEA to reconsider this proposal and work to ensure that all children and adolescents have access to the mental health care they deserve.

Photo: sorbetto, Getty Images

Geoffrey Boyce is the CEO of Array Behavioral Care, the leading telepsychiatry service provider in the U.S., with a mission to transform access to quality behavioral health care. Boyce is a leader in telemedicine advocacy, education and reform initiatives. He serves as a national voice promoting telemedicine and telepsychiatry and regularly interacts with state and local healthcare regulators and administrators. Boyce is an active participant in several ATA Special Interest Groups and Workgroups including: the Telemental Health SIG, the Interstate SIG, the controlled substances prescribing and telehealth workgroup and the proposed workgroup on the expatriate telemedicine providers. He also serves on the advisory board of directors for the Mid-Atlantic Telehealth Resource Center (MATRC). Boyce frequently speaks about the potential of telemedicine and the best practices for establishing new programs.

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