EMS Changes in November – The Tidewater News

Changes to federal rules governing how emergency medical services agencies can dispense medications have given Isle of Wight County a four-month window to bring its fire and rescue department into compliance.

In 2013, Congress passed the Drug Supply Chain Security Act, which set an effective date of November 27 of this year for electronic tracking of prescription drug containers stored and dispensed by EMS agencies.

The current practice in Virginia, which will no longer be allowed, is for ambulance crews at hospitals to exchange used containers of Schedule II through VI medications for unopened containers on a one-for-one basis.

Garry Windley, head of the Isle of Wight Fire and Rescue Service, said the change in the law aims to eliminate the risk of information being lost about used medicines if containers are returned to a hospital other than the one they came from.

Instead, agencies will have to buy their own drug kits and stock them at their stations. That would require a Virginia Board of Pharmacy fee and expensive security modifications for each station that serves as a pharmacy.

Windley estimates it will cost more than $113,000 to equip the Isle of Wight and Windsor ambulance stations and volunteer ambulances. The largest expense is purchasing safes that use radio-frequency identification, or RFID, tags to track their contents. The 15 safes alone — one per station and 13 mobile safes that can be mounted inside the ambulances — will cost more than $56,000. The six-figure sum also includes $6,500 for software to inventory medications, $4,000 for security upgrades at two stations to comply with U.S. Drug Enforcement Agency regulations, and the cost of medication kits and the medications themselves.

This amount also includes the $120 cost of a Controlled Substances Registration (CSR) with the Virginia Board of Pharmacy and the $888 cost of a DEA license, which is required by the 2017 Congressional Amendment to the Controlled Substances Act for EMS agencies to obtain a license.

Windley said the CSR application is ready to go this month, but he is waiting for the safes to be installed, because part of the approval process is an in-person inspection of each station. Once each station has its CSR, Isle of Wight Fire and Rescue can apply for a DEA license, Windley said. Once both licenses are in place, Isle of Wight can apply to the U.S. Food and Drug Administration for a certificate authorizing the county to purchase the drugs, which Windley said will involve hiring someone to be Isle of Wight’s coordinator for the federal controlled substance ordering system.

The costly and complicated process has been compounded by conflicting information from federal and state sources, as well as changes at Virginia’s emergency medical services office, Windley said.

“We’re trying to navigate the constantly changing information that we’re getting,” Windley told Isle of Wight County supervisors July 11. “Every meeting we go to … we hear something different that we need to do to comply with the regulations. We’re not getting anything from the EMS office; we have to go out and find it ourselves.”

The EMS office, according to a budget request from earlier this year, has its hands full tracking down $33 million in unpaid bills, including $6.6 million in delinquent payments to localities. According to the budget document, the state office is funded solely through the “4 for Life” program, which charges $6.25 for vehicle registration. Each fee collected is to go toward a $12.5 million transfer to Virginia’s General Fund. The budget request notes that in June 2023, when funds needed to cover the $12.5 million transfer were unavailable, an internal audit found “financial irregularities” dating back “several years.” The state’s EMS Office Director, Gary Brown, retired last year amid ongoing state and federal investigations, which the budget request now includes the U.S. Attorney’s Office.

“We have not seen a decrease in state funding,” Windley said. “However, we may have been entitled to more than we received, which is being audited by multiple state and federal agencies to determine whether more money should be distributed to localities.”

It wasn’t until May 2 that the Board of Pharmacy adopted emergency regulations for EMS agencies, and those, Windley said, were based on proposed 2020 DEA regulations that ultimately weren’t adopted. Before that date, “EMS agencies didn’t have the guidance to know what was required in terms of safety, purchasing, recordkeeping and distribution,” Windley said.

The Office of Emergency Medical Services, according to its spokeswoman Marian Hunter, is working with the working group and the Virginia Board of Pharmacy on emergency regulations.

“The Virginia Regional Medication Kit Transition Workgroup has been meeting since December 2023 to develop recommendations and tools to help EMS agencies transition from regional hospital medication kits exchanged one-on-one with EMS agencies to an alternative that is consistent with the FDA’s Drug Supply Chain Security Act effective date of November 27, 2024 — a federal rule that was not known to EMS until November of last year, Hunter said.

The working group, which includes representatives from Virginia’s regional ambulance boards, the state office, the Board of Pharmacy and other stakeholders, has divided into teams to address licensing, policy, drug purchasing and financial assistance, Hunter said.

Despite conflicting and in some cases missing information, Windley said he is “confident we are ahead of the curve.”

“Most agencies across the region and state still don’t have a plan or the funding to meet the demands of this unfunded mandate,” he said. “We have the support of the county administration and the Board of Supervisors, which is something other agencies are struggling with.”

Much of the six-figure cost cited by Windley could be funded from unspecified capital reserve funds, according to County Administrator Randy Keaton. Keaton said revenue from Isle of Wight’s billing from insurance companies, which ranges from $450 to $800 for basic or advanced life support, plus $11.25 per mile a patient is transported by ambulance, came to about $185,000 above what the county budgeted for the 2023-24 fiscal year, which ended June 30. But one item that higher-than-expected EMS revenue won’t cover is the cost of hiring a dedicated employee to oversee in-house drug distribution.