The U.S. Drug Enforcement Agency (DEA) has recently extended COVID-19 Public Health Emergency (COVID-19 PHE) telemedicine flexibilities with regards to the prescribing of controlled substances until December 31, 2024, as it continues its rulemaking with regards to whether the requirement for at least one in-person medical evaluation for such prescribing can be removed under certain circumstances, and if so, what safeguards might be appropriate.

On the one hand, the DEA has stated that it “recognizes the importance in providing Americans with access to needed medications,” while on the other, it is concerned with public health and safety, including the specific possibility of the diversion of controlled substances, indicating a need to find the right balance between benefits and dangers.

For its part, the public has shown substantial interest and concern when it comes to this issue by generating 38,369 comments to the DEA’s proposed rules, the General Telemedicine Notice of Proposed Rulemaking (General Telemedicine NPRM) and the Buprenorphine Notice of Proposed Rulemaking (Buprenorphine NPRM), which were both published to the Federal Register on March 1, 2023. Finding the balance between access to prescribed medications via telemedicine and maintaining public safety was also frequently mentioned by participants of Listening Sessions concerning the practice of telemedicine held by the DEA, according to transcripts of the sessions, which were held on September 12 and 13.

The Agency has stated in general terms that it is “working to promulgate new standards or safeguards by the fall of 2024,” before the lapse of the extended flexibilities on December 31, 2024.

ORIGINS OF THE REQUIREMENT FOR AT LEAST ONE IN-PERSON MEDICAL EVALUATION

The requirement for at least one in-person medical evaluation for the prescribing of controlled substances was brought about by the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (Ryan Haight Act), which according to the DEA’s final implementing rule, “amended the Controlled Substances Act (CSA) by adding various provisions to prevent the illegal distribution and dispensing of controlled substances by means of the internet.”

COVID-19 PUBLIC HEALTH EMERGENCY EXCEPTIONS

According to the DEA, after the COVID-19 PHE was declared on January 31, 2020, the Agency granted temporary exceptions to the requirement by allowing for the “prescribing of controlled medications via telemedicine encounters even when the prescribing practitioner had not conducted an in-person medical evaluation of the patient.”

Also referred to by the Agency as telemedicine flexibilities, more specifically, the DEA “authorized practitioners to prescribe schedule II-V controlled medications via audio-video telemedicine encounters.” This included, “schedule III-V narcotic controlled medications approved by the Food and Drug Administration (FDA) for maintenance and withdrawal management treatment of opioid use disorder via audio-only telemedicine encounters, provided that such prescriptions otherwise [complied] with the requirements outlined in DEA guidance documents, DEA regulations, and applicable Federal and State law.”

THE DEA SEEKS TO MAKE SOME EXCEPTIONS PERMANENT

As mentioned above, the DEA published two proposed rules – the General Telemedicine NPRM and the Buprenorphine NPRM to the Federal Register on March 1, 2023, which sought to make some of the COVID-19 PHE telemedicine flexibilities permanent.

The General Telemedicine NPRM, which has as its full title, “Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation,” sought to allow the prescription of non-narcotic schedule III-V controlled medications under certain circumstances, such as “when a practitioner, prior to issuing a prescription, reviews recent prescription drug monitoring program (“PDMP”) data.”

The Buprenorphine NPRM, which has as its full title, “Expansion of Induction of Buprenorphine via Telemedicine Encounter,” sought to “expand the circumstances under which registered practitioners would be authorized to prescribe buprenorphine for OUD via telemedicine, including an audio-only telemedicine encounter meeting the requirements of 42 CFR 410.78(a)(3),” with the term OUD referring to opioid use disorder.

TENS OF THOUSANDS OF PUBLIC COMMENTS AND LISTENING SESSIONS

When the comment period for the General Telemedicine NPRM closed on March 31, 2023, the DEA had received 35,454 public comments and when the comment period for the Buprenorphine NPRM closed on the same day, 2,915 comments had been received. According to the DEA, the combined number was among the “highest number of public comments received on an NPRM in DEA’s history.”

As a result, instead of promulgating final rules, the DEA held public Listening Sessions on September 12, and 13 of this year with the stated reason being in order to “receive additional input concerning the practice of telemedicine with regards to controlled substances and potential safeguards that could effectively prevent and detect diversion of controlled substances prescribed via telemedicine.” According to one of its sites, the DEA received more than 180 requests to present at the sessions and received comments from healthcare practitioners, experts, advocates, patients, and other members of the public, with transcripts of the proceedings being made available there.

EXTENSIONS OF TELEMEDICINE FLEXIBILITIES

Given the official end of the COVID-19 PHE on May 11, 2023 and citing the numerous public comments in response to the March 1, 2023 NPRMs, on May 10, 2023, the DEA, together with HHS, published a rule temporarily extending the COVID-19 PHE telemedicine flexibilities for the prescription of controlled substances, to be effective from May 11, 2023, through November 11, 2024.

Not having finalized the March 1, 2023 NPRMs, the DEA and HHS published another rule on October 10, 2023, which constituted a second extension of the COVID-19 PHE telemedicine flexibilities, this time until December 31, 2024. In addition to requiring more time to review the public comments, the DEA also stated that it was continuing to consider revisions “in light of [the] Telemedicine Listening Sessions,” held on September 12 and 13.

ACCESS TO CARE

While the dangers associated with the potential diversion of controlled substances are real and potentially life-threatening, in various documents concerning the March 1, 2023 NPRMs, the DEA has set forth the benefits associated with the greater access to care the telemedicine prescribing flexibilities offer.

The General Telemedicine NPRM says that the “greater range of telemedicine practice that would be possible under [the] proposed rule would allow practitioners to reach a greater number of patients, improving healthcare outcomes and reducing costs for patients throughout the country.”

It also states that telemedicine “has the potential to help address accessibility issues and improve access to care, including specialty care, for patients in remote and underserved areas,” going on to note that 50 percent of U.S. counties do not have any mental health professionals, and more than 75 percent are classified as mental health shortage areas.

The Buprenorphine NPRM provides information on the severity of drug poisoning and related deaths in the U.S. and asserts that lives can potentially be saved by the increased access to treatment for OUD through the greater ability to prescribe buprenorphine.

POTENTIAL SAFEGUARDS

When it comes to the prescribing of schedule II medications, it can be noted that the DEA has sought more information on whether there should be no exceptions allowed to the requirement for at least one in-person medical evaluation to take place through the Listening Sessions held on September 12 and 13.

It also sought feedback to the question of whether any circumstances might exist under which the prescribing of schedule II medications could take place absent an in-person evaluation, as well as recommendations as to what safeguards attendees of the Listening Sessions could share to ensure patient safety and prevent diversion under such circumstances.

More generally, the DEA has noted that entirely new frameworks may be needed to ensure safety, stating that “making permanent some telemedicine flexibilities on a routine and large-scale basis would potentially create a new framework for medicine that fundamentally expands access to controlled substances.” It also noted that such a framework would potentially include increased data collection and increased visibility into prescription practices, which could help as to accountability.

The Agency has also noted the numerous comments – several hundred – to the March 1, 2023 NPRMs, “raising the possibility of a separate Special Registration for those practitioners who seek to prescribe controlled substances without conducting an in-person medical evaluation of patients at all.” It has stated it is open to considering such a Special Registration for some controlled substances.

NEXT STEPS AND FINALIZATION OF RULES

As mentioned above, the DEA has already taken the additional steps of holding public Listening Sessions and extending COVID-19 PHE telemedicine prescribing flexibilities a second time, and according to a DEA site, there is at least one more announced step. Before the General Telemedicine NPRM and the Buprenorphine NPRM are finalized, the DEA will have “another comment period this fall for written comments.”

The Agency has stated that it will also continue to review the tens of thousands of comments in response to the NPRMs and also the information that was shared during the Listening Sessions.

Although it has not announced a formal deadline by which it will finalize the above telemedicine rules, as mentioned earlier, it has stated that it is working to finalize new standards or safeguards by the fall of 2024. There is also the practical deadline of December 31, 2024, when the second extension of the COVID-19 PHE telemedicine prescribing flexibilities are set to expire.

Categories: TELEHEALTH