Telemedicine, DEA, Congress and Ryan Haight
Updated: Jul 17, 2019
Published on KevinMD.com
Telemedicine. It should be easy.
Here’s why it’s not. Who was Ryan Haight? Ryan Haight was an 18 year old honor student from La Mesa, California who died February 12,2001, from an overdose of hydrocodone ordered from an online doctor he never saw - and shipped to his home from a rogue online pharmacy during the beginning of the opioidepidemic. The pharmacist, Clayton Fuchs, filled the online prescription and thousands more like it along with four doctors who authorized the prescriptions. All five were charged in 2002 and subsequently either pleaded guilty or were convicted several months later. The four doctors involved in the conspiracy were paid between $40 to $100 dollars for every prescription they approved online (sometimes reaching 200 or more prescriptions in one day) without meeting,examining or diagnosing any online patient.Prior to 2008, many rogue online pharmacies were distributing hydrocodone more than 30 times what a normal brick and mortar pharmacy was distributing in partnership with unscrupulous providers who were approving prescriptions online without ever establishing a valid doctor-patient relationship.
On October 15, 2008, President George W. Bush signed into law the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 which amended and added several provisions to the Controlled Substance Act to prevent the illegal distribution of controlled substances like opioids to adolescents and others for non-medical purposes by means of the Internet and telemedicine.
The law was composed of several parts but focused on two key areas.
First, the law focused on tighter regulations and registrations for anonymous rogue online pharmacies. Shortly after the law went into effect, these deadly and dangerous online pharmacies ceased to exist.
Secondly, the legislation mandated that an in-person medical evaluation be conducted by a medical provider at least once, if prescribing controlled substances by the Internet. The intent of this section was to prevent unscrupulous providers who had been approving hundreds of prescriptions a day by the click of a “mouse” from prescribing to those they had never a met,examined, took a medical history from or diagnosed.
For over 100 years federal law has required that all controlled substance prescriptions be issued only for a “legitimate medical purpose by an individual practitioner acting in the usual course of a professional practice.”
The Ryan Haight Act took effect on April 13, 2009 and DEA was charged with its oversight. The Act included seven telemedicine exceptions which included those for the Veterans Administration, Indian Health Services, and another exception called the ‘’special registration” which would be obtained by DEA once the agency determined the requirements through its rule making process.
Since this law took effect in the midst of the opioid epidemic, DEA never moved to create the regulations relative to the “special registration.” DEA is currently in the process of promulgating regulations to define this "special registration” requirement of the act.
It is expected that DEA will release these new regulations in the coming months, which likely will loosen the current telemedicine requirements for Schedule III through V controlled substances.Due to DEA’s regulatory charges enacted by Congress in 1973, namely preventing, detecting,and investigating the diversion of pharmaceutical controlled substances from legitimate sources while ensuring an adequate and uninterrupted supply to meet legitimate medical,commercial and scientific needs, it is unlikely that DEA will loosen the telemedicine regulations linked to Schedule II opioid drugs like hydrocodone and oxycodone given their potential for abuse, addiction and overdose death. Telemedicine and final thoughts Telemedicine is federally lawful now - as long as the provider has conducted at least one in-person medical evaluation of the patient.
The Ryan Haight act only applies to controlled substances. Approximately 90% of all manufactured drugs are uncontrolled.
Providers contemplating engaging in telemedicine should be aware of their state laws in addition to federal law and seek counsel from an attorney or their state medical association.
Telemedicine providers should incorporate the same medical policies and practices in their telemedicine practice as they do in their office setting.
Telemedicine providers whenever possible should follow national telemedicine guidelines tomitigate risk and ensure best practices.
With respect to the opioid epidemic, telemedicine providers should be cognizant that prescriptions opioids including buprenorphine continue to be the most diverted and abused narcotic drugs encountered by law enforcement and carry increased risks.
Lastly, those practicing telemedicine according to state and federal guidelines and prescribing only “for a legitimate medical purpose” and “in the usual course of a professional practice” should have no fear of DEA or any other oversight agency.
Dennis Wichern is a retired DEA Agent who now works to mitigate controlled substance risk for providers and hospital organizations worldwide.