Maine Delegation Calls on DEA to Clarify Rule Threatening Maine EMS Providers with New Costs

WASHINGTON, D.C. - U.S. Senators Angus King (I-ME) and Susan Collins (R-ME) and Representatives Chellie Pingree (D-ME) and Jared Golden (D-ME) are calling on the U.S. Drug Enforcement Administration (DEA) to quickly clarify federal guidance that is threatening Maine emergency medical service (EMS) agencies with new costs. In a letter to DEA Administrator Terrance Cole, the lawmakers explained that uncertainty surrounding the DEA's implementation of a 2017 law has led several Maine hospital systems to end longstanding agreements that allowed local EMS agencies to obtain certain emergency supplies and medications through their hospital partners. Without these agreements, EMS agencies have already begun to spend thousands of their own dollars on these expenses, likely resulting in cost increases to patients to recoup the additional charges.

The Controlled Substances Act (CSA), along with related DEA regulations, requires registration for any practice that dispenses controlled substances. Prior to 2017, the CSA did not directly mention EMS, and thus EMS departments historically were not required to register to procure or dispense controlled substances - allowing EMS to acquire medications and supplies from hospital partners to do their critical work.

"We write today to request that the Drug Enforcement Administration (DEA) issue clarifying guidance regarding implementation of the Protecting Patient Access to Emergency Medicines Act of 2017 (PPAEMA)," the lawmakers began. "As you know, PPAEMA amended the Controlled Substances Act (CSA) to allow Emergency Medical Services (EMS) agencies to obtain independent registrations to administer controlled substances. This statutory change was intended to codify existing law and ensure EMS responders operate seamlessly under the supervision of a licensed physician. Unfortunately, the DEA's subsequent final rule has created disruption and confusion for Maine's healthcare system."

"The conflicting interpretations of this rule have led our state's largest hospital networks to abruptly terminate long-standing agreements held with local EMS providers for such medical supplies. Therefore, swift clarification from the DEA is urgently needed not only to prevent exorbitant, unexpected costs from being forced onto Maine's EMS agencies but also to preserve vital local partnerships," the lawmakers continued.

"Therefore, we ask DEA to issue clarifying guidance as soon as possible to prevent further confusion and to ensure more unnecessary costs are not borne by our EMS agencies. Thank you for your attention to our request, and we look forward to your response," the lawmakers concluded.

The full text of the letter can be found here and below.

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Dear Administrator Cole:

We write today to request that the Drug Enforcement Administration (DEA) issue clarifying guidance regarding implementation of the Protecting Patient Access to Emergency Medicines Act of 2017 (PPAEMA). As you know, PPAEMA amended the Controlled Substances Act (CSA) to allow Emergency Medical Services (EMS) agencies to obtain independent registrations to administer controlled substances.

This statutory change was intended to codify existing law and ensure EMS responders operate seamlessly under the supervision of a licensed physician. Unfortunately, the DEA's subsequent final rule has created severe disruption and confusion for Maine's healthcare system. The conflicting interpretations of this rule have led our state's largest hospital networks to abruptly terminate long-standing agreements held with local EMS providers for such medical supplies. Therefore, swift clarification from the DEA is urgently needed not only to prevent exorbitant, unexpected costs from being forced onto Maine's EMS agencies but also to preserve vital local partnerships.

PPAEMA established a new registration category under the CSA for EMS agencies that are authorized to conduct emergency services under state law. Congressional intent in enacting PPAEMA was clear in focusing on clarifying existing law to align with current practices to allow EMS to administer controlled substances under the supervision of a physician. The purpose was not to create a new requirement whereby EMS agencies would be required to procure controlled substances and other required medications.

However, subsequent rulemaking and implementation of PPAEMA has created uncertainty and significant costs to our EMS agencies as they look to comply with the law and new regulations. Per the final rule, "… controlled substances must be delivered to the registered location of the EMS agency or the hospital if the EMS agency operates under the hospital's DEA registration." Hospitals in our state interpret this to mean that previous purchasing and distribution agreements with EMS agencies outside of the hospital organization's direct oversight are no longer valid and violate PPAEMA rulemaking.

As a result, approximately 140 EMS agencies across Maine are reportedly spending tens of thousands of dollars each to procure the secure systems required for independent storage compliance. Additionally, these agencies are facing the likelihood of having to spend thousands of dollars, if not more, on required substances. Because these medications are often exclusively sold in bulk, smaller EMS agencies will be forced to buy quantities they cannot realistically use before the drugs expire. At a time of severe budget constraints, this rigid interpretation is creating a crippling operational and financial burden for our EMS agencies.

In a recent article, quotes from DEA staff and Maine EMS suggest that previous arrangements remain accessible and that registration by EMS agencies with DEA are optional. According to Heidi Carroll, diversion program manager at DEA Northeast Region, "This is not a requirement by DEA. This is an additional registration category made available, but it does not replace any previous compliant arrangements to provide patient care and emergency services to the public." However, our hospitals must ensure that they are compliant with DEA regulations and without clarifying guidance, believe that they cannot maintain previous arrangements to procure and distribute controlled substances to EMS agencies.

Therefore, we ask DEA to issue clarifying guidance as soon as possible to prevent further confusion and to ensure more unnecessary costs are not borne by our EMS agencies. Thank you for your attention to our request, and we look forward to your response.

Sincerely,

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