December 10, 2020

ACEP Responds to Long-awaited DEA Regulation on EMS Controlled Substances Policies

In my last Regs & Eggs post, I highlighted the good, the bad, and the ugly in the 2021 Physician Fee Schedule (PFS) final regulation, including discussing ACEP’s response to the 6 percent Medicare payment reduction that emergency medicine faces next year. Please know that ACEP continues to advocate on your behalf and is pushing Congress to hold emergency physicians harmless from any payment cuts. As our work on that important issue remains ongoing, I want to switch topics this week and focus on another area that deserves our attention. Last week, ACEP responded to a proposed reg issued by the Drug Enforcement Administration (DEA) that will have a significant impact on how emergency medical services (EMS) agencies store, handle, and administer controlled substances going forward. With the levels of opioid-related overdoses increasing during the COVID-19 pandemic, it will be even more important for EMS professionals, including physician medical directors (which include some of you), to have the flexibility they need to effectively serve their communities.

The DEA proposed reg implements the ‘‘Protecting Patient Access to Emergency Medications Act of 2017’’ (the Act), an instrumental law that ACEP strongly supported. The Act modifies specific requirements under the existing Controlled Substances Act (CSA) that govern how EMS professionals can administer controlled substances to individuals receiving emergency medical services. Specifically, the Act:

  • Authorizes EMS professionals to administer controlled substances outside the physical presence of a medical director or authorizing medical professional through standing or verbal orders. The ability for EMS medical directors to issue verbal and standing orders is extremely important and expands the ability for EMS agencies to treat individuals experiencing medical emergencies.
  • Allows EMS agencies to register with the state to be able to administer controlled substances. An EMS agency only needs to obtain one registration per state regardless of how many locations they operate in within that state. Previously, EMS agencies couldn’t register on their own. In fact, the CSA didn’t even mention EMS. Most EMS vehicles (such as ambulances, helicopters, water vehicles, etc.) had to operate under the registration of a hospital to obtain controlled substances that could eventually be administered to patients. While this wasn’t an issue for EMS agencies that were owned by hospitals, independent EMS agencies had to enter into contractual arrangements with hospitals to receive and store controlled substances.
  • Includes a variety of other requirements for how registered EMS agencies must deliver controlled substances, store controlled substances, restock EMS vehicles, maintain records, and otherwise conduct their operations.

While it took the DEA a few years to issue the proposed reg (the Act was passed in 2017), it was worth the wait. The general consensus from ACEP members who serve as EMS medical directors and the broader EMS community was that the DEA’s interpretation of the Act supports how EMS agencies treat patients across the country and will make it easier for EMS agencies to operate. In ACEP’s response to the reg, we thank the DEA for implementing the Act, but also point out some technical and clarifying comments and questions that we ask the DEA to address in the final reg.

Most of our comments focus on areas where we believe the DEA could provide even more flexibility to EMS agencies. For example, the DEA includes strict requirements around where and how EMS vehicles can store controlled substances before a patient encounter occurs. Under the reg, EMS vehicles that store controlled substances must be housed in enclosed structures (called “stationhouses”)—which may be impossible depending on the size of the vehicle. We therefore request that the DEA broaden the definition of stationhouse to accommodate larger and outdoor vehicles. Further, the DEA provides uniform instructions on how EMS vehicles must store controlled substances—and since not all EMS vehicles have the same storage capabilities, we ask the DEA to grant EMS agencies some degree of flexibility when deciding how to appropriately secure controlled substances in their vehicles.

Another concern that we raise relates to recordkeeping requirements that EMS agencies must comply with when administering controlled substances pursuant to verbal and standing orders. In the reg, the DEA outlines a long list of records that must be kept for each dose of controlled substances that is administered under a standing or verbal order including the initials of the medical director or authorizing medical professional who issued the order. Having physician medical directors provide their initials in a log every time a controlled substance is administered is extremely burdensome and many even be logistically impossible if the medical director’s jurisdiction covers a wide area. We believe that the DEA must allow for electronic signatures from physician medical directors and/or provide an alternative, less burdensome approach to meeting the initialing requirements in the final reg.

These issues aside, we are overall pleased with the reg and look forward to seeing it finalized in the near future. We also hope to work with the DEA on this and other issues that relate to the use of controlled substances to treat patients. As we continue to tackle the opioid pandemic, the DEA will be a key partner in ensuring that physicians and other heath care professionals have the flexibility they need to appropriately serve their patients, while also making sure that controlled substances are kept secure and used for their intended purposes.  

Until next week, this is Jeffrey saying, enjoy reading regs with your eggs.

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