US Drug Enforcement Administration and Department of Health and Human Services Delay Two Final Rules
Why It Matters
The U.S. Drug Enforcement Administration (DEA) and the Department of Health and Human Services (HHS) have decided to delay the effective date of two final rules that were expected to go into effect on March 21. The rules, which were first promulgated on January 17, would have allowed for the expansion of buprenorphine treatment via telemedicine and continuity of care via telemedicine for Veterans Affairs patients.
The Long-Awaited Clarity on Prescribing Controlled Substances via Telemedicine
The expansion rule would have permanently allowed virtual care providers to prescribe a six-month supply of buprenorphine to treat opioid use disorder. After the six-month mark, the rule requires patients to see a provider in person. The long-awaited clarity on prescribing controlled substances via telemedicine included establishing three special registries for practitioners and platforms to balance patient access with safeguards against misuse.
The DEA’s Responsibility and Healthcare Organizations’ Concerns
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. Healthcare organizations raised concerns about the registries proposed in the DEA’s final rule, arguing that they could limit telemedicine access and impose burdensome restrictions. One concern has been limiting virtual prescribing access to terminally ill patients in hospice care.
The Alliance for Connected Care’s Request and the DEA’s Response
In response to a request, the DEA said it received 32 new comments since February. The Alliance for Connected Care asked U.S. Attorney General Pam Bondi last month to intervene on the DEA’s e-prescribing rules and urged broader telehealth access, stating that the draft special telehealth registries should be tossed out.
The Larger Trend
Congress and telehealth industry groups have urged the DEA and HHS to jointly extend prescribing flexibilities allowed under the original COVID-19 public health emergency since it was initially set to expire. The agencies agreed to a third temporary extension of virtual prescribing for controlled substances allowed under the original COVID-19 public health emergencies in November. With this new postponement of the rules’ effective dates, telehealth providers are back to an end-of-year deadline.
On the Record
"The Department of Justice wishes to further postpone the effective dates for the purpose of further reviewing any questions of fact, law and policy that the rules may raise," said HHS Secretary Robert F. Kennedy, Jr., and Heather Achbach, the DEA’s Federal Register liaison officer, Monday in their joint notice on the new postponement.
Conclusion
The delay of the effective date of the two final rules provides more time for the DEA and HHS to review the comments they have received and to further consider the concerns raised by healthcare organizations. This extension is seen as a positive step towards ensuring that patients have access to the care they need while also ensuring that the regulations are effective and safe.
FAQs
Q: What were the two final rules that were delayed?
A: The two final rules that were delayed are the Expansion of Buprenorphine Treatment via Telemedicine Encounter and Continuity of Care via Telemedicine for Veterans Affairs Patients.
Q: Why were the rules delayed?
A: The rules were delayed to allow for further review of the comments received and to consider the concerns raised by healthcare organizations.
Q: What is the significance of the delay?
A: The delay allows for more time to ensure that the rules are effective and safe, and that patients have access to the care they need.
Q: What is the next step?
A: The next step is for the DEA and HHS to review the comments and concerns raised, and to make any necessary changes to the rules before they go into effect.
