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Feds Focus on Helicopter EMS Growth & Safety


Air ambulance crashes continue to weigh heavily on the EMS community. Twenty-one people have died in aeromedical accidents as of Aug. 31. In 2008, the National Transportation Safety Board added EMS flights to its “Most Wanted” list of desired safety improvements, and the agency released safety recommendations in 2006 and again in 2009. Although many helicopter EMS organizations have voluntarily implemented NTSB recommendations and other safety measures, the recommendations aren’t mandatory.

That may soon change. On Oct. 12, the Federal Aviation Administration released its much-anticipated Notice of Proposed Rulemaking regarding air ambulance and commercial helicopter operations. The FAA’s proposed rules address air ambulance and commercial air operations, Part 91 helicopter operations and load manifest requirements for all Part 135 aircraft. The NPRM incorporates many—but not all—NTSB recommendations (see sidebar “The Proposed Rules,” in November EMS Insider.) Notably, the NTSB recommends the use of night-vision goggles and autopilots, and these devices aren’t included in the FAA’s proposal.

As expected, the industry’s response to the proposed rules is mixed. Some believe the rules don’t go far enough. Then there’s concern over dollars. According to the FAA, the estimated cost of its proposal in present value to the air ambulance providers is $136 million “with a total benefit of $160 million over 10 years.”

More patients take flight
A spike in air ambulance fatalities in recent years combined with a significant jump in the number of providers offering air medical services has drawn increased scrutiny from the government and the media. A September GAO report titled “Air Ambulance: Effects of Industry Changes on Services are Unclear,” says that “from 1999 through 2008, the number of patients transported by helicopter air ambulance increased from just over 200,000 to over 270,000, or by about 35%, and the number of dedicated air ambulance helicopters increased from 360 to 677, or by about 88%.”

Many attribute this rapid growth to implementation of the Medicare Fee Schedule, said Bob Bass, MD, executive director of the Maryland Institute for EMS Systems and chair of the National Association of State EMS Officials’ air medical committee. “But other contributing factors may include increased regionalization and specialty care for things like STEMI and trauma.” Before about 2000, aeromedical services tended to be hospital-affiliated programs “that were fairly well integrated with the EMS systems,” he said. Today, many air ambulance companies are for-profit entities that often aren’t as integrated and resist regulation.

Who should regulate what remains an issue, although the number of crashes suggests further oversight may be warranted. According to the FAA, the 135 air ambulance crashes from 1992 through 2009 resulted in 126 fatalities.

“Obviously, the FAA has been under enormous pressure,” said Tom Judge, CCT-P, executive director of LifeFlight of Maine, a past-president of the Association of Air Medical Services and chairman of the Association of Critical Care Transport (ACCT for Patients). “From my perspective, everything that the FAA has said is important to do; we don’t disagree with any of it.” He said, however, that “push back” is expected from some in the industry, particularly with regard to Helicopter Terrain Awareness and Warning Systems (HTAWS), because these systems will require a significant investment.

The argument against many potential safety enhancements—such as HTAWS, autopilots and night-vision goggles—is that the additional costs to operators may ground some air ambulances, creating an access-to-care issue, particularly in rural communities.

“It’s a valid question,” Judge said. “But I’m in a very poor, rural environment. We have 30% uninsured patients; we don’t get any subsidy and we’re an independent provider, albeit nonprofit. Yet we can fly IFR. We can fly NVG, and we’ll put in HTAWS. Yes, it will cost us some money. But if the data tell us that this is the safest thing to do for patients, we’ll do it. I don’t buy the argument that this is somehow going to diminish success. Cost is always an issue. It’s an issue for me; it’s an issue for everyone. But I don’t buy that it can’t be done.”

Chip Sovick, president and chief executive officer of West Virginia-based HealthNet Aeromedical Services, also believes the FAA’s proposed rules are reasonable and feasible. His operation transports approximately 4,000 patients per year by air, using seven full-time helicopters.

“These accidents are what keep us up at night,” said Sovick, adding that his organization aggressively implemented multiple voluntary safety enhancements. He said his service was one of the first in the nation to use night-vision goggles on all the aircraft, which was no small investment considering they cost $12,000–$15,000 per set. “These things are expensive, but it’s the right thing to do to ensure safety.”

Medical vs. air safety
The FAA’s proposed rules can’t address the ambiguities that persist since the Airline Deregulation Act was enacted in 1978. The ADA prevents states from regulating such economic issues as rates, routes and services. States, which have wide regulatory authority over ground ambulance transport, are hampered by the ADA.

“What it boils down to is this whole issue of what’s medical and what’s air safety,” Bass said. “By and large, it’s the state that regulates health care; it’s the state that ensures there is a safety net. Patients who fly on these helicopters are not like patients who fly an airline. They don’t have the choice based on quality or price or accessibility or acceptability. So we feel it’s very important to make sure that the states have regulations in place to ensure patients are protected.”

But it’s not always clear what the ADA specifically prohibits and allows. The Department of Transportation has tried to bring clarity, issuing eight opinion letters since 1986.

Unfortunately, questions remain. The GAO study—which examined the changes within the air ambulance industry over the past decade, as well as the relationship between federal and state oversight and regulation of HEMS—made no recommendations. Essentially, the report said not enough evidence is available to either definitively support or reject the existing regulatory framework. It said, however, that states can continue to seek the DOT’s opinion on a case-by-case basis. It also said, “States can also contract directly with air ambulance providers, which would allow states to control specific services as the customer.”

The notion that states can solve their regulatory concerns by contracting directly with providers isn’t realistic, Bass said. “There’s just not enough money for all the states to do that, particularly when these ambulance companies bill for their services,” he said. “It’s not a reasonable solution.”

Judge agreed. “A., I don’t think the states are going to do that. I just don’t think it’s practical. B., it’s actually not clear that the states could do it. I’m not certain that under the ADA that states could just decide on a market area if they’re going to contract for a service. Maybe they could, but I’m not certain that’s been thought through very well,” he said.

ACCT issued a statement in response to the GAO report. The statement asserted that the “most concrete finding … is the continuing lack of meaningful data.”

“Given the remaining lack of clarity surrounding the boundaries of state authority under the Airline Deregulation Act to regulate the ‘medical’ aspects of air ambulance services, ACCT calls upon the DOT to provide consistent clarity to all states and stakeholders under existing federal law and upon Congress to remove the federal barrier preventing states from fully protecting their citizens requiring air medical services, just as states do for fire, police and ground medical transport services.”

Bass said the ambiguity that surrounds some of the DOT opinion letters and court rulings in several states is hampering efforts to improve patient care on air ambulances.

“The federal government and the states should be working together cooperatively so that both can do their jobs,” Bass said. “We don’t want to interfere with their ability to regulate air safety. On the other hand, they shouldn’t be interfering with our efforts to regulate medical safety.

“We’re committed to working with DOT to try to resolve this ambiguity. And where we can’t resolve it and where we feel that, in particular, air safety should not trump medical safety, then we’ll go after whatever relief necessary, because it’s just not acceptable. There should be both air safety and medical safety.”

Culture of safety
The FAA rules, if enacted, may reduce the number of fatalities. But thoughtful system design and a culture of safety are key to both reducing crashes and ensuring good patient care, Judge said. “I think without question that if you implement all these safety rules, it will improve safety. … I don’t think it goes far enough.

“You can build a series of defenses, but the final defense is the way people choose to do things. There’s a lot of good work that’s being done by people in safety management systems, but the underlying assumption is that you have to properly design the system. Design the system right, so we’re not pushing people to do things where they feel like they’re under economic pressure to fly when they might not in another circumstance,” Judge said.

Read the FAA’s NPRM at http://edocket.access.gpo.gov/2010/pdf/2010-24862.pdf. Comments are due on or before Jan. 10, 2011. See the second page for instructions on how to submit comments.

Read the GAO report at www.gao.gov/products/GAO-10-907.


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