On October 5, 2020, the Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (NPRM) establishing a registration category for emergency medical services (EMS) agencies and the corresponding regulatory requirements for the new category of registrants. This regulatory action implements the ‘‘Protecting Patient Access to Emergency Medications Act of 2017 (the Act). The NPRM includes the following provisions mandated by the Act:
- Adds EMS agencies as a new category of DEA registrants;
- Permits the EMS agency to obtain one DEA registration for each state where the EMS agency operates;
- Allows hospital-based EMS agencies to operate using the hospital’s DEA registration;
- Delineates the circumstances where EMS personnel may administer controlled substances outside the physical presence of a medical director or authorizing medical professional; and
- Provides for recordkeeping, security, and storage requirements specific to EMS agencies.
While the Act and DEA’s proposed regulations provide much-needed consistency and clarity for “traditional” EMS agencies purchasing, storing, and administering controlled substances, the absence of specific guidance for emergency services provided by non-traditional means, such as air transport, is one area that will require clarification in the Final Rule.
Comments to the NPRM are due on or before December 4, 2020.