New federal rules will hit EMS budgets

 It’s going to be expensive. It’s also not something emergency medical service (EMS) agencies in Charlotte County or anywhere across this region budgeted or planned for. In fact, if this federal rule gets enforced, EMS agencies all over Virginia will be forced to change the way they operate. It might heavily impact their finances – and have an effect on patients. 

The issue here is something that was put together seven years ago and forgotten. You see, some EMS agencies, mostly rural ones like Charlotte, Lunenburg and nearby 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 the ruling to the end of 2024. Well, here we are in 2024 and the clock is ticking. 

As it stands right now, the FDA will be enforcing the policy by the end of the year, which means EMS agencies may not be able to restock and exchange kits from hospitals – instead being forced to rely only on their own supply.

“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 (than expected),” said Heidi Hooker. She works as executive director of the Old Dominion EMS Alliance. She sent out a letter to EMS agency leaders across Virginia last month, saying as of now, the FDA regulation will take effect Nov. 1, 2024. 

It’s also 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. Some said they needed to hold off talking with The Gazette because they simply didn’t know what would happen. Others, like neighboring Cumberland EMS, said they’re in a wait and see mode. 

“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 

Now there’s another problem here as well. Typically in a situation like this, EMS agencies around the state would ask the Commonwealth for help. But they’ve been told not to expect any grant funding anytime soon to help cover the cost. 

WHY CAN’T THE STATE HELP? 

That’s because of a $33 million shortfall 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 is still going. 

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 nearby 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 for Centra, said they will follow the FDA’s guidelines, but also want to help EMS agencies 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.

SO WHAT HAPPENS NEXT? 

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. 

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.