Congress Presses Federal Action to Update Remote Prescribing of Controlled Substances Policy
December 20, 2018
By: Libby Baney, Megan Herber, and Matthew Rubin, Faegre Baker Daniels Consulting
Many consumers, health systems, and technology-focused health care companies have embraced the potential of telehealth services as a way to improve patient outcomes and reduce costs of health care. Getting care remotely can be more convenient, enhance access to specialists that otherwise would not be available, and ensure that conditions are managed in a timely – and often non-urgent – manner. Due to the potential of these technological interventions, Congress and the Department of Health and Human Services have taken a number of actions in federal telehealth policy in 2018 that will be implemented next year and in years to come.
One such policy action related to the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 will have a direct impact on remote prescribing of controlled substances (CS) as regulated by Drug Enforcement Administration (DEA). The Ryan Haight Act was enacted in 2008 to address rampant illegal internet drug sales in the 1990s and 2000s. To restrict illegal internet drug sales, the bill requires a valid prescription – issued for legitimate medical purposes following at least one in-person evaluation – for a CS to be delivered, distributed, or dispensed by means of the internet.
Recognizing that there may need to be exceptions to the in-person evaluation requirement for the purposes of legitimate prescribing via telemedicine, the law specifies a few limited scenarios for which the in-person requirement does not have to apply. The main exception requires first that the remote prescribing practitioner be licensed in the state where the patient resides and registered with DEA to dispense CS (even though the practitioner is not a pharmacist). Secondarily, the exception requires that the patient be in a hospital or clinic that is also licensed in the state and registered with DEA to dispense CS when the telemedicine prescription occurs.
This is a very narrow and limited exception given that some practitioners may prescribe CS, but not dispense them in their normal course of practice. Similarly, patients who need a prescription via telemedicine would likely not have access to a hospital or clinic that is licensed to dispense CS. Otherwise, they would just obtain the prescription at that location.
Stakeholders have been pushing DEA for years to implement another exception outlined in the Ryan Haight Act that would create a special registration process for legitimate actors who are not already able to register with DEA for the purpose of remote prescribing. This exception could expand access to needed treatment, such as medication-assisted treatment to treat opioid use disorder, while maintaining DEA’s strict oversight of prescribers and ability to prevent diversion. Recognizing this, Congress used the comprehensive opioid legislative package passed in October 2018, H.R. 6, to require DEA to write rules to implement the provision by October 2019.
It remains to be seen exactly who will be eligible to participate in this special registration process and how DEA will ensure that patients with legitimate medical need, and providers otherwise licensed to practice and prescribe, will be able to use telemedicine for this purpose.
If, in fact, this provision is successful in expanding access to prescribers of CS, DEA-registered pharmacies will be the ones dispensing the medication to patients with a legitimate prescription.
Efforts such as this highlight the growing use of the internet and technology to improve accessibility and utilization of health care services, as seen through NABP’s .Pharmacy Verified Websites Program. With this increased reliance, health care providers and patients alike must ensure that the resources leveraged for both the identification and delivery of care work to ensure public health and patient safety.