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Report to Congressional Requesters:
United States Government Accountability Office:
GAO:
September 2010:
Air Ambulance:
Effects of Industry Changes on Services Are Unclear:
GAO-10-907:
GAO Highlights:
Highlights of GAO-10-907, a report to congressional requesters.
Why GAO Did This Study:
Changes in the air ambulance industry’s size and structure have led to
differences of opinion about the implications for air ambulance use,
safety, and services. Some industry stakeholders believe that greater
state regulation would be good for consumers. While states can
regulate the medical aspects of air ambulances, the Airline
Deregulation Act (ADA) preempts states from economic regulation—i.e.,
regulating rates, routes, and services—of air ambulances. Other
stakeholders view the industry changes as having been beneficial to
consumers and see no need for a regulatory change.
Asked to review the U.S. air ambulance industry, GAO examined (1)
changes in the industry in the last decade and the implications of
these changes on the availability of air ambulances and patient
services and (2) the relationship between federal and state oversight
and regulation of the industry. GAO analyzed available data about the
industry; synthesized empirically based literature on the industry;
visited four air ambulance providers with differing views on the
industry changes; and interviewed federal and industry officials.
GAO is not making recommendations in this report. GAO incorporated
comments on a draft this report from the appropriate federal agencies
and key industry and emergency medical services stakeholders.
What GAO Found:
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 percent, and the number of dedicated air
ambulance helicopters increased from 360 to 677, or by about 88
percent. During the same period, the structure of the industry changed
from a preponderance of providers affiliated with a specific hospital
to a fairly even split between hospital-based and independent
providers, often located outside hospitals, in suburban or rural
communities. Perspectives on the implications of these changes vary.
Supporters of the existing regulatory framework say that the growth in
the number of helicopters provides, among other things, flexibility to
perform aircraft maintenance on some helicopters while keeping others
available to respond as needed. Proponents of a change in the
regulatory framework maintain that the growth in helicopters has led
to medically unnecessary flights. These stakeholders assert that high
fixed costs create economic pressure to fly in unsafe weather and use
less costly small helicopters that limit some patient services. GAO
found few data that support either perspective.
Court cases and advisory opinions from the Department of
Transportation (DOT) have helped to clarify the relationship between
federal and state oversight and regulation of the air ambulance
industry, but DOT has acknowledged a continuing lack of clarity in
some areas. Generally, the federal government has authority and
oversight concerning the economic and safety aspects of the industry;
states—which are preempted from regulating matters related to prices,
routes, and services—have authority over the medical aspects. However,
when both economic and medical or safety and medical issues are
involved, questions about jurisdiction may arise. To resolve such
questions, states have sought DOT’s opinion and, in response, DOT has
issued eight opinion letters since 1986. Some state officials have
expressed concerns, particularly in relation to a DOT opinion letter
on Hawaii laws, that the open-ended nature of the opinion could allow
any medical regulation to be challenged as an economic regulation and
thus be preempted under the ADA. States can continue to seek DOT’s
opinion on a case-by-case basis, as further questions surface.
Additionally, states can also contract directly with air ambulance
providers, which would allow states to control specific services as
the customer.
Figure: Air Ambulance Helicopter:
[Refer to PDF for image: photograph]
Source: Mark Mennie.
[End of figure]
View [hyperlink, http://www.gao.gov/products/GAO-10-907] or key
components. For more information, contact Gerald L. Dillingham, Ph.D.,
(202) 512-2834, dillinghamg@gao.gov.
[End of section]
Contents:
Letter:
Background:
The Air Ambulance Industry Has Seen Growth and Structural Change, but
Perspectives Differ on Implications for Availability, Efficient Use,
Safety, and Services Provided:
Federal and State Courts and DOT Have Clarified Some Boundaries of
Federal and State Regulation of Air Ambulances, but Questions Remain:
Agency and External Comments and Our Evaluation:
Appendix I: Scope and Methods:
Appendix II: Literature Synthesis:
Appendix III: Key Court Cases and Opinion Letters from DOT or State
Attorneys General:
Appendix IV: Comments from the National Transportation Safety Board:
Appendix V: GAO Contact and Staff Acknowledgments:
Bibliography:
Tables:
Table 1: Differing Results of Sequential Helicopter Requests:
Table 2: Perceived and Intentional Call Jumping:
Table 3: Issues Related to Air Ambulances That Courts, DOT, and State
Attorneys General Have Ruled Can and Can Not Be Regulated by States:
Table 4: Summary of Key Court Cases Related to the Air Ambulance
Industry:
Table 5: Summary of DOT or State Attorneys General Opinions Related to
the Air Ambulance Industry:
Figures:
Figure 1: Percentage of Payments for Air Ambulance Transports Received
from Different Sources:
Figure 2: Number of Air Ambulance Helicopters and Patient Transports,
1999 through 2008:
Figure 3: Number of Air Ambulance Helicopters in Each State in 2009:
Figure 4: Schematic Representation of Helicopter Air Ambulance
Geographic Coverage When Based at a Hospital Compared with Bases in
the Community:
Figure 5: Example of a Medical Bay in a Single-Engine Helicopter:
Figure 6: Depiction of Aviation and Medical Components of an Air
Ambulance:
Figure 7: Literature Synthesis Process and Results:
Abbreviations:
AAMS: Association of Air Medical Services:
ACCT: Association for Critical Care Transport:
ADA: Airline Deregulation Act of 1978:
ADAMS: Atlas and Database of Air Medical Services:
AMOA: Air Medical Operators Association:
ASRS: Aviation Safety Reporting System:
CUBRC: Calspan-University of Buffalo Research Center:
DOT: Department of Transportation:
EMS: emergency medical services:
EVENT: Emergency Medical Service Voluntary Event Notification Tool:
FAA: Federal Aviation Administration:
NAEMSP: National Association of EMS Physicians:
NASEMO: National Association of State EMS Officials:
NTSB: National Transportation Safety Board:
[End of section]
United States Government Accountability Office:
Washington, DC 20548:
September 30, 2010:
The Honorable John L. Mica:
Ranking Member:
Committee on Transportation and Infrastructure:
House of Representatives:
The Honorable Jerry F. Costello:
Chairman:
The Honorable Thomas E. Petri:
Ranking Member:
Subcommittee on Aviation:
Committee on Transportation and Infrastructure:
House of Representatives:
The Honorable Jason Altmire:
House of Representatives:
The Honorable John D. Rockfeller:
Chairman:
The Honorable Kay Bailey Hutchinson:
Ranking Member:
Committee on Commerce, Science, and Transportation:
United States Senate:
During the past decade, the air ambulance industry has grown and its
structure has changed. Air ambulances are generally helicopters or
fixed-wing aircraft that are specifically outfitted to transport ill
or injured persons. Air ambulances may transport patients from
accident scenes to hospitals, or transport patients between hospitals
to receive more sophisticated medical care at specialty facilities
such as trauma, burn, or cardiac centers. Most air ambulance companies
operate as commercial entities and are subject to a mixture of federal
and state regulation. The industry is subject to Federal Aviation
Administration (FAA) safety regulations covering areas such as pilot
training requirements, flight equipment, and aircraft configuration.
States can regulate the medical aspects of air ambulances, but the
Airline Deregulation Act of 1978 preempts states from economic
regulation--i.e., regulating rates, routes, and services--of air
ambulances. Some industry stakeholders are concerned with the growth
in the industry and view the industry's changes as having a negative
effect on the services provided to patients. These stakeholders
generally support changing the regulatory and oversight framework to
provide states more regulatory authority. Other groups of stakeholders
view the growth in the industry as having been beneficial to society
and generally don't support such a change.
Given the differences of opinion about the effects of the air
ambulance industry's growth and changes to its structure, you asked us
to review the U.S. air ambulance industry. To do this, we examined:
(1) how the industry changed in the last decade and the implications
of these changes for the availability of services, efficient use of
air ambulance resources, safety, and services provided and (2) the
relationship between federal and state oversight and regulation of the
air ambulance industry. To examine these issues, we obtained and
analyzed available data that provided information on the growth and
evolution of the industry, shifts in business models, and the types of
air ambulance aircraft that are used to provide services.
Specifically, we obtained and analyzed data on the trends in air
ambulance industry growth from a research database[Footnote 1] and
from the Atlas and Database of Air Medical Services (ADAMS).[Footnote
2] We also analyzed Medicare payment data. We reached out to the air
ambulance community by emailing more than 400 air ambulance providers,
industry associations, and state emergency medical services (EMS)
officials, asking that they provide us any data, information,
published or unpublished reports, papers, articles, or other
potentially relevant sources of information of which they would like
us to be aware. We also conducted a comprehensive literature search to
identify peer-reviewed studies that reached empirically based
conclusions on air ambulance practices or outcomes. We identified and
synthesized over 250 studies related to the air ambulance industry,
dating as far back as 1975. We reviewed past GAO reports, transcripts
of congressional and National Transportation Safety Board (NTSB)
hearings, industry association position papers, and other industry
documents. In addition, we conducted interviews with representatives
from the key air ambulance associations--Association of Air Medical
Services (AAMS), Association for Critical Care Transport (ACCT), and
the Air Medical Operators Association (AMOA). We also met with the
National Association of State EMS Officials (NASEMSO). We conducted
four site visits to air ambulance providers that reflected differing
geographic locations, business models, and opinions about the
implications of changes in the industry.
To analyze the relationship between federal and state oversight and
regulatory responsibilities, we reviewed federal and state court cases
and opinions issued by the Department of Transportation's (DOT) Office
of General Counsel. We also discussed the implications of industry
trends and federal and state authority with the key industry
stakeholders mentioned above, as well as with officials at FAA, the
National Highway Traffic Safety Administration, NTSB; as well as
representatives of NASEMSO. See appendix I for a more complete
description of our scope and methodology and appendix II for a more
complete description of our literature review and synthesis.
We conducted this review from December 2009 to September 2010, in
accordance with generally accepted government auditing standards.
Those standards require that we plan and perform the audit to obtain
sufficient, appropriate evidence to provide a reasonable basis for our
findings and conclusions based on our audit objectives. We believe
that the evidence obtained provides a reasonable basis for our
findings and conclusions based on our audit objectives.
Background:
Air ambulances can play an important role in transporting patients
with time critical injuries and conditions to medical facilities and
providing patients with advanced care while en route. Air ambulances
transported more than 270,000 patients in 2008, and their use is
widely believed to improve the chances of survival for trauma victims
and other critical patients. Composing more than 80 percent of air
ambulance aircraft, helicopter air ambulances transport patients from
the scene of an accident to a hospital or perform short-distance
interhospital patient transfers. Because fixed-wing aircraft only fly
between airports, they are not typically used to transport injured
patients from an accident scene. Patients are transported by ground to
and from the airport. Fixed-wing air ambulances generally perform more
long-distance interhospital transports, often moving patients from a
hospital to a distant specialized facility. Just over half of air
ambulance transports are for moving patients between hospital
facilities, one-third are for transporting victims from the accident
scene to a hospital, and the remainder are for other purposes, such as
organ transports or specialty care flights such as for pediatric and
neonatal patients.
Most air ambulances carry a pilot and a two-person medical crew. The
medical crew may include a physician, nurse, paramedic, emergency
medical technician, or other medical personnel. According to AAMS, the
typical medical crew includes a critical care nurse and a paramedic. A
critical care nurse has specialized training in responding to life-
threatening health problems, such as those faced by many patients who
are transported on air ambulances. Paramedics represent the highest
licensure level of prehospital emergency care in most states, as they
have enhanced skills and can administer a range of medications and
interventions. Other caregivers and physicians may be added to a
medical crew if the patient's condition necessitates further care.
Air Ambulance Providers Operate Under Three Basic Business Models:
In the air ambulance industry, the business model is generally defined
by the entity that owns or contracts for the aviation and medical
services that are provided. Air ambulance providers generally use one
of the following three business models.
* Hospital-based: a hospital generally controls the business by
providing medical services and staff while usually contracting out for
the aviation component, including the pilots, mechanics, and aircraft.
* Independent: operations are not controlled or run by a specific
medical facility. Independent providers may directly employ, or can
contract for, the medical and flight crews to provide air ambulance
services.[Footnote 3]
* Government operator: a state or local government or military unit
owns and operates the air ambulances.
However, a large number of variations exist within these structures.
Some providers have adopted a "hybrid" model or have established joint
ventures with hospitals.
Air Ambulance Providers Receive Revenue from a Variety of Sources,
Including Federal Medicare and Medicaid Programs:
Air ambulance companies receive payment for transports from several
sources, including private health insurance, government programs such
as Medicare and Medicaid, and the patient. While industry revenue and
payment data are not widely available, we obtained data on the
percentage of total income that four air ambulance providers receive
from each source. (See figure 1.) For these four companies, private
insurance companies or Medicare paid for most of the transport costs.
A relatively small percentage of the costs were paid for by the
patient themselves.
Figure 1: Percentage of Payments for Air Ambulance Transports Received
from Different Sources:
[Refer to PDF for image: vertical bar graph]
Source of payment: Insurance;
Company A: 46%;
Company B: 49%;
Company C: 32%;
Company D: 68%.
Source of payment: Medicare;
Company A: 37%;
Company B: 28%;
Company C: 39%;
Company D: 18%.
Source of payment: Medicaid;
Company A: 16%;
Company B: 19%;
Company C: 13%;
Company D: 12%.
Source of payment: Patient;
Company A: 1%;
Company B: 3%;
Company C: 15%;
Company D: 2%.
Source: GAO analysis of air ambulance company data.
Note: Includes providers of various sizes that operate under
variations of the hospital-based or independent business models. Does
not include government operators.
[End of figure]
From 2002 through 2006, the Centers for Medicare and Medicaid
Services, the agency within the Department of Health and Human
Services that administers Medicare and Medicaid, phased in a national
fee schedule for air ambulance providers as a part of a series of
Medicare payment reforms that Congress mandated in 1997. The national
fee schedule redistributed, on a budget-neutral bases, payments among
various types of ambulance services. Prior to 2002, Medicare
reimbursement differed depending on the air ambulance provider's
business model: hospital-based providers were reimbursed based on
reasonable costs[Footnote 4], while independent providers were
reimbursed based on reasonable charge[Footnote 5]s. This policy
contributed to wide variation in the reimbursement rate for the same
service, with hospital-based providers generally receiving higher
reimbursement than independent providers for similar services. The new
national fee schedule established one payment rate for fixed-wing
transports and another rate for helicopter transports. The fee
schedule also provides higher reimbursement for transports in rural
areas, but it does not differentiate payments according to the
business model followed, the size of the aircraft used, or the level
of medical or safety equipment on board.[Footnote 6]
In addition to the revenue they receive from transports, air ambulance
providers may receive or generate income for their operations from
other sources. For example, hospital-based providers may receive
funding from the hospital, and some independent air ambulance
providers have established membership programs that generate income
from annual fees.[Footnote 7] Government operators may receive funding
through taxes or surcharges. For example, Maryland's government-
operated air ambulance service receives funding through a surcharge on
state motor vehicle registrations.
The Air Ambulance Industry Has Seen Growth and Structural Change, but
Perspectives Differ on Implications for Availability, Efficient Use,
Safety, and Services Provided:
From 1999 through 2008, the number of patients transported by
helicopter air ambulances increased from just over 200,000 to over
270,000, or about 35 percent, and the number of air ambulance
helicopters increased from 360 to 677,[Footnote 8] or by about 88
percent. The data also show that between 2007 and 2008 there were an
increasing number of helicopter air ambulances and a decreasing number
of transports. (See figure 2.) We were unable to determine whether the
downward movement in 2008 represents a trend because 2009 data on
patients transported were not available.
Figure 2: Number of Air Ambulance Helicopters and Patient Transports,
1999 through 2008:
[Refer to PDF for image: multiple line graph]
Calendar year: 1999;
Patients transported: 204,164;
Helicopters: 360.
Calendar year: 2000;
Patients transported: 197,143;
Helicopters: 377.
Calendar year: 2001;
Patients transported: 206,857;
Helicopters: 400.
Calendar year: 2002;
Patients transported: 213,258;
Helicopters: 413.
Calendar year: 2003;
Patients transported: 202,612;
Helicopters: 443.
Calendar year: 2004;
Patients transported: 225,325;
Helicopters: 513.
Calendar year: 2005;
Patients transported: 264,621;
Helicopters: 585.
Calendar year: 2006;
Patients transported: 274,924;
Helicopters: 648.
Calendar year: 2007;
Patients transported: 284,286;
Helicopters: 663.
Calendar year: 2008;
Patients transported: 270,800;
Helicopters: 677.
Source: GAO analysis of University of Chicago Aeromedical Network data.
Note: This research data was compiled by Ira J. Blumen, MD, Medical/
Program Director, University of Chicago Aeromedical Network, as
presented to NTSB, February, 2009. Dr. Blumen's data is the only
source that we could find that provided continuous data spanning the
past decade.
[End of figure]
The number of air ambulance helicopters varies widely by state. (See
figure 3.) Most states have multiple helicopters based in their state.
Vermont and Rhode Island have none, but their air transport needs are
served by providers in bordering states.
Figure 3: Number of Air Ambulance Helicopters in Each State in 2009:
[Refer to PDF for image: U.S. map and associated data]
Alabama: 14;
Alaska: 35;
Arizona: 57;
Arkansas: 13;
California: 87;
Colorado: 13;
Connecticut: 2;
Delaware: 6;
District of Columbia: 4;
Florida: 47;
Georgia: 19;
Hawaii: 4;
Idaho: 8;
Illinois: 19;
Indiana: 17;
Iowa: 9;
Kansas: 13;
Kentucky: 26;
Louisiana: 11;
Maine: 2;
Maryland: 19;
Massachusetts: 4;
Michigan: 12;
Minnesota: 15;
Mississippi: 9;
Missouri: 32;
Montana: 5;
Nebraska: 6;
Nevada: 7;
New Hampshire: 2;
New Jersey: 8;
New Mexico: 13;
New York: 32;
North Carolina: 18;
North Dakota: 3;
Ohio: 34;
Oklahoma: 18;
Oregon: 7;
Pennsylvania: 47;
Rhode Island: 0;
South Carolina: 10;
South Dakota: 4;
Tennessee: 26;
Texas: 70;
Utah: 8;
Vermont: 0;
Virginia: 21;
Washington: 10;
West Virginia: 9;
Wisconsin: 11;
Wyoming: 1.
Sources: GAO analysis of Atlas and Database of Air Medical Services,
2009 edition; Map Resources (map).
Note: ADAMS is based on voluntary data reporting and shows, among
other things, the number and location of air ambulance helicopters in
each state. The numbers for Alaska and North Carolina include air
ambulance helicopters, 17 and 3 respectively, from selected military
units that are routinely used in civilian rescue.
[End of figure]
Since 1999, the structure of the air ambulance industry has also
changed. In the past, most air ambulance providers were hospital-
based, whereas today, about half the providers are independent, with
no support from hospitals in terms of ownership, risk, and financial
support.
According to industry stakeholders, a variety of factors contributed
to the industry's growth and structural change. The downsizing or
closing of some community hospitals, according to stakeholders,
resulted in longer transports to get some patients to hospitals,
making it more advantageous to use air ambulances that could transport
patients over longer distances more quickly than by ground ambulances.
Similarly, the establishment of regional medical facilities, such as
cardiac and stroke centers that provide highly specialized care for
critically ill patients, encouraged the use of air ambulances, again
because they could transport patients more quickly from outlying
areas. Finally, implementation of the Medicare fee schedule provided
those wishing to provide air ambulance services a degree of
predictability for Medicare reimbursement, which stakeholders noted
enabled air ambulance providers to develop more accurate financial
plans.
Growth in the Number of Air Ambulances and Movement of Their Bases
into Communities Have Increased Availability:
The growth in the number of helicopters and their movement into
communities have generally made them more available to those in need.
According to some stakeholders, having multiple air ambulances in an
area increases the industry's capacity to meet regional needs. For
example, if one helicopter is unavailable because it is undergoing
scheduled maintenance or responding to an air medical transport
request, another helicopter in the same region is more likely to be
available. Additionally, with more air ambulances available in rural
communities, rural ground ambulances may be involved less frequently
in transporting patients over long distances, and rural communities
are less likely to be left without an ambulance or EMS crew.
Providers also relocated air ambulance bases, moving them from
hospitals into surrounding communities and thereby extending their
availability. (See figure 4.) A 2005 nationwide study of access to
trauma centers in the United States found that 84 percent of the
population had access to a Level I or II trauma center within 60
minutes. Of that population, almost 28 percent could only access those
trauma centers in an hour or less because they were located within the
coverage of an air ambulance.[Footnote 9] Stakeholders concerned with
the growth in the industry, noted that the increase in the number of
helicopters has been focused in areas that already have multiple air
ambulance services while rural areas remain underserved. They said
that ensuring the availability of air ambulance services in rural
areas is problematic because covering a large, sparsely populated
geographic area affects profitability and impacts companies' ability
to provide services in these areas.
Figure 4: Schematic Representation of Helicopter Air Ambulance
Geographic Coverage When Based at a Hospital Compared with Bases in
the Community:
[Refer to PDF for image: illustration]
Source: GAO.
Note: Ground ambulances may also be based in the communities
surrounding hospitals, but their geographic range is more limited than
that of an air ambulance. Fly circles and locations of specific air
ambulance providers vary based on several factors, including the
capabilities of their aircraft and local terrain.
[End of figure]
Literature Indicates That Questions about the Medical Necessity of
Some Air Ambulance Transports Have Existed for Decades:
Stakeholders concerned with industry growth believe that uncontrolled
growth of air ambulances in a region leads to medically unnecessary
use--that is, when an air ambulance is dispatched for a patient whose
injury or illness is not severe enough for the patient to need air
transport. One stakeholder group compared data on the severity of
patients' injuries and discharge rates, developed by Arizona's
Department of Health Services, with similar data for a Level I Trauma
Center in New Hampshire, and an air ambulance service in Boston.
According to their analysis, the injuries of patients transported in
Arizona, a state with a comparatively large number of helicopters,
were less severe than those of patients transported in the two other
states that have fewer helicopters.[Footnote 10] However, the
comparison does not examine other factors involved in decisions about
how to transport patients, including transport distances, who makes
the transport decision, and what protocols guide the decision maker.
Additionally, the decision to request an air ambulance is generally
made by the attending physician at a hospital or by first responders
at an accident scene.
Concerns about medically unnecessary use of air ambulances have
existed since the early 1980s. We identified 32 studies examining
triage criteria using data collected from as early as 1975 to as
recently as 2008.[Footnote 11] Fifteen study authors conclude that
further measurement indices are needed to better identify over-and
undertriage of patients transported by air ambulance.[Footnote 12],
[Footnote 13] Because triage protocols and patterns of air ambulance
utilization have changed considerably in the past 30 years, early
reports must be interpreted with caution and their relevance to
current triage protocols and air ambulance is unclear. It is also
important to consider these studies in their historical context.
Numerous guidelines on appropriate use of ambulances have been
published. In 2006, the American College of Emergency Physicians and
the National Association of EMS Physicians (NAEMSP) issued Guidelines
for Air Medical Dispatch that built upon earlier guidelines published
by NAEMSP, AAMS, and the American Academy of Pediatrics. The 2006
position statement recognized the continuing debate surrounding air
medical transport and noted that research regarding the appropriate
deployment of complex medical care systems was in its infancy.
Furthermore, the position statement noted that many EMS systems have
their own criteria for air medical dispatch, which usually differ
between regions based on demographic, geographic, and health care
resource considerations.
Work on developing national guidelines is under way. After its
February 2009 air ambulance safety public hearing, NTSB recommended
that the Federal Interagency Committee on Emergency Medical Services
develop national guidelines for selecting the most appropriate
emergency transportation mode for urgent care.[Footnote 14] In
response, the committee has begun to develop guidelines for the
emergency transport of trauma victims from the scene of injury. These
guidelines may eventually include recommendations for the transport of
patients with other medical emergencies and for interfacility
transports.
Little Evidence Exists to Link Industry Growth to Safety Concerns:
Proponents of increasing state regulatory authority argue that having
multiple providers in the same area creates pressure to fly that can
lead to a number of unsafe practices.[Footnote 15] They maintain that
providers' high fixed costs create economic pressure to fly, and the
concentration of many air ambulances in a geographic area further
exacerbates this pressure. Air ambulance providers' fixed costs can
amount for up to 80 percent of a provider's total costs. The air
ambulance itself can cost from $600,000 to $12 million when outfitted
with varying levels of flight and medical equipment.
Participants at NTSB's February 2009 public hearing discussed
potential safety concerns with helicopter shopping. Helicopter
shopping refers to the practice of calling, in sequence, various
providers until a provider agrees to take a flight assignment.
Stakeholders who support the existing regulatory and oversight
framework noted that there are situations where calling additional
providers is an appropriate and safe use of resources. (See table 1.)
Table 1: Differing Results of Sequential Helicopter Requests:
Results in potentially unsafe flight:
A dispatcher calls a provider who turns down the request because of
weather conditions. The dispatcher then calls other providers,
potentially not disclosing information about the prior turndown, until
a provider accepts the flight. This provider might have less weather
information than the provider that turned down the flight and might
not have accepted the flight had it known of the prior turndown.
Results in appropriate use of resources:
A dispatcher calls a provider who turns down the request because of
localized weather conditions. The dispatcher then calls a second
provider and informs this provider of the prior turndown and the
reason for it. The second provider accepts the transport because its
helicopter is located in a different geographical area, and its flight
path to the patient would not be affected by the localized weather
conditions.
Source: GAO.
[End of table]
Having information on prior turndowns or aborted missions could help a
provider decide whether it is safe to fly. FAA has provided state EMS
officials with a sample letter that could be given to dispatchers
within their state that outlines sample communications policies,
including policies on disclosing information about prior turndowns.
However, even with information on prior turndowns, pilots are
responsible for checking weather conditions and determining if the
conditions meet FAA's requirements for flying. NASEMSO representatives
suggested that the time spent sequentially calling additional air
ambulance providers consumes time during which a patient could be en
route to a trauma center via ground ambulance.
Call jumping occurs when a provider sends an air ambulance to an
accident scene without a request. If another air ambulance provider is
also responding based on a request from first responders, there is a
heightened risk of collision. Stakeholders who advocate for an
increase in state regulatory authority maintain that, like helicopter
shopping, call jumping can result from economic pressure to fly.
However, some instances perceived as call jumping may stem from a lack
of communication among first responders. (See table 2.)
Table 2: Perceived and Intentional Call Jumping:
Two providers respond to separate requests for the same emergency:
Two providers are independently dispatched to respond to an accident
scene by different first responders at the scene--for example, by the
paramedics and by the police. The first responders' failure to
communicate with each other may lead each provider to perceive that
the other has "jumped" the call.
Air ambulance is dispatched by provider:
A provider dispatches an air ambulance to a scene based on monitored
radio traffic, without being requested.
Source: GAO.
[End of table]
To minimize the risk of two helicopters responding based on separate
requests from first responders, states can establish communication and
coordination protocols to be followed at the more than 6,000 public
safety answering points, or 911 call centers, nationwide. These
centers provide the opportunity to coordinate air ambulance requests
and avoid dispatching two air ambulances to the same crash scene.
However, these centers are locally based and operated, and their
structure varies widely.
Beyond anecdotes, we found little evidence of helicopter shopping
resulting in unsafe flights or of call jumping. We identified FAA's
Aviation Safety Reporting System (ASRS)[Footnote 16] as a potential
source for such information. As a voluntary reporting system, ASRS
contains reporting biases reflecting that not all participants in the
aviation system are equally aware of ASRS or equally willing to file
reports. Consequently, ASRS statistics represent a conservative
measure of the number of such events that are occurring. In our review
of 464 air ambulance reports submitted to ASRS over 15 years, we found
2 that contained information about call jumping and none that
described instances of helicopter shopping. These data could indicate
that helicopter shopping and call jumping occur infrequently. On the
other hand, these practices may be underreported if air ambulance
crews are unaware that they can report safety issues to ASRS.[Footnote
17]
During the summer of 2010, the Center for Leadership, Innovation and
Research in EMS[Footnote 18] established the EMS Voluntary Event
Notification Tool (EVENT)--an anonymous, non-punitive and confidential
web-based system that allows anyone in the United States or Canada to
report an event or action that leads to or has the potential to lead
to a worsened patient outcome. Reports received in EVENT are sent to
the EMS governing body of the state, territory or province responsible
for the EMS system in which the event occurred. Once the governing
body receives the anonymous notification, they would be encouraged to
address systemic issues in order to improve the overall quality of
care provided. As of September 1, 2010, EVENT had received one report.
While it is too early to evaluate the impact of the EVENT reporting
system, it appears to be a positive step that could provide useful
data for state regulators.
FAA is in the process of addressing several NTSB recommendations
related to safety issues that NTSB has made regarding helicopter air
ambulance safety.[Footnote 19] FAA officials expect to release a
notice of proposed rulemaking in the fall of 2010 that would address
issues such as additional safety equipment requirements, minimum
acceptable weather conditions, use of risk management practices, and
additional training requirements.
Perspectives Differ on the Impact of Cost-Related Business Decisions
on the Services Provided in Air Ambulances:
Stakeholders concerned with the growth of the industry assert that
economic pressures have led some air ambulance providers to cut costs
by using smaller, less expensive helicopters and less experienced
medical crews.[Footnote 20] In particular, they point to the use of
small, single-engine helicopters instead of twin-engine helicopters.
According to these stakeholders, larger helicopters allow access to
the patient's entire body, while the smaller helicopters that some
providers use restrict medical access to the full body of the patient.
However, single-engine helicopters are not always smaller than twin-
engine helicopters.[Footnote 21]
During our site visits, we observed how patients were transported in
one particular single-engine helicopter. We also saw that medical
personnel had access to the patient's upper body, which facilitates
airway management, an important component of prehospital care. (See
figure 5.) The patient's lower body is situated next to the pilot with
a transparent barrier separating the patient and the pilot. A senior
official at that provider agreed that the space inside the helicopter
is limited but said the helicopter meets the medical needs of most
patients. However, there are differing perspectives in the industry
about the need to have access to a patient's entire body during
transport.
Figure 5: Example of a Medical Bay in a Single-Engine Helicopter:
[Refer to PDF for image: photograph]
Depicted on the photograph are the following:
Pilot compartment, separated by transparent barrier;
Patient litter;
Medical crewseat.
Source: GAO.
[End of figure]
Stakeholders concerned with growth in the industry told us that small
helicopters generally lack climate control, which results in
temperatures in the aircraft that may be either too cold or too hot.
According to an experienced emergency medical technician-paramedic,
air that is too cold has a bad effect on trauma patients, while air
that is too hot has a bad effect on cardiac patients. Stakeholders who
favor the existing regulatory and oversight framework point out that
the need for climate control might vary depending on the region in
which the air ambulance operates. An air ambulance provider that
operates in a southern climate may not need a heater, while one that
operates in a northern climate may not need an air conditioner. One
provider we visited that generally operates smaller helicopters told
us that all of its 87 aircraft have heaters and are being outfitted
with air conditioning as they undergo refurbishment. We were told that
physicians and hospitals can exercise some degree of control over
helicopter characteristics. For example, we were told that the
requesting physician sometimes requires that an air ambulance have
climate control when it is necessary for the medical care of the
patient in interfacility transfers. One stakeholder we spoke with
commented that physicians are often unaware that air ambulances may
lack climate control and would therefore not be inclined to ask about
it. According to a senior DOT official, the department was exploring
whether regulation of climate control in air ambulance helicopters is
under federal or state jurisdiction.
Stakeholders concerned with the growth in the industry also argue
that, to save on costs, some providers are hiring less experienced
medical crews, which they maintain degrade patient services. We were
unable to validate this argument through our literature synthesis. We
identified seven studies on the impact of a medical crew's
composition--whether, for example, the crew consists of a physician
and a nurse or a nurse and a paramedic--but there was no consensus on
how the composition of the medical crew influences a patient's
outcome.[Footnote 22] We also found three studies examining the impact
of crew composition on transport time, and all three studies found
that crew composition had no impact on transport time.[Footnote 23] We
found no studies examining the impact of a medical crew's experience
on patient outcomes.
Evidence Lacking to Suggest Recent Growth Has Affected Medical
Outcomes from Air Transports:
Several of the concerns raised by stakeholders within the air
ambulance community appear to be outcomes of industry growth and
competition. For example, concerns about helicopter shopping or call
jumping might arise if providers are competing to gain business.
Similarly, concerns about migration toward single-engine aircraft or
reductions in the qualifications of medical staff might arise as
companies seek to cut costs to improve profitability. The pressure of
competing for business and working to obtain maximum efficiency
through cost containment arises in nearly all business endeavors.
These forces are usually good for consumers because they lead to
efficiency, lower prices, and service offerings better tailored to the
needs and desires of consumers. However, health care markets have some
imperfections and these forces might work differently in these
markets. For example, health care consumers may lack information about
their diagnoses, treatment needs, the quality of different providers,
as well as the prices charged by different providers. Additionally,
health insurance can affect consumer's ability or inclination to make
informed health care choices. [Footnote 24] Air medical patients have
limited influence on air medical markets and are not typically making
the choice in terms of mode of transport or provider.
For air ambulance services, medical outcomes are a critical measure of
quality. Through our research, we identified numerous articles
documenting rigorous research on various aspects of air ambulances,
but very few shed light on the effect of the growth of the industry.
For example, we found no studies that compare patient outcomes between
states that have multiple providers in the same region, and states
with fewer providers. Consequently, we were unable to draw definitive
conclusions to support or refute many of the allegations that have
been raised. DOT's General Counsel and National Highway Traffic Safety
Administration officials agreed that more data on many aspects of air
ambulance operations would enlighten the debate about providing states
greater regulatory authority over air ambulances. While there was
consensus among the stakeholders in the industry that there is a lack
of data about potential concerns, ACCT stated that the debate about
the extent of state regulatory authority of air ambulances is
fundamentally one of philosophical differences about the government's
role in controlling public services, such as emergency medical
services.
Federal and State Courts and DOT Have Clarified Some Boundaries of
Federal and State Regulation of Air Ambulances, but Questions Remain:
Because air ambulances have both an aviation component, regulated by
the FAA, and a medical component, regulated by the states, the
boundaries of federal and state regulation have come under question.
The aviation components include the aircraft itself, including its
airworthiness and safety, as well as the personnel who maintain and
pilot the aircraft, communicate with ground personnel, and monitor
flight instruments, while medical personnel attend to the health of
the patient on board. (See fig 6.) These safety components are under
the jurisdiction of FAA, which administers federal aviation
regulations that govern safety and operational requirements,
nationwide. [Footnote 25] Hence, the industry is subject to FAA safety
regulations covering areas such as pilot training requirements, flight
equipment, and aircraft configuration. The medical component, on the
other hand, is under state regulatory authority. DOT opinion letters
and federal and state court decisions have affirmed that states have
the authority to enact and enforce requirements for medical services
delivered to patients in air ambulances and for the medical staffing,
personnel, and equipment used to deliver those services.[Footnote 26]
States also have the authority to develop training on how to use an
aircraft or equipment so as to ensure proper patient care. For
example, such training might focus on how pressurization in the
aircraft cabin affects specific medical conditions.[Footnote 27]
Figure 6: Depiction of Aviation and Medical Components of an Air
Ambulance:
[Refer to PDF for image: illustration]
FAA regulates the aviation component of air ambulances, which
encompasses maintaining and piloting the aircraft.
States can regulate the medical component, which includes caring for
the patient, as well as the medical equipment carried on board.
Source: GAO.
Note: State regulations governing medical equipment on board an
aircraft must be consistent with FAA's safety requirements.
[End of figure]
As noted earlier, some stakeholders favor changing the regulatory and
oversight framework so that states would have a stronger role in
regulating the nature and scope of services that an air ambulance
provider must offer. For example, state EMS officials believe that
they should be able to determine the appropriate number of air
ambulances serving a particular area and set additional standards in
terms of equipment used and services provided, as they currently do
for other parts of the EMS system. However, strengthening the states'
role would require federal legislation to alter the Airline
Deregulation Act (ADA) of 1978 that deregulated the air carrier
industry. Court decisions subsequent to the passage of the ADA
determined that air ambulances were air carriers as defined by the
ADA.[Footnote 28] In enacting the ADA, Congress determined that
"maximum reliance on competitive market forces" would best further
"efficiency, innovation, and low prices" as well as "variety [and]
quality ... of air transportation."[Footnote 29] One ADA provision,
designed to phase out state governments' economic control over the
industry, explicitly precludes state regulation of matters related to
air carrier rates, routes, and services.[Footnote 30] Courts have
ruled that this provision preempts states from acting in some
regulatory areas, such as requiring prospective air ambulance
providers to obtain a certificate of need based on the state's
assessment of the population to be served and the potential for
unnecessary duplication of services.
Over the past two decades, federal and state courts, and DOT, through
opinion letters issued by its Office of General Counsel, have affirmed
these authorities and have determined the specific issues that states
can and can not regulate. (See table 3.) Dating as far back as 1986,
courts have ruled that state certificate of need laws are
unenforceable because they conflict with the ADA by limiting the
number of air ambulance services doing business within the state.
[Footnote 31] DOT, responding to numerous inquiries from state
Attorneys General and private industry, has advised that certificate
of need provisions and similar "public convenience and necessity"
provisions are expressly preempted by the ADA because the states are
attempting to regulate in the area of price, routes, and services.
[Footnote 32] Most recently and prominently, a federal district court
in North Carolina found that the state's certificate of need
requirement was preempted by ADA.[Footnote 33] These rulings are
limited to specific states.
Table 3: Issues Related to Air Ambulances That Courts, DOT, and State
Attorneys General Have Ruled Can and Can Not Be Regulated by States:
States can regulate:
* Requirements for appropriate medical supplies--patient oxygen masks,
litters, blankets, etc.;
* Adequacy of medical equipment;
* Medical personnel qualifications;
* Requirements for maintenance of sanitary conditions;
* Communication equipment for use with EMS officials;
* Medically dictated pickup and dispatch protocols;
* Inspections for compliance with medically related regulations;
* Aircraft configuration serving medical purposes, to the extent
consistent with FAA safety and operations requirements.
States can not regulate:
* Certificates of need, public necessity, and convenience;
* Rates;
* Passenger/third party flight accident liability insurance
requirements;
* 24/7 availability requirements;
* Advertising;
* Bonding requirements;
* Requiring participation by air ambulance providers in an EMS peer
review committee that provides local government officials with a
mechanism to prevent an air ambulance provider from operating within
the state;
* Pilot training;
* Aircraft configuration unrelated to medical purposes;
* Limitations on geographic service areas;
* Weather-minimum performance standards;
* Safe storage of equipment;
* Avionics equipment;
* Very high frequency aircraft transceivers.
Sources: GAO analysis of federal and state court cases and DOT and
state attorneys general opinions.
[End of table]
Stakeholders concerned with the growth in the industry generally
support a stronger role for states in regulating the air ambulance
industry. They believe that many of the court rulings and DOT opinions
diminish states' ability to oversee patient care and safety. For
example, DOT, in a letter to an attorney in the state of Hawaii, wrote
that states cannot require, through regulation, that air ambulance
providers operate on a 24/7 basis on the grounds that such a
requirement constitutes economic regulation. These stakeholders view a
requirement for air ambulances to operate on a 24/7 basis as a patient
care issue that states should be able to control. DOT further stated
in its letter that states could contract with air ambulance providers
for these services. Under such circumstances, the states would be
functioning as customers rather than regulators, and therefore not be
subject to federal preemption of state regulation.[Footnote 34] In
commenting on a draft of this report, ACCT and NASEMSO stated that
contracting for air ambulance services in this manner is not a
realistic option for states because of fiscal resource limitations.
(See appendix III for a complete description of significant federal
and state court cases and DOT and state attorneys general opinions.)
However, there are some limited instances in which state regulations
of air ambulances have served multiple purposes. Particularly, when
these state regulations involve both medical and safety or medical and
economic aspects of air ambulances, the federal and state courts and
DOT have issued opinions determining the boundaries of federal and
state regulations. For example, DOT's letter to Hawaii stated that a
state's requirements concerning the quality, accessibility,
availability and acceptability of air ambulance services are
preempted. Stakeholders who favor change in the regulatory and
oversight framework interpret these preemptions as limiting states'
abilities to regulate quality or acceptability of medical care. In
opinion letters pertaining to regulations in Texas, DOT acknowledged
that certain types of regulations, such as equipment and service
issues with possible FAA safety implications, did not lend themselves
to "bright-line standards," and recommended that the state raise these
issues with its local FAA safety inspectors. One of the most
controversial DOT opinions appeared in the letter to Hawaii, in a
discussion of the state's requirement for specific medical equipment
on air ambulances.[Footnote 35] DOT stated that Hawaii's requirements
for items such as "patient oxygen masks, litters, blankets, sheets,
and trauma supplies" were acceptable state medical regulations, but
then maintained that states would not be allowed to enact medical
requirements as a means of indirectly engaging in economic regulation.
Specifically, DOT stated that,
it is possible that a state medical program, ostensibly dealing with
only medical equipment/supplies aboard aircraft, could be so pervasive
or so constructed as to be indirectly regulating in the pre-empted
economic area of air ambulance prices, routes or services.
Stakeholders have expressed concern that the open-ended nature of this
statement allows any medical regulation to be challenged as an
economic regulation and thus be preempted under the ADA. However, it
is important to note that DOT did not find that any specific "medical"
regulation was preempted under this reasoning and has not yet found
that any state regulation to date falls within this category.
Stakeholders have raised concerns that there is no regulation at
either the federal or state level to protect the public from the
economic consequences of air ambulance practices. These stakeholders
also expressed concerns about areas of state regulation that create
uncertainty because DOT and the federal and state courts have yet to
rule on them, such as a requirement for climate control on air
ambulances. Uncertainty about how the courts would rule has led to
calls for a federal legislative solution that would spell out federal
and state authorities. Several federal legislative proposals seek to
clarify the states' role in regulating medical issues and to allow the
states to institute certain types of economic regulation for air
ambulances, including certificate of need requirements, by carving out
an exception to the ADA's preemption of state regulation of prices,
routes, and services. However, the current scheme of regulation of air
ambulances has been in place since 1978 and has generated four
significant court decisions that, for the most part, have addressed
fact-specific questions about the relationship between federal and
state authority to oversee and regulate the industry. DOT has stated
that the continued use of case-by-case departmental determinations can
still clarify the appropriate role of states in regulating air
ambulance services. DOT officials told us that states should address
their uncertainties to DOT, and the department is more than willing to
respond with an opinion based on the facts and circumstances
presented. However, it appears that states have not fully utilized
this option. Since 1986, DOT has issued only eight opinion letters in
response to inquiries on the limits of federal and state authority
over air ambulances. Stakeholders favoring increased state regulatory
authority have expressed concerns with continuance of this case-by-
case approach, stating that it results in piecemeal guidance,
inconsistency, and confusion.
DOT officials have also raised concerns that allowing states to exert
authority, in this case in the economic area, could create a patchwork
of state regulation disrupting what has been, until now, a fairly well-
understood set of uniform rules. Moreover, DOT, along with the Federal
Trade Commission and the Department of Justice, have expressed concern
that state authority to implement certificate of need laws could be
used to limit market entry for air ambulances and reduce competition
in the air ambulance industry--an outcome Congress sought to avoid
when enacting the ADA.
Agency and External Comments and Our Evaluation:
We provided a draft of this report to the Departments of
Transportation (DOT) and Health and Human Services (HHS), and the
National Transportation Safety Board (NTSB) for comment. We also
invited representatives from the Association of Air Medical Services
(AAMS), the Association for Critical Care Transport (ACCT), the Air
Medical Operators Association (AMOA) and the National Association of
State EMS Officials (NASEMSO) to review a draft of this report and
provide comments. There was a consensus among the reviewers that there
is a lack of data about the air ambulance industry and a recognition
that the study had to rely on available data and information, which we
obtained by conducting a comprehensive review of the existing subject
area literature and recording stakeholder comments and opinions.
Further, this lack of empirical evidence limited our ability to
determine the full impact of changes in the industry. Our research of
the air ambulance industry and discussions with stakeholders within
the industry identified two distinct perspectives about the impact of
the changes. To the extent that data or other information was
available, we provided it to inform these perspectives. Where data or
other information did not exist, we clearly attributed statements and
identified the perspective of the stakeholders making the comment.
DOT's Office of General Counsel and HHS provided technical comments
that we incorporated as appropriate. NHTSA, within DOT, provided
detailed comments that we also incorporated as appropriate. NTSB
transmitted written comments to us in a letter. (See appendix IV).
NTSB's statement in its letter that GAO was asked to "review the U.S.
air ambulance industry to determine if changes in oversight authority
are needed" is not accurate. As stated in the report, the objectives
of our work were to examine how the air ambulance industry had changed
over the last decade and the implications of these changes, as well as
to examine the relationship between the federal and state oversight
and regulation of the industry. While our report contains information
that may be used when considering whether changes in oversight
authority for the air ambulance industry may be needed, we were not
asked to determine if changes are needed and thus do not address this
question in our report. NTSB identified three issues that it believed
should be discussed in more detail in our report. First, NTSB noted
that the draft should have addressed in greater detail that
competition in the air ambulance industry is restricted because of
fixed fee reimbursements by payers (private insurers, Medicare, and
Medicaid) for air ambulance services and the industry's limited
capacity to adjust prices. While Medicare and Medicaid reimbursement
rates are fixed, private sector prices are not. As is the case with
most health care services, air ambulance providers generally negotiate
prices with insurance companies. NTSB further noted that such
restricted competition could be linked to safety concerns. Following
the Board's February 2009 public hearing on air ambulance helicopter
safety, NTSB issued several safety recommendations, including one to
HHS to determine if reimbursement rates should differ according to the
level of air ambulance transport safety provided. In response, HHS
stated that it did not believe that payment should vary based on the
level of transport safety provided but that all air ambulance
operators should meet minimum FAA safety standards. Second, NTSB also
noted said that the draft did not clearly state whether there is
evidence that helicopter shopping and call jumping occur, and if so,
to what extent. In response, we clarified that beyond anecdotes, we
found little evidence of helicopter shopping resulting in unsafe
flights or of call jumping. NTSB additionally raised questions about
our use of ASRS as a source of information regarding the prevalence of
these practices. We agree that ASRS has limitations, and opted to
include it in the report because it is one of the few available data
sources with information applicable to the industry. We added
additional information in the report about the limitations and
potential under-reporting. Finally, NTSB noted that it would be
helpful to know if there is evidence to support the belief that the
use of air ambulances improves the chances of survival for trauma
victims and other critical patients. It was not our objective to
determine if air ambulance transport is beneficial and we did not do
the research necessary to comment on the validity of the belief.
AAMS provided technical comments which we incorporated where
appropriate. Comments provided by ACCT, AMOA, and NASEMSO were
generally reflective of their views regarding the implications of the
changes in the air ambulance industry and the role of states in
regulating the industry. We incorporated their comments throughout the
report as appropriate.
We are sending copies of this report to the appropriate congressional
committees, DOT, the Department of Health and Human Services, NTSB,
and other interested parties. The report also is available at no
charge on the GAO Web site at [hyperlink, http://www.gao.gov].
If you or your staff members have any questions about this report,
please contact me at (202) 512-2834 or dillinghamg@gao.gov. Contact
points for our Offices of Congressional Relations and Public Affairs
may be found on the last page of this report. GAO staff who made major
contributions to this report are listed in appendix IV.
Signed by:
Gerald L. Dillingham, Ph.D.
Director, Physical Infrastructure Issues:
[End of section]
Appendix I: Scope and Methods:
[End of section]
The scope of our review was the structure and practices of the air
ambulance industry in the United States, and framework for overseeing
and regulating U.S. air ambulance services.
To determine how the U.S. air ambulance industry changed from 1999
through 2008, we obtained and analyzed available data that provided
information on the growth and evolution of the industry, including
shifts in business models, and the types of air ambulance aircraft
that are used to provide services. Specifically, we reviewed and
analyzed data compiled by Ira Blumen, MD. Dr. Blumen is the
Medical/Program Director, University of Chicago Aeromedical Network.
His database on the air ambulance industry extends back to 1980 and
includes the number of helicopter air ambulances used in the industry
and the number patients transported.[Footnote 36] We also reviewed and
analyzed the data contained in the Atlas and Database of Air Medical
Services (ADAMS) and interviewed a senior official at the Calspan-
University of Buffalo Research Center (CUBRC), the research
organization that maintains and publishes the database in partnership
with the Association of Air Medical Services (AAMS). ADAMS has been
annually updated since 2004 and serves as a centralized source of
information on air medical service providers, including the number and
location of air ambulance helicopter bases. ADAMS began including data
for fixed-wing air ambulances in 2007. At our request, CUBRC also
provided us with an update of the types of helicopters used in the air
ambulance industry. We also obtained and analyzed data on Medicare
payments to air ambulance providers from the Centers for Medicare and
Medicaid, the agency within the Department of Health and Human
Services that administers the Medicare and Medicaid programs.[Footnote
37] Additionally we reached out to more than 400 air ambulance
providers, industry associations, and state Emergency Medical Services
officials asking that they provide us any data, information, published
or unpublished reports, papers, articles, or other potentially
relevant sources of information of which they would like us to be
aware. To determine how the industry has evolved, we examined
industry, National Transportation Safety Board, and stakeholder
documents. To determine the implications of these changes for the
availability of services, efficient use of air ambulance resources,
safety, and services provided, we undertook an extensive literature
synthesis covering over 250 articles describing scholarly research
that produced quantitative results. For more detailed information on
the literature synthesis, see appendix II. We attended two semiannual
meetings of the Federal Interagency Committee on Emergency Medical
Services. We also reviewed previous GAO reports; Federal Aviation
Administration (FAA) documents; the transcript of a 2009 National
Transportation Safety Board's (NTSB) hearing on helicopter emergency
medical services and the board's recommendation letters; a
congressional hearing transcript; and congressional testimonies,
reports, and position papers published by AAMS and other stakeholder
associations; and published documents of the Foundation for Air-
Medical Research and Education, and the Flight Safety Foundation. In
addition, we conducted interviews with representatives of AAMS;
industry stakeholders who favor changing the regulatory and oversight
framework, including representatives of the Association for Critical
Care Transport (the leading proponent of change in the regulatory and
oversight framework) and industry stakeholders who oppose changing the
regulatory and oversight framework, including representatives of the
Air Medical Operators Association (the key industry group favoring the
existing regulatory and oversight framework). We also conducted four
site visits to air ambulance providers that reflected differing
geographic locations, business models, and opinions about regulatory
structure. Specifically, we observed operations at a government-
provided air ambulance service operated by Maryland State Police, a
hospital-based air ambulance service in the mid-Atlantic region
(MedStar Transport) and independent providers headquartered in
Missouri (Air Evac Lifeteam) and Maine (LifeFlight of Maine). Air Evac
LifeTeam's management favors the existing regulatory structure, while
LifeFlight of Maine's management advocates increased state regulation
of the air ambulance industry. We also met with representatives of
Dartmouth-Hitchcock Advanced Response Team, which is a hospital-based
provider, and Boston Medflight, which is consortium-owned.
To determine the relationship between federal and state oversight and
regulation of the air ambulance industry, we reviewed federal aviation
laws, and the Airline Deregulation Act (ADA) of 1978, and challenges
to state authority to regulate in matters that are federally preempted
under these acts. We also reviewed Department of Transportation (DOT)
General Counsel letters and state attorneys general opinion letters to
state officials or attorneys. We discussed these letters, which
interpret provisions of the ADA, with DOT General Counsel officials.
We also discussed the implications of industry trends and federal and
state regulatory authority with the key industry stakeholders
mentioned above, as well as with officials at the Federal Aviation
Administration (FAA); the National Highway Traffic Safety
Administration; NTSB; and representatives of the National Association
of State Emergency Medical Services Officials. We also received
briefings and reviewed documents provided by proponents and opponents
of increased state regulation.
[End of section]
Appendix II: Literature Synthesis:
We reviewed literature and studies related to the air ambulance
industry to obtain an understanding of what is known about the
implications of the industry's growth and structural change for the
availability of services, efficient use of air ambulance resources,
safety, and services provided. The team used the following steps to
perform the literature synthesis:
Step 1. Literature search:
To identify and evaluate literature and studies that contain empirical
data related to the air ambulance industry, we conducted a literature
synthesis. Our objective was to identify any studies with empirical
data related to air ambulance availability, services provided in the
air ambulance, competition, and cost. We initially searched for
articles published in the preceding 5 years, from January 2005 to
January 2010. The search focused on the safety, cost, quality, and
oversight of air ambulance services, including studies and articles
that addressed the issues of helicopter shopping and call jumping. The
search statements included a variety of terms to capture materials
that examined these issues. We queried various bibliographic research
databases including:
* ProQuest,
* AcademicOneFile,
* MEDLINE,
* Dialog Transportation and Transportation Business,
* Electronic Collections Online,
* Nexis for scholarly and trade literature,
* Congressional Research Service,
* Congressional Budget Office,
* GAO,
* Government Printing Office,
* National Technical Information Service databases for publications
produced by or funded by the federal government,
* PolicyFile, and:
* WorldCat for government publications and literature that is not
published commercially or is not generally accessible.
The results of this search, combined with articles obtained through
discussions with stakeholders in the air ambulance industry, Internet
searches, and our review of air ambulance-related Web sites, yielded
36 relevant studies.
As the job progressed, and the dearth of quantifiable data became
evident, we expanded our search criteria to include all articles
published between January 1, 2000, and May 2010, which contained
empirically derived results. We determined that this time frame would
include studies performed prior to the proliferation of helicopters in
the air ambulance industry that started occurring around 2002-2003. In
this search, we looked at air ambulances in a broader context and
aimed to be more comprehensive than in previous searches. Search
statements relied primarily on subject terms (when available) for air
ambulances and similar concepts and did not include any other search
terms as modifiers. The databases searched were:
* Nexis Statistical Master File,
* ProQuest,
* Academic OneFile,
* GAO,
* MEDLINE,
* Biosis,
* SciSearch,
* Cumulative Index to Nursing and Allied Health Literature,
* EMBASE,
* PASCAL,
* Gale Group Health and WellnessDatabase,
* National Technical Information Service,
* TRIS,
* Government Printing Office,
* Electronic Collections Online, and:
* Ovid.
The librarian reviewed the search results and removed duplicate
citations, foreign air ambulance service, military based, or medical
procedure studies, and nonrelevant articles. A total of 641 citations
were sent to the team for review.
Step 2. Abstract review:
The team reviewed all the titles sent by the librarian. Articles with
no abstract were excluded due to lack of empirical findings, high
probability of article pertaining to current events, or an editorial
commentary of current policy issues. For articles with abstracts, two
team members independently reviewed the abstract to determine if the
article addressed the previously identified topics and appeared to
contain empirical data. If both reviewers agreed that the article was
relevant or not relevant, the article was saved or rejected
accordingly. When the reviewers disagreed, a third team member
reviewed the abstract and made the final decision. The team requested
that the librarians obtain complete copies of all saved, relevant
articles. This process yielded 91 relevant studies.
Step 3. Synthesis:
All relevant full text studies underwent three reviews--first by an
analyst who synthesized the study, second an initial review by a
methodologist, and the third and final review by a second
methodologist. The methodologists determined whether the research was
sufficiently rigorous to support the stated conclusions. Articles that
were not based on U.S. populations or did not include empirical data
were excluded. Relevant articles were summarized in a synthesis
document that captured the title, authors, setting, sponsor of the
research, methods, findings and conclusions, and limitations.
Step 4. Bibliography review:
The team reviewed the bibliography for relevant articles synthesized
in step 3 to identify additional potentially relevant articles. The
team then selected articles from the bibliographies that appeared
relevant and were (1) in English, (2) not based on a foreign
population, (3) not international studies, and (4) not military
studies. For articles that met these criteria, the team attempted to
obtain the abstracts from the National Institute of Health's, National
Library of Medicine PubMed database [hyperlink,
http://www.ncbi.nlm.nih.gov/pubmed].
The team then repeated the abstract review, synthesis, and
bibliography review process one additional time (see figure 7).
Figure 7: Literature Synthesis Process and Results:
[Refer to PDF for image: illustration]
Studies identified during initial search:
36 relevant studies reviewed (identified in Step 1);
Bibliography review of 36 studies identifies 98 studies;
63 relevant studies reviewed;
Bibliography review of 63 relevant studies identifies 121 studies;
25 relevant studies reviewed.
Studies identified during expanded search:
91 relevant studies reviewed (identified in Step 2);
Bibliography review of 91 studies identifies 133 studies;
46 relevant studies reviewed;
Bibliography review of 46 studies identifies 52 studies;
12 relevant studies reviewed.
Source: GAO.
[End of figure]
Step 5. Analysis:
With a methodologist's help, the team analyzed and aggregated the
synthesized articles to develop narratives describing the findings of
the literature.
[End of section]
Appendix III: Key Court Cases and Opinion Letters from DOT or State
Attorneys General:
Table 4 summarizes key court cases related to the air ambulance
industry. Table 5 summarizes DOT or state Attorneys General Opinions
related to the air ambulance industry.
Table 4: Summary of Key Court Cases Related to the Air Ambulance
Industry:
Court case: Med-Trans Corp. v. Benton, 581 F. Supp. 2d 721 (E.D. N.C.
2008);
Issues court determined to be preempted:
Safety and operational standards:
* "Flight" equipment requirements that cannot be detached from
aviation safety and associated solely with EMS;
* Prohibiting structural or functional defects affecting the "safe
operation of the aircraft";
* Regulations requiring crew members to be trained in "in flight
emergencies specific to the aircraft used in the program" and
"aircraft safety";
* Requiring a helicopter pilot to provide backup medical care for EMS
personnel;
Economic requirements:
* Requiring air ambulances to provide service 24 hours per day;
* Certificate of need requirement;
* Requirement to document "defined service area";
* Requirements to document "a written plan for transporting patients
to appropriate facilities when diversion or bypass plans are
activated";
* Requirements to install very high frequency aircraft transceivers;
* Requiring an air ambulance provider to undergo an EMS Peer Committee
Review that provides local government officials with a mechanism to
prevent an air ambulance provider from operating within the state;
Issues court determined not to be preempted:
Medical aspects:
* Requirement for air ambulances to synchronize voice radio
communications with local EMS resources (requiring air ambulances to
be equipped with special two-way radios to communicate with public
safety entities);
* Requirements that are primarily medical in nature;
* Requirement for air ambulances to be inspected for compliance with
medically related regulations;
* Medically related equipment, and sanitation, supply and design
requirements;
* Requirement for air carriers to document a plan for inspecting,
repairing, and cleaning medical and other patient care related
equipment;
* Requirement for vehicle or equipment-related training undertaken
specifically for the purposes of ensuring proper patient care (i.e.,
training regarding cabin pressurization as it relates to specific
medical conditions);
* Requirement for air ambulance to be staffed by at least two persons.
Court case: Abdullah v. American Airlines, Inc., 181 F.3d 363 (3rd
Cir. 1999);
Issues court determined to be preempted:
Safety and operational standards:
* Standards of care in the field of aviation safety;
Issues court determined not to be preempted:
Safety and operational standards:
* Traditional state and territorial law damage remedies for violation
of federal aviation standards.
Court case: Hiawatha Aviation of Rochester v. Minn. Dept. of Health,
389 N.W.2d 507 (Sup. Ct. Minn. 1986);
Issues court determined to be preempted:
Economic requirements:
* Requirement for license from the state to operate;
Issues court determined not to be preempted:
Medical aspects:
* Requirements for equipment and promulgation of standards for
maintenance of sanitary conditions;
* Regulation of staffing requirements and qualifications of personnel
as part of traditional role in delivery of medical services.
Court case: Air Evac v. Robinson, 486 F. Supp. 2d 713 (M.D. Tenn.
2007);
Issues court determined to be preempted:
Flight and safety requirements:
* Requirement for helicopters licensed in the state to have certain
avionics equipment on board;
Issues court determined not to be preempted: [Empty].
Court case: Eagle Air Med Corp. v. Colorado Board of Health, 570 F.
Supp. 2d 1289, (D. Col. 2008);
Issues court determined to be preempted:
Safety standards:
* Requirement for air ambulance providers to acquire and maintain
accreditation by the Commission on Accreditation of Medical Transport
Systems, whose standards primarily address aviation safety issues;
Issues court determined not to be preempted: [Empty].
Court case: Rocky Mountain Holdings, LLC v. Cates, Director, Mo. Dept.
of Health, No. 97-4165-CV-C-9 (W.D. Mo. Central Div. September 3,
1997);
Issues court determined to be preempted:
Economic requirements:
* Making the determination that the "public convenience and necessity"
requires a proposed air ambulance service;
Issues court determined not to be preempted: [Empty].
Source: GAO analysis of key court cases.
Note: State court decisions are generally limited to the state, and
federal appellate decisions, the circuit, in which the challenge was
raised. However, these decisions could be used as support for legal
challenges in other states or circuits.
[End of table]
Table 5: Summary of DOT or State Attorneys General Opinions Related to
the Air Ambulance Industry:
DOT and State Attorneys General letters: DOT to Texas 2/20/2007;
Issues DOT and State Attorneys General determined to be preempted:
Safety and operational standards:
* Regulation of flight safety aspects of medical services, such as
safe storage of equipment;
* Regulating aviation safety, including minimum standards for
aircraft, pilots, and "weather minimums";
* Requiring accreditation by outside body that sets aviation standards;
Economic requirements:
* Regulating when and where ambulances can fly, scheduling, routing,
and rates;
* Limiting federal preemption to interstate transportation;
* Regulating advertising;
* Insurance requirements (air carrier liability insurance for
injuries, death, and/or property damage to third parties caused by
crash of aircraft);
Issues DOT and State Attorneys General determined not to be preempted:
Medical aspects:
* Minimum requirements for medical equipment;
* Regulating medical services, particularly as delivered to
patients/passengers in the cabins of aircraft;
* Training and licensing requirements for medical crew;
* Insurance addressing "other perils" (such as medical malpractice by
the medical staff) would be considered on a case-by-case basis;
* Requiring accreditation of an outside body that deals exclusively
with medical care.
DOT and State Attorneys General letters: DOT to Texas 5/23/2007;
Issues DOT and State Attorneys General determined to be preempted:
Flight requirements:
* Requiring certain avionics equipment;
* Licensing requirements to ensure ambulances are following FAA flight
requirements;
* Taking punitive action, in context of a state licensing regime, if
FAA requirements are not being followed;
Issues DOT and State Attorneys General determined not to be preempted:
Flight requirements:
* Review of air ambulance records and documents to ensure air
ambulances are following FAA requirements;
* Bringing to the attention of FAA or DOT enforcement office any
information or evidence that a carrier may be violating federal
requirements.
DOT and State Attorneys General letters: DOT to Texas 11/3/2008;
Issues DOT and State Attorneys General determined to be preempted:
Economic requirements:
* Requiring air ambulance service be available to all people,
including nonsubscribers;
* Establishing minimum standards for the creation and operation of an
EMS subscription program, including obtaining State Health Services
department approval (which depends on many levels of approval from
state and local officials) prior to soliciting, advertising, or
collecting subscription or membership fees;
* Requiring air ambulance provider based in another state to obtain an
EMS license from the state;
* Compliance with state and federal rules on billing and reimbursement;
* Requirement to show financial responsibility through bonding or self-
insurance in order to receive state approval for EMS subscription
program;
Issues DOT and State Attorneys General determined not to be preempted:
[Empty].
DOT and State Attorneys General letters: DOT to Hawaii 4/23/2007;
Issues DOT and State Attorneys General determined to be preempted:
Safety and operational standards:
* Regulating aircraft operation and equipment;
* Medical equipment installation and storage aboard aircraft;
* Regulating pilot qualifications;
Economic requirements:
* State operating certificates based on state's determination of
"public need" for it, the "reasonableness" of the "cost of the ...
service," and other criteria including "quality, accessibility,
availability and acceptability";
* Requirement to operate 24 hours per day. (Note: A 24-hour
requirement may be pursued through contractual means rather than
through regulatory actions);
* A state medical program, ostensibly dealing with only medical
equipment/supplies aboard aircraft, that is so pervasive or so
constructed as to be indirectly regulating in the preempted economic
area of air ambulance prices, routes, or services;
* Accident liability insurance;
Flight requirements:
* Requirements as to medical training for flight crew;
Issues DOT and State Attorneys General determined not to be preempted:
Medical aspects:
* Requirements for patient oxygen masks, litters, blankets, sheets,
and trauma supplies.
DOT and State Attorneys General letters: DOT to San Diego 1/2/1997;
Issues DOT and State Attorneys General determined to be preempted:
Flight requirements:
* Aircraft configuration and airman certification;
Issues DOT and State Attorneys General determined not to be preempted:
[Empty].
DOT and State Attorneys General letters: DOT to Nebraska 12/5/1989;
Issues DOT and State Attorneys General determined to be preempted:
Economic requirements:
* Controlling entry into the field of interstate air ambulances, or
imposing economic regulations;
Issues DOT and State Attorneys General determined not to be preempted:
Medical aspects:
* Equipment requirements as part of regulation of medical services;
* Staffing requirements, personnel qualifications, and sanitary
condition standards;
* Governing medical services.
DOT and State Attorneys General letters: DOT to Arizona 6/16/1986;
Issues DOT and State Attorneys General determined to be preempted:
Economic requirements:
* Certificate of public convenience and necessity;
* Regulating rates;
* Regulating operating and response times and the base of operations;
* Bonding requirements;
* Accounting and report systems;
Issues DOT and State Attorneys General determined not to be preempted:
[Empty].
DOT and State Attorneys General letters: DOT to Florida 10/10/2007;
Issues DOT and State Attorneys General determined to be preempted:
Economic requirements:
* Certificate of public convenience and necessity from each county
within the state where it wants to operate (with counties free to
reject applications);
Issues DOT and State Attorneys General determined not to be preempted:
[Empty].
DOT and State Attorneys General letters: Letter from Richard E.
Israel, Assistant Attorney General, Maryland, to Sen. John J. Hafer
(4/11/02);
Issues DOT and State Attorneys General determined to be preempted:
Safety and operational requirements:
* For intrastate commercial air ambulances: "Clearance" regulations,
including regulation that air ambulance can only respond to scene of
public safety emergency if cleared by the state communication center;
Economic requirements;
* For intrastate commercial air ambulances, requirements that
responses to transports shall be carried out without regard to
patient's ability to pay and with no charge to the state or a
jurisdictional EMS program;
* For interstate commercial air ambulances: "Clearance" regulations
that place limitations on charges;
* For interstate commercial air ambulances: "Clearance" regulations
dealing with helicopter landings that allow clearance decisions based
on considerations of economic competition;
Issues DOT and State Attorneys General determined not to be preempted:
Medical requirements:
* For interstate commercial air ambulances: "Clearance" regulations
that reference a determination of the safety and appropriateness of a
helicopter landing for patient transport that are concerned only with
the health and safety of the patient.
DOT and State Attorneys General letters: Tex. Atty. Gen. Op. GA-0634,
2008 WL 4964344 (Tex. A.G.);
Issues DOT and State Attorneys General determined to be preempted:
Medical aspects:
* Regulation by Department of State Health Services of EMS providers'
subscription programs for emergency medical services;
Issues DOT and State Attorneys General determined not to be preempted:
[Empty].
DOT and State Attorneys General letters: 1987 Ariz. Op. Atty. Gen.
261, 1987 WL 121388 (Ariz. AG 1987);
Issues DOT and State Attorneys General determined to be preempted:
Economic regulations:
* Economic regulation under certificate of need statutes;
Issues DOT and State Attorneys General determined not to be preempted:
Safety and operational requirements:
* Essential public health and safety matters (regulation of transport
of sick, injured, wounded, or otherwise incapacitated or helpless
individuals by air ambulance only in critical and emergency situations
and only with regard to essential medical health and safety aspects of
such transport).
Sources: GAO analysis of DOT and state attorneys general opinions.
[End of table]
[End of section]
Appendix IV: Comments from the National Transportation Safety Board:
National Transportation Safety Board:
Office of Research and Engineering:
Washington, D.C. 20594:
September 16, 2010:
Gerald L. Dillingham, Ph.D.
Director, Civil Aviation Issues:
U.S. Government Accountability Office:
441 G Street, NW:
Washington, DC 20548:
Dear Dr. Dillingham:
The NTSB staff appreciates the opportunity to provide comments on the
GAO's draft report titled Air Ambulance - Effects of Industry Changes
on Services and Need for Changes in Oversight Authority are Unclear.
According to the draft report, Congress asked the GAO to review the
U.S. air ambulance industry to determine if changes in oversight
authority are needed. The focus of this evaluation is articulated on
page 1 of the draft where GAO states:
Given the differences of opinion about the effects of the air
ambulance industry's growth and changes to its structure, you asked us
to review the U.S. air ambulance industry. To do this, we examined:
(1) how the industry changed in the last decade and the implication of
these changes for the availability of services, efficient use of air
ambulance resources, safety, and services provided and (2) the
relationship between the federal and state oversight and regulation of
the air ambulance industry.
The NTSB staff believes the GAO met some of the goals of the study. We
do not believe, however, that the study adequately evaluated the
impact of rapid growth and change on the safety of the air medical
industry. We believe that the discussion of certain issue areas needs
to be expanded and we also have concerns about the strength of some of
the evidence cited in the draft report. These concerns are further
discussed below.
Competition and Air Medical Consumers:
Pages 19 and 20 of the draft report address air medical transport
growth and competition, and medical outcomes. The GAO states:
These [competitive] forces are usually good for consumers because they
lead to efficiency, lower prices, and service offerings better
tailored to the needs and desires of consumers. However, health care
markets have some imperfections. Health care consumers may lack
information about their diagnoses, treatment needs, the quality of
different providers, and the prices charged by difference providers.
[ ] Because of the various imperfections in health care markets, it is
difficult to discern the extent to which the beneficial properties
afforded by competition have been realized.
Competition in air medical transport is not the same as competition
between retailers or other open markets. While the statement quoted
above hints at the differences, NTSB staff believes that the GAO
report does not go far enough by fully describing the unique
characteristics of a competitive environment for air medical operators
or recognize its potential negative influence on operational safety.
Air medical patients have limited influence on air medical markets.
They typically have no choice in transport mode or provider since they
are in acute need of transport. The choice is usually made for the
patient, often by pre-arranged agreements between hospitals, air
medical providers and first responders. It is common for hospitals and
independent air medical providers to work with other hospitals and
first responders to pre-arrange transport request procedures and areas
of coverage. In those geographic areas where more two or more air
medical operators provide service, decisions about who covers what
area become more difficult and are subject to competitive pressures.
Air medical operators typically respond by targeting marketing efforts
to first responders and hospitals, using financial incentives and
other types of marketing efforts to establish transport agreements.
A key component of a free market is the determination of prices and
wages by unrestricted competition between businesses. This principle
does not work in the air medical market. Prices for patient transport
are fixed at a set rate by private insurance companies, Medicare, and
Medicaid. Only a small portion of transport fees is self-paid by
patients. Competitive forces therefore have very limited influence on
the price of transport. Air medical transport reimbursement is
discussed on pages 5-7 of the GAO draft report but it is not addressed
within the context of competition.
Air medical companies have few factors they can adjust to respond to
competitive pressures. All air medical operators are limited by fixed
pricing, only get paid when patients are transported, and (according
to the GAO) have significant fixed costs that approach 80%. There are
three primary factors air medical operators can use to ensure revenues
covers costs. These include reducing fixed costs relating to items
such as aircraft, staffing, and facilities; increasing revenue through
increased patient volume and/or improved revenue collection; and
finding supplemental sources of income, such as subscription
membership programs or hospital support.
The NTSB has expressed concern that the combination of these unique
competitive pressures and fixed fee reimbursement practices in the air
medical industry may result in decreased levels of safety. Following
the NTSB's February 2009 public hearing on the safety of helicopter
emergency medical (HEMS) operations, during which sworn testimony was
provided on these topics, the NTSB issued safety recommendations to
the Department of Health and Human Services (HHS).[Footnote 1] We do
not believe the draft GAO report adequately addresses this area of
concern and we respectfully submit that the discussion of this topic
should be expanded in the GAO report to address the issues identified
above.
Helicopter Shopping and Call Jumping:
The GAO draft report identifies helicopter shopping (the practice of
calling various providers until a provider agrees to take a flight
assignment) and call jumping (when a provider sends an air ambulance
to an accident scene without a request) as potential safety risks.
However, we believe that the discussion of this issue is incomplete
and does not clearly state whether or not there is evidence that these
practices occur and if so, to what extent.
One statement in the draft report that downplays the issue of call
jumping is the following on page 14-15:
Stakeholders maintain that, like helicopter shopping, call jumping can
result from economic pressure to fly. However, some instances
perceived as call jumping may stem from a lack of communication among
first responders.
The GAO draft report cites the Aviation Safety Reporting System (ASRS)
as a potential source of information on the topic, stating there were
464 air ambulance ASRS reports submitted over 15 years (31 per year).
Of these, GAO states there were 2 reports (over 15 years) that
discussed helicopter call jumping and no reports that addressed
helicopter shopping. The GAO states:
This data could indicate that helicopter shopping and call jumping
occur infrequently. On the other hand, these practices may be
underreported if air ambulance crews are unaware that they can report
safety issues to ASRS.
The NTSB believes that the GAO reference to the low number of ASRS
reports associated with call jumping and helicopter shopping is
somewhat misleading. First, ASRS reports are typically submitted by
aviation operational personnel such as pilots and air traffic
controllers who report operational anomalies associated with operation
of the aircraft. The issue of call jumping and helicopter shopping are
not operational issues associated with aircraft operation. It is
therefore unlikely that air medical pilots would report such issues to
ASRS. Second, ASRS air medical reports overall are exceedingly rare.
One air medical flight typically involves the transport of one
patient. There were approximately 3,150,000 patients flown by air
medical transport for the time period of 1993-2007 (210,000 per
year).[Footnote 2] Using this as a frame of reference, one can
estimate that roughly 0.007% of all air medical flights result in an
ASRS report.
ASRS reports are submitted voluntarily. NASA, which manages the ASRS
program, states on its website that "the existence in the ASRS
database of reports concerning a specific topic cannot, therefore, be
used to infer the prevalence of that problem within the National
Airspace System."[Footnote 3]
The NTSB supports the development and use of voluntary safety
reporting programs. We believe, however, that there is no evidence to
suggest that voluntary reporting of safety events in the air medical
community is routine or representative. The evidence cited by the GAO
highlights this fact and should be so noted in the text. Further, the
fact that the GAO chose to focus on voluntary reporting as the primary
source of evidence on the presence or absence of call jumping and
helicopter shopping ignores the body of sworn testimony provided
during the NTSB's February 2009 public hearing. While that testimony
does not establish that such practices are common or directly
associated with air medical crashes, we believe it does provide useful
information and insight that should be cited in the GAO report.
Air Ambulance Effectiveness:
On page 3 of the draft report, GAO states "Air ambulances transported
more than 270,000 patients in 2008 and their use is widely believed to
improve the chances for survival for trauma victims and other critical
patients." While this may in fact be a widely-held belief, it would be
useful to know if the GAO found factual support for this statement.
Later in the report, the GAO states that evidence of air medical
transport effectiveness is "uneven." The GAO cites 17 peer-reviewed
articles that show no medical benefit compared to ground transport, 12
that showed air transport provided a benefit and 5 showing that ground
transport was resulted in better patient outcomes (pages 11-12).
In closing, we acknowledge that evaluating the influence of air
medical growth and structural changes on service and safety is
challenging. While we believe the GAO study is a good first step, we
find that there is significant reliance on anecdotal information
provided by various stakeholders within the air medical community.
This is not surprising due to the lack of reliable empirical evidence
on the topic. We believe that lack of evidence limited the GAO's
ability to adequately answer the primary questions associated with
this topic. A related area of concern is the lack of conclusions or a
summary statement in the report. This makes it difficult for the
reader to determine the main results of the study. The lack of clear
conclusions may be related to the lack of good evidence. We believe
that the GAO should add conclusions to the report to highlight those
areas where the evidence is, and isn't, clear.
Thank you for the opportunity to comment on this draft report.
Sincerely,
Signed by:
Joseph M. Kolly:
Director, Office of Research and Engineering:
Footnotes:
[1] See Safety Recommendations A-09-104 through 107, issued September
24, 2009 asking the 1-H4S, Centers for Medicare and Medicaid Services,
to evaluate the existing HEMS reimbursement rate structure to
determine if reimbursement rates should differ according to the level
of HEMS transport safety provided and, if warranted, establish a new
reimbursement rate structure.
[2] Derived from presentation of lea Blumen, MD, NTSB public hearing
on the safety of HEMS operations, Feb3, 2009. [hyperlink,
http://www.ntsb.gov/Dockets/Aviation/DCAO9S11001/411077.pdf].
[3] [hyperlink, http://asrs.arc.nasa.govidocs/rpsts/acr_fatg.pdf].
[End of section]
Appendix V: GAO Contact and Staff Acknowledgments:
GAO Contact:
Gerald L. Dillingham, Ph.D., (202) 512-2834, or dillinghamg@gao.gov:
Staff Acknowledgments:
In addition to the contact named above, Maria Edelstein, Assistant
Director; Edmond Menoche, Senior Analyst; Amy Abramowitz; Heather
Bartholomew; Owen Bruce; Christine Brudevold; Leia Dickerson; Leslie
Gordon; David Hooper; Karla Lopez; Ashley McCall; Sara Ann Moessbauer;
Cynthia Saunders; and Kristin VanWychen made key contributions to this
report.
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[End of section]
Footnotes:
[1] With permission, we used the data compiled by Ira J. Blumen, MD;
Medical/Program Director, University of Chicago Aeromedical Network,
University of Chicago Medical Center; Professor, Section of Emergency
Medicine, University of Chicago. We determined that these data are
sufficiently reliable for our purposes.
[2] The Atlas and Database of Air Medical Services shows, among other
things, the number and location of fixed wing and helicopter air
ambulances in each state. It has been published annually since 2004 as
a partnership effort between the Association of Air Medical Services
and the Calspan-University of Buffalo Research Center (CUBRC). We
determined that these data are sufficiently reliable for our purposes.
[3] The hospital-based model is sometimes referred to as the
"traditional model," while the independent provider model is sometimes
referred to as the "community based model." In this report, we use the
terms hospital-based and independent provider, respectively, to refer
to these models.
[4] Reasonable-cost payments were based upon the provider's cost of
providing ambulance services as reported on costs reports.
[5] Reasonable-charge payments were based on the bill from the
ambulance service provider, but were subject to an upper limit.
[6] Payments for Medicare air ambulance transports are determined
through a nationally uniform unadjusted base rate; and a geographic
adjustment factor.
[7] Membership programs cover the patient's cost in the event that the
member requires an air ambulance transport. To utilize membership
benefits, the member must be transported by the company that sold the
membership. The member does not pay for any cost of the transport that
is not covered by insurance. These services specify some limitations
to the availability of service such as when aircraft are currently
transporting another patient, maintenance of the aircraft is required,
or weather conditions limit the ability to fly. One large air
ambulance provider that sells memberships has about 800,000 members.
[8] Excludes military helicopters and dual-use helicopters
(helicopters that are used as air ambulances and for other purposes).
[9] See Bibliography: Branas (2005); Criteria used in differentiating
levels of trauma care vary by state, but are mostly based on the
guidelines published by the American College of Surgeons Committee on
Trauma. Level I and II trauma centers provide comprehensive care for
the most critically injured patients and have immediate availability
of trauma surgeons and certain other physician specialists. Level III
centers provide prompt assessment, resuscitation, surgery, and
stabilization with transfer to a Level I or II center when necessary.
[10] This analysis is unpublished and has not been peer reviewed.
[11] See Bibliography: Bledsoe (2006), Tiamfook-Morgan (2008),
Cunningham (1997), Brathwaite (1998), Boyd (1989), Moront (1996),
Wuerz (1996), Carr (2006), Schwartz (1990), Jacobs (1989), Emerson
(2003), King (2009), McCowan (2008), Benson (1993), Purtill (2008),
Norton (1996), Cocanour, (1997), O'Malley (1994), Stohler (1991),
Urdaneta (1987), Urdaneta (1984), Eckstein (2002), Burney (1988),
McCowan (2006), Gabram (1991), Williams (1990), Falcone (1993), Fromm
(1992), Baxt (1987), Johnson (1995), Savitsky (1995), and Cook (2001).
[12] See Bibliography: Bledsoe (2006), Tiamfook-Morgan (2008), Moront
(1996), Wuerz (1996), Carr (2006), Schwart (1990), Coconaur (1997),
Eckstein (2002), Burney (1988), McCowan (2006), Gabram (1991), Falcone
(1993), Fromm (1992), and Savitsky (1995).
[13] Overtriage refers to unnecessary mobilization of the trauma
response team for patients without significant injuries, whereas,
undertriage refers to missing significant injuries in patients.
[14] The Federal Interagency Committee on Emergency Medical Services
was established to, among other things, ensure coordination among the
federal agencies involved with state, local, tribal and regional
emergency medical services and 9-1-1 systems and advise, consult, and
make recommendations on matters relating to the implementation of the
coordinated state emergency medical services programs.
[15] In 2007, we reported on safety issues facing the air ambulance
industry and FAA's safety oversight of air ambulances. See GAO,
Aviation Safety: Improved Data Collection Needed for Effective
Oversight of Air Ambulance Industry, [hyperlink,
http://www.gao.gov/products/GAO-07-353] (Washington D.C.: Feb. 21,
2007). We found that while the number of air ambulance accidents did
increase in some years, FAA lacks basic information on the industry to
determine the extent to which the increased number of accidents
resulted from increased air ambulance traffic or decreased safety. We
recommended that FAA identify the data needed to better understand the
air ambulance industry and develop a systematic approach for gathering
and analyzing the data. FAA agreed with, but as of September 2010, had
not implemented this recommendation.
[16] ASRS is a confidential, voluntary, and nonpunitive online
reporting system that allows pilots (including air ambulance pilots),
air traffic controllers, maintenance personnel, flight attendants, and
others to report safety-related incidents. ASRS is available to the
public and can be accessed at [hyperlink,
http://asrs.arc.nasa.gov/index.html]. FAA has other voluntary programs
that rely on cooperation between FAA and industry personnel. These
include the Aviation Safety Action Program, Flight Operational Quality
Assurance, and the Voluntary Disclosure Reporting Program. See GAO,
Aviation Safety: Improved Data Quality and Analysis Capabilities are
Needed as FAA Plans a Risk-Based Approach to Safety Oversight,
[hyperlink, http://www.gao.gov/products/GAO-10-414] (Washington, D.C.:
May 6, 2010).
[17] The remaining ASRS reports related to air ambulances dealt with
issues such as landing zone coordination, pressure to fly potentially
unsafe aircraft, weather issues, air traffic control, and maintenance
concerns.
[18] Center for Leadership, Innovation and Research in EMS is a
nonregulatory, not-for-profit group that is promoting and advancing
the practice and profession of EMS internationally.
[19] NTSB has made numerous recommendations aimed at improving
helicopter air ambulance safety. NTSB's searchable recommendations
database can be found at [hyperlink,
http://www.ntsb.gov/safetyrecs/private/QueryPage.aspx].
[20] These stakeholders maintained that because Medicare payments are
the same regardless of the type of helicopter and crew configuration,
the financial incentives to use less expensive equipment and staffing
could negatively affect the services provided in air ambulances.
[21] For example, both the single-engine Aerospatiale AS350 and twin-
engine AS355 are used in the air ambulance industry, and both have the
same cabin cubic volume. The single-engine Bell 205 and twin-engine
Bell 212 are also used in the air ambulance industry and have the
identical aft cubic volume of 220 cubic feet. The Bell 205 also has a
larger aft cubic volume than the twin-engine Bell 429.
[22] See Bibliography: Burney (1992), Wirtz (2002), Rhee (1986),
Hamman (1991), Pettett (1975), Snow (1986), Baxt (1987).
[23] Burney (1995), Housel (1994), Rodenberg (1992).
[24] Consumers who enroll in an air ambulance provider's subscription
program would have information about cost and that provider's level of
service, but they may not have information on other providers prices
or services to use as a basis for comparison.
[25] Courts have found that federal law preempts state regulation in
the area of aviation safety. See e.g., Abdullah v. American Airlines,
Inc., 181 F.3d 363, 371 (3d Cir. 1999) ("it follows from the evident
intent of Congress that there be federal supervision of air safety and
from the decisions in which courts have found federal preemption of
discrete, safety-related matters, that federal law preempts the
general field of aviation safety."); Air Evac EMS v. Kenneth S.
Robinson, Commissioner of Health, 486 F. Supp. 2d 713 (M.D. Tenn 2007)
(holding that Congress has preempted the field of aviation safety and
that state laws regulating air ambulance avionics equipment are
therefore invalid).
[26] See, e.g., Hiawatha Aviation of Rochester, Inc. v. Minnesota
Department of Health, 389 N.W. 2nd 507 (Sup. Ct. Minn. 1986); Letter
dated February 20, 2007 from James R. Dann, Deputy Assistant General
Counsel for the Department of Transportation to Donald Jansky,
Assistant General Counsel, Office of the General Counsel, Texas
Department of State Health Services.
[27] See Med-Trans Corp. v. Benton, 591 F.Supp. 2d 812 (E.D.N.C. 2008)
(Order of Permanent Injunction).
[28] Under the ADA, air ambulances are considered on-demand air
carriers, along with air taxis and helicopter tour operators.
[29] Morales v. Trans World Airlines, Inc., 504 U.S. 374, 378(1992)
(citing 49 U.S.C. App. 1301(a)(4), 1302(a)(9)).
[30] 49 U.S.C. §41713, "...States may not enact or enforce a law,
regulation, or other provision having the force and effect of law
related to a price, route, or service of an air carrier..."
[31] See, e.g., Hiawatha Aviation of Rochester, Inc. v. Minnesota
Department of Health, 389 N.W. 2d 507 (Minn. 1986).
[32] Letter dated June 16, 1986 from Jim J. Marquez, General Counsel
of the Department of Transportation to Chip Wagoner, Office of
Attorney General, State of Arizona (The Arizona Letter); Letter dated
April 23, 2007 from Rosalind A. Knapp, Acting General Counsel of the
Department of Transportation to Gregory S. Walden, Counsel for Pacific
Wings, LLC (The Hawaii letter); Letter dated October 10, 2007 from
D.J. Gribbin, General Counsel of the Department of Transportation to
Michael Grief, Assistant General Counsel, Office of the General
Counsel, Florida Department of Health (The Florida letter).
[33] Med-Trans Corporation v. Benton, 581 F. Supp. 2d 721 (E.D.N.C.
2008) (Known as the Med-Trans decision).
[34] Letter dated April 23, 2007, from Rosalind A. Knapp, Acting
General Counsel of the Department of Transportation to Gregory S.
Walden, Counsel for Pacific Wings, LLC (the Hawaii letter).
[35] Letter dated April 23, 2007, from Rosalind A. Knapp, Acting
General Counsel of the Department of Transportation to Gregory S.
Walden, Counsel for Pacific Wings, LLC (the Hawaii letter).
[36] We determined that Dr. Blumen's and ADAMS' data were sufficiently
reliable for our purposes.
[37] Medicare is the federal health care program for elderly and
certain disabled individuals. Medicaid is a joint federal-state health
care financing program for certain categories of low-income
individuals.
[End of section]
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