New Delay in Telehealth Drug Rule

“Hurry up and wait.” That may be the message some are starting to get in the telehealth provider community as it concerns new rules that were supposed to go into effect last month but have now since been twice delayed.

Healthcare IT News (HITN) and other news outlets are reporting that the U.S. Drug Enforcement Administration (DEA) and the U.S. Department of Health and Human Services (HHS) will delay the effective date of two final rules that were expected to go into effect on Friday, March 21. 

The two rules at issue are (a) the Expansion of Buprenorphine Treatment via Telemedicine Encounter (hereinafter, “Expansion”) final rule, and (b) the Continuity of Care via Telemedicine for Veterans Affairs Patients final rule. According to a March 23 entry in the Federal Register, the new effective dates for these rules will be the last day of this calendar year.

Rationale for Delay

The reason given for the delay lies in the 32 comments received by the DEA in response to the request for public comments regarding the delayed effective date. After considering these comments, the U.S. Department of Justice (DOJ) weighed in, expressing a desire to further postpone the effective dates.

New HHS Secretary Robert Kennedy, Jr. stated the postponement request from DOJ was “for the purpose of further reviewing any questions of fact, law, and policy that the rules may raise.” As a result, the DEA and HHS decided to grant the requested delay, extending the new effective date for the two final rules to December 31, 2025.

Background of Rule

The two rules were originally scheduled to become final on February 18 of this year; however, following a January 20 general regulatory freeze imposed by the incoming administration, the DEA and HHS postponed their implementation dates by one month. 

According to HITN, the Expansion rule, referenced above, would have “permanently allowed telehealth providers to prescribe new patients a six-month supply of the drug buprenorphine to treat opioid use disorder. After the six-month mark, the rule requires patients to see a provider in person.”

The long-awaited regulatory clarification on the prescribing of controlled substances by way of telemedicine included establishing three special registries for the implementation of the program, which would prioritize safeguards against misuse.  The DEA has had a responsibility to create a telehealth prescribing registry under the 2018 Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, known as the SUPPORT Act.

Certain healthcare organizations raised concerns about the registries proposed in DEA’s final rule, arguing that they could limit telemedicine access and impose burdensome restrictions. HITN reports that one concern has been the potential for “limiting virtual prescribing access to terminally ill patients in hospice care.”

In response to such concerns, the Alliance for Connected Care asked U.S. Attorney General Pam Bondi to intervene on DEA’s e-prescribing rules and urged broader telehealth access, stating that “the draft special telehealth registries should be tossed out.” We will have to wait and see if the new administration will revisit the particulars of these registry-related rules. Stay tuned, as further adjustments to these rules may be in the offing.