DEA Temporarily Lifts Restrictions for Controlled Substances

Medicare Set-Aside Blog, Opioids, Rx/Pharmacy on April 29, 2020
Posted by Leah King, PharmD, JD, Independent Pharmacy Consultant

The COVID-19 pandemic has provoked a variety of responses from the federal government in addition to nearly every state government. On January 31, 2020, the Secretary of HHS declared a public health emergency due to COVID-19. In turn, this declaration prompted the DEA to identify steps it could take to ensure the public’s continued access to necessary medications. In March, the DEA posted an announcement on its website, alerting the public that it was temporarily allowing DEA-registered practitioners to issue prescriptions for controlled substance prescriptions following a telemedicine evaluation. This practice is permitted to continue for as long as the COVID-19 public health emergency exists.  

The requirement for healthcare practitioners to conduct an in-person medical evaluation before prescribing controlled substances arises from the Ryan Haight Online Pharmacy Consumer Protection Act of 2008. The DEA is responsible for ensuring compliance with the act. On its website, the DEA has communicated that it is temporarily permissible to prescribe a controlled substance following a telemedicine call if the following conditions are met:

  • The prescription is written for a legitimate medical purpose by a healthcare practitioner acting in the usual course of his or her professional practice;
  • The telemedicine communication is conducted using audio-visual, real-time and two-way interactive communication features; and
  • The practitioner is acting in accordance with all applicable federal and state laws.

If all of the above criteria are satisfied, then the healthcare practitioner is permitted to issue the prescription using any of the methods currently allowable under DEA regulations, such as electronic prescription or telephonic prescription.[1]  

In early April, the DEA also announced an increase to aggregate production quotas for certain schedule II controlled substances which are applicable to pharmaceutical manufacturers. The increased quotas will allow pharmaceutical manufacturers to produce higher quantities of certain drugs, if the circumstances call for such higher quantities. The DEA has taken this step to ensure an adequate supply of controlled substances which are currently in high demand due to the COVID-19 pandemic. These controlled substances include fentanyl, morphine, hydromorphone, codeine, ephedrine, pseudoephedrine and other compounds which are necessary for the production of semi-synthetic and synthetic opioids.

In addition to increases to production quotas, the DEA has also indicated that it will allow higher amounts of schedule III and IV controlled substances to be imported into the United States. These substances include ketamine, diazepam, midazolam, lorazepam and phenobarbital. These medications are sometimes used in the treatment of ventilator-dependent patients, such as those who are suffering with COVID-19. After the COVID-19 pandemic has subsided, it is anticipated that both production quotas and allowable import quantities will return to normal levels.[2]

Both of the interim steps are beneficial to patients across the United States, including workers’ compensation claimants. These temporary measures instituted by the DEA will help to prevent interruptions in prescription drug therapy that may have otherwise resulted from a drug shortage or the inability to have an in-person office visit with a provider.