On October 24, 2018, President Trump signed the Special Registration for Telemedicine Act of 2018, Public Law No. 115-271 (Special Registration Act) into law, which has the potential to expand medical providers’ ability to prescribe controlled substances via telemedicine.
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (Ryan Haight Act), a federal law, has governed the prescription of controlled substances via telemedicine since it took effect on April 13, 2009. The Ryan Haight Act prohibits the prescription of controlled substances via telemedicine to patients in their home—unless the patient had at least one prior in-person medical evaluation with the physician or met one of seven narrow exceptions. Among the exceptions, the “special registration” exception provides for the most flexibility and allows certain practitioners to obtain a special registration with the United States Drug Enforcement Agency (DEA) to prescribe controlled substances via telemedicine to patients in their homes and other locations. However, since the signing of the Ryan Haight Act in 2008, the DEA has not implemented the special registration exception and essentially caused the law to become overly restrictive.
Although, across the country, a number of states have passed laws that would permit prescribing controlled substances via telemedicine (in the home and other locations not currently permitted under the Ryan Haight Act), prescribers must still consider compliance with federal law. For example, in Connecticut, Senate Bill 302, recently passed in June, allows for the prescribing of Schedule II and III controlled substances via telemedicine for patients with psychiatric and substance abuse disorders. The changes associated with the Special Registration Act may give states, such as Connecticut, more flexibility to effectively implement less-restrictive telemedicine and controlled substance laws.
Similarly, it is important to note that some state law requirements may be more stringent than federal law. Currently in New York, the Office of Alcoholism and Substance Abuse Services (OASAS) telepractice standards require that all patients “have at least one in-person evaluation session with clinical staff prior to participation in telepractice . . .” Although the new Special Registration Act may provide prescribers with more flexibility, if a state law is more restrictive than the federal law, physicians in that state must consider obligations to comply with the more-restrictive state provisions. We recommend working with counsel to analyze the interplay between the state and federal laws and regulations.
The Special Registration Act amends the “Special Registration for Telemedicine” provision (21 U.S.C. § 311(h)(2)) and requires that the “limited circumstances in which a special registration under [section 311(h)] may be issued” and “the procedure for obtaining a special registration under [section 311(h)]” are promulgated by the attorney general, in consultations with the secretary of the Department of Health and Human Services, within one year of its enactment. Congress established three general requirements practitioners must meet to use the special registration to deliver, distribute, dispense or prescribe controlled substances via telehealth. Practitioners must:
It is not yet known how “legitimate need” will be interpreted, which will have a significant impact on the breadth of the special registration exception.
Throughout the lawmaking process, advocates have supported the Special Registration Act and urged the DEA to expand prescribers’ abilities to prescribe controlled substances—including medication-assisted treatments—via telemedicine as a means to combat the opioid epidemic. It is not yet clear if the exception will be focused on expanding access to opioid addiction treatment or will be broader in scope.
Nixon Peabody will continue to monitor the rulemaking activity associated with the special registration exception and will provide subsequent alerts as the regulations develop.
The foregoing has been prepared for the general information of clients and friends of the firm. It is not meant to provide legal advice with respect to any specific matter and should not be acted upon without professional counsel. If you have any questions or require any further information regarding these or other related matters, please contact your regular Nixon Peabody LLP representative. This material may be considered advertising under certain rules of professional conduct.