APA Responds to DEA’s Proposed Rules Regarding Telehealth, Buprenorphine

On March 31 APA filed two letters with the U.S. Drug Enforcement Administration (DEA) in response to two proposed rules that if finalized would affect how health professionals implement telehealth services and prescribe certain controlled medications. The proposed rules, which were developed with the U.S. Department of Health and Human Services and in close coordination with the U.S. Department of Veterans Affairs and announced on February 24, would extend certain flexibilities in these areas after the COVID-19 public health emergency expires on May 11. Yet in several ways the proposed rules are more restrictive than what the public health emergency has allowed.

The first proposed rule (Docket No. DEA–407) would prohibit health professionals who offer telehealth services from prescribing Schedule II controlled substances such as methylphenidate (Ritalin), mixed amphetamine salts (Adderall, etc.), and opioid pain relievers (Vicodin, Oxycontin, etc.) and Schedule III-V narcotics other than buprenorphine without examining patients in person first. However, health professionals would be able to prescribe a 30-day supply for buprenorphine and non-narcotic Schedule III-V drugs such as benzodiazepines (Valium, Xanax, etc.) and prescription sleep aids (Ambien, etc.) without an in-person visit if the telemedicine appointment is for a legitimate medical purpose. Prescriptions for more than a 30-day supply would require an in-person visit.

In its response, APA recommended that the DEA balance common-sense safeguards for DEA enforcement without decreasing access to lifesaving treatment, stating that the requirement may cause the following three harms:

• It penalizes patients who face barriers to accessing care, such as inadequate or no health insurance and/or challenges with mobility and transportation.

• It may incentivize nonspecialist practitioners to treat complex conditions on their own rather than referring a patient to a specialist.

• It would create significant additional and unnecessary costs to the patient and the health care system by generating duplicative high-cost care rather than making appropriate use of community-based professionals.

The second proposed rule (Docket No. DEA–948) would expand the situations in which physicians may prescribe controlled substances through the internet for legitimate medical conditions even without an in-person evaluation as long as the medications have been approved for treatment of opioid use disorder (OUD) and the physician is able to conduct a patient evaluation. To date, buprenorphine is the only Schedule III-V medication approved by the U.S. Food and Drug Administration for this purpose. Nonetheless, this proposed rule would also create restrictions that were not in place during the public health emergency. Patients would either have to be examined in person by the physician within 30 days, have a referral from another practitioner, or the physician would have to examine the patient via telehealth while the patient is in the physical presence of another DEA-registered health professional.

In its response, APA recommended that the DEA remove the in-person requirements for the prescribing of buprenorphine for the treatment of OUD via telemedicine when clinically indicated.

“If the DEA does not permanently remove the in-person requirement for the prescribing of buprenorphine for the treatment of OUD via telemedicine, APA strongly encourages DEA to continue the waiver of the in-person requirement for the duration of the opioid [public health emergency],” APA wrote. “The flexibilities during the COVID-19 PHE have allowed practitioners to use clinical decision-making to determine when and how often to see a patient in-person, and we recommend that this flexibility continue.”

In both letters, APA also offered the following recommendations:

• Allowance for referring practitioners to not be registered with the DEA.

• Reduction in administrative requirements for referring and prescribing practitioners.

• Reduction in additional state-based registration requirements.

• Removal of clinical decision-making from regulation in these proposed rules.

• Clarification of key inconsistencies in the proposed rules.

The DEA provided a 30-day comment period for the proposed rules, which ended March 31. According to regulations.gov, the agency received more than 32,000 public comments regarding Docket No. DEA–407 and nearly 3,000 comments regarding Docket No. DEA–948 by the deadline. ■