The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “Ryan Haight Act”) was enacted to amend the Controlled Substances Act to crack down on online prescribing of highly addictive substances, especially to teenagers and young adults, and impose stricter regulations on the use of telemedicine to prescribe controlled substances. When the pandemic hit in 2020, however, many of the requirements in the Ryan Haight Act were suspended due to the public health emergency (the “PHE”), allowing providers to prescribe controlled substances to new patients without an in-person exam. 

With the end of the PHE occurring in just two weeks on May 11, 2023, the Drug Enforcement Agency (“DEA”) has stepped in with a new Proposed Rule (the “Rule”) to phase out the PHE waivers and establish a post-PHE standard for prescribing controlled substances via telemedicine. The Ryan Haight Act currently recognizes seven exemptions from the in-person evaluation requirement, where telemedicine is practiced through (1) treatment in a hospital or clinic; (2) treatment in the physical presence of another DEA-registered practitioner; (3) treatment by Indian Health Service or Tribal practitioners; (4) treatment during a PHE; (5) treatment by a practitioner with a “special registration”; (6) treatment by a Department of Veterans Affairs practitioner in a medical emergency; and (7) other circumstances specified by regulation. The Rule would create a circumstance under the seventh exemption and would create two new options for telemedicine providers prescribing controlled substances: 

1. Initial Prescriptions:

Providers will be allowed to issue an initial 30-day prescription for a non-narcotic Schedule III-V controlled substance without an in-person exam. A 30-day prescription of buprenorphine as used in the treatment of opioid use disorder may also be issued without an in-person exam. However, before any additional prescribing can occur, the patient must have an in-person exam. 

2. Qualified Telemedicine Referrals:

If a provider receives a referral and conducts a telemedicine exam for a patient who received an in-person exam from a DEA-registered referring provider, they may prescribe controlled substances, including Schedule II-V and narcotic drugs, without an additional in-person exam. 

Additionally, for patients who established a telemedicine relationship during the PHE (i.e., sometime between March 16, 2020, and May 11, 2023), the in-person exam waiver will be extended an additional 180 days. After the 180 days, any additional prescribing will require an in-person exam. 

While these requirements are stricter than what has been required during the PHE, they do provide more flexibility for telemedicine providers than the Ryan Haight Act. The comment period for the Rule closed March 31, 2023, and the DEA has received over 2000 comments on the Rule. Provider concerns include decreased access to mental health and substance abuse treatment and a “telemedicine prescription stigma” that could cause pharmacies to decline to fill telemedicine prescriptions, causing delays and harm to patients seeking to get their medications. 

The final version of the Rule is intended to go into effect on May 11, 2023, as the PHE expires, and will take effect immediately. In this case, the 180-day in-person exam waiver for existing telemedicine patients will last through November 2023. Providers should start taking steps now to make sure their telemedicine prescribing processes are up to date and ready for the transition at the end of the PHE.

If you have questions about the end of the PHE or prescribing controlled substances, please reach out to any member of  Gardner Skelton’s healthcare team.