On a normal day, Corin Meehan would refill medications at an automated drug box when he drops off a patient at Maine Medical Center in Portland.
The deputy chief of Limington Fire and EMS does this about once a month. Maybe he’s picking up extra norepinephrine for heart attacks, or replacing midazolam, which can stop seizures. On a normal day, he’d return to his ambulance fully stocked and ready for the next call.
Those days are coming to an end.
MaineHealth will stop supplying controlled substances to roughly 90 emergency medical services agencies on July 14, while Northern Light Health has said it will also end about 50 medication agreements. Both health systems say they are complying with a new rule from the U.S. Drug Enforcement Administration.
The rule, released in February as part of a federal statute, established a pathway for agencies to administer controlled substances under their own DEA registrations, rather than a hospital’s. The DEA says it’s just that: a pathway.
But hospital leaders have told more than 100 EMS agencies that it’s a requirement.
As a result, MaineHealth and Northern Light are pushing agencies to register with the DEA to obtain controlled substances independently, rather than refilling at hospital pharmacies at lower costs and quantities.
As EMS chiefs scramble to respond against time and funding constraints, they’re finding that support from state and health leaders falls short.
“It’s a manufactured crisis,” Meehan said about MaineHealth’s July deadline. “The DEA doesn’t mandate that every ambulance service does this. You’re allowed to have distribution agreements with a hospital. (MaineHealth is) a private entity, but they do have a certain responsibility to be a good partner for the bigger picture.”
“This is not a requirement by DEA,” said Heidi Carroll, diversion program manager at DEA Northeast Region. “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.”
Registration is costly. Some EMS agencies are preparing to spend tens of thousands of dollars to upgrade safes and record-keeping systems for safe storage of fentanyl, midazolam, ketamine and other necessary controlled substances. That doesn’t include the ongoing costs to purchase and stock drugs from wholesalers, rather than replacing them regularly at hospitals.
For some agencies, it will strain budgets and services. Others have no funding to fall back on.
“When the money runs out, we don’t exist,” said Mike Hatch, deputy chief of Sacopee Rescue, a private nonprofit that provides EMS services for the western Maine towns of Hiram, Cornish, Parsonsfield and Porter. “So 26 grand is a big walk.”
The administrative burden also falls disproportionately on small agencies. Where Meehan would normally be leading his staff or jumping on emergency calls, he spends hours holed inside his tiny station, comparing safes and drug vendors so Limington can procure its own controlled substances by July 14.
MaineHealth will also stop supplying more than 30 other medications to EMS agencies by Oct. 1.
“We want to make sure that patients are safe. We want to make sure that medications are safe. We want to make sure that patients always have access to their medications,” said Eric Wellman, EMS and transfer communications manager at MaineHealth.
“And we’re also firmly supportive of the fact that EMS agencies should have a role in their destiny for these things.”
‘Our interpretation’
EMS agencies in Maine are required to carry five controlled substances and more than 30 medications in order to perform the highest level of care. There are nearly 180 agencies at the paramedic level.
Maine EMS, the state regulatory body that oversees them, has few rules on medication storage.
The DEA’s new guidelines are stricter. Registered agencies must now follow a number of rules on drug delivery, storage, security and documentation, all aimed to reduce the diversion of drugs.
Dr. Tim Pieh, associate medical director for the Maine EMS region that includes Kennebec, Somerset and Androscoggin counties, said for many agencies, the rules are “paralyzing.”
“You should control a narcotic,” Pieh said. “It shouldn’t just be sitting in an open ambulance on the side of the street outside of Dunkin’ Donuts. I do get that, but the ripple effect of these rules landing when they do and the complexity of these rules are not something that most EMS chiefs in Maine are used to abiding by.”
The DEA released those storage requirements in February as the last piece of a 2017 law, the Protecting Patient Access to Emergency Medications Act. At first, nothing in Maine changed. Chiefs attended information sessions with DEA officials. Registration hadn’t opened in the state. There seemed to be no rush.
Then, in March, Northern Light notified dozens of EMS agencies that they had to register with the DEA, saying the health system could no longer supply them controlled substances under the new law. Hospital officials asked for proof within 14 days that agencies had applied. MaineHealth announced its deadline a couple months later.
“That was our interpretation of the law,” said Matt Marston, vice president of clinical ancillary services and chief pharmacy officer at Northern Light Health. “I will say, it’s not just our interpretation, either. Multiple other hospital groups reading through the law have come out with the same answer.”
“The DEA has even said this themselves,” Wellman said. “Registration is part of this process. To have controlled substances, you have to be registered.”
However Carroll, with the DEA, said that message “was not communicated by DEA, nor is it factually correct.” She said the additional registration option “does not replace the ability for an EMS to work under the DEA registration of the hospital.”
Guidance from Maine EMS has also been unclear. Registration with the DEA “is an option,” according to state EMS Director Wil O’Neal, but the department has not publicly clarified that to Maine’s chiefs, or with the two health systems it has been meeting with regularly.
Communication from the health systems has caused confusion and frustration for chiefs across Maine. Dozens online have decried MaineHealth’s short notice. One chief called it a “shady” move to cut costs.
Sen. Jim Libby, R-Cumberland, wrote in a letter to MaineHealth CEO Dr. Andrew Mueller that responders are “panicking” and asked him to reconsider the changes. Mueller responded last week that MaineHealth is beholden to federal law.
Amid the confusion, at least 54 EMS agencies in Maine have applied for registration with the DEA.
Others are still figuring things out.
“We’re all in a dither,” said Hatch of Sacopee Rescue. “We don’t understand totally all the requirements, we haven’t had time to look at it, we certainly haven’t had time to find the money for these.”
MaineGeneral Health, which supplies medication to 24 agencies in central Maine, is “expecting that this change in the law will require some changes to our practice,” but according to a spokesperson, “no decisions have been made yet.”
Efforts to reach Central Maine Healthcare officials in Lewiston were not successful.
MaineHealth and Northern Light leaders say there is no financial incentive to end medication agreements. But there is a risk management motive. A big part of Wellman’s job is tracking and investigating medication issues for each EMS agency MaineHealth supplies. The more agencies, the more liability.
The health system doesn’t want it.
“If they weren’t storing their medications appropriately,” Wellman said, “now they are.”
The cost
When agencies are not able to restock at hospitals, they lose out on lower costs and the ability to acquire smaller quantities of drugs. Some will have to return to their stations, dozens of miles away across rural Maine, to restock between emergency calls. It will take them out of service.
Paramedic-level agencies don’t have a choice, Pieh said. Without controlled substances like fentanyl and midazolam, agencies can’t perform critical prehospital interventions that give patients the best chance of surviving an emergency.
“Those EMS agencies are dead in the water,” Pieh said.
Delta Ambulance, a private nonprofit serving more than a dozen towns in central Maine, is preparing to spend $80,000 to purchase 17 new safes that are DEA-compliant.
Biddeford’s budget is already set, but the fire department needs $40,000 to buy a high-end safe system.
“This whole thing is an unfunded mandate that has come down to us,” said Deputy Chief Steven Kiesman. “No one has budgeted for it. We’re at the end of our budget prep for next year, and everything’s set in stone.”
Limington Fire and EMS requested $28,000 from the town’s emergency fund. If the department goes with a “Cadillac” safe system, Meehan said, he will have to make modifications to increase space and rig wires at the station, which doubles as the town office.
With just two people working around the clock to cover roughly 750 fire and EMS calls a year, Meehan isn’t sure there will be someone at the station to sign every time a drug delivery arrives.
Standing in the department’s garage in early June, he flipped through neat rows of drugs in an orange medication box, looking for topical nitroglycerin, which is used to treat acute congestive heart failure.
“We can only buy them in a box of 48, and that’s $177,” he said, holding up the tiny bottle. “We see very few acute congestive heart failure patients.”
That wasn’t a problem when Meehan could replace expired medications one-for-one at the hospital. Now, most of the department’s drugs will go to waste. Replacing them could cost up to $5,000 a year.
And most of those will get thrown out, too.
MaineHealth has said it will work with agencies that can’t meet the July 14 deadline. By the time Oct. 1 rolls around, Wellman said, it will actually make more sense for agencies to order all of their medications independently, in quantities and mixes that work better for ambulance settings and patients.
“We brought clarity to a situation that was somewhat ambiguous,” Wellman said.
On the ground, people are working to make things better. Community pharmacy leaders have suggested ordering medications in bulk to sell to agencies. Libby, the Cumberland state senator, told Maine’s congressional delegates that agencies across southern Maine need help. Meehan and Kiesman are speaking out about the conflicting information coming from the hospitals, the state and the federal government.
As frustration builds, Meehan hopes chiefs will talk about their struggles in public. Community members should know what’s happening and what they stand to lose, he said.
“We’re advocating, because this doesn’t have to happen,” Meehan said. “We will do what we have to do, but part of that is advocating for our communities, and for our peers, other towns.”
This story was originally published by the Maine Trust for Local News. Hannah Kaufman can be reached at hkaufman@centralmaine.com.