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It’s going to be expensive. That’s what Buckingham County Emergency Services Chief Cody Davis sees it. And he’s not alone. Emergency medical service (EMS) agencies across this region and all over the state will be forced to change the way they budget, and possibly operate, thanks to a federal regulation going into effect this fall. It might heavily impact their finances – and have a domino effect on rural patients.

The issue here is something that was put together seven years ago and forgotten. You see, some EMS agencies, mostly rural ones like Buckingham and Cumberland, rely on regional hospitals to stock and exchange medication kits. The Drug Enforcement Agency (DEA) created a policy in 2017 that aims to regulate how EMS handle medications. But they held off on actually enforcing it, pushing enforcement to the end of 2024. Well, here we are. 

The FDA will be enforcing the policy by the end of the year, which means EMS groups may not be able to restock and exchange kits from hospitals – instead being forced to rely only on their own supply. The biggest problem is that everyone has questions and nobody can give a definitive answer. 

EMS Alliance explains

“We learned that the Drug Supply Chain Security Act by the U.S. Food and Drug Administration (FDA), would impact the regional medication kit systems and force a transition much sooner. The FDA regulation has an enforcement date of November 1, 2024,” said Heidi Hooker, the executive director of the Old Dominion EMS Alliance in a note to statewide EMS leadership last month.

Now it’s not just as simple as making a supply run and stocking up. The new regulations require all EMS agencies to obtain a controlled substance registration. Local agencies are still waiting on guidance from the state and board of pharmacy regarding stocking medication.

“We don’t have any definitive answers,” said Cumberland County Fire and EMS Chief Andy Aigner. “We do have decisions to make if they move forward with this.”

Waiting to see what’s next 

Buckingham County Department of Emergency Services Chief Cody Davis said his agency has already gotten their Virginia pharmacy license and controlled substance registration. They’re waiting anxiously to see what comes next.

“That’s going to be expensive, buying all of these medications that we used to not have to purchase,” said Davis. “It’s going to be difficult especially for small, rural, especially volunteer agencies to keep up with such a logistical burden and ensure that they have the right amount of medications.”

The Buckingham County Department of Emergency Services revenue crossed a million dollars last calendar year, up $100,000 from the previous year, according to Davis. Davis said that additional revenue won’t help them break even if they must pay for the medication. He informed the Buckingham County Board of Supervisors in this month’s meeting that the county may have to absorb the costs.

“We were hoping there would be a regional approach… or grants that would help us split the bills, but then we saw the $33 million dollars misplacement of funds from the state, so any sort of grant funding is absolutely not going to come,” said Davis.

Why can’t the state help with EMS? 

He’s referring to a $33 million shortfall that the Virginia Office of EMS (OEMS) is dealing with. Back in January, the Virginia Department of Health investigated after a routine audit and found the office owed $33 million to multiple EMS providers in an issue that dates back years. Money was moved from one account to another to temporarily cover up the shortfalls but that didn’t work forever. The audit showed contracts were overspent and it’s still unclear where some of that money went, with state officials saying the investigation continues. 

Now how does this affect the larger EMS issue? Well, in a normal situation like this, the Office of EMS would give out grant funding, while discussions are held about fixing the problem long-term in the state budget. But after the $33 million shortfall was found, several grant funds, like the OEMS Rescue Squad Assistance Fund, were put on hold until that situation is sorted and the $33 million shortfall is corrected.  

So with no grant funding on the way, what happens next? That’s a good question that nobody seems to have an answer to. 

“The gravity of this situation cannot be overstated, as it directly impacts many critical services including medication exchange, drug box programs, medical supply and equipment programs, and whole blood initiatives,” said Regional EMS Council Executive Director Tracey McLaurin during a State EMS Advisory Board meeting last November. “The EMS Councils and our system as a whole is in crisis right now and it not only jeopardizes the seamless functioning of EMS, essential EMS systems but also poses a serious threat to the very existence of our regional EMS councils.”

Hospitals want to help 

And to be clear, hospitals want to help. But officials with each system we spoke with said they had to follow FDA guidelines. Centra Health, which operates Centra Southside Community Hospital in Farmville, has a longstanding practice of exchanging medication boxes with local EMS agencies. They don’t charge the EMS or the patients’ insurance. 

Randall Puckett, the Director of Pharmacy operations, said they will follow the FDA’s guidelines, but also want to help EMS as much as possible.

“We’re just going to have to work through this,” said Puckett. “Whatever we’re asked to do by the federal agencies or the state or even the DEA, we’re going to do whatever we can do to comply with that, but we’re also going to do everything we can to help.”

Puckett said he hopes there will be recommendations from the state Board of Pharmacy in regard to the change soon.

“In my mind, there’s no way we can stop providing some sort of support for the agencies. We can’t just stop providing service at some level,” said Puckett.

EMS agencies have been instructed to not acquire their own medication boxes or purchase their own medications while state and federal leaders figure out the next steps.  

EMS Alliance looks for path forward

According to the Old Dominion EMS Alliance, there have been “ongoing discussions about purchasing coalitions and central warehousing to reduce the cost of medications for EMS agencies.”
A workgroup that consists of the Regional EMS Councils, representatives from the Virginia Regional EMS Councils, the Virginia Office of EMS, the Virginia Society of Health Systems Pharmacists, the Virginia Hospital and Healthcare Association, the State Medical Direction Committee, and EMS Agency stakeholder groups have been meeting to discuss alternatives. They are aiming to have solutions for EMS agencies by May 1 to allow for a 6-month implementation window.
Davis said one positive result that could come out of the new policy is more tailored medication and tailored boxes to better match protocol, but he lists more cons than pros.
“The middle of the night calls where they use the drugs and have to replenish them – it’s going to be tough,” said Davis. “I do really feel for those very small volunteer organizations, for both the potential and logistical burden they’re going to have to endure.”