Tag: DEA

DEA Final Rule Takes Effect for EMS Controlled Substances

Member News

A new Drug Enforcement Administration (DEA) final rule took effect March 9, codifying regulations enacted in 2017 within the Controlled Substances Act (CSA) related to the handling of controlled substances by Emergency Medical Services (EMS) agencies.

While many provisions reiterate existing statutory requirements, the rule creates a process allowing EMS agencies to register with the DEA. It remains unclear whether EMS agencies must register with the DEA or if the rule creates an alternative to operating under a hospital’s existing DEA registration (the current process in Michigan).

If the rule requires EMS agencies to register with the DEA, it would conflict with the state’s current statutory framework, which does not allow EMS agencies to obtain their own controlled substance licenses.

Michigan’s Current Framework

Three key aspects of Michigan law include:

  • Hospital pharmacies own and maintain inventory of all EMS medications; EMS agencies serve only as custodians.
  • EMS agencies are ineligible for a state-controlled substance license under the current statute.
  • Existing MDHHS licensure and Medical Control Authority protocols authorize EMS agencies to administer controlled substances but not to purchase, own or independently store them.

MHA Actions

The MHA has engaged key stakeholders, including Michigan Department of Health and Human Services (MDHHS), the Michigan Department of Licensing and Regulatory Affairs, the Michigan Pharmacists Association, the Michigan Board of Pharmacy and the Michigan Association of Ambulance Services — as well as the Michigan DEA Field Office to provide guidance. DEA staff have informally recommended a “business as usual” approach and the MHA is working to obtain a more formal written statement.

MDHHS Bureau of Emergency Preparedness, EMS and Systems of Care released a memo on March 6 outlining that Michigan’s existing custodial framework and EMS licensure protocols remain sufficient to comply with the new rule and reaffirm the DEA position of “business as usual.”

The MHA believes this clarification will allow Michigan hospitals and EMS agencies to continue operating under current processes without disruption and will share further direction from the DEA when available.

Members with questions should contact Kelsey Ostergren at the MHA.

DEA Extends Telemedicine Rule for Controlled Substances Through 2025

Member News

The Drug Enforcement Administration (DEA) and the Department of Health and Human Services (HHS) recently issued a rule extending telemedicine prescribing flexibilities for controlled substances through Dec. 31, 2025. This extension continues pandemic-era provisions, allowing controlled substances to be prescribed via telemedicine without requiring a prior in-person visit, which is crucial for Michigan hospitals, particularly in rural and underserved communities.

The rule will:

  • Extend the ability to prescribe Schedule II-V controlled substances, including medications like buprenorphine for opioid use disorder, via telemedicine.
  • Allow flexibilities to apply to all practitioner-patient relationships, not just those established during the COVID-19 public health emergency.
  • Serve as an effort to ensure continued access to essential healthcare, reduce requirement of in-person evaluations and provide critical medications, especially for opioid use disorder.

While the rule extends telemedicine prescribing flexibilities, certain conditions remain in place:

  • The prescription must be issued for a legitimate medical purpose and within the usual course of professional practice.
  • The prescription must be issued through an interactive telecommunications system, ensuring that the patient and practitioner are engaged in a real-time communication.
  • The practitioner must be authorized to prescribe the controlled substance under their DEA registration or be exempt from the need for a registration.
  • The prescription must comply with all relevant legal and regulatory requirements for controlled substances.

This extension provides the DEA and HHS more time to continue reviewing and evaluating telemedicine and controlled substance policies. The MHA submitted a comment letter advocating for expanded access to telehealth and will remain actively involved in these efforts throughout 2025.

Members with questions may contact Kelsey Ostergren at the MHA.