Author: Matt Brockmeier, Emerge Of Counsel Attorney
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the Act) amended the Controlled Substances Act (CSA) to help prevent the illegal distribution of controlled substances on the internet. The Act required an in-person medical evaluation before prescribing or otherwise dispensing controlled substances online. It also established seven exceptions to that requirement, allowing practitioners to prescribe medications for a patient without first evaluating that patient in person. One exception allowed DEA to waive the in-person requirement during the COVID Public Health Emergency (PHE). During the pandemic several companies began providing large volumes of controlled substances via telehealth under that exception, including ketamine and Adderall. However, the exception it is set to expire on May 11, 2023, threatening the future of the nascent telehealth prescription industry.
Falling within the Act’s definition of the ‘‘practice of telemedicine’’ is ‘‘a practitioner who has obtained from the [DEA Administrator] a special registration under [21 U.S.C. 831(h)].’’ 21 U.S.C. 802(54)(E) contemplates that the DEA must issue regulations to effectuate this special registration provision. In 2017, under President Trump, DEA was statutorily instructed to finalize a rule on the registration’s application process and procedures. Disappointingly, as of this writing, DEA has yet to promulgate “special registration” rules, despite pleas from patients, clinicians, and the medical and business communities.
Analysts familiar with DEA’s intransigence and stall tactics predicted that the expiration of the PHE declaration would devastate the ketamine telehealth industry. In a surprise to most, including this author, on March 1 DEA issued a notice of rulemaking that would authorize telemedicine where 1) the prescribing practitioner has not conducted an in-person medical evaluation with the patient; 2) the prescription was issued pursuant to a telemedicine encounter and 3) the telemedicine encounter results in a prescription for controlled medications. There are some limitations, including that prescribing practitioners could only issue telehealth prescriptions for up to a 30-day supply, and there are labeling and recordkeeping requirements. Nonetheless, this is an encouraging development from an agency with a reputation for being dilatory and obstructionist, especially when it comes to making regulated medicines available to patients in need.