Throughout 2008, the EMS helicopter crashes mounted, and the industry stewed. Given the legislative dichotomy surrounding air-medical issues--states control the medical, the feds govern the air--and the disparate interests of the fast-growing numbers of providers filling the HEMS market, doing anything about it was going to be difficult. Even identifying the measures most likely to improve safety stoked disagreement and factionalization. Did the best solution lie in technologies like night-vision goggles or terrain awareness warning systems (TAWS)? Would using a flight risk-evaluation checklist or safety management systems help? Was better infrastructure for low-altitude flights or limiting aircraft numbers the answer? It often depended on whom you asked and what their interests were.

By early 2009, though, that lack of consensus was no longer inhibiting action. A flurry of activity in the federal executive and legislative branches aimed to change the rules of the airborne-EMS game, and a major effort from within the industry itself sought to clarify matters of safety and clinical capability.

As this is written at the end of April, it's not known which of these efforts might come to fruition, mutate into something else or die unripened on the vine. Nor is it known for sure, should any or all of them succeed, what the impact to the bottom-crash-line or any unintended consequences might be.

But know this: If the HEMS crash and fatality rate doesn't decline in the near future, it won't be from a lack of trying.

NTSB VS. FAA

The National Transportation Safety Board (NTSB) started agitating for new rules to enhance HEMS safety in 2006. Following an investigation of 55 accidents over three years, it urged the FAA to institute four new safety requirements: operations under Part 135 of the Federal Aviation Regulations anytime a medical crew is on board; use of flight risk evaluation programs; use of formalized dispatch procedures with weather and risk-assessment assistance; and use of TAWS. Rather than mandating these, though, the FAA sought voluntary compliance with them by operators.

Three years later, with crashes spiking again, the NTSB was back on the case, hosting four days of hearings in February to suss out the industry's current profile and potential solutions to its problems.

"I think the NTSB truly was looking for information," says Christine Zalar, who heads the air-medical consulting arm of EMS consultants Fitch & Associates and was a witness at the hearings. "They clearly weren't trying to be investigative, which is their normal role. It seemed they were just trying to understand the many perspectives and facets of how this all works."

Those they heard from more than 40 witnesses representing a range of positions and views. Among these were representatives of the FAA, still being nudged by the NTSB to act.

"[When] we regulate it and force folks to do it," NTSB hearing officer Lorenda Ward said, comparing the board's recommended measures to seat belts in automobiles, "that's when we're going to have the most safety benefit."

The FAA kept its cards close to the vest when it came to potential new rulemaking. "We are considering it," Flight Standards Service Director John Allen told panelists. "It's a big task for us, in providing rulemaking, to scope it intelligently. What are the salient aspects we have to include?"

How these bodies proceed will be clear soon enough. Meanwhile, they're not the only interested parties looking to do something.

IN CONGRESS

A pair of bills presently before Congress could have impacts on the HEMS field comparable to anything done in the executive branch.

First there's H.R. 1201, the Air Medical Safety Act. Introduced in February by Rep. John Salazar (D-CO), it would make law of several of the NTSB's 2006 recommendations. Specifically, it would require the Part 135 operations, and direct FAA rulemaking for a standard flight risk evaluation checklist; collaboration with the air-medical community on dispatch procedures; and study and ultimately rulemaking for flight data and cockpit voice recorders.

"Some of those measures are fairly well supported by pretty much all the industry," says James Riley, president of the International Association of Flight Paramedics and another NTSB witness. "I don't know of anyone who's really opposed. Having a risk assessment tool and safety briefings before taking flights is a good thing that's easily manageable, and the recorder technology would let us go back after adverse events with additional data to investigate. That's an important thing."

Legislation that goes even farther may be forthcoming, insiders say, potentially addressing areas like night-vision goggles or instrument flight capability.

"All those things are expensive, but I don't think anything they've asked so far is terribly unreasonable," says David Thomson, MD, FACEP, national medical advisor for the major private operator PHI. "These are technologies that are proven, and the price is actually coming down."

A bit more contentious is H.R. 978, the Helicopter Medical Services Patient Safety, Protection and Coordination Act. Introduced in February by Rep. Jason Altmire (D-PA), it stabs at the heart of the regulatory schism that hamstrings so many state-level safety efforts.

Basically, while states regulate the practice of medicine within their borders, aviation is the exclusive purview of the FAA. Where those jurisdictions intersect, things get tricky. That's largely due to the Airline Deregulation Act of 1978. The ADA preempts all state regulation of air carriers' prices, routes or services, handcuffing states that wish to restrict or control many aspects of air medicine delivery. For instance: States have been told they can't limit their numbers of air ambulances or require demonstrations of need for new ones. They can't designate base locations to ensure coordinated response. They can't require 24/7 operation or peer review of flights.

There are also plenty of grey areas where these jurisdictions cohabit. Think areas like climate control or electrical supply--attributes of aircraft, but also important to patient care.

The preemption in some areas and uncertainty in others have created a confusing tapestry for states. Take Hawaii's experience: It can require oxygen masks and certain other medical items aboard its helicopters, a federal review determined, but if its overall HEMS medical regulations become too "pervasive," they could cumulatively amount to prohibited economic restriction.

"So now there's a question about oxygen itself, because it's attached to the frame of the aircraft and has other aviation uses," notes Gary Wingrove, head of government relations and strategic affairs for Minnesota's Mayo Clinic Medical Transport. "The state has an interest in making sure there's enough oxygen on board to, for example, power a ventilator. But because the DOT letter specified oxygen masks, and that Hawaii stay away from areas where the FAA has jurisdiction, now there's a question about whether the state can require enough oxygen to power a ventilator for an entire helicopter trip."

The idea behind Altmire's legislation is to clear the deck for states to address such matters. The bill would "recognize and clarify the authority of the states to regulate intrastate helicopter medical services pursuant to their authority over public health planning and protection, patient safety and protection, emergency medical services, the quality and coordination of medical care, and the practice of medicine within their jurisdictions."

H.R. 978 (and its Senate companion, S. 848) has the support of the Patient First Air Ambulance Alliance, which represents more than 50 air-medical providers and groups like the National Association of EMS Physicians and National Association of State EMS Officials.

"Our interest is in making sure states have the right to regulate the medical part of air medical as they do every other part of healthcare," says Wingrove. "This bill won't cross lines with the FAA's jursidiction, but it will provide clarity on what states can regulate. It'll clear up the murky areas."

The bill itself doesn't require anything of states; it would still be up to them to evaluate their own circumstances and act if and how they deem appropriate. And it's that aspect that alarms some of the bill's opponents: It could lead to a patchwork of 50 different jurisdictions with discrete rules and requirements.

We have that with ground EMS now, and it's almost no one's ideal state. And air resources, covering greater distances, are even more likely to cross state boundaries.

"As a resident, I flew in Pittsburgh, which meant we went into Ohio and West Virginia," notes Thomson. "Then I flew in Cincinnati, and we were in Ohio, Kentucky, Indiana and West Virginia. In North Carolina, we occasionally went into South Carolina and Virginia. So what do you do if every state has its own little quirks? One state wants you to have 15 4x4s, another wants 23. Those kinds of arcane things can get in the way of making rational decisions. For a provider with a large radius of service, that can be difficult."

Those difficulties seem likely in such a scenario, but the current scenario has its problems too. One consequence of the ADA is that EMS helicopters have been untethered from hospitals, and private, community-based for-profit services have proliferated. That's been a blessing, bringing emergency air service to rural areas that had none. But it's also led to saturation in some markets and divided flights among increasing numbers of flyers. That's raised questions about medical necessity, skills proficiency and competitive behaviors.

"You have economic pressure to fly, and that pushes people into marginal situations," says Tom Judge, executive director of LifeFlight of Maine and chair of the Patient First Alliance. "You've impacted safety by the way you're designing and operating the system, so you end up flying in marginal weather and flying to get patients when it may not be medically necessary. And you can get all this other bad behavior, like selfdispatching and call-jumping."

These are central issues to the HEMS debate. The NTSB cited nighttime operations in poor weather conditions as contributing to several recent crashes. Yet in a for-profit environment where existence is volume-dependent, turning down flights can't be done cavalierly.

"With air programs, the fixed costs are extraordinarily high," notes Zalar. "How do you overcome that? You need volume. And there are only so many flights out there."

There can be pressure, then, oblique if not overt, to fly as many patients as possible, or at least as needed to break even. No one intentionally flouts safety, of course, but the lines between safe and unsafe aren't always clear and bright.

When it's optimal to fly patients and when they should go by ground is a source of ongoing debate, but many observers maintain that more patients are being flown in recent years who may not need to be. And that leads to questions about who's summoning air resources and when.

In a new public education campaign, the Association of Air Medical Services (AAMS) assures the public self-dispatch doesn't happen. Thomson emphasized the same point to the NTSB. "We don't just fly around and say, 'Oh, that looks like a good accident,'" he says. "We have to be called." But Judge, a past president of AAMS, isn't so sure: "I think it's more common than anyone realizes," he says. "It happens where you have lots of helicopters on top of each other, because they know if you don't get this number of flights a month, the helicopter goes away."

At the very least, helicopter shopping has been problematic in some places, and some critics take issue with aggressive marketing practices like selling subcriptions and courting non-medically trained police and firefighters who can call choppers to scenes. The more egregious excesses may have diminished in recent years, but the Altmire bill would give states a freer hand to combat them. It could, for better or worse, pave the way for a return to certificates of need.

The idea that states should be able to control things like the number of medical aircraft within their borders and where they're situated was bolstered in April by a report from the Flight Safety Foundation. Its comprehensive HEMS Industry Risk Profile (see www.flightsafety. org) identified oversight and organizational issues as contributors to HEMS fatalities. Among the "very high" risks it cited were problems with states' authority to determine the need for and location of services, and nonalignment and lack of clarity around federal, state and local oversight--areas the Altmire bill was intended to remedy.

"Things are unregulated, and providers are acting based on business interests," says Judge. "We have to get a handle on it. We want air medicine for our citizens, but we need to be able to assure them of safety. In a marketplace where the providers set the standards and there's no enforcement, then at some point I think there are questions about public accountability."

WHAT YOU'RE GETTING

When you go out to eat in southern California, the establishment you visit will often display a letter grade in its window. This is the result of an evaluation of its food handling and maintenance procedures, and it lets consumers know what they're getting. The A at Lulu's Rib Shack tells you it fared better on inspection, safety- and cleanliness-wise, than its competitors with lower marks.

This public accountability has an apparent benefit: When Los Angeles County created its grading system, hospitalizations linked to bad food dropped by 30% in three years.

That's the idea the Patient First Alliance wants to bring to air-medical resources. In a January position paper (issued as the Patient First Air Medical Transport Alliance and available at www.airmed.com/ Patient-First), it proposed a typing scheme for air resources that would categorize them based on their clinical capabilities and safety profiles. Knowing this, this idea goes, will let users know exactly what they'll get when they call, and help dispel the misconception that all air services are equal.

"The idea is, not just with safety but also with clinical capabilities, that physicians and PAs and nurses working in these rural hospitals will know what they can expect from airmedical transport," says Jeff Stearns, RN, quality management coordinator for Mayo and its MedAir service, which are part of the Alliance. "As it stands now, few people have an understanding of what care is provided and what capabilities programs have."

That's due to some vagueness in how services can promote themselves. A service can call itself critical care, and even be certified as such by the Commission on Accreditation of Medical Transport Systems (CAMTS), just by having a nurse on board, even if it only delivers ALS care in the air. If you summon a CCT resource, then, will you actually get critical care? The typing notion is to help ensure you do.

"The problem right now is that nobody knows what they're getting," Wingrove says. "A physician transferring a patient doesn't know the qualifications of the crew that's coming, and can't make any judgement about how safe the aircraft is. Yet they have an obligation under EMTALA to ensure they're choosing the right resource."

The Alliance anticipates other benefits as well. Typing would concentrate mission types among providers with appropriate expertise, enhancing their proficiency. It would assist outcomes research by letting apples be compared to apples. It would facilitate evaluation of crash data by mission type and safety level. It would incentivize investments in safety. And it would provide a basis for improving compensation to services that invest in safety and clinical excellence.

"Our intent is to ultimately change Medicare reimbursement," Wingrove says. "In the ground ambulance world, you have different payments based on levels of service. In the aircraft world, you don't have that. Whether you have a technologically advanced aircraft with a critical-care nurse/ physician team or a technologically unadvanced aircraft with just an EMT, the payment is the same."

That means, even if you add NVGs, TAWS, instrument flight capability or anything else, you still get reimbursed at the same rate as services that don't. "That gives you a choice of investing and being put in a poor business position, or not investing and being in a more lucrative business position," Stearns says. "So what's the incentive?"

The Alliance's proposal contains five levels of medical capabilities and four levels of safety capabilities. Existing federal emergency resource typing provided a framework. The model was finished for the NTSB hearings and presented at the Critical Care Transport Medicine Conference in April. There's been an effort to engage providers and get feedback, and refinements will come based on input from key organizations and further review of relevant literature.

"We've gotten a lot of positive comments and a couple of negative comments," says Stearns. "High quality programs think it's great and will help distinguish them."

Resistance may come from services that operate with more modest clinical capabilities or have made fewer investments in safety. No one boasts about meeting minimum standards of training, safety and medical care.

"CAMTS offers its levels of accreditation," notes Thomson, a CAMTS board member, "and we've had very few takers for ALS and BLS. Even some very rural services go for critical care accreditation, because they figure that gives them the broadest scope and biggest opportunity to transport patients. So I just wonder if anybody's going to be a taker for saying, for instance, 'We only fly daytime VFR.'"

NO HARD FEELINGS?

Push creates pushback, and as HEMS' various advocates work to implement their best answers, an unfortunate side effect is an exacerbation of divisions. Positions, and feelings, can get hardened. That's unfortunate, when everybody wants, at bottom, what's best for patients and safest for providers.

"Our members work for different companies, and their paychecks come from different people," notes Riley. "Things like this can pit our members against each other. It's disturbing that the economics of the industry end up putting the clinicians in the middle."

"There's a lot of polarizing going on," agrees Zalar. "Given the current environment, that's not so unnatural. But you don't want to see the leadership bifurcating. You don't want a situation where aviation and medicine have truly created stress and conflict between themselves. Because this is a very tight marriage.

When folks get in that aircraft, you want them to be on the same sheet." It's a marriage, all right: Whatever happens next, someone's probably going to be unhappy. But as in a marriage, they'll get over it if the whole ultimately grows stronger in the long run.

AAMS Launches Public Education Effort for Air Medical Transport

With increased scrutiny of the airmedical industry by authorities in Washington and the public at large, the Association of Air Medical Services has begun a public education campaign to emphasize the importance of air transport, especially for rural and underserved areas.

"Most people don't realize the life-and- death role emergency medical helicopters play in our healthcare system," AAMS President Sandy Kinkade said in a statement announcing the campaign. "But the critically ill and injured are airlifted once every 90 seconds in our nation. That's why it's important to have medevac services in places where they are needed--because the life saved might be yours or a loved one's."

AAMS wants the public to know that besides just covering long distances faster, EMS helicopters can often provide higher levels of care than ground resources, with crews that may include critical-care nurses and other specialists (e.g., neonatologists, respiratory therapists). Because they frequently transport critically ill and injured patients, air crews tend to have substantial experience managing them, and they can bring advanced drugs, blood and blood products, patient monitoring tools and equipment to areas that don't have them. In this way, they've formed a "rural healthcare safety net."

Medical helicopters must be called by a medical or public-safety provider--they do not self-dispatch. While numbers have proliferated--there are now around 840 in the U.S.--the increase is partially due to greying Baby Boomers experiencing the diseases of age.

Accordingly, medevac reliance is greater in rural and Sun Belt retirement areas, as well as places that have experienced ED closures or cutbacks in ambulance services.

AAMS acknowledges the recent "intolerable increase" in fatal medical helicopter crashes, and promotes several proposals for greater safety. It supports requiring night-vision goggles or similar enhanced-vision systems for all nighttime operations, or conducting those flights strictly under instrument flight rules. The organization also urged Congress at a House Aviation Subcommittee hearing in April to expedite funding for hospital helipads, enhanced off-airport weather reporting and global positioning systems technologies, and other initiatives aimed at improving low-altitude aviation infrastructure. AAMS also supports use of technologies like the HEMS Weather Tool, www.weather.aero/hems. For more, see www.aams.org.

ACEP: Let Docs Make Flight Calls

The American College of Emergency Physicians followed February's NTSB hearings with several recommendations for better HEMS safety. ACEP called for physician oversight of state systems and for medical decisions about air-medical patients to be made by physicians, based on each patient's best interests. It also called for states to develop their EMS protocols and to require accreditation for HEMS systems. Other priorities were accurate and timely weather data for pilots; terrain/fixed object warning and avoidance technologies; destination protocols based on medical need; NTSB best-practice guidance for states; and research for HEMS dispatch decision-making.

Figure 1: Air-Medical Capability Resource Typing Model
The Patient First Air Ambulance Alliance's proposed levels of medical capability resource typing:

Level 1: Advanced Critical Care--Meets DHS/FEMA EMS resource typing medical care requirements of Type I disaster resource. Includes highly specialized care of patients whose conditions are life-threatening and who require comprehensive intensive care and constant monitoring. Provides transport for patients with cardiac/ventricular assist devices or extracorporeal membrane oxygenation; point-of-care laboratory services in flight; blood product initiation; transvenous and epicardial cardiac pacing; central venous/arterial line insertion and monitoring; chest tube thoracostomy; continuous high-risk obstetric monitoring; actively conducts air-medical research; plus provides all Level 2 services.

Level 2: Critical Care--Meets DHS/FEMA resource typing medical care requirements of Type I disaster resource. Includes specialized care of patients whose conditions could be life-threatening and may require care beyond ALS care. Provides invasive and noninvasive ventilation; medication infusions beyond Level 3 (specifics to be addressed); 12-lead ECG capability; invasive line monitoring and maintenance; intermittent high-risk obstetric monitoring; has CAMTS critical-care certification; plus provides all Level 3 services.

Level 3: Advanced Life Support--Meets DHS/FEMA resource typing medical care requirements of Type III disaster resource, except that a nurse, midlevel or physician may substitute for the paramedic, and the service is not required to carry blood, but must be capable of maintaining a blood product infusion.

Level 4: Advanced Life Support Services--Meets DHS/FEMA resource typing medical care requirements of Type IV disaster resource, except that a nurse, midlevel or physician may substitute for the paramedic.

Level 5: Basic Life Support Services--Does not meet any DHS/FEMA resource typing care level, but provides state-licensed medical personnel.

Figure 2: Rotary-Wing Aircraft and Safety Capability Resource Typing Model
The Patient First Air Ambulance Alliance's proposed levels of rotary-wing aircraft and safety capability resource typing:

Level A--Consistently provides the highest standards in pilot and crew training and education, safety and risk-management processes, and aircraft capabilities. Competent and equipped to safely complete all EMS missions in remote areas during darkness and/or technical-rescue operations. Specific qualifications may include Platinum ARGUS rating; IFR-current aircraft and pilots; other advanced technology/processes/training (e.g., flight data or voice recorders); plus all Level B capabilities.

Level B--Consistently provides high standards in pilot and crew training and education, safety and risk-management processes, and aircraft capabilities. Competent and equipped to safely complete all EMS missions in uncontrolled landing zones during daylight hours and in controlled heliports during darkness. Specific qualifications may include Gold-Plus ARGUS rating; NVG capability; obstacle-avoidance warning systems; no patient/light intrusion into the pilot compartment; plus all Level C capabilities.

Level C--Consistently provides moderate standards in pilot and crew training and education, safety and risk-management processes, and aircraft capabilities. Competent and equipped to safely complete all EMS missions in controlled or uncontrolled landing zones during daylight hours. Specific qualifications may include Gold ARGUS rating; CAMTS certification; accurate and appropriate use of operational control for aircraft operations; plus all Level D capabilities.

Level D--Consistently provides minimum standards in pilot and crew training and education, safety and risk-management processes, and aircraft capabilities. Competent and equipped to safely complete all EMS missions to and from controlled landing zones during daylight hours. Specific qualifications may include Silver or no ARGUS rating; FAA Part 135 compliance with medical crews on board; working radar altimeter; climate control for patient transport; use of standardized mission risk-management tools; use of interagency weather turndown communication process; annual Air Medical Resource Management training; interagency communication processes that enhance multiple-aircraft missions and mitigate collision potential.

Figure 3: Fixed-Wing Aircraft and Safety Capability Resource Typing Model
The Patient First Air Ambulance Alliance's proposed levels of rotary-wing aircraft and safety capability resource typing:

Level A--Consistently provides the highest standards in pilot and crew training and education, safety and risk-management processes, and aircraft capabilities. Competent and equipped to safely complete all EMS missions in remote areas or internationally. Specific qualifications may include Platinum ARGUS rating; other advanced technology/processes/training (e.g., flight data or voice recorders); APU-equipped for operations in remote regions or involving international tech stops; oversight by Part 121 dispatchers for international operations; two-pilot operation; appropriate type rating for flight crew members on aircraft exceeding 12,500 lbs.; plus all Level B capabilities.

Level B--Consistently provides high standards in pilot and crew training and education, safety and risk-management processes, and aircraft capabilities. Competent and equipped to safely complete long-range domestic missions. Specific qualifications may include Gold-Plus ARGUS rating; obstacle-avoidance warning systems; uninterrupted communication with medical control; trip oversight by experienced aviation professionals; lavatory facilities on aircraft; redundancy of equipment, electrical, medical gas and pneumatic systems for remote/international operations; plus all Level C capabilities.

Level C--Consistently provides moderate standards in pilot and crew training and education, safety and risk-management processes, and aircraft capabilities. Competent and equipped to safely complete medium-range domestic missions. Specific qualifications may include Gold ARGUS rating; IFR-current aircraft and pilots; CAMTS certification; no patient/light intrusion into the pilot compartment; use of operational control for aircraft operations to include flight following procedures; oxygen capacity not dependent on ground support at every remote/international tech stop; plus all Level D capabilities.

Level D--Consistently provides minimum standards in pilot and crew training and education, safety and risk-management processes, and aircraft capabilities. Competent and equipped to safely complete short-range domestic missions. Specific qualifications may include Silver or no ARGUS rating; FAA Part 135 compliance with medical crews on board; working radar altimeter; climate control for patient transport; use of standardized mission risk-management tools; annual Air Medical Resource Management training; patient access for necessary medical assessments and interventions per program scope; premission planning to include confirmation of available medical oxygen at tech stops, confirmation of GPU availability on non-APU aircraft, and aircraft utilization appropriate to length of transport, patient size and condition, equipment needed, regional geography and aircraft performance.