[Senate Hearing 106-1008]
[From the U.S. Government Publishing Office]
S. Hrg. 106-1008
COMPETITION AND SAFETY IN THE DELIVERY OF ANESTHESIA SERVICES
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HEARING
before the
SUBCOMMITTEE ON ANTITRUST,
BUSINESS RIGHTS, AND COMPETITION
of the
COMMITTEE ON THE JUDICIARY
UNITED STATES SENATE
ONE HUNDRED SIXTH CONGRESS
SECOND SESSION
__________
JUNE 7, 2000
__________
Serial No. J-106-87
__________
Printed for the use of the Committee on the Judiciary
__________
U.S. GOVERNMENT PRINTING OFFICE
73-136 WASHINGTON : 2001
COMMITTEE ON THE JUDICIARY
ORRIN G. HATCH, Utah, Chairman
STROM THURMOND, South Carolina PATRICK J. LEAHY, Vermont
CHARLES E. GRASSLEY, Iowa EDWARD M. KENNEDY, Massachusetts
ARLEN SPECTER, Pennsylvania JOSEPH R. BIDEN, Jr., Delaware
JON KYL, Arizona HERBERT KOHL, Wisconsin
MIKE DeWINE, Ohio DIANNE FEINSTEIN, California
JOHN ASHCROFT, Missouri RUSSELL D. FEINGOLD, Wisconsin
SPENCER ABRAHAM, Michigan ROBERT G. TORRICELLI, New Jersey
JEFF SESSIONS, Alabama CHARLES E. SCHUMER, New York
BOB SMITH, New Hampshire
Manus Cooney, Chief Counsel and Staff Director
Bruce A. Cohen, Minority Chief Counsel
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Subcommittee on Antitrust, Business Rights, and Competition
MIKE DeWINE, Ohio, Chairman
ORRIN G. HATCH, Utah HERBERT KOHL, Wisconsin
ARLEN SPECTER, Pennsylvania ROBERT G. TORRICELLI, New Jersey
STROM THURMOND, South Carolina PATRICK J. LEAHY, Vermont
Pete Levitas, Chief Counsel and Staff Director
Jon Leibowitz, Minority Chief Counsel and Staff Director
C O N T E N T S
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STATEMENTS OF COMMITTEE MEMBERS
Page
DeWine, Hon. Mike, a U.S. Senator from the State of Ohio......... 1
Specter, Hon. Arlen, a U.S. Senator from the State of
Pennsylvania................................................... 3
Thurmond, Hon. Strom, a U.S. Senator from the State of South
Sarolina....................................................... 5
WITNESSES
Fallacaro, Michael D., Professor and Chair, Department of Nurse
Anesthesia, Virginia Commonwealth University, prepared
statement...................................................... 6
Pierce, Ellison C., Jr., M.D., Executive Director, Anesthesia
Patient Safety Foundation, prepared statement.................. 10
Silber, Jeffrey H., M.D., Director, Center for Outcomes Research,
The Children's Hospital of Philadelphia, prepared statement.... 14
Stewart, Jan, President, American Association of Nurse
Anesthetists, prepared statement............................... 18
SUBMISSIONS FOR THE RECORD
American Society of Anesthesiologists, statement................. 52
Anesthesia Patient Safety Foundation, letter..................... 60
Reid, Hon. Harry, a U.S. Senator from the State of Nevada,
prepared
statement...................................................... 51
COMPETITION AND SAFETY IN THE DELIVERY OF ANESTHESIA SERVICES
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WEDNESDAY, JUNE 7, 2000
U.S. Senate,
Subcommittee on Antitrust, Business Rights,
and Competition,
Committee on the Judiciary,
Washington, DC.
The committee met, pursuant to notice, at 2:03 p.m., in
room SD-226, Dirksen Senate Office Building, Hon. Mike DeWine
(chairman of the subcommittee) presiding.
Also present: Senator Specter.
OPENING STATEMENT OF HON. MIKE DeWINE, A U.S. SENATOR FROM THE
STATE OF OHIO
Senator DeWine. Good afternoon. Welcome to the Judiciary
Committee, Subcommittee on Antitrust, Business Rights, and
Competition, for today's hearing on competition and safety in
the delivery of anesthesia services.
As many of you know, for several years, a controversy has
been brewing about the standards and the rules that guide the
delivery of anesthesia services to Medicare patients. The
physician community, for the most part, has argued that safe
administration of anesthesia requires advanced and specialized
medical education and that anesthesia services should either be
provided by or supervised by an anesthesiologist or other
medical doctor. This position has been opposed by many
Certified Registered Nurse Anesthetists, known as CRNA's, who
argue that the CRNA's are perfectly capable of providing safe
and effective services and, in fact, already provide such
services, especially in rural areas.
In a nutshell, the doctors argue that this is a safety
issue. The CRNA's believe that doctors are using the safety
argument to limit competition in the provision of anesthesia
services and exclude them from the market.
This type of dispute commonly arises when rules and
standards are being formulated or changed. From an antitrust
point of view, it is difficult to resolve these disputes, but
basically it comes down to whether the standards are, in fact,
reasonable. Reasonable standards assure quality, increase
consumer confidence, and allow an industry to grow freely.
On the other hand, unreasonable standards or standards that
are not related to product quality can harm consumers by
excluding products or services that consumers might otherwise
choose. The analysis of any particular set of standards and
whether they are appropriate is, of course, dependent on the
specific structure of the industry and must be done on a case-
by-case basis.
Now, in this particular instance, the standards at issue
have been in place since 1966, when HCFA imposed a minimum
standard of care for delivery of anesthesia to Medicare
patients, specifically, that anesthesia delivery must be
supervised by a physician. In 1992, HCFA issued a proposed rule
which, among other things, restated that anesthesia
administered by a CRNA must be done under the supervision of
the operating practitioner or an anesthesiologist. In fact,
HCFA specifically found, ``we do not believe it would be
practical to adopt as a national minimum standard for care a
practice that is allowed in only some States. . . . In view of
the lack of definitive clinical studies on this issue and in
consideration of the risk associated with anesthesia
procedures, we believe it would not be appropriate to allow
anesthesia administration by non-physician anesthetists unless
under supervision by either an anesthesiologist or the
operating practitioner.''
In December 1997, however, HCFA issued a proposed rule that
would eliminate the physician supervision requirement for
CRNA's. HCFA acknowledged that there has been no new studies
comparing outcomes between patients who have received doctor-
supervised anesthesia versus those who received anesthesia
without the supervision of a doctor. Instead, the rationale
offered for the proposed rule was essentially that HCFA is
interested in decreasing regulatory requirements and increasing
State flexibility. HCFA argues that anesthesia regulations are
an appropriate area to do so, given that the anesthesia-related
death rate is extremely low.
Again, this proposal has generated a great deal of
controversy. The CRNA's are supporting the rule change as a
long overdue correction to the market which will allow them to
compete fairly and freely against the anesthesiologists. The
anesthesiologists consider the proposal to be a medical mistake
which will imperil the safety of patients.
Now, personally, although I am generally in favor of
deregulation wherever possible, I am concerned about this
proposed rule and I have already publicly stated this. It is
always difficult to determine whether standards are being used
for anticompetitive purposes or if they are useful and
reasonable regulations for a particular industry. It is
particularly difficult and important in the medical field,
where the lives of the patients are at stake.
Accordingly, before making changes to medical regulations,
I think it is incumbent upon the Federal government to be as
certain as possible that changes will not harm patient care. In
this instance, HCFA has, in my opinion, failed to take the
required steps. HCFA is considering changing the Federal
requirement for physician supervision of anesthesia delivery
without having conducted a comparative outcome study to
determine whether removing the physician supervision
requirement will have a negative impact on the health and
safety of Medicare patients.
In order to ensure against any premature change to the
current Federal standard, I have introduced a bill, along with
Senator Harry Reid, to require that the Secretary of Health and
Human Services conduct a comparative outcomes study on the
impact of physician supervision on the mortality and adverse
outcome rates of Medicare patients related to the provision of
anesthesia services.
Now, despite my concerns about the proposed rule, I
understand that many CRNA's believe that the rule change is
long overdue and that the CRNA's themselves have been critical
of those in the physician community who have been fighting the
proposed rule. I think that today's hearing is a good
opportunity to hear from both sides of this very controversial
and also very important issue.
Accordingly, we will be receiving testimony from four
witnesses today, two who support the proposed rule, one who
opposes it, and one witness who will describe the most recent
outcomes study in this area. That study is a potentially
important part of this debate and we look forward to exploring
it today. More generally, this hearing will be a good
opportunity to discuss with our witnesses whether this proposed
rule is best looked at from the perspective of safety,
competition, or both.
Let me turn at this point to my colleague from Pennsylvania
for an opening statement, Senator Specter.
Senator Specter.
STATEMENT OF HON. ARLEN SPECTER, A U.S. SENATOR FROM THE STATE
OF PENNSYLVANIA
Senator Specter. Thank you, Mr. Chairman. The issue as I
see it is whether there ought to be Federal control or State
control, just that direct and that simple. My background comes
from living in a city of two million, somewhat reduced now, and
living in a town of 5,000, Russell, KS, and I know that the
availability of anesthesiologists is very different in downtown
Philadelphia as opposed to downtown Russell. When this issue
has come before the Subcommittee on Labor, Health, Human
Services, and Education, that has been the perspective that I
have brought to it.
There is no doubt that there is a very high-powered, high-
cost lobbying battle going on between the respective parties
here and it is not a very pretty situation, in my opinion. I am
not going to get involved in it beyond that point.
I have a little hard time understanding, candidly, the
antitrust jurisdiction on this matter. If we are considering
legislation for additional studies, that is a matter for the
subcommittee which I chair or the Labor and Health Committee
which Senator Jeffords chairs. Again, I do not want to get into
a turf battle here, but I am searching for antitrust
implications on this issue. I have been on this Antitrust
Subcommittee for a long time and have had some experience in
litigation in antitrust matters and I am a little lost as to a
jurisdictional basis here.
I have had an open door to talk to anybody who wanted to
come see me about this matter, and I was urged to talk to Dr.
Silber, which I did. I met with Dr. Silber at the 30th Street
Station in Philadelphia. It saves a constituent a day of travel
and $200 in train fair if the Senator is going to meet him at
the train station as opposed to meeting him in a corridor in a
Senate office building. I talked to Dr. Silber about his
approach, and I understand the gravamen and thrust of Dr.
Silber's approach is that direction is better than supervision.
I see an affirmative nod, may the record show. And directions
when the anesthesiologist is there all the time as opposed to
supervision, when there may be four people that he is looking
after who may be attended by someone else.
The standard which HCFA currently has does not deal with
the issue of direction versus supervision. The standard that
HCFA has really talks only about supervision. Dr. Silber would
like to have direction. I can understand why. When I am subject
to operative procedures, I would like to have direction,
myself.
I would like to see the highest standards applied
everywhere, but it is a question as to who is to make the
decision. There are just very, very different considerations
that operate out of Topeka, KS, the State capital of Kansas,
and Harrisburg, PA, the State capital of my State now.
When the issue has arisen as to what the Secretary of HHS
ought to do, this is what the Labor-HHS report says. ``The
committee urges the Secretary to base retaining or changing the
current requirement of physician supervision of anesthesia
services in Medicare on scientifically valid outcomes data,''
so that what the subcommittee which I chair has talked about is
scientific data. That is what we are looking at.
This is not the first issue to come to Capitol Hill in
which there are proposals for studies and re-studies and re-re-
studies. The process will take its course. But I think when you
strip it all down, it is a question of whether there are
differences among the States and whether our Federal system is
going to be respected, and it is not just a matter of States'
rights as a generalization and as a platitude, it is a matter
of whether there are real differences between rural areas and
big city areas and how you can provide the best kind of care
for patients in circumstances which differ very, very widely.
Thank you, Mr. Chairman.
Senator DeWine. I appreciate my colleague from
Pennsylvania's comments, and I understand his concern about
jurisdiction. I would say this, though, that the full title of
this subcommittee, as my colleague well knows from his many
years of service here, is Antitrust, Business Rights, and
Competition. We have in the last few years looked at a number
of different issues, everything from college football to
aviation to telecommunications, et cetera, and any one of those
hearings could have probably been handled in another
subcommittee, which probably had concurrent jurisdiction. I do
not know that there is anything this subcommittee ever deals
with where, without too much of a stretch of the imagination,
we could have concurrent jurisdiction with another committee.
I think it is interesting that in this case, the CRNA
community has made this an issue of competition and I think
that is what it does boil down to. It is a balancing test. We
look at many things here, but clearly, the issue of competition
has been raised and, therefore, it is a legitimate issue for
this subcommittee. I think anytime further that we are
examining and reexamining rules and standards that regulate a
profession, those rules and regulations need to be examined to
discover whether they are reasonable regulation of the industry
or inappropriate rules that unfairly exclude competitors. And
so again we get back to the area of competition.
At this point, I would like to include in the record a
statement from Senator Strom Thurmond.
[The prepared statement of Senator Thurmond follows:]
Prepared Statement of Hon. Strom Thurmond, a U.S. Senator From the
State of South Carolina
Mr. Chairman, I am pleased that the Subcommittee is holding this
hearing on competition and safety issues surrounding the delivery of
anesthesia services.
Under current policy, the Health Care Finance Administration
(``HCFA'') requires Medicare patients receiving anesthesia to have a
medical doctor present while the anesthesia is being delivered. Now,
despite the lack of any new information that would support a change
from the established practice, HCFA is preparing to abolish the
requirement that physicians supervise the administration of anesthesia.
The many medical doctors who choose to specialize in anesthesiology
play an important role in patient care. While I am sensitive to the
need for increased competition as a means to lower the spiraling costs
of health care, we must be very cautious in reducing the safeguards on
patient care. I am further concerned that if Medicare no longer deems
the services of anesthesiologists to be necessary, the door would be
open for Medicare to start denying payments for anesthesiologists even
in cases where the services of an anesthesiologist are manifestly
warranted.
One recently completed study at the University of Pennsylvania,
which will be published this summer in a peer-reviewed scientific
journal, raises concern. It suggests that where an anesthesiologist is
not involved in the medication of a patient, there are 2.5 excess
deaths per thousand Medicare general surgical and orthopedic cases
without complications. The study also states that when there are post-
operative complications, the lack of involvement by an anesthesiologist
may contribute to as many as 6.9 excess deaths per thousand patients.
I believe further study is needed regarding this matter before any
major policy changes are made. S. 818, the Safe Seniors Assurance Study
Act of 1999, would require the Secretary of Health and Human Services
to study the wisdom of a proposal to change the minimum level of care
Medicare patients should expect in receiving anesthesia. I believe this
legislation is a reasonable approach at the present time.
Senator DeWine. Let me introduce our panel, beginning on my
left. Dr. Michael Fallacaro is a Certified Registered Nurse
Anesthetist, a Doctor of Nursing Science, and the Chair of the
Department of Nurses at Virginia Commonwealth University.
Dr. Ellison Pierce is the Executive Director and Past
President of the Anesthesia Patient Safety Foundation. He was
Chair of the New England Deaconess Hospital Department from
1972 to 1996 and also has served as Past President of the
American Society of Anesthesiologists.
Dr. Jeffrey Silber is Director of the Center for Outcomes
Research at the Children's Hospital of Philadelphia, Associate
Professor of Pediatrics and Anesthesia at the University of
Pennsylvania School of Medicine.
Jan Stewart is a Certified Registered Nurse Anesthetist and
Advanced Registered Nurse Practitioner and is the 1999-2000
President of the American Association of Nurse Anesthetists.
We welcome all of you. We look forward to the testimony
this afternoon. Doctor, we will start with you. Thank you for
joining us. We are going to set the time limit here at 5
minutes. We will not be too strict about that. We would like
for you to keep your comments within the 5 minutes if you could
and then that will give us more time for questions. If you go
over a few minutes, a couple minutes, that is okay. Your
written statements, which we have received and we appreciate
very much, will now become a part of the record.
Doctor, thank you.
PANEL CONSISTING OF MICHAEL D. FALLACARO, PROFESSOR AND CHAIR,
DEPARTMENT OF NURSE ANESTHESIA, VIRGINIA COMMONWEALTH
UNIVERSITY, RICHMOND, VA; ELLISON C. PIERCE, JR., M.D.,
EXECUTIVE DIRECTOR, ANESTHESIA PATIENT SAFETY FOUNDATION,
BOSTON, MA; JEFFREY H. SILBER, M.D., DIRECTOR, CENTER FOR
OUTCOMES RESEARCH, THE CHILDREN'S HOSPITAL OF PHILADELPHIA,
PHILADELPHIA, PA; AND JAN STEWART, PRESIDENT, AMERICAN
ASSOCIATION OF NURSE ANESTHETISTS, SEATTLE, WA
STATEMENT OF MICHAEL D. FALLACARO
Mr. Fallacaro. Thank you very much. Chairman DeWine,
Honorable Senators of the committee, their staffs, presenters,
and guests, I am Michael Fallacaro, CRNA, Doctor of Nursing
Science, Professor and Chair of the Department of Nurse
Anesthesia at Virginia Commonwealth University. I appreciate
the opportunity to address this committee relative to nurse
anesthesia education, its past, its present, and its future.
Nurse anesthetists take great pride in our history, our
education, our practice, and our contributions to the field of
anesthesiology.
It has been well over 100 years, dating back to the late
1870's, that surgeons began to invite nurses to come to their
hospitals. These surgeons believed that the establishment of a
nursing specialty in the field of anesthesia would resolve the
problems of high mortality rates they associated with the
occasional anesthetist, a physician, a nurse, a medical
student, or anyone who happened to be free when surgery was
attempted. Nurses responded to that call, and by 1914, four
nurse anesthesia educational programs were in existence.
Prior to World War I, the U.S. Army and Navy sent nurses to
notable surgical and anesthesia centers for preparation as
anesthetists to meet projected military needs. Nurse
anesthetists gained a remarkable reputation for their service
in World War I. In fact, they have been called to service in
far greater numbers than any other anesthesia provider in every
war or conflict this Nation has endured in the 20th century.
In 1931, our national association, the American Association
of Nurse Anesthetists, was founded with the primary objective
to assure the educational quality of nurses who would provide
much of the anesthesia services in this country.
As science and technology advanced, affecting the field of
anesthesiology, the educational standards and admission
requirements for these programs accommodated such changes. From
the 1970's onward, nurse anesthesia education has progressively
moved from hospital-based certificate programs to university
hospital cooperative programs at the baccalaureate level until
1998, when all accredited nurse anesthesia programs had to be
at the graduate level, 24 to 36 months in length, offering at
least a Master of Science degree.
The typical applicant to the nurse anesthesia program I
chair at Virginia Commonwealth University is 32 years of age.
They must be a registered nurse, possessing an undergraduate
degree in science with a superior grade point average and high
scores on the National Graduate Record examinations.
Additionally, our applicants average at least 3 years of
critical care hands-on nursing experience. We choose only the
best applicants, having far more applications than we can
accommodate.
Once enrolled, the graduate students enter a rigorous 72-
credit hour, seven-semester program of study. Course work
includes advanced physiology, medicinal chemistry, advanced
pharmacology, pathophysiology, a research core, extensive
principles of anesthesia, and a demanding clinical practicum.
The Council on Accreditation of Nurse Anesthesia Educational
Programs accredits our programs and our graduates must write
the national certification exam administered by the Council on
Certification of Nurse Anesthetists. Both of these councils are
autonomous bodies, nationally recognized by appropriate
government and civilian groups.
In total, most certified registered nurse anesthetists will
have spent near 10 years overall in preparation for practice.
Despite the lengthy education of both CRNA's and physician
anesthesiologists, length of education is never the guarantee
for competence or quality. We must look to learner outcomes and
their capabilities and performance in positions for which they
are prepared. CRNA's score very high in that regard.
Graduates of our programs are prepared to practice as full-
service anesthesia providers, working with and without
anesthesiologists. Today, you will find a single nurse
anesthetist serving as the sole provider of anesthesia on
isolated military missions, such as Kosovo and Macedonia, and
routinely on naval aircraft carriers and isolated bases, such
as Reykjavik, Iceland, with no anesthesiologist present.
Further, such competence is imperative because CRNA's are the
sole providers in close to one-third of America's hospitals, as
well as the majority of rural hospitals.
Anesthesia is now safer than it has ever been. Better
education for both CRNA's and anesthesiology residents may be
one of the causes. However, the most important factor, as many
credible providers will confirm, are the advances in science
and technology that have brought us better drugs, equipment,
monitoring capability, better surgeons and less-invasive
surgical techniques.
Regardless of why, the fact is, St. Paul Insurance Company,
which is the Nation's largest provider of liability insurance
for health care professionals, has reported that from 1988 to
1998, nurse anesthetists' liability premiums decreased across
the country by a full 52 percent, demonstrating the high
quality of care provided by CRNA's is recognized and fully
appreciated by the insurance industry, as well.
Despite the opinion of the American Society of
Anesthesiologists and the American Medical Association,
anesthesia is not the exclusive practice of medicine or any one
discipline. Anesthesia is a body of knowledge unto itself and
is taught as such, an art grounded in science. It is far more
accurate to state that it is within the scope of practice of a
physician, a nurse, a dentist, a podiatrist, or whoever to
deliver anesthesia so long as they have been properly educated
and certified to do so.
I would like to close by saying, God forbid you or any of
your loved ones should ever need surgery or anesthesia.
However, if a need arises, I would like to assure you that
research has proven anesthesia care safe and I now stand at the
ready, along with over 28,000 of this Nation's enlightened
CRNA's, to answer your call, and thank you.
Senator DeWine. Doctor, thank you very much.
[The prepared statement of Mr. Fallacaro follows:]
Prepared Statement of Michael D. Fallacaro, DNS, CRNA
My name is Michael D. Fallacaro. I am a certified registered nurse
anesthetist (CRNA), Doctor of Nursing Science, Professor and Chair of
the Department of Nurse Anesthesia at Virginia Commonwealth University.
I appreciate the opportunity to offer my testimony to this committee
regarding nurse anesthesia education and preparation, and how that
translates into high quality health care for patients across the
country. Nurse anesthetists take great pride in our history, our
education, our practice, our contributions to the field of anesthesia,
and our national association, the American Association of Nurse
Anesthetists (AANA).
HISTORY OF THE EDUCATION AND PROFESSION OF NURSE ANESTHESIA
It was well over one-hundred years, dating back to the late 1870's,
when surgeons began to invite nurses to come to their hospitals, learn
how and provide anesthesia services for the purpose of enhancing the
safety of anesthesia for their patients. These surgeons believed that
the establishment of a nursing specialty in the field of anesthesia
would resolve the problems of high mortality rates they associated with
the occasional anesthetist--a physician, nurse, medical student, or
anyone who happened to be free. Nurses responded to that call, and
surgeons, both in their laboratories and the operating rooms taught the
first nurses to become anesthetists.
Initially, the need for anesthetists was so great, that some of the
more notable teams of surgeons and nurse anesthetists trained other
nurses, physicians, and dentists in short courses of a few weeks or
months. By 1909, the need for formalized nurse anesthesia educational
programs was evident. By 1914, four such programs, each approximately
six months in length, were in existence. These programs included both
academic and clinical courses and were built on the applicable science
known at the time. Their nurse applicants were graduates of
professional nursing education programs. They usually had a few years
of nursing experience, and held a nursing license or registration from
the state. Both physicians and nurse anesthetists served as instructors
in the academic and clinical portions of these programs.
Prior to World War I, the U.S. Army and Navy sent nurses to these
notable centers to be prepared as anesthetists based on projected
military needs. Many nurse anesthetists signed up with the Red Cross,
becoming Army or Navy nurses and accompanying these units to Europe.
Nurse anesthetists gained a remarkable reputation for their service in
WWI. They also trained other nurses and physicians as anesthetists in
British and French hospitals during that war. World War I served as a
major impetus to increase the number of educational programs for nurse
anesthetists in the U.S., and programs were developed in numerous major
hospitals and medical centers.
At this time, there were a few physician anesthetists who devoted
their full practice to anesthesia. However, AMA did not recognize the
anesthesiology medical specialty until 1940, about a half century after
the nurse anesthesia specialty was formalized. At that time there were
only 285 anesthesiologists devoting their full practice to the field.
Of these only about 33% were certified in the specialty. Further, there
were only 7 anesthesiology residencies of at least a year in length at
the beginning of World War II. According to a noted hospital historian,
there were 17 qualified nurse anesthetists for every one
anesthesiologist in 1942.
During the war, the military also undertook to prepare both
physician and nurse anesthetists to meet their needs. While the war-
time physician training program in the Army was four-five months in
length, according to Dr. Robert B. Dodd, an anesthesiologist who had
taken such training, the Army Nurse Corps configured their nurse
anesthesia education program to meet the AANA's curricular standards
when and where possible. These were six months in length. The Army
prepared about 2,000 nurse anesthetists during World War II, including
four Army nurse anesthetists who spent three years as POWs after the
attack on the Philippines. There were no anesthesiologists stationed in
the Philippines at that time. Put simply, CRNA's have been an integral
part of the nation's armed forces and tend to be the predominant
anesthesia provider in combat situations.
EDUCATIONAL STANDARDS HAVE BEEN CONSISTENTLY HIGH
One of the primary aims for AANA upon its founding in 1931 was to
assure the educational quality of nurses who would provide much of the
anesthesia services in this country. Setting standards for the
educational programs and developing a program approval system were the
first critical undertakings of the AANA. During World War II, the AANA
moved forward with its plans to develop an accreditation process for
nurse anesthesia educational programs, and a national certification
examination for nurse anesthetists. The first certification examination
was given in 1945. A more formalized nurse anesthesia education
accreditation program was developed and implemented in 1955. As science
and technology advanced affecting the field of anesthesiology, the
educational standards for these programs changed to accommodate such
changes, as did admission requirements.
In addition to expanding the academic component, the clinical
program was also expanded, growing to one year in length in the 1950s,
expanded to 18 months in the 1960s, and in 1970, it was mandated that
the programs be at least 24 months in length. Like anesthesiology
residencies, most of the nurse anesthesia programs during this period
were hospital based. Many nurse anesthesia educational programs co-
existed with anesthesiology residency programs, using the same
textbooks, and attending many of the same classes. This co-existence of
nurse anesthesia education and anesthesiology residency training came
about despite the American Society of Anesthesiologists adopting an
ethical code stating that anesthesiologists that participated in the
education and practice of nurse anesthetists were in violation of the
ASA code of ethics.
The first graduate program to prepare nurse anesthetists within a
University setting was initiated in 1969, awarding graduates of that
program masters degrees and eligibility for certification. From the
1970s up to today, nurse anesthesia education has progressively moved
from hospital-based certificate programs to University-Hospital
cooperative programs at the baccalaureate level, until 1998, when all
accredited nurse anesthesia programs had to be at the graduate level,
offering at least a Master's degree.
A growing number of our programs have their own, or have access to
anesthesia and critical care simulators where students can gain
experience through simulation prior to entering the operating room and
learning on actual patients. As educational technology changes the
profession continues to make adjustments based on their value for
application to our particular field, just as we modify the basic and
advanced curriculum based on changes in the science and technology.
Today's graduate nurse anesthesia programs range from 24 to 36
months in length, depending upon the university. The typical applicant
to the nurse anesthesia program is approximately 32 years of age, they
must be a registered nurse possessing an undergraduate degree in
science with a superior grade point average and must have scored well
in the national graduate record examination. Additionally, applicants
must possess at least one year of critical care hands-on professional
nursing experience. Gaining admission to a nurse anesthesia program is
difficult; many apply but acceptances are reserved for only the best
and brightest. Once enrolled, graduate students enter a rigorous full-
time program of study. Coursework includes Advanced Physiology,
Medicinal Chemistry, Advanced Pharmacology, Patho-
physiology, a research core, extensive Principles of Anesthesia content
and a demanding Clinical Practicum. The anesthesia portion of the
education for nurse anesthetists is very similar to the anesthesia
education received by physician anesthesiologists.
But here is one difference between nurse anesthetists and
anesthesiologists. Upon successful completion of study, nurse
anesthetists graduates must pass a national certification examination
administered by the Council on Certification of Nurse Anesthetists, an
autonomous body recognized by the U.S. Department of Education. They
must be recertified every two years thereafter in order to continue
practicing the profession of anesthesia. It is my understanding that
board certification is not required for anesthesiologists.
In total, most CRNAs will have spent nearly 10 years in preparation
when one considers undergraduate work, critical nursing experience and
up to 3 years of graduate nurse anesthesia study. Even in light of the
substantial time commitment in CRNA education preparation, we must all
be careful not to necessarily equate competency or quality of any
provider with the duration in years of their preparation alone. Instead
we should judge educational preparation in terms of the quality of the
time spent in study and outcomes of such preparation, which for nurse
anesthetists have been measured and continue to be exemplary.
Our educational programs are conducted utilizing university
faculty, nurse anesthetists, basic and applied scientists,
pharmacologists, physicians (including anesthesiologists), and others.
Clinical instruction of students is performed by both CRNAs and
anesthesiologists. AANA has had four autonomous credentialing Councils
since the mid-1970's--Accreditation, Certification, Recertification,
and one for Public Interest that also serves as the appellate body for
the other Councils. These are multidisciplinary Councils, including
members of the CRNA communities of interests. They include CRNAs,
hospital administrators, anesthesiologists, surgeons, students, and
public members. They are fully compliant with national standards
promulgated by federal and civilian oversight/recognition
organizations, both federal and civilian. Their credentials are
accepted by State Boards of Nursing in recognizing CRNAs as advanced
practice nurses. The National Council of State Boards of Nursing has
evaluated our examination and certification process and deemed it
psychometrically credible.
NURSE ANESTHETISTS PROVIDE HIGH QUALITY, SAFE ANESTHESIA
Graduates of our programs are prepared to practice as full service
anesthesia providers, working with and without anesthesiologists. This
is imperative because CRNAs are the sole anesthesia providers in close
to \1/3\ of America's hospitals--as well as in a majority of rural
hospitals. We must prepare them well, to meet the needs of the American
people wherever they live.
The U.S. military has long recognized the superior education and
the quality of care that nurse anesthetists provide. Nurse anesthetists
have gained a remarkable reputation for their service in every war and
conflict the United States has participated since World War I. In fact
they have been called to service in far greater numbers than any other
anesthesia provider in every war or conflict this nation has ever
endured. Today you will find a single nurse anesthetist serving as the
sole provider of anesthesia on isolated missions such as Kosovo and
Macedonia, with no anesthesiologists present. Nurse anesthetists
routinely work alone on aircraft carriers and on isolated bases such as
Reykjavik, Iceland. The reputation of CRNAs in the military is
undisputed.
Anesthesia is now safer then it has ever been. In the past 20 years
we have seen dramatic improvements in both CRNA and anesthesiologist
educational preparation. We have experienced an explosion in advanced
patient monitoring technology giving us vital moment-to-moment
physiologic information. Our pharmaceutical industry has equipped
providers with far safer therapeutics. Additionally, nursing care,
preventative health care, and patient education have all contributed to
safer outcomes. The fact is, that anesthesia has gotten increasingly
safer over the years. In fact, St. Paul Insurance Company, which is the
nation's largest provider of liability insurance for healthcare
professionals (both CRNAs and anesthesiologists included) has reported
that from 1988 to 1998, nurse anesthetists liability premiums decreased
across the country by a full 52 percent, which demonstrates the high
quality of care and safety record provided by CRNAs recognized and
fully appreciated by the insurance industry as well.
Despite the opinion of the American Society of Anesthesiologists
and American Medical Association, anesthesia, is not the exclusive
practice of medicine or any one discipline. Anesthesia is a body of
knowledge unto itself and is taught as such ``an art, grounded in
science.'' It is far more accurate to state that it is within the scope
of practice of physicians, nurses, dentists, podiatrists, etc. . . . to
deliver anesthesia care so long as they have been properly educated and
certified.
CONCLUSION
Our aim, as it has always been is to prepare highly qualified nurse
anesthetists capable of meeting America's needs for anesthesia service.
However, we would like to assure you that research has proven
anesthesia care is safe regardless of whether a CRNA or
anesthesiologist administers it. CRNAs have an excellent safety record,
and they provide high quality anesthesia care in all types of settings.
I hope that you will keep these indisputable facts in mind as you face
this controversial issue. I look forward to responding to any questions
you may have.
Senator DeWine. Dr. Pierce.
STATEMENT OF ELLISON C. PIERCE, JR., M.D.
Dr. Pierce. Mr. Chairman and members of the subcommittee, I
am Ellison C. Pierce, Jr., M.D., Executive Director and Past
President of the Anesthesia Patient Safety Foundation, APSF. I
am also a Past President of the American Society of
Anesthesiologists and still am Associate Professor of
Anesthesia at the Harvard Medical School.
APSF is a nonprofit corporation representing the anesthesia
provider community, equipment manufacturers, insurers, and
other parties concerned with the issue of anesthesia safety.
The purpose of APSF is to raise the levels of consciousness and
knowledge about anesthesia safety issues, both through fostered
research and publication of patient safety materials in a
variety of media. The current annual budget of our foundation
is approximately $500,000, all of which is dedicated to the
dissemination of information designed to improve anesthesia
safety and to sponsor research on patient safety issues.
I understand that the subcommittee today is considering the
appropriate relationship between competition and safety in the
delivery of health care services. Although I think I understand
the importance of competition in our economy, I would like
principally to discuss the role of private and public
regulation in improving patient safety in the anesthesia field.
The issue of competition is discussed in ASA's written
statement to this hearing, a copy of which I have reviewed.
In December of last year, the Institute of Medicine, in its
now very well known report on the incidence of medical errors,
repeatedly cited the specialty of anesthesiology as having
assumed that patient safety leadership role over the past two
decades. This has been the result of an integrated attack by
anesthesiologists and others on the root causes of anesthesia-
related mortality and morbidity, an effort in which my
Anesthesia Patient Safety Foundation has played a very
significant part.
In my view, the current anesthesia patient safety campaign
was precipitated by a 1982 nationally televised program on
anesthesia mishaps entitled, ``The Deep Sleep,'' noting that
some 6,000 Americans were dying or suffering brain damage in
anesthesia-related incidents each year. Following this
broadcast, intense interest developed in the anesthesia
community toward making our specialty safer.
At the national level, the American Society of
Anesthesiologists in the mid-1980's initiated an integrated
effort to attack the problem. It initially formed a Committee
on Patient Safety and Risk Management, a step which eventually
led to the formation of our foundation as a free-standing
organization representing all those interested in the issue.
At about the same time, it developed a program through its
closed-claims study to determine the cause of adverse
anesthesia incidents. Today, professional liability insurers
representing about half the practicing anesthesiologists
provide anonymous closed-claims files for study by specially
trained volunteer members. Analytical data are compiled over
extended periods of time and results are published in
scientific journals.
Perhaps the most important purpose of this hearing is the
fact that research fostered by APSF and the closed-claims study
have led to the development by ASA of a series of practice
parameters or standards. In terms of patient safety, the best
known of these standards are basic standards for pre-anesthesia
care, standards for basic anesthesia monitoring, and standards
for post-anesthesia care. These standards specify the minimal
requirements for sound anesthesia practice and require, among
other things, that the patient's oxygenation, ventilation,
circulation, and temperature should be continually evaluated.
In effect, they make use of the pulse oximeter and the
capnograph mandatory.
Although the standards are not technically binding on
anyone, including ASA members, their existence as national
definitions of proper care compel adherence, either because
professional liability insurers now require them or because any
anesthesia provider not following them would be at severe risk
of legal action following an adverse event.
Development of these standards by ASA is certainly anti-
competitive in the sense that they constrain anesthesia
providers as a practical matter from delivering anesthesia care
in some less-demanding and perhaps less-costly manner not using
the standards as they wish. In my judgment, these standards are
essential to the process by which the specialty of anesthesia
has markedly improved its record.
Safety-oriented documents by the ASA House of Delegates
also call for medical direction of non-physician members of the
anesthesia care team. The medical supervision requirement
essentially parallels that of the Medicare standard that I
understand now is under significant debate in the Congress.
This association has opposed the proposed elimination of
this requirement. In a letter dated February 17, 1998, the
foundation executive committee wrote, ``A basic tenet of
medicine is, first do no harm. Administration of anesthetics is
a high-risk activity. Prior to making any change in the
existing supervision requirement, the burden of proof must be
based on definitive evidence that the change in practice is
safe. No such evidence exists. If the proposed rule is enacted
in the absence of evidence that the change in practice is safe,
HCFA will have set a dangerous precedent by having shifted the
burden of proof, in my view, in the wrong direction.''
[The letter referred to can be found on page 60 of the
Appendix.]
Dr. Pierce. It is not my purpose here to further draw
anesthesia into this debate as to the wisdom of the HCFA
proposed change. Even though I personally support your bill,
Mr. Chairman, that would require HCFA to undertake a definitive
outcome study prior to considering the wisdom of the proposed
rule.
I would say, incidentally, that our newsletter and research
efforts have been directed over these 15 years equally to nurse
anesthetists and anesthesiologists because we have felt very
strongly that safety in anesthesia is the responsibility of all
providers.
My only point is that regulation, whether public or
private, in the name of medical safety should not be
constrained by application of the principles of competition
and, in my judgment, the true legitimacy in safety terms of the
current HCFA restraint can only be established by scientific
data not yet in hand. Thank you.
Senator DeWine. Doctor, thank you very much.
[The prepared statement of Dr. Pierce follows:]
Prepared Statement of Ellison C. Pierce, Jr., M.D.
Mr. Chairman and Members of the Subcommittee, I am Ellison C.
Pierce, Jr., M.D., Executive Director, and Past President of the
Anesthesia Patient Safety Foundation (APSF). Since 1960, I have been a
member of the faculty of the Harvard Medical School, and from 1972 to
1996, I was chair of the New England Deaconness Hospital Department of
Anesthesia. I am also a Past President of the American Society of
Anesthesiologists.
Founded in 1986, APSF is a nonprofit corporation representing the
anesthesia provider community, equipment manufacturers, insurers and
other parties concerned with the issue of anesthesia safety. The
purpose of APSF is to raise the levels of consciousness and knowledge
about anesthesia safety issues, both through fostered research and
publication of patient safety materials in a variety of media. The
current annual budget of APSF is approximately $500,000, all of which
is dedicated to the dissemination of information designed to improve
anesthesia safety and to sponsor research on patient safety issues.
APSF is the model, incidentally, upon which the National Patient Safety
Foundation--sponsored by the AMA, was organized.
I understand that the Subcommittee today is considering the
appropriate relationship between competition and safety in the delivery
of health care services. Although I think I understand the importance
of competition in our economy, I would like to discuss the role of
private and public regulation in improving patient safety in the
anesthesia field. The issue of competition is discussed in ASA's
written statement to this hearing, a copy of which I have reviewed.
In December of last year, the Institute of Medicine, in its now
well-known report on the incidence of medical errors, repeatedly cited
the specialty of anesthesiology as having assumed a patient safety
leadership role over the past two decades. Although various statistics
have been cited to demonstrate the radical improvement in anesthesia
safety during this period, the soundness of this conclusion is perhaps
best demonstrated by the fact that average anesthesia professional
liability insurance premiums have dropped over this period to
approximately one-third their levels twenty years ago. This has been
the result of an integrated attack by anesthesiologists and others on
the root causes of anesthesia-related mortality and morbidity--an
effort in which my organization has played a significant part.
In my view, the current anesthesia patient safety campaign was
precipitated by a 1982 nationally-televised program on anesthesia
mishaps, entitled ``The Deep Sleep'', noting that 6000 Americans were
dying or suffering brain damage in anesthesia-related incidents.
Following this broadcast, intense interest developed in the anesthesia
community toward making our specialty safer.
Several events occurred in rapid succession after the broadcast. An
international symposium of anesthesia morbidity and mortality was held
in Boston, and at about the same time, the Department of Anesthesia at
Harvard Medical School promulgated the first standards requiring the
intra-operative monitoring of patients, including the requirement that
an anesthesia practitioner must be present in the operating room at all
times during the administration of anesthesia. Contemporaneously,
manufacturers of anesthesia equipment made a significant contribution
with the introduction of the pulse oximeter to measure blood oxygen
levels and the capnograph to measure carbon dioxide in the breath.
At the national level, ASA in the mid-1980's initiated an
integrated effort to attack the problem. It initially formed a
committee on patient safety and risk management, a step which
eventually led to the information of APSF as a free-standing
organization representing all those interested in the issue. At about
the same time, it developed a program--through its closed claims study,
to determine the causes of adverse anesthesia incidents. Today,
professional liability insurers representing about half of all
practicing anesthesiologists provide anonymous closed claims files for
study by specially-trained volunteer ASA members. Analytical data are
compiled over extended periods of time, and the results are published
in scientific journals for use by all concerned.
Perhaps most important for purposes of this hearing is the fact
that research fostered by APSF and the closed claims study have led to
the development by ASA of a series of practice parameters, or
standards, for the practice of anesthesiology. In terms of patient
safety, the best known of these are the Basic Standards for
Preanesthesia Care, the Standards for Basic Anesthesia Monitoring, and
the Standards for Postanesthesia Care.
These standards specify the minimum requirements for sound
anesthesia practice, and require among other things that the patient's
oxygenation, ventilation, circulation and temperature shall be
continually evaluated. In effect, they make the use of the pulse
oximeter and capnograph (or similar equipment) mandatory: although the
Standards are not technically binding on anyone, including ASA members,
their existence as national definitions of proper care compel
adherence--either because professional liability insurers now require
them or because any anesthesia provider not following them would be at
severe risk of legal action following an adverse event.
Development of these standards by ASA is certainly anticompetitive,
in the sense that they constrain anesthesia providers as a practical
matter from delivering anesthesia care in some less demanding, and
perhaps less costly, manner as they wish. But in my judgment, these
standards are essential to the process by which the specialty of
anesthesiology has markedly improved its safety record.
Safety-oriented documents approved by ASA's House of Delegates also
call for medical direction of non-physician members of the anesthesia
care team. This medical supervision requirement essentially parallels
the current Medicare standard that I understand is now under
significant debate in the Congress. APSF has opposed the proposed
elimination of this requirement: in a letter dated February 17, 1998
(attached), the APSF Executive Committee commented:
``A basic tenet of medicine is ``first do no harm''. Administration
of anesthetics is a high risk activity. Prior to making any change in
the existing supervision requirement, the burden of proof must be based
on definitive evidence that the change in practice is safe. No such
evidence exists! If the proposed rule is enacted in the absence of
evidence that the change in practice is safe, [the Health Care
Financing Administration] will have set a dangerous precedent by having
shifted the burden of proof in the wrong direction.''
It is not my purpose here further to draw APSF into the debate as
to the wisdom of the HCFA proposed change, even though I personally
support your bill, Mr. Chairman, that would require HCFA to undertake a
definitive outcomes study prior to considering the wisdom of the
proposed rule change. My only point is that regulation--whether public
or private--in the name of medical safety should not be constrained by
application of the principles of competition, and in my judgment, the
true legitimacy in safety terms of the current HCFA restraint can only
be established by scientific data not yet at hand.
I close by saying that I am proud of the record of APSF and my
specialty in improving anesthesia safety over the past two decades, and
I hope the Subcommittee will share with me and my organization the
sense that we are only beginning. New anesthetics, new equipment, new
teaching methods such as use of anesthesia simulators are continually
coming into play, and though we still have much to learn through
research about safety techniques and appropriate standards in
anesthesia, the challenge for all of medicine is equally great. I urge
the Congress to support this process. Thank you.
Senator DeWine. Dr. Silber.
STATEMENT OF JEFFREY H. SILBER, M.D.
Dr. Silber. Mr. Chairman, members of the subcommittee,
thank you for giving me the opportunity to make this
presentation before you today. I am Jeffrey Silber, Director of
the Center for Outcomes Research at the Children's Hospital of
Philadelphia. I have been conducting medical outcomes studies
using the data from the Health Care Financing Administration
since 1987 and have developed numerous tools for the proper
adjustment of outcomes data so that meaningful comparisons
across providers can be made. I have published widely in this
field.
In 1992, we published a paper in the journal Medical Care
using Medicare data which showed that hospitals with higher
percentages of board-certified anesthesiologists had lower
rates of death in those patients with complications, otherwise
known as lower failure-to-rescue rates. In 1995, we published a
second study in the Journal of the American Statistical
Association. That study found similar results using different
data.
These studies interested the American Board of
Anesthesiology, and as a result, in July 1995, our group,
through the Children's Hospital of Philadelphia and the
University of Pennsylvania, was awarded an $88,000 grant from
the American Board of Anesthesia to explore the influence of
board certification in more detail. From that ongoing study,
though not directly requested by the ABA and using methodology
developed as part of other Agency for Health Care Research and
Quality supported studies, our group has recently completed a
study of medical direction provided by the anesthesiologist on
patient outcomes. This afternoon, I would like to share some
interesting findings from that research, briefly discuss the
methodology, then talk about the significance of this work as
it relates to current policy questions.
Our study showed that the lack of an anesthesiologist was
associated with an increase of 2.5 excess deaths per 1,000
patients and an even higher number, 6.9 deaths per 1,000
patients, when there were complications.
We also found three provider-level factors remained
significantly associated with lower mortality rates after full
adjustment: First, higher registered nurse-to-bed ratio;
second, larger hospital size; and third, the personal
performance or medical direction by an anesthesiologist. All
three factors were significant and independently related to
lower mortality.
These study results are cause for concern and raise
important questions regarding the quality of care delivered to
Medicare patients undergoing general surgical and orthopedic
procedures who did not have an anesthesiologist personally
perform or medically direct their anesthesia care. Here is how
we developed the study and the methodology used.
Our study compared the outcomes of surgical patients whose
anesthesia care was personally performed or medically directed
by an anesthesiologist, the directed cases, with the outcomes
of patients whose anesthesia care was not personally performed
or medically directed by an anesthesiologist, the undirected
cases. Under HCFA billing rules, personal performance and
medical direction require direct and extensive involvement of
the physician in the anesthesia procedure.
Medicare claims records were analyzed for all elderly
patients in Pennsylvania who underwent general surgical or
orthopedic procedures between 1991 and 1994. The study involved
194,430 directed and 23,010 undirected cases across 245
hospitals. Outcomes studied included the death rate within 30
days of the hospital admission, in-hospital complication rate,
and the failure-to-rescue rate, defined as the rate of death
after complications. Cases were defined as being either
directed or undirected depending on the type of involvement of
the anesthesiologist as determined solely by HCFA billing
records. Outcome rates were adjusted to account for the
severity of each patient's medical condition and for other
provider characteristics using logistic regression models. The
final model included 64 patient and 42 procedure covariants
plus an additional 11 hospital characteristics often associated
with quality of care. Numerous alternative models were
developed using different data elements and subsets of the full
data set. These are reported at great length in our soon to be
published paper in the journal Anesthesiology.
The results from these other adjustments confirmed our main
findings. After extensive adjustments for patient and hospital
characteristics, we found that lack of direction by an
anesthesiologist was associated with an increase of 2.5 excess
deaths per 1,000 patients, one excess death in 400 cases. This
corresponded to an adjusted death rate of 3.49 percent in the
directed group and 3.74 percent in the undirected group. We
further found that lack of an anesthesiologist was associated
with 6.9 excess deaths per 1,000 patients with complications,
one excess death in 145 cases with complications.
After appropriate adjustments, we saw no difference in the
rate of complications between directed and undirected groups.
However, as we had published in numerous articles prior to this
study, complication rates found in Medicare data should not be
used for assessing quality due to imprecision in the coding of
these complications. Our previous work has shown that adjusted
complication rates are almost never correlated with adjusted
mortality rates and that adjusted complication rates are best
thought of as a severity of illness indicator.
The methodology used for this study was standard for
claims-based outcomes research analyses. The techniques of
adjustment used in this study are well known, commonly used
methods that appear in the medical and statistics literature.
Nevertheless, confirmatory studies should be conducted. Such
studies ideally should involve case control methodology to most
efficiently extract patient charts in the directed and
undirected groups. If such studies were to be done as the next
logical step in my research agenda, my belief is that we would
observe similar results. However, such studies would provide us
with greater confidence concerning this important topic.
From my perspective, there are three policy issues raised
by these results. First, crucial quality of care results need
to be addressed regarding anesthesiologist direction of
anesthesia care. Second, our results need to be confirmed by
other studies, some involving direct chart review. And third,
we need to ask why there are these differences in adjusted
mortality and failure to rescue across hospital and provider
type and we need to develop better systems that reduce such
differences. Reducing the differences would clearly improve the
quality of medical care for all Americans.
Thank you, Mr. Chairman and members of the committee. I am
ready to answer your questions.
Senator DeWine. Doctor, thank you very much.
[The prepared statement of Dr. Silber follows:]
Prepared Statement of Jeffrey H. Silber, M.D., Ph.D.
Mr. Chairman, Members of the Subcommittee, thank you for giving me
the opportunity to make this presentation before you today:
I am Jeffrey H. Silber, M.D., Ph.D., Director of the Center for
Outcomes Research at The Children's Hospital of Philadelphia, and
Associate Professor of Pediatrics and Anesthesia at The University of
Pennsylvania School of Medicine and Associate Professor of Health Care
Systems at The Wharton School. I am also an attending physician in
pediatric oncology at The Children's Hospital of Philadelphia.
I have been conducting medical outcomes studies using data from the
Health Care Financing Administration since 1987, and have developed
numerous tools for the proper adjustment of outcomes data so that
meaningful comparisons across providers can be made. I have published
widely in this field.
In 1992 we published a paper in the journal Medical Care, using
Medicare data, which showed that hospitals with higher percentages of
board certified anesthesiologists had lower rates of death in those
patients with complications (otherwise known as lower ``failure-to-
rescue'' rates). In 1995, we published a second study in the Journal of
the American Statistical Association. That study found similar results
using different data. These studies interested the American Board of
Anesthesiology (ABA), and as a result, in July of 1995 our group,
through The Children's Hospital of Philadelphia and The University of
Pennsylvania, was awarded an $88,000 grant from the ABA to explore the
influence of board certification in more detail. From that ongoing
study, though not directly requested by the ABA, and using methodology
developed as part of other Agency for Healthcare Research and Quality
supported studies, our group has recently completed a study of medical
direction provided by the anesthesiologist on patient outcomes.
This afternoon I would like to share some very interesting findings
from that research, briefly discuss the methodology, then talk about
the significance of this work as it relates to current policy
questions.
Before I do, let me say a few words about the history of outcomes
research. Outcomes research techniques have been used since 1968 when
Lincoln Moses and Frederick Mosteller, two renowned statisticians,
published a now famous report from the National Halothane Study, an
observational study assessing the safety of the then new anesthetic
agent Halothane. In that report, it was noted that some hospitals had
very different deaths rates than other hospitals. Moses and Mosteller
performed numerous statistical adjustments, many of which we still use
today, and concluded that differences in adjusted mortality rates may
reflect differences in quality of care.
Over the past 32 years, literally hundreds of studies have been
performed using large data sets across hospitals looking at many
different medical questions concerning quality of care. The study I
will discuss today is one of many such studies that use large data
bases with various forms of medical data to measure differences across
providers or hospitals.
Outcomes research uses large numbers of observations in order to
detect small effects not readily apparent at any single hospital or
within any single provider group. While the data in these large
outcomes studies is usually not as refined as in smaller chart review
studies, the large sample size often allows us to gain insight into
differences in quality of care and outcomes that would not be apparent
using other methodology.
Our study showed that the lack of an anesthesiologist was
associated with an increase of 2.5 excess deaths per thousand patients,
and an even higher number, 6.9 deaths per thousand patients, when there
were complications.
We also found that three provider level factors remained
significantly associated with lower mortality rates after full model
adjustment: (1) higher registered nurse-to-bed ratio; (2) larger
hospital size and (3) the personal performance or medical direction by
an anesthesiologist. All three factors were significant and
independently related to lower mortality.
These study results are cause for concern, and raise important
questions regarding the quality of care delivered to Medicare patients
undergoing general surgical and orthopedic procedures who did not have
an anesthesiologist personally perform or medically direct their
anesthesia care.
Here is how we developed the study and the methodology used.
Today, anesthesia services for surgical procedures may or may not
be personally performed or medically directed by anesthesiologists. Our
study compared the outcomes of surgical patients whose anesthesia care
was personally performed or medically directed by an anesthesiologist
(``directed cases'') with the outcomes of patients whose anesthesia
care was not personally performed or medically directed by an
anesthesiologist (``undirected cases''). Under HCFA billing rules,
personal performance and medical direction require direct and extensive
involvement of the physician in the anesthesia procedure.
Medicare claims records were analyzed for all elderly patients in
Pennsylvania who underwent general surgical or orthopedic procedures
between 1991-1994. The study involved 194,430 directed and 23,010
undirected cases across 245 hospitals. Outcomes studied included death
rate within 30 days of hospital admission, in-hospital complication
rate and the failure-to-rescue rate (defined as the rate of death after
complications).
Cases were defined as being either ``directed'' or ``undirected'',
depending on the type of involvement of the anesthesiologist as
determined solely by HCFA billing records. Outcome rates were adjusted
to account for the severity of each patient's medical condition and for
other provider characteristics using logistic regression models. The
final model included 64 patient and 42 procedure convariates plus an
additional 11 hospital characteristics often associated with quality of
care. Numerous alternative models were developed, using different data
elements and subsets of the full data set. These are reported at great
length in our soon-to-be-published paper in the journal Anesthesiology.
The results from these other adjustments confirmed our main findings.
After extensive adjustments for patient and hospital
characteristics, we found that lack of direction by an anesthesiologist
was associated with an increase of 2.5 excess deaths per 1000 patients
(1 excess death in 400 cases). This corresponded to an adjusted death
rate of 3.49 percent in the directed group and 3.74 percent in the
undirected group. We further found that lack of an anesthesiologist was
associated with 6.9 excess deaths per 1000 patients with complications
(1 excess death in 145 cases with complications).
After appropriate adjustments, we saw no difference in the rates of
complications between the directed and undirected groups. However, as
we have published in numerous articles prior to this study,
complication rates found in Medicare data should not be used for
assessing quality, due to imprecision in the coding of these
complications. Our previous work has shown that adjusted complication
rates are almost never correlated with adjusted mortality rates, and
that adjusted complication rates are best thought of as a severity of
illness indicator.
The methodology used for this study was standard for claims based
outcomes research analyses. The techniques of adjustment used in this
study are well known, commonly used methods that appear in the medical
and statistics literature. Nevertheless, confirmatory studies should be
conducted. Such studies ideally should involve case-control methodology
to most efficiently abstract patient charts in the directed and
undirected groups. If such studies were to be done as the next logical
step in my research agenda, my belief is that we would observe similar
results. However, such studies would provide us with greater confidence
concerning this important topic.
From my perspective, there are three important policy issues raised
by these results. (1) Crucial quality of care results need to be
addressed regarding anesthesiologist direction of anesthesia care. (2)
Our results need to be confirmed by other studies, some involving
direct chart review. (3) We need to ask why there are these differences
in adjusted mortality and failure to rescue across hospital and
provider type, and we need to develop better systems that reduce such
differences. Reducing the differences will clearly improve the quality
of medical care for all Americans.
Thank you Mr. Chairman and members of the committee. I am ready to
answer your questions.
Senator DeWine. Ms. Stewart, thank you very much for
joining us. You may proceed.
STATEMENT OF JAN STEWART
Ms. Stewart. Thank you. Good afternoon, Chairman DeWine,
members of the subcommittee. I am Jan Stewart and I currently
serve as the President of the American Association of Nurse
Anesthetists, the AANA. Our 28,000 members provide invaluable
access to anesthesia services in literally every type of
setting. CRNA's are the predominant anesthesia provider in the
armed services, particularly in combat situations, where they
have often been deployed without any anesthesiologist. Nurse
anesthetists are also the only anesthesia providers in some 70
percent of rural hospitals, and we are the first specialists in
the delivery of anesthesia.
The concerns voiced by the anesthesiologists are all about
incomes, not outcomes. The safety record of CRNA's does not
come into question except at the behest of the
anesthesiologist, and thus that questioning seems to be self-
serving. Their statements would have you believe that CRNA's
must be closely supervised to provide safe care. However,
CRNA's are all too familiar with the sundown rule. When the sun
goes down, CRNA skills goes up in inverse proportion to the
level of daylight, and mystically, the anesthesiologist does
not need to be present.
Although CRNA's and anesthesiologists disagree on some
fundamental issues, their relationship when the two providers
work together in the operating room is overwhelmingly one of
cooperation and collegiality. However, the recent attacks that
the American Society of Anesthesiologists, the ASA, has made
upon the profession of nurse anesthesia are beyond the pale and
are damaging to the public's confidence in anesthesia in
general.
The messages have often left the public and some members of
Congress with the erroneous notion that there will be no
physician in the OR if HCFA's proposed regulation is
implemented. The ASA has publicly stated in press releases and
materials to Capitol Hill that CRNA's will kill people if their
proposed regulation goes forward. Now, I do not know about you,
but when someone says that I will be killing patients, I tend
to get a bit defensive.
These distortions and desperate tactics are not only
designed to scare senior citizens but to force Congress into
blocking a regulation that has been on the table for years.
HCFA has carefully and thoroughly considered the change which
will simply allow the States to determine the need for
supervision of nurse anesthetists.
Contrary to what the ASA might have you believe, CRNA's
will continue to work in a highly interdependent collaborative
relationship with surgeons and other physicians in the
operating room as we always have. CRNA's are not going to be
offering anesthesia to passers by onstreet corners around
America. Clearly, there would not be much need for CRNA services
without surgeons. The actual administration of anesthesia for the vast
majority of situations will not change. The change in the supervision
requirement eliminates the onus on surgeons of the unfounded concern
about vicarious liability, and case law clearly shows that surgeons are
no more liable when working with an CRNA than with an anesthesiologist.
The change in the regulation also increases the flexibility
of health care facilities in their staffing arrangements. The
concern that this change in the regulation would displace
anesthesiologists is completely unfounded. If health care
organizations wanted to do away with their anesthesiologist, it
could have been done years ago. Even with the current
regulation in place, there is no requirement for
anesthesiologists at all. In reality, health care facilities
design their anesthesia delivery system according to their own
philosophical needs and that clearly will not change.
Anesthesiologists will retain their ability to compete in the
anesthesia market.
The facts are these. As my colleague has alluded to, the
St. Paul, which is the largest insurer of nurse anesthesia for
liability premiums, has dramatically decreased the premiums in
the last several years. It is hard to see that that would have
been the case if anesthesia were unsafe if it were delivered by
nurse anesthetists.
HCFA is simply following their current practice, which is
to focus on outcomes. HCFA has deferred to State law with
respect to other advanced practice nurses as recently as in
November 1999.
This issue is about incomes of the anesthesiologists and
their desires to suppress legitimate competition, not about
patient outcomes. After hearing about the proposed regulation
change, former ASA President Bill Owens advised members to
consider the socio-economic impact associated with the proposed
regulation.
The study by Dr. Silber, which is held up by the ASA as the
holy grail of anesthesia outcome studies, is clearly flawed.
The ASA has promised imminent publication for over 2 years.
Thus far, only an abstract of the article has been published.
One of the co-authors, Dr. David Longnecker, said the study
does not explore the role of nurse anesthetists in anesthesia
practice, nor does it compare anesthesiologists versus nurse
anesthetists. The abstract also admits it remains to be
determined whether the findings were the result of a caregiver
or a hospital effect. The death rates cited in the abstract are
100 times greater than the death rates reported in recent
years.
The ASA has a lot to answer for. When will these unethical
scare tactics stop? When will the ASA stop these self-serving
machinations to undermine patient confidence in the health care
system? When will they stop the irresponsible and erroneous
statements that CRNA's will kill people because of a change in
Federal regulation that has absolutely nothing to do with
safety or quality?
To paraphrase a famous statement made years ago, I would
say to the ASA, at long last, have you no sense of decency, at
long last? Thank you.
[The prepared statement of Ms. Stewart follows:]
Prepared Statement of Jan Stewart, CRNA, ARNP
The American Association of Nurse Anesthetists (AANA) is the
professional association that represents over 28,000 Certified
Registered Nurse Anesthetists (CRNAs), which is approximately 94
percent of the practicing nurse anesthetists in the United States. I
appreciate the opportunity to testify today regarding nurse
anesthetists and our history of promoting competition in the anesthesia
marketplace, especially as it pertains to the Health Care Financing
Administration's (HCFA) proposed rule to defer to the states on the
issue of physician supervision of nurse anesthetists.
As you may know, nurse anesthetists have a long history of
promoting and protecting competition between health care providers in
order to provide the highest level of care and access to patients.
Nurse anesthetists and anesthesiologists are frequently in direct
competition with each other. We believe that this competition is
helpful to consumers and to the marketplace, as long as the playing
field is level. AANA has on numerous occasions supported this position
with Congress and federal agencies.
1. The Proposed HCFA Rule Promotes Competition.--If finalized, the
1997 proposed HCFA rule that would defer to the states on the issue of
physician supervision of nurse anesthetists would promote greater
competition between nurse anesthetists and anesthesiologists. AANA
strongly supports the proposed rule because it would ensure greater
access to anesthesia care for patients, eliminate physician concerns
regarding liability, and enable hospitals and ambulatory surgical
centers greater flexibility while maintaining a high level of care.
2. The Current Antitrust Laws are Crucial to Protect Competition
and Consumer Choice.--We believe that strong antitrust laws and robust
enforcement are crucial to protect competition and consumer choice in
the health care system. We have testified before the House Judiciary
Committee recently on proposed changes to these laws and expressed our
position: changes to these laws would allow anesthesiologists to form
cartels that could discriminate against or exclude nurse anesthetists
from the marketplace; changes could eliminate competition between
anesthesiologists and nurse anesthetists by their use of spurious
claims regarding patient health and safety; and changes could
unnecessarily drive up the cost of health care coverage for all
Americans without any concomitant increase in the quality or
availability of health care.
3. The Physician Community Has Attempted to Restrict Practice
Opportunities for CRNAs.--Organized medicine has a long record of
attempting to restrict opportunities of CRNAs or otherwise control non-
physician providers such as nurse anesthetists.
BACKGROUND INFORMATION ABOUT CRNA'S
In the administration of anesthesia, CRNAs perform virtually the
same functions as physician anesthetists (anesthesiologists) and work
in every setting in which anesthesia is delivered including hospital
surgical suites and obstetrical delivery rooms, ambulatory surgical
centers, health maintenance organizations' facilities, and the offices
of dentists, podistrists, ophthalmologists, and plastic surgeons.
Today, CRNAs administer approximately 65% of the anesthetics given to
patients each year in the United States. CRNAs are the sole anesthesia
provider in at least 65 percent of rural hospitals which translates
into anesthesia services for millions of rural Americans.
CRNAs have been a part of every type of surgical team since the
advent of anesthesia in the 1800s. Until the 1920s, anesthesia was
almost exclusively administered by nurses. In addition, nurse
anesthetists have been the principal anesthesia provider in combat
areas in every way the United States has been engaged in since World
War I. CRNAs provide anesthesia services in the medical facilities of
the Department of Defense, the Public Health Service, the Indian Health
Service, the Department of Veterans Affairs, and countless other public
and private entities.
The most substantial difference between CRNAs and anesthesiologists
is that prior to anesthesia education, anesthesiologists receive
medical education while CRNAs receive a nursing education. However, the
anesthesia part of the education is very similar for both providers,
and both professionals are educated to perform the same clinical
anesthesia services. CRNAs and anesthesiologists are both educated to
use the same anesthesia processes and techniques in the provision of
anesthesia and related services. The practice of anesthesia is a
recognized specialty within both the nursing and medical professions.
Both CRNAs and anesthesiologists administer anesthesia for all types of
surgical procedures, from the simplest to the most complex, either as
single providers or in a ``care team setting.''
There are currently 87 accredited nurse anesthesia education
programs in the United States lasting between 24-36 months, depending
upon the university. As of 1998, all programs offer a master's degree
level for advance practice nurses, and these programs are accredited by
the Council of Accreditation of Nurse Anesthesia Educational Programs
which is recognized by the U.S. Department of Education.
THE PROPOSED HCFA RULE PROMOTES COMPETITION AND ACCESS TO ANESTHESIA
As you know, HCFA issued a proposed rule in December, 1997 that
would defer to state law on the issue of physician supervision of nurse
anesthetists. Since that time, AANA has supported the rule change for
the following reasons:
1. It would place the regulation of healthcare professionals where
it belongs--at the state level. The proposed rule defers to state law
on the issue of physician supervision of nurse anesthetists, advocating
states' rights over federal government regulation in healthcare
matters. We are mystified that the anesthesiologists would oppose CRNAs
being regulated by the states. At the same time, if the
anesthesiologists oppose the removal of a Part A requirement, would
they support similar federal restrictions being imposed on
anesthesiologists?
2. It promotes flexibility. The deferral to state law gives
hospitals and ambulatory surgical centers greater flexibility in the
use of anesthesia providers and improving operating room efficiency
without affecting quality of care. The proposed rule is supported by
the American Hospital Association and the Federation of American Health
Systems.
3. It may help to remedy ongoing cases where anesthesiologists deny
care. The proposed rule would ensure patient access to safe, high-
quality anesthesia care, particularly in rural and inner-city
hospitals. This is particularly critical given what has transpired in
rural and underserved areas. In Los Angeles, an anesthesiologist
refused to provide an epidural to a Medicaid patient in labor unless
she could provide a cash payment. The indigent patient could not pay
cash and was forced to undergo a delivery without anesthesia. In 1998,
a story in the Los Angeles Times reported the case of Mrs. Ozzie Chavez
who was told she would have to pay $400 cash in order to get an
epidural during her labor. Though she was on MediCal, she offered to
pay with a credit card or check but was denied and had to endure a
painful delivery because the anesthesiologist demanded cash. According
to the news story, this anesthesiologist had denied epidurals to a
number of Medicaid patients as well. Interestingly, in the April 2000
issue of the American Society of Anesthesiologists Newsletter,
Christine A. Doyle, M.D. writes that ``the `Northridge labor epidural
incident' here in California was brilliantly converted by the
California Society of Anesthesiologists (CSA) from an apparent disaster
into a vehicle for achieving the first increase in Medi-Cal (Medicaid)
reimbursement for obstetrical anesthesia in over 10 years.'' So much
for compassion; instead the theme for anesthesiologists seems to be
``show me the money.'' In Utah, it was reported in the Salt Lake
Tribune (July 2, 1998) that Kelly DeFeo, a CRNA, volunteered to provide
help for children at a school-based clinic in Ogden but was denied the
ability to do so since McKay-Dee Hospital--the hospital which
apparently cooperated with the clinic refused to allow her privileges.
She was barred from volunteering because the hospital policy required
anesthesiologist supervision. At least at that time, no
anesthesiologist volunteered to provide the services nor was the policy
changed so that the CRNA could provide the anesthesia.A few years ago
in Montana and Wyoming, anesthesiologists refused to allow nurse
anesthetists to provide epidurals even though it is within the scope of
practice of CRNAs to do so. This denied numerous women epidurals
themselves because there were apparently not enough anesthesiologists
who were willing to provide the service. The result was thatmany women
were being denied access to epidurals. (Great Falls Tribune,
``Epidurals still not available,'' by Carol Bradley, September 3, 1995;
Casper Star Tribune, ``Nursing ethics group says epidural access at WMC
depends on knowing `right person' '', by Tom Morton, 1993; Denver Post,
``Montana women seek deliverance'', by Carol Bradley, July, 1995). As
these cases demonstrate, it is critically important to ensure access to
anesthesia, particularly when anesthesiologists are either unavailable
or unwilling to provide certain services in rural or underserved urban
areas.
4. The rule addresses liability concerns. It eliminates the
misperception some surgeons have that they are liable for the actions
of CRNAs due to the federal supervision requirement. We have had many
reports from CRNAs around the country about anesthesiologists who have
dissuaded surgeons from working with CRNAs or hospitals from employing
CRNAs inferring that somehow they are automatically liable for the
actions of the CRNA by virtue of the supervision requirement. This
assessment, of course, is not legally correct as the surgeon or other
physician may rely upon either the CRNA or the anesthesiologist for the
anesthesia portion of the case, unless the surgeon or other physician
decides to become involved in the delivery of anesthesia. This
perception of liability has been artfully used by some
anesthesiologists to evict nurse anesthetists from their positions.
5. Finally, the rule recognizes CRNAs and affords them the
opportunity to practice within their scope. It recognizes CRNAs for
what they are: healthcare professionals who generally have a graduate-
level education, who administer 65 percent of all anesthesia in the
United States and are the sole anesthesia providers in two-thirds of
all rural hospitals. Further, it recognizes that anesthesia care is
safer today than it has ever been due to advancements in technology,
pharmacology, and provider education.
For all of these reasons, the HCFA rule would enhance competition
by providing flexibility in the marketplace, while ensuring continued
access to high quality health care. To delay its implementation would
only delay the improvements in the marketplace that we believe this
rule will bring.
HCFA has made a careful, clinical decision and is under no obligation
to further study this issue
It is a fallacy that HCFA has not studied this issue. HCFA has been
considering this issue since 1994 when it circulated a draft
regulation, three years before it issued the proposed rule in 1997.
HCFA has given thoughtful consideration to this issue over the past six
years. In addition, HCFA has recognized the merits of federal
deregulation of health care providers by deferring to the states on the
supervision of other types of clinicians. Reinforcing the nurse
anesthetist rule, HCFA has now removed supervision requirements for
nurse practitioners and clinical nurse specialists in their Revisions
to the Year 2000 Physician fee schedule. (Federal Register 11/2/99;
59415).
HCFA is moving forward deliberately and in an appropriate fashion.
Contrary to what the ASA may be telling Congress, HCFA has had no
mandated directive from Congress to further study this issue. Report
language from the Balanced Budget Refinement Act states in part:
``If the Secretary believes that she has sufficient mortality and
quality information regarding the provision of anesthesia services by
nurse anesthetists and anesthesiologists, then she could make the
appropriate regulatory changes to ensure access to quality care for
Medicare beneficiaries.''
On March 9, 2000, HCFA informed the American Association of Nurse
Anesthetists (AANA) and the American Society of Anesthesiologists (ASA)
that it intends to move forward with its proposal to remove the federal
requirement that nurse anesthetists must be supervised by physicians.
It is expected that HCFA will publish this rule sometime this summer.
Clearly the Secretary determined that the voluminous available data was
sufficient for her to make her decision.
Regardless of all the available evidence, ASA first began pressing
Congress in 1998 for another national anesthesia outcomes study. It is
interesting that they were comfortable with the amount of data
available in 1994, when the draft proposed rule was first circulated,
as they expressed no concerns at that time. It has only been since
1998, once the publication of a final rule appeared to be a
possibility, that their concerns about lacking data emerged. AANA has
consistently opposed a mandated national study for the following
reasons:
1. No previous study has shown a significant difference in the
quality of anesthesia care provided by nurse anesthetists and
anesthesiologists. Various studies have been done over the years and
AANA has compiled a synopsis summarizing the studies--all of which
indicate that there is no difference in outcomes. We do not need yet
another study to show us what we already know--that CRNAs provide high
quality care that promotes access to health services.
2. In 1990, the Centers for Disease Control examined anesthesia
outcomes and concluded that morbidity and mortality rates in anesthesia
were too low to warrant a multi-million dollar national study.
3. In 1994, a legislatively mandated study by the Minnesota
Department of Health determined there are no studies that conclusively
show a difference in patient outcomes by type of anesthesia provider.
4. The ASA's appeal to Congress to legislatively mandate yet
another study, which could cost more than $15 million, is simply a
tactic to delay HCFA from implementing its proposal to remove
supervision. The anesthesiologists have had ample time to perform a
study but it was not until HCFA proposed this rule that they suggested
any study was necessary. In fact, the anesthesiologists havealways
heretofore touted the safety of anesthesia, but only now suggest the
dangers of anesthesia in order to reinforce their political message.
5. There is no way to objectively study nurse anesthesia outcomes
while the supervision requirement is still in place. And we believe
this is well known by the ASA. Quite simply, if any study were to be
performed under the current regulatory scenario, and it were shown that
CRNAs were safe anesthesia providers, the anesthesiologists would
simply argue that it was due to supervision, thereby creating an
obvious ``Catch 22.''
The anesthesiologists have frequently changed their tune about this
regulation. As for the HCFA rule, Congress should listen to what the
ASA had said earlier in this battle: ``ASA believes issues relating to
treatment of Medicare patients, including anesthesia care, are best
dealt with in the context of thoughtful dialogue among the affected
parties, and ultimately through the reliance on rule-making process by
HCFA, the agency charged by law with the responsibility.'' (Letter to
Congress, May 23, 1995).
They clearly believed that HCFA should be responsible, not
Congress, for making this regulatory decision. They reiterated this
position a second time in their own Newsletter: ``. . . [the issue]
belongs there (with HCFA) and not in Congress.'' (ASA Newsletter,
November 1995, Vol. 59, No. 11, p. 5)
Nevertheless, when HCFA appropriately used the regulatory rule-
making process as ASA suggested, and decided to propose a deferral to
state law on the issue of physician supervision of nurse anesthetists,
ASA quickly changed its mind and ran straight to Congress to get it
reversed.
Even the ASA's own website and their lobbying materials argued in
favor of state regulation. Their materials stated in part: ``ASA
believes that the qualifications of members of a particular class of
health professionals may vary significantly from state to state and
that state legislatures and licensing bodies are in the best position
to determine the appropriate scope of practice in their
jurisdictions.'' We couldn't agree more.
CRNA'S PROVEN TO PROVIDE HIGH QUALITY CARE
At this point, it is not necessary nor helpful to the healthcare
marketplace for Congress to intervene by requiring yet another study
about the quality of care that CRNAs provide. There is no question
about the safety or quality of care that is provided by CRNAs.
A published article on malpractice data from the National
Practitioners Data Bank (NPDB) reveals that from 1990 through 1997,
anesthesia-related malpractice claims against physicians outnumber
claims against nurses by nearly 7 to 1. Think about that--700 percent
more physician anesthesia malpractice codes than nurses. While AANA did
not elevate this issue into a question of patient safety, the ASA's
relentless attacks on our safety force us to advise Congress that the
anesthesiologists have problems of their own.
CRNAs safely provide over 65 percent of the nation's anesthesia.
According to the recently released Institute of Medicine report titled
``To Err is Human,'' anesthesia delivery provides a model for
advancement in the safe delivery of health care: ``Anesthesiology has
successfully reduced anesthesia mortality rates from two deaths per
10,000 anesthetics administered to one death per 200,000/300,000
anesthetics administered.''
In fact, the Institute of Medicine cites the improvements in
anesthesiology numerous times throughout the report. What is
interesting is the factors cited include: improved monitoring
techniques, the development and widespread adoption of practice
guidelines, and other systematic approaches (p. 27); or, technological
changes, information-based strategies, application of human factors to
improve performance, such as the use of simulators for training,
formation of the Anesthesia Patient Safety Foundation, and having a
leader who could serve as a champion for the cause. Nowhere in the IOM
report is the astounding increase in anesthesia safety attributed to
anesthesiologist supervision of nurse anesthetists. If CRNAs were such
a danger to patients, surely the IOM would have cited such a danger in
this preeminent report on patient safety. Yet, the IOM only touts how
the profession of anesthesia has dramatically improved patient safety.
We believe the IOM report speaks volumes about the profession of nurse
anesthesia and the quality of care we provide.
We have evidence that senior citizens feel the same way. A
nationwide survey of Medicare patients conducted in October, 1999 by
Wirthlin Worldwide reveals that 88 percent of Medicare patients would
be comfortable if their surgeon chose a nurse anesthetist to provide
their anesthesia. Nearly two-thirds of the respondents indicated it
would be acceptable for the nurse anesthetist to not be supervised by
their surgeon, but work collaboratively with the surgeon who is always
present throughout the operation. When supervision is eliminated, CRNAs
will continue to work with a physician, usually the surgeon, in a
collaborative relationship, and will remain with their patients from
the beginning to the end of their procedures. Compared to nurse
anesthetists, many anesthesiologists rarely provide hands-on patient
care, and even fewer remain with their patient throughout the surgical
procedure (when anesthesia is given through the care team in which both
nurse anesthetist and anesthesiologist participates).
In fact, we would like to bring to your attention questions about
the adequacy of the preparation of anesthesiologists, as raised within
their own profession. The anesthesiologists have systematically sought
to discredit CRNAs as not having enough education. However, you should
take note of the comments recently printed in their own Newsletter. Dr.
Michael Ryan, M.D. in his article, ``Anesthesiology's Workforce: The
Good, the Bad, and the Ugly--A Resident's Perspective'' (American
Society of Anesthesiologists Newsletter, April, 2000, Vol. 64, Number
4, pp. 17-18) said, in part: ``Owing to the isolated nature of our
practice, anesthesiologist training in some regard has been one of
those specialties that is `self taught.' '' and, ``Anesthesiology
residents feel short-changed in that hard work is rewarded with less
actual training. They have less time to read prior to taking the
boards, and they have greater difficulty dealing with the rare but
deadly operating room emergency because they are tired and poorly
trained.''
Yet another article in the same Newsletter, written by Fran Thayer,
MD, entitled ``Survey of Residency Programs' Didactics'' states: ``All
respondent programs seemed to be suffering a similar problem: a lack of
teaching in the operating room.''
So while the anesthesiologists will likely disparage our training
as insufficient, there are clearly those in their own profession
pointing out the flaws of their own educational experiences. In truth,
nurse anesthetists are busy providing high quality anesthesia to
Medicare and other patients while the physician is still in medical
school.
The anesthesiologists' opposition to HCFA's proposal is about
income and control, not patient safety. This was clearly demonstrated
when their former president said in their own publication: ``ASA
members should recognize the socioeconomic impact of HCFA's proposal as
well. Although the proposed change would not affect the Medicare
reimbursement rules for medical direction of nurse anesthetists, it
takes little imagination to see that a move away from required
supervision of nurse anesthetists potentially erodes the number of
cases in which medical direction will apply . . .'' (Dr. William Owens,
ASA President's update, December 31, 1997).
CRNAs already provide high quality care at a fraction of the cost
of anesthesiologists. According to a study conducted by the Medical
Group Management Association and published in the October, 1995 issue
of Anesthesiology News, the median annual income for nurse anesthetists
in calendar year was $72,001 but, the median annual income for an
anesthesiologist in 1994 was $244,600. If the finalization of the rule
``erodes the number of cases'' in which anesthesiologists participate,
it is clear that consumers benefit by competition from a lower cost
provider that can maintain high quality care.
It is as clear now as it was then, that the real reason for their
opposition, apart from losing control over anesthesia, is their likely
loss of income. That is the real source of their vitriolic opposition.
THE SILBER STUDY
With all due respect to Dr. Silber, we would like to address the
subject of his ``soon-to-be-published'' study completed at the
University of Pennsylvania.
Since September 1998, anesthesiologists have been extolling the
virtues of a scientific abstract titled ``Do Nurse Anesthetists Need
Medical Direction by Anesthesiologists?'' The abstract reports the
findings of a recent study comparing the outcomes of surgical patients
whose anesthesia was directed by anesthesiologists with patients whose
anesthesia was directed by other physicians, such as surgeons. It is
peculiar that this study, which the ASA has touted for approximately
two years as ``about to be published,'' has not yet been published to
our knowledge. From the limited information available about this study,
it is also clear that it does not focus on the issue at hand, and we
question its applicability to this debate.
On its surface, the abstract appears to present damaging evidence
that patient outcomes are better when nurse anesthetists are directed
by anesthesiologists. However, a closer examination clearly reveals:
the study does not address the question posed by the abstract's title,
and the results are inconclusive.
Background
The study was conducted using data obtained from Health Care
Financing Administration (HCFA) claims records. The study group
consisted of 65,595 Medicare patients distributed across 219 hospitals
in Pennsylvania who underwent general surgical or orthopedic procedures
between 1991-94. Jeffrey H. Silber, MD, PhD, headed a research team
that included three anesthesiologists.
The abstract has been published (Anesthesiology, 1998; 89:A1184);
however, no peer-reviewed article about the study results has been
published to date.
Study does not answer the question posed by the abstract's title
According to David E. Longnecker, MD, one of the anesthesiologist
researchers involved in the study:
``The study . . . does not explore the role of (nurse anesthetists)
in anesthesia practice, nor does it compare anesthesiologists versus
nurse anesthetists. Rather, it explores whether anesthesiologists
provide value to the delivery of anesthesia care.'' (Source: memorandum
from Dr. Longnecker to Certified Registered Nurse Anesthetists in
University of Pennsylvania Health System's Department of Anesthesia,
October 5, 1998).
When, then, was such a misleading title chosen? The answer can only
be for political reasons. Consider these facts:
The abstract was published in the midst of the controversy between
anesthesiologists and nurse anesthetists over HCFA's proposal to remove
the physician supervision requirement for nurse anesthetists in
Medicare cases, and
The study was funded in part by a grant from the American Board of
Anesthesiology, which is affiliated with the American Society of
Anesthesiologists (ASA). The ASA vehemently opposes HCFA's proposal.
Problems with the data
Careful examination of the ``findings'' reported in the abstract
reveal numerous problems.
Glaring Admission: The researchers conclude the abstract by
admitting that it ``remains to be determined'' whether their findings
were the result of a ``caregiver or hospital effect'' (or, in layman
terms, whether their findings were due to the actions of the nurse
anesthetists/physicians or to the hospital environments). This
admission by the researchers seriously limits the application of the
data. The significance of a hospital's environmental characteristics on
patient outcomes cannot be underestimated given these facts:
Anesthesiologists are heavily concentrated in urban and suburban
areas where they typically practice in well-funded, high-tech,
appropriately staffed hospitals and surgical centers.
Nurse anesthetists, on the other hand, often play major roles in
rural and inner-city hospitals, facilities where anesthesiologists
don't generally work.
What this means is: nurse anesthetists often treat sicker patients
in facilities that don't have the same caliber resources to which
anesthesiologists are accustomed.
Time Frame: Nurse anesthetists do not diagnose or treat non-
anesthesia postoperative complications--they administer anesthesia.
According to the Joint Commission on Accreditation of Healthcare
Organizations (JCAHO), anesthesia mishaps usually occur within 48 hours
of surgery. The study, however, evaluated death, complication, and
failure to rescue rates within 30 days of admission, encompassing not
only the time period of the actual surgical procedures, but also a
substantial period of postoperative care as well. Therefore, it is
impossible to know from the data how many or what percentage of deaths,
complications, and failures to rescue occurred within that 48-hour and
were directly attributable to anesthesia care.
Death Rates: The data show that the death rate when nurse
anesthetists were supervised by anesthesiologists was substantially
lower than the death rate when nurse anesthetists were supervised by
other physicians. However, the death rates cited in the abstract were
more than 100 times the anesthesia-related death rates commonly
reported in recent years, regardless of whether the nurse anesthetists
were supervised by anesthesiologists or other physicians! This would
lead one to conclude that the high death rates were almost certainly
due to nonanesthesia factors, which would be more in keeping with the
30-day time frame of the study.
Further, it has been noted by Dr. Michael Pine, a board-certified
cardiologist widely recognized for his expertise in analyzing clinical
data to evaluate health care outcomes, that after adjusting the death
rates for case mix and severity, the patients whose nurse anesthetists
were supervised by nonanesthesiologist physicians were about 15% more
severely ill than the patients whose nurse anesthetists were supervised
by anesthesiologists. The abstract provides no information to explain
why the anesthesiologist-supervised cases involved less severely ill
patients.
Complication Rates: After adjusting for case mix and severity, the
study found no statistically significant difference in complication
rates when nurse anesthetists were supervised by anesthesiologists or
other physicians. Dr. Pine noted that poor anesthesia care is far more
likely to result in significant increases in complication rates than in
significant increases in death rates. Therefore, Dr. Pine concluded
that this finding strongly suggests that medical direction by
anesthesiologists did not improve anesthesia outcomes.
Failure to Rescue: For the most part, failure to rescue occurs when
a physician is unable to save a patient who develop nonanesthesia
complications following surgery. Therefore, it is not a relevant
measure of the quality of anesthesia care provided by nurse
anesthetists.
Patients Involved in More than One Procedure: For reasons not
explained in the abstract, patients involved in more than one procedure
were assigned to the nonanesthesiologist physician group if for any of
the procedures the nurse anesthetist was supervised by a physician
other than an anesthesiologist. It is impossible to measure the impact
of this decision by the reachers on the death, complication, and
failure to rescue rates presented in the abstract.
To emphasize the importance of this, consider the following
hypothetical scenario: A patient is admitted for hip replacement
surgery. A nurse anesthetist, supervised by the surgeon, provides the
anesthesia. The surgery is completed successfully. Three days later the
patient suffers a heart attack while still in the hospital and is
rushed into surgery. This time the nurse anesthetist is supervised by
an anesthesiologist. An hour after surgery, and for reasons unrelated
to the anesthesia care, the patient dies in recovery. According to the
researchers, a case such as this would have been assigned to
thenonanesthesiologist group!
Conclusion of Silber analysis
The following conclusions can be drawn from a careful examination
of the abstract ``Do Nurse Anesthetists Need Medical Direction by
Anesthesiologists?''
The study described has nothing to do with the quality of care
provided by nurse anesthetists.
The study does not answer--or attempt to answer--the question posed
by the abstract's title.
The timing of the abstract's publication and selection of its title
were politically motivated.
At best, the study's findings are inclusive.
It is unfortunate that anesthesiologists have misrepresented the
study results to mean that nurse anesthetists need to be supervised by
physicians, and specifically, anesthesiologists.
We strongly support the proposed rule and believe that the
anesthesiologists have misled Congress and engaged in highly
questionable tactics to scare senior citizens. They have designed
websites that accuse U.S. Senators of supporting policies endangering
the lives of senior citizens by supporting the HCFA rule and
misrepresented studies on this issue in order to try and prevail on
this issue. We strongly believe that any attempts to characterize this
proposed rule as somehow anticompetitive strains credibility,
particularly given the numerous antitrust lawsuits which have been
brought against various anesthesiologists over the years.
THE CURRENT ANTITRUST LAWS PROTECT COMPETITION AND CONSUMER CHOICE
Based on historical and recent experience, the AANA believes that
strong antitrust laws and enforcement serve to protect competition
between anesthesiologists and CRNAs. CRNAs provide the same services as
anesthesiologists with the same high degree to care. In the market for
health services, a market which is widely considered complex and
imperfect by economists, this sort of direct competition between rival
professional groups should be vigorously defended. While many CRNAs
practice in an anesthesia team which includes anesthesiologists and
other ancillary support staff, CRNAs also practice as independent
providers and receive direct reimbursement from multiple payors, as
allowed by federal law. Independent CRNAs may function as independent
contrators--negotiating the best price for the service with different
health entities. Therefore, many CRNAs compete directly with their
physician colleagues--anesthesiologists. Because of the prevalence of
insurance in the health care field, recipients of anesthesia services
are seldom the direct payors while physicians benefit from tremendous
influence with insurance companies and others who actually pay for
health care services. For this reason, the threat of swift and vigorous
enforcement of the federal antitrust laws and the deterrent effect that
those laws have on anticompetitive conduct are the most important
protections that CRNAs have against anticompetitive conduct by
physicians who may seek to exclude them from the market because they
are lower cost competitors. In light of the power and influence of the
medical community on staffing decisions, weakening the antitrust laws
by new and sweeping immunity for negotiations between health care
professionals and health care plans could undermine the ability of
CRNAs to compete with anesthesiologists, or any other similarly
positioned health professional.
Further, the current antitrust laws serve to protect the ability of
other types of establish health professionals to offer competitive
health services. These groups include the nurse-midwives who provide
obstetrical care to women in need; optometrists who provide post-op
cataract eye care; occupational therapists who diagnose and provide
rehabilitation care; and speech-language pathologists. It is no
exaggeration to say that the antitrust laws have been a major force
enabling nonphysician health professions to compete with physicians
when they provide comparable services. Such competition has been an
enormous boon to consumers and third party payors who benefit from
having a wider choice of highly qualified providers.
A brief history of CRNAs as anesthesia competitors
By the end of the nineteenth century, two developments--the
discovery and utilization of anesthesia and the discovery and
development of asepsis--resulted in an enormous expansion of the
numbers and types of surgeries performed. Consequently, hospital
construction flourished as the need grew for operating rooms to
accommodate aseptic surgery. Simultaneously, demand grew for anesthesia
specialists to focus their attention on the anesthesia care of patients
while a physician performed surgery.
Nurses, whose hallmark is monitoring vital signs and administering
medications, were a natural choice to provide anesthesia. Physicians
turned increasingly to sisters in Catholic hospitals, as well as to
other registered nurses from a growing number of nurse training
programs, to administer anesthesia with wide acceptance. World War I
accelerated the demand for qualified CRNAs. Advances made in
medications and equipment and nurse anesthesia education during the war
contributed to the nurse anesthetists' dominant position in the
anesthesia services field.
Even before World War I, however, the growth and acceptance of the
nurse anesthesia profession and its training programs provoked
anticompetitive reactions from anesthesiologists. As early as 1911, in
a harbinger of future anti-nurse anesthetist activity, counsel for the
New York State Medical Society declared that the administration of an
anesthetic by a nurse violated the law of the State of New York. The
following year, the Ohio State Medical Board passed a resolution
stating that only registered physicians could administer anesthesia.
Early efforts to crush the nurse anesthesia profession gained
momentum as anesthesiologists organized in their opposition to nurse
anesthetists. In 1915, anesthesiologists founded the Interstate
Association of Anesthetists (``IAA'') which successfully petitioned the
Ohio State Medical Board to withdraw recognition of Cleveland's
Lakeside Hospital as an acceptable training school for nurses on the
grounds that Lakeside's use of nurse anesthetists violated the Ohio
Medical Board Act. Nurses and prominent surgeons alike protested the
board's decision, and succeeded in having it reversed.
Similarly, in 1917, the Kentucky State Medical Association, with
prompting from organized anesthesiologists, passed a resolution
prohibiting members from employing nurse anesthetists. In a test
lawsuit brought by a nurse anesthetist, the Kentucky Court of Appeals
ultimately rejected the proposition that the administration of
anesthesia by a nurse constituted the unauthorized practice of
medicine.
In 1921, another anesthesiologist group, the American Association
of Anesthetists, commenced a boycott by adopting a resolution
prohibiting its members from teaching nurse anesthetists.
Anesthesiologists also moved into the political arena, supporting
legislation which would prohibit qualified nurse anesthetists from
administering anesthesia.
Unlike anesthesiologists, the American College of Surgeons,
comprised of physicians who utilized nurse anesthetists, opposed
legislative prohibitions of nurse-administered anesthesia. In a 1923
resolution, they opposed all legislative enactments which would
prohibit qualified nurses from administering anesthesia.
Surgeon support of nurse anesthetists, however, did not stop the
anesthesiologists' efforts to keep nurse anesthetists from practicing
their profession. In 1933, anesthesiologist associated with the Los
Angeles County Medical Association brought a lawsuit against a nurse
anesthetist claiming that nurse anesthetists' administration of
anesthesia constituted the illegal practice of medicine. As had other
courts, the California court found that the administration of
anesthesia by nurse anesthetists was not the practice of medicine.
In 1937, the American Society of Anesthesiologists (``ASA'') was
formed. (The American Association of Nurse Anesthetists had been
founded in 1931). Immediately after its inception, the ASA presented a
master plan for the eventual elimination of nurse anesthesia to the
American College of Surgeons. The plan specified that nurses should not
be permitted to continue to provide anesthesia. It also provided, inter
alia, that a provision should be included in the Minimum Standards of
Hospitals (the forerunners of the Joint Commission on Accreditation of
Hospitals' standards) directing that the department of anesthesia in
each hospital shall be under the direction and responsibility of a
well-trained physician anesthetist. The plan cautioned, however, ``that
no legislation should be forced until physician anesthetists can take
over the work in a competent way.''
World War II increased the number of anesthesiologist. See the
discussion in United States of America v. The American Society of
Anesthesiologists, 435 F. Supp. 147, 150 (SDNY, 1979) at page 150).
After the war, the anesthesiologists, as they sought to establish
themselves in a civilian economy, renewed their activities against
CRNAs. Between 1946 and 1948, the ASA conducted a campaign to discredit
CRNAs in the eyes of the public. The campaign was successful in
reducing the numbers of nurses attending nurse anesthesia training
programs. The campaign was halted when the American Medical
Association, the American College of Surgeons, and the Southern
Surgical Society expressed their opposition to the ASA's negative
publicity, and expressed their support of, and continued intention to
utilize, CRNAs.
Attempts to eliminate CRNAs have often been more subtle. For
example, in 1947 the ASA adopted an ``ethical principle'' prohibiting
members in good standing from participating in nurse anesthesia
programs and from employing or utilizing CRNAs. Measures to enforce the
ethical guidelines included the threat to revoke the American Board of
Anesthesiology certificates of physicians training nurse anesthetists.
History of antitrust actions brought by CRNAs
CRNAs have brought actions against anesthesiologists for
restricting competition. In Oltz v. St. Peter's Community Hospital, 861
F.2d 1440 (5th Cir. 1988), Oltz, a nurse anesthetist, sued four
anesthesiologists and the hospital that gave them an exclusive contract
to provide anesthesia services, under the antitrust laws. Oltz charged
the anesthesiologist and the hospital with a group boycott, which can
be a per se violation of the antitrust laws. The anesthesiologists
settled before going to trial.
In affirming the district court's finding that the hospital joined
the anesthesiologists' conspiracy to terminate Oltz's billing contract,
the Ninth Circuit noted that the anesthesiologists had ``pressured the
hospital at St. Peter's to eliminate Oltz as a direct competitor.'' The
court found that the anesthesiologists had threatened to boycott St.
Peter's unless Oltz's independent billing status was terminated and
that the anesthesiologists annual earnings at the hospital increased by
forty to fifty percent after Oltz was terminated.
In Bhan v. NME Hospitals, Inc., 929 F.2d 1404 (USCA Ninth Cir.,
1991) a nurse anesthetist and an anesthesiologist were anesthesia
providers in a small hospital in Manteca, California. Surgeons at the
hospital decided to attach another anesthesiologist. When the third
provider arrived the nurse anesthetist alleged that the
anesthesiologist who was to be replaced tried to save his job by
suggesting to the hospital administration an all-physician anesthesia
policy and the elimination of the CRNA. The CRNA brought suit under the
antitrust laws arguing that a physician only anesthesia policy was a
coercive boycott. The Ninth Circuit ruled that nurse anesthetists and
anesthesiologists directly compete for purposes of the antitrust laws
but the trial court held that the Hospital's conduct had to be
evaluated under the rule of reason and the case was dismissed.
But the Bhan court added: ``On the other hand, a plaintiff may able
to establish in a certain situation that the physicians are conspiring
to drive the nurses out of business because their services are just as
good but cheaper. The hospital may be shown to be acceding to the
doctors' wishes because of its wish to retain certain of the doctors'
services. In that case, the practice of excluding nonphysician
providers as a class would appear to be anti-competitive. 929'' F.2d at
1412 (emphasis supplied).
In Anesthesia Advantage, Inc. v. Metz, 708 F. Supp. 1171, 1175
(10th Cir. 1990), four nurse anesthetists in the Denver, Colorado area
and their professional corporation, The Anesthesia Advantage, Inc.
(``TAA''), brought suit against several anesthesiologists and Humana
Hospital. The nurse anesthetists alleged per se violations of the
antitrust laws, including price fixing,market allocation and a group
boycott. The charges were based on (1) a hospital-instituted ``call
schedule'' for anesthesiologists and the anesthesiology staff's
recommendation to adopt guidelines for supervising nurse anesthetists;
(2) a conspiracy to induce another hospital to reject a fee-for-service
proposal by TAA to provide out-patient ambulatory surgery anesthesia on
pre-arranged days; and (3) an attempt to persuade a third hospital to
reject a proposal that the hospital use TAA for an obstetric epidural
anesthesia program.
The nurse anesthetists alleged that they were ``illegally squeezed
out of business by anesthesiologists because the presence of CRNAs
forced down the market price for anesthesiologist services.''
The Tenth Circuit Court of Appeals reversed the trial court's
dismissal of the case, and some of the defendants eventually settled
the case, by among other things, agreeing that they would not interfere
in the future with CRNAs' right to practice anesthesia.
In Minnesota Association of Nurse Anesthetists v. Unity Hospital,
et al., 208 F. 3rd 655 (8th Cir. 2000), the Minnesota Association of
Nurse Anesthetists (``MANA'') alleged that three hospitals and their
staffs of M.D. anesthesiologists (``MDAs'') conspired to terminate
nurse anesthetists from the employ of the hospitals for whom they had
worked and to put the nurse anesthetists to the Hobson's choice of
either working for their competitors--the MDA groups at the hospitals--
or ceasing to work at the hospitals. They did so by arranging with the
hospitals to implement exclusive or sole-source contracts between each
hospital and its anesthesia group. Curiously, however, three hospitals
did this at the same time.
MANA alleged that the exclusive contracts, even if they might have
been lawful at each hospital individually, were adopted pursuant to a
conspiratorial plan among all three hospitals and their MDA groups to
prohibit nurse anesthetists, who in the late 1980's had been granted
direct billing rights under Congressional legislation, from competing
independently of the MDAs at these hospitals. Indeed, the MDAs,
according to the evidence, had professed the desire to rid the area of
the new, direct, cost driven competition for anesthesia dollars--and
the clear threat to their incomes it posed. In the words of their
leadership, they vowed to the CRNAs (according to the evidence) that
they were not going to ``lose one thin dime,'' ``a single dollar,'' or
``power and control.'' One of the MDAs even enunciated a plan to
achieve this goal: ``We have a way to take care of the CRNAs in
Minnesota . . . without worrying about antitrust. We will get the
hospitals to fire the CRNAs and force them to work for us . . .''
But antitrust cases are not proved by motive alone. MANA had to
prove the existence of an unlawful conspiracy and an adverse impact on
competition. Proving conspiracy has always been difficult, even more so
in the last twenty years, as courts pulled in the reins in antitrust
cases in several different ways. MANA believed that the evidence it had
discovered during the litigation, however, contained various
indications that the hospitals and the MDA groups were not making
individual decisions but had conspired among themselves to impose these
arrangements at all three defendant hospitals. There was evidence that
the MDAs had taken advantage of their close relationships to act in
concert; proceeded in accordance with a ``blueprint'' for action
supplied under the guide of legal advice by the attorney for the
Minnesota Society of Anesthesiologists; exchanged confidential
information about the negotiations of the sole source contracts at each
hospital; shared information among hospital officials about how they
implemented the sole source arrangements; and undertaken suspiciously
similar steps in the way the hospitals and MDA groups went about
executing these arrangements--even to the point of doing so through the
same consultants and negotiating the termination of the nurse
anesthetists' employment on very similar terms.
But the Eighth Circuit Court of Appeals rejected the notion that a
conspiracy had been proved, partly because it did not find convincing
several of the events MANA had alleged to be indicative of a
conspiracy. The court found the inter-hospital exchange of information
to be a ``pro-competitive'' exchange designed to enable the hospitals
to accomplish efficiencies in sole source contracting. The opinion
accepted without much scrutiny the defendants' explanations for their
conduct, giving short shrift to competing inferences of conspiracy to
be drawn from the contemporaneous behavior of the hospitals and MDAs.
The court did not say that excluding nurse anesthetists from the
market is legal. All the case stands for is that, on the litigated
facts, the hospitals made (in the court's view) the individual, non-
conspiratorial choice to have anesthesiologist-directed anesthesia
departments, and did so without violating the antitrust laws. But the
antitrust cases are clear that conspiracies by physicians to exclude or
restrict the practice or reimbursement of categories of providers are
unlawful, whether the effort is directed at nurse anesthetists (Oltz),
podiatrists (Hahn v. Oregon Physicians' Service, 868 E. 2d 1022 (9th
Cir. 1988)), psychologists (Virginia Academy of Clinical Psychologists
v. Blue Shield of Virginia, 624 F.2d 476 (4th Cir. 1980), cert.,
denied, 450 U.S. 916 (1981)), osteopaths (Weiss v. York Hospital, 745
F.2d (2nd Cir. 1984)), or chiropractors (Wilk v. American Medical
Association, 895 F.2d 352 (7th Cir.), cert. denied, 498 U.S. 982
(1990).
PHYSICIAN COMMUNITY ATTEMPTS TO RESTRICT PRACTICE OPPORTUNITIES FOR
CRNA'S
To a large degree, this is a turf battle. That is the definition of
competition. But this is an important battle in which today's consumer
has a major stake. If CRNAs are pushed out of the market, it is not
just nurse anesthetists pushed out of the market. It is yet another
consumer choice which falls by the wayside and there is a good
possibility that anesthesia prices could needlessly rise. It is clear
from our history that the anesthesiologists, and some elements of the
physician community as a whole, view CRNAs as an economic threat.
The American Medical Association (AMA) has attempted to orchestrate
a concerted campaign to restrict practice opportunities for CRNAs. In
December 1998, its House ofDelegates adopted a resolution calling for
the AMA's support of legislative and regulatory proposals defining
anesthesia as the practice of medicine--AMA Resolution 216.
Specifically, the AMA Resolution 216 states:
1. ``That anesthesiology is the practice of medicine.''
2. ``That the American Medical Association seek legislation to
establish the principle in federal and state law and regulation that
anesthesia care requires the personal performance or supervision by an
appropriately licensed and credentialed doctor of medicine, osteopathy,
or dentistry.''
What the AMA meant to accomplish by stating that ``anesthesiology
is the practice of medicine,'' is to limit the administration of
anesthesia exclusively to anesthesiologists and to ensure that CRNAs--
when they are permitted to practice at all--are supervised by
anesthesiologists at all times and in all settings. Such an
interpretation would seriously restrict the ability of CRNAs to
practice independently in settings, such as office-based or free-
standings surgical centers, where the only physician available is
likely to be the operating surgeon. It would also restrict their
ability to provide anesthesia services in rural areas where no
anesthesiologist may be available.
Currently, the AMA has no way to put its unfair and discriminatory
resolution into effect, except to call upon lawmakers to adopt such
restrictions. However, AANA advised the House Judiciary Committee when
testifying about its opposition to H.R. 1304, that if such legislation
was passed, nothing would prevent AMA members from insisting that
health plans adopt the most restrictive interpretation of proposal for
the administration of anesthesia to their patients. This would be in
order to exclude CRNAs from their plan or severely limit their
participation. Such a restriction would penalize CRNAs and increase
health care costs by eliminating healthy competition between
anesthesiologists and nurse anesthetists, and would reduce the options
now available to patients, payers and physicians to choose, if they
desire, to obtain anesthesia services from independent CRNAs. This
resolution has caused some organizations to contact AANA to inquire
whether this requires them to employ only anesthesiologists.
Another interesting perspective comes from one of their own
members. Consider the comments of former ASA President John B. Neeld,
Jr., M.D. In his article ``Market Factors Demand the Evolution of the
Care Team'', in the Georgia Society of Anesthesiology Newsletter (date
uncertain) he clearly sets out his ideas about the role of
anesthesiologists and nurse anesthetists in the health care system. He
said in part:
``In addition to the reduction in demand for services and the
reduction in reimbursement for those services, the supply side of
Anesthesia personnel has also changed. There is now an excess number of
Physician and Anesthetists competing for the same positions. An excess
supply has brought the compensation levels that new anesthesiologists
are willing to accept close in the salary levels enjoyed by
anesthetists that the differential is negligible, particularly when one
places a reasonable value on the greater skills, education, and
professionalism that the physicians bring to a practice. Replacement of
anesthetists by anesthesiologists is by no means a death knell for
these personnel; most practices will always have a need for a certain
number of non-physician practitioners to provide economically viable
coverage for underutilized anesthetizing locations. Doing the right
thing is frequently unpopular; doing the wrong thing in this case will
deprive patients of the opportunity for improved care and deprive our
specialty of the opportunity for continued improvements in our
knowledge base and technology that are dependent upon the maintenance
of our Educational and Research Institutions and upon the continued
attraction of the best and brightest medical students into
Anesthesiology. Each of us must step forward and do the proper thing
for our patient population, our specialty, and for Anesthesiologists
and Anesthetists. Anesthetists who add value to practices and are loyal
to the true concept of a Care-Team should be retained and rewarded;
those who do not should be replaced by our Young Physician
Colleagues.'' (Emphasis added)
We think Dr. Neeld clearly states the apparent agenda of the
American Society of Anesthesiologists (ASA): CRNAs who cooperate with
anesthesiologists have their place, but those who don't should be
replaced by anesthesiologists. We don't know what other conclusion you
could reasonably draw from Dr. Neeld's comments. Bottom line for nurse
anesthetists: play ball, or be replaced.
Attempts at the State level to restrict the scope of practice for CRNAs
In addition to the AMA Resolution, there has been an increase in
activity at the state level to circumscribe the practice opportunities
of CRNAs. Many of these restrictions are being hard fought in state
legislatures, medical licensure boards and the like. These proposed
restrictions include:
Requiring CRNAs to be physician supervised in states that do not
currently require such supervision.
Requiring that anesthesiologists supervise CRNAs in states that
already require physician supervision, by requiring anesthesiologist
supervision of CRNAs when anesthesiologists are ``available,'' or by
discouraging surgeons from working with CRNAs by requiring that
physicians who supervise CRNAs be required to meet criteria possessed
only by anesthesiologists (such as advanced anesthesia education and
training ``appropriate credentials.'')
Requiring CRNAs practice to be jointly regulated by the board of
medicine and the board of nursing, rather than the board of nursing
alone, and
Reducing CRNAs' scope of practice (e.g. limiting the types of
anesthesia that a CRNA can perform).
Other analysis of the issue
This activity by the medical community at large is not isolated,
and has been recognized by people other than CRNAs. In his book, ``Not
What the Doctor Ordered, How to End the Medical Monopoly in Pursuit of
Managed Care'', (McGraw Hill, 1998) Jeffery C. Bauer, Ph.D., explains
at length and in specifics, how organized medicine has, over the years,
sought to constrain nonphysician providers from gaining a foothold in
the healthcare delivery system. His chapter on nurse anesthetists and
anesthesiologists provides an interesting perspective from a health
care futurist and medical economist. He states in part:
``In the context of this chapter's main theme, I have saved the
best example for last. (To be clear and fair, it is the example, not
the professional group, that is best.) Nurse practitioners, nurse
midwives, and nurse anesthetists are all excellent in their different
areas of practice). The CRNA story illustrates perfectly the benefits
of competition from qualified nonphysician practitioners and the
harmful effects of doctors' anticompetitive efforts to control the
market. In particular, it shows why persistent enforcement of antitrust
law, something very different from health reform, is needed to protect
consumers' welfare from doctors' monopoly when acceptable substitutes
are available. . . .
``My reason for featuring the market for anesthesia services is
actually quite strong from the economic perspective. Physicians may
have been unsuccessful in their ongoing attempts to eliminate nurse
anesthetists as an alternative, but they have been remarkably
successful in depriving American consumers of the potential economic
benefits of potential competition. In other words, doctors have
controlled the market to their own economic benefit, which means
consumers have been paying uncompetitive prices for anesthesia
services. How else could one explain the fact that anesthesiologists
have consistently earned more than twice as much as nurse anesthetists
while providing the same service?
``The principal measure of economic harm has been the fee that
anesthesiologist receive for `supervising' nurse anesthetists. Unable
to prevent state legislatures from licensing CRNAs, anesthesiologists
have used their influence with health insurance plans (often as owners
or directors) to make sure that payment flowed through the doctor's
account. For years, many private health plans have had various schemes
that allowed anesthesiologists to charge their full fee for services
provided by CRNAs operating under their supervision. (The term is
`medical direction' in the arcane language of Medicare reimbursement.
This technicality allows an anesthesiologist to be partially reimbursed
for `medically directing' up to four CRNAs as a time. It is nice work
if you can get it . . . and having monopoly power helps.
``You can easily guess the rest of the story: the doctor they pays
the nurse anesthetist a lower amount for performing the service, and he
pockets the often substantial difference. This difference between an
anesthesiologist's fee and the cost of the CRNA who actually provided
the service might be justifiable if supervision were necessary, but it
isn't. This practice is a textbook example of economic exploitation. It
is a sign of unwarranted economic power which makes consumers pay more
than what is necessary or fair. It reminds me of featherbedding, the
discredited labor practice of using more workers than are necessary.
Thanks to modern technology and excellent training, CRNAs do not need
medical `supervisors' any more than railroads needs superfluous
brakemen and conductors riding in a caboose.
``Finally doctors have used their economic power to deny or
restrict hospital privileges for nurse anesthetists. Even in states
where CRNAs have full rights to independent practice and direct
reimbursement, anesthesiologists have regularly prevented their
nonphysician counterparts from having equal access to operating rooms,
the site where most anesthesia is administered. This practice
constitutes a significant barrier to entry, one of the key indicators
of monopoly power in economic theory and antitrust law.
``This brief look at the market for anesthesia services shows that
medical monopolists have many ways to suppress competition, even when
qualified nonphysician practitioners receive licenses for independent
practice. CRNAs have achieved much of the recognition sought by other
advanced practice nurses, but consumers are still denied a free, fully
informed choice in the marketplace because doctors continue to defend
`captain of the ship' authority with the outdated argument that they
are unique (i.e., better). The many successes of CRNAs in a still
imperfect market remind us that the medical monopoly must be fought on
many fronts.
``To armchair economists, the story might seem to have a happy
ending. Anesthesiologists' incomes have fallen dramatically in the past
few years, which might be interpreted as a sign that competition has
finally prevailed in this market. More than one force could be at work
here, however, so do not jump to simple conclusions. Managed care has
certainly exerted some downward pressure on money paid to hospital-
based physicians. An oversupply of anesthesiologists is also believed
to be a major explanatory factor. Anesthesiologists' professional
associations are already working on plans to reduce the number of
training positions and to restrict the entry of foreign medical
graduates into residency programs.
``These efforts must not become red herring that divert our
attention from the market's long-term problems, unjustifiable
restrictions on consumer choice and related barriers to entry. Believe
me, anesthesiologists have not lost interest in this issue just because
they have realized they are too numerous. They are pushing like never
before to control CRNAs. Monopolists do not go down easily when their
incomes are threatened. Intensive, anesthesiologist-led efforts to
place restrictions on nurse anesthetists have been initiated within the
past two years inseveral areas of the country, including the bellwether
states (in terms of health policy) like Ohio, Minnesota, New York, New
Jersey, Pennsylvania, and Oregon.
`` `A proposal made by the Oregon delegation to the 1997 mid-year
meeting of the AMA House of Delegates serves as fitting proof that
doctors are still fighting all advanced practice nurses to retain their
monopoly power:
``Whereas, Increasing pressure by special interest groups has
persuaded state legislators to introduce legislation unjustifiably
expanding scopes of practice of alternative and allied health workers;
and Whereas, Many healthcare workers seek to legislate their ability to
practice medicine, rather than obtain a high level of expertise and
competence through medical school education and training; and Whereas,
Medical decisions for patients are best made by medical doctors; and
Whereas, There is considerable confusion on the part of the public and
some legislators regarding the qualifications and training of
healthcare workers versus medical doctors; and Whereas Education of the
public and legislature needs to occur to replace confusion and
ignorance with facts; therefore be it RESOLVED, That is the it is the
policy of the American Medical Association to protect the public by
supporting medical doctors against efforts advanced by alternative
providers seeking increased medical control of patients by
legislatively expanding their scopes of practice without physician
directions and state boards of medical examiners oversight.' ''
Dr. Bauer concludes that the resolution was reaffirmed by the
Delegates as a statement of existing AMA policy.
This academic analysis of the situation between nurse anesthetists
and anesthesiologists is enlightening, as it shows from a neutral
source what this battle is all about--competition.
ANESTHESIOLOGISTS HAVE PROBLEMS OF THEIR OWN
Clearly a case can be made that to the extent there are adverse
events in anesthesia, both providers share in that unfortunate fact.
However, a recent spate of activities should be brought to light, given
the relentless attacks that anesthesiologists have made on CRNAs.
In April of this year, an Army anesthesiologist was charged with
involuntary manslaughter of a high school student at Walter Reed Army
Medical Center. The allegations are that the anesthesiologist
improperly administered an antibiotic too rapidly causing the death of
a young girl during what should have been routine surgery. There were
further allegations that the anesthesiologist attempted to cover up,
``lying to doctors who were trying to save'' her. (Washington Post,
``Doctor's Lies Not Fatal, Lawyer Says'', by Steve Vogel, April 26,
2000).
Senator DeWine. Let me thank all of you. I want to start,
if I could, maybe by talking a little bit about and focusing on
Dr. Silber's study. I have a couple of questions for him, we
can have a little discussion about the study itself and then we
will get into some other areas, as well.
First, Doctor, you testified and you mentioned that you
had, what, an $88,000 grant from the American Board of
Anesthesiology to examine the influence of board certification
on outcomes, is that correct?
Dr. Silber. That is correct.
Senator DeWine. Was there any other source of funding for
your study? You may have already mentioned it and I apologize.
Dr. Silber. While the study has been going on, we have
received grants from the Agency for Health Care Research and
Quality that relate to developing methodology and that
methodology was applied to our study. So indirectly, we have
been funded through that agency, and also, we have self-funded
this work because the $88,000 grant which we received in 1995
only represents about one-quarter of the cost of this study. It
is a major study that has taken us a long time to do.
Senator DeWine. When will that actually be published?
Dr. Silber. In about 3 weeks.
Senator DeWine. In about 3 weeks. Where will it be
published?
Dr. Silber. In the journal, Anesthesiology.
Senator DeWine. So we can look forward to seeing the entire
study at that point?
Dr. Silber. Yes.
Senator DeWine. I want to make sure that--I am sorry.
Dr. Silber. I was going to make one other point, if I may.
I am sorry.
Senator DeWine. Sure.
Dr. Silber. That we had done a line of work looking at the
influence of board certification on outcome prior to the
issuing of that grant, which is why the American Board of
Anesthesiology was interested in our work. We had published a
few papers prior to that time. So this was not a new work that
we just took on because of the grant. We were following our
line of research during that period.
Senator DeWine. I want to make sure that I fully understand
exactly, and you have gone over this but I am just going to ask
you to go over it again. In layman's terms, explain exactly
what you studied so we understand what you studied and maybe
what you did not study.
Dr. Silber. We looked at the Medicare claims data for
patients who underwent general surgical or orthopedic
procedures in Pennsylvania for 1991 through 1994. So we had the
billing data. We----
Senator DeWine. Excuse me, if I can.
Dr. Silber. Yes?
Senator DeWine. Why did you use the billing data?
Dr. Silber. Well, that is the only data available from
Medicare and it is a very rich source of data. It has a wealth
of information on the illnesses of the patients and their
previous hospitalizations, and from the Medicare data we know
exactly when the patients died. So it is a great data set that
lets us know what was done to the patient in the
hospitalization, how sick were they when they went into the
hospitalization and when they died.
Senator DeWine. To follow up on that, what is the relevance
of using the 30-day period? For a layman, I might think, well,
if something happens 15 days later or 25 days later, what does
that have to do with the whole issue that we are talking about
today?
Dr. Silber. I approached this subject through the field of
health services research, and the gold standard in most studies
that use claims data is 30-day mortality, or 30 days after
hospitalization. That is because many different factors that
can occur during an operation or during the initial treatment
of a patient that may influence their ultimate survival later
on in the hospitalization. So by looking at 30-day mortality,
you have a long enough period to see what effects might occur
from things that went on during the hospitalization. It is not
too long so that other risks would enter in. So it is generally
considered the gold standard for looking at outcomes.
Now, the trouble with using anesthesia-related deaths,
which was alluded to by Jan Stewart, is that it is a very
restrictive definition. To talk about one death in 250,000
probably is really not the true estimate of how many patients
might die from an operative procedure or from an anesthesia
procedure because people can die days or weeks after the
surgical event with problems that were related to the surgical
event. So the classic time period is 30-day mortality, and that
is why we use that.
Senator DeWine. And so there is no attempt to distinguish
why that person died?
Dr. Silber. What we do in these analyses is adjust for how
sick the patient was when they went in for the hospitalization,
and then we ask what was different about their care, they were
directed or they were undirected, and then we ask, were they
alive or dead at 30 days. That accounts, by adjusting for how
sick the patient was initially and what the procedure was, then
what we are left with is the residual difference in the death
rates is the difference related to the initial factor, meaning
direction or undirection.
Senator DeWine. OK. Go ahead. Thank you very much. Now go
ahead and tell us, again, what you were comparing here.
Dr. Silber. We looked at patients who were directed and
undirected in Pennsylvania----
Senator DeWine. Do you want to give me your definition of
those terms or the standard definition?
Dr. Silber. The definition that we used was as follows. A
patient was directed if we found evidence that an
anesthesiologist billed for their services for anesthesia. So
in the directed group, we were referring to cases that had
anesthesiologists directing their care. There were some
instances where we had non-anesthesiologists directing care. We
only looked and only counted patients who were directed by an
anesthesiologist as being in the directed group.
The non-directed group means you were not directed by an
anesthesiologist, which meant that you might have been either
supervised by a physician who was not an anesthesiologist or
supervised by an anesthesiologist.
Direction----
Senator DeWine. So as a practical matter, I want to make
sure I understand the universe and how it really works if I am
being operated on, and anyone can jump in if they disagree with
what the doctor is saying, but he happens to be the person I am
talking to at this moment, so jump in.
But explain to me what the universe is. In the United
States today, what are the potential combinations on this
issue? If I were to be operated on tomorrow, what might I
encounter?
Dr. Silber. Your anesthesia care can be performed
personally by an anesthesiologist. It can be performed by a
team of an anesthesiologist and a nurse anesthetist. Or it
could be performed by a nurse anesthetist who was not directed
by an anesthesiologist but was supervised by a physician. That
would be the universe of possibilities in the Medicare
population.
Senator DeWine. OK. The first one is the anesthesiologist
personally does it.
Dr. Silber. Personally performing the case.
Senator DeWine. OK. The second option is what?
Dr. Silber. If the anesthesiologist works with the nurse
anesthetist and is directing the case. And our definition of
directed included personally performed or directing. That was
in our directed group. You had an anesthesiologist physically
present for your case, whereas----
Senator DeWine. Does that mean at all times? What does that
mean?
Dr. Silber. There are regulations according to the Health
Care Financing Administration that relate to the times that you
have to be in the operating room. There are critical times that
you must be there in order to bill for those services.
Senator DeWine. In order for the term of art----
Dr. Silber. Directed.
Senator DeWine [continuing]. Directed.
Dr. Silber. That is correct.
Senator DeWine. And your third possibility----
Dr. Silber. I am calling that group the undirected case, or
the undirected group, and that undirected group would include
cases where nurse anesthetists were supervised but they were
not directed.
Senator DeWine. And do you want to tell me what supervised
means?
Dr. Silber. Supervised is a term that really is used when
you do not direct, so that basically signing off on a chart
would constitute supervision, but there would be some
interaction between the physician and the nurse anesthetist. I
would maybe ask----
Senator DeWine. Somebody jump in. What does it mean? Who is
there? Who is in my room while I am being operated on?
Dr. Pierce. Well, it does vary enormously across the
country from rural to city areas and even from city to city,
but the last category, the so-called non-directed but
supervised, would include rural areas usually in which the
nurse anesthetist operates or gives anesthesia with only
thesurgeon present, and that is called supervision because that is what
the Medicare law requires. I do not remember the----
Senator DeWine. So the supervision, does that mean the
supervision is actually then provided by that operating
surgeon?
Dr. Pierce. By that surgeon.
Senator DeWine. By that surgeon who is operating on the
patient.
Dr. Pierce. If there is not an anesthesiologist involved,
the supervision, according to Medicare rules at the moment, is
provided by the surgeon.
Senator DeWine. Is everybody OK with all this?
Ms. Stewart. That is true. I would point out----
Senator DeWine. Ms. Stewart, jump in here.
Ms. Stewart. I would point out, Mr. Chairman, that those
rules for medical direction are for payment purposes. They are
not quality standards. They are for--there are seven conditions
of participation under Part B for an anesthesiologist in order
to be paid for medical direction, and that is what medical
direction refers to are those payment modality conditions.
Senator DeWine. But they do--I understand it is a payment
issue, but it also does tell us something about what actually
happens. There is a relationship between that and the real
world----
Ms. Stewart. That is a theoretical relationship.
Senator DeWine. Theoretical, OK.
Dr. Pierce. Well, I must say that I have not prepared for
this with help from the American Society of Anesthesiologists
because, indeed, my only interest for 25 years has been patient
safety. I would point out that, however, during this 25 years,
I practiced in the anesthesia care team mode with a large group
of physicians and nurse anesthetists and most of our anesthesia
consisted of an anesthesiologist and a nurse present, usually
on a directed basis of one to two nurses being directed by the
anesthesiologist.
In those 25 years, we never did a case, morning, noon,
night, Saturday, Christmas, or any other time at all unless the
anesthesiologist was present for the induction of anesthesia,
and I do not understand some statements made by the AANA
indicating that this is not true. Not once in my life did a
nurse in my group give anesthesia without the anesthesiologist.
So I start back where I was. It is a very complicated question.
It varies all over the map and I think you can find almost any
situation you want to look for.
Dr. Silber. But to simplify things, in our study, we make
it simple.
Senator DeWine. To get back to your study, which is where--
--
Dr. Silber. To get back to the study----
Senator DeWine [continuing]. And I took you off of it, so I
apologize, but I wanted to make sure we got our terms and
everything set here. Go ahead.
Dr. Silber. But what we did was we looked at cases that had
an anesthesiologist present in the OR because the billing
suggested they were present in OR and those cases where the
anesthesiologist was not present. So the directed meant the
anesthesiologist was there and the undirected cases meant we
did not have evidence that the anesthesiologist was actually
there. So that, in the simplest form, we are looking at an
anesthesiologist involved with the case directly and one that
is not. I hope that that is----
Senator DeWine. I want to come back to you, but go ahead.
Ms. Stewart, go ahead.
Ms. Stewart. I would like to say that all this, you know,
the dialogue around medical direction has been going on a long
time, too----
Senator DeWine. I understand.
Ms. Stewart [continuing]. But what we are talking about in
this hearing is the elimination of supervision by physicians,
whether that be anesthesiologists or operating practitioners of
any ilk. It really does not have to do with the quality of what
is delivered in any given care team setting or what happens
with those conditions of participation. It is the elimination
of supervision under Part A for facility payment and not for
providers.
Senator DeWine. Good. I want to get to that in a minute
because what I want to do is, to make it very clear what the
study did do, and then I am going to ask for all of your
comments about what the significance of the study is. If you
could finish, Doctor, I will try not to interrupt you again.
Dr. Silber. We created this data set that looked at who
were directed and who were not directed. We looked at their 30-
day mortality status and we adjusted for many different medical
conditions that one should adjust for when trying to compare
across two groups. We would not want it to be that one group
had sicker patients and therefore looked worse because they had
sicker patients.
After adjusting in numerous ways using Medicare data and
also adding to Medicare data special data from Pennsylvania--
Pennsylvania is a special State because it has physiologic data
that it collects on every discharge--we included physiological
data in the analysis and found the results to be the same. We
found that difference in outcome, and that was that there were
2.5 excess deaths per 1,000 cases in the group that was not
directed, and we also found 6.9 excess deaths per 1,000 cases
with complications.
Senator DeWine. All right. Now, Doctor----
Dr. Pierce. Let me just say one more word about the
differences.
Senator DeWine. Excuse me. What I want to do, and I am
going to give each one of you a chance, I want to know what you
think the significance of the study is, and then if anyone
wants to talk about what you think the significance of this
study is in regard to the ultimate issue here that we are
talking about. Maybe we will start with the person who did the
study. Doctor, what does this mean? What does this tell us? If
you were to write for Time magazine, or Newsweek or the New
York Times tomorrow or the Cleveland Plain Dealer, what would
you write about the study? What does it mean?
Dr. Silber. To me, the study means that if I am operated
on, I would want my care directed by an anesthesiologist, that
I would have a higher rate of survival if I have an
anesthesiologist directing my care. That is the first point in
why it is significant. This is not a hospital effect. We
adjusted greatly for differences across hospitals. This is an
effect from, as best we can tell, from the provider, from the
anesthesiologist direction versus lack of direction.
Now, to me, that is important because I would be concerned
about any regulation that might change the chancethat the
average patient gets direction by an anesthesiologist. The Senate will
have to decide whether these regulations will increase or decrease the
chance that a patient gets direction from an anesthesiologist. But what
my study says is that patients survive--there is higher survival in
patients who have direction by an anesthesiologist.
Senator DeWine. Let me do this. You say there is a higher
rate of survival if an anesthesiologist directs the care.
Dr. Silber. Right.
Senator DeWine. You say the second question then, in your
opinion, is whether or not these proposed regulations will
decrease or increase, change in any way that fact, the number
that we have today, is that correct?
Dr. Silber. Yes.
Senator DeWine. Now, let me ask the rest of the panel,
number one, if you agree with what Dr. Silber's two statements
are. Number one, is that what it shows, in your opinion, and
number two, is that ultimately the issue, and if it is
ultimately the issue, as he says, number two, what do you think
the change in regulations would do? What will the change in
regulations do?
Mr. Fallacaro. I believe, Senator, with all respect to Dr.
Silber, that his statement is a leap of faith at this point.
Senator DeWine. OK. Why?
Mr. Fallacaro. Right now, as an academician, I do not even
consider an abstract. I sit on editorial boards that will not
even look at an abstract until that paper has seen the light of
day and is opened up to the scientific community for rebuttal.
I have not had the privilege of looking at Dr. Silber's data,
but I can tell you a couple of concerns that I have about it.
He stated in his testimony that he was funded and his
funding was for, as I understand it, the effect of board
certification on outcomes, not to look at the differences
between nurse anesthetists and anesthesiologists. So I would
like the record clear on that, unless I am mistaken.
The second thing is, because the article is not published
and in my mind has no scientific credibility until that time, I
do not believe that it is on point, and let me explain. The
high death rates that Dr. Silber cites in his study are 200
times--200 times that of the Institute of Medicine's report
that Dr. Pierce just talked about as being significant from
anesthesiology's contributions. They cannot both be right on
this issue.
I think so far as the three outcomes that were looked at, I
am very concerned about a statement in the abstract that says
this. It says, admissions involving more than one procedure
were assigned to the non-anesthesiologist group if for any
procedure the nurse anesthetist was supervised by a non-
anesthesiologist, and let me explain what that means to me.
That means if somebody comes into the hospital and has four
procedures in a row and any one of those, any one of those was
done by a nurse anesthetist with a surgeon, then it gets
assigned to the nurse group. That is what it says. Admissions
involving more than one procedure were assigned to the non-
anesthesiologist group if for any procedure the nurse
anesthetist was supervised by a non-anesthesiologist.
Example, if somebody comes in for open heart surgery and
they need a cysto, a look into their bladder, and I happen to
be the nurse anesthetist doing that with a surgeon and that is
on the first admission, the second admission he comes in and
has open heart with an anesthesiologist, the third admission
has a carotid with an anesthesiologist and he dies 30 days out,
it appears that that is assigned to my group. It appears that
it is a huge selection bias, one again, that--again, I only see
the abstract in front of me.
The other thing that makes me very concerned is that I know
that complications occur much more frequently, much more
frequently than mortality. Yet in Dr. Silber's study, he states
that after he does the statistical tests, that complications
were not significantly different, and I had to do some work and
look into some of his older articles to see what those
complications were, and he lists things such as psychosis,
internal organ damage, wound infection, gangrene, all things
that could lead to mortality but things I think all anesthesia
providers would agree that have little impact upon our work
that we do.
The thing that is most temporal, most temporal to
anesthesia is complications, and the fact that there is no
significant difference validates what we have been saying, that
there is no significant difference, in my mind, at least.
Finally, the title suggests a comparison. This study
clearly is not a comparison, and where Dr. Silber states that
the number of anesthesiologists were associated with, I would
say it is coincidental that they were there, that there is
clearly no cause or effect that shows that anesthesiologists
were definitely involved in intervention on any of those
deaths. These are just some of the concerns I have with the
study.
And then one final thing, Senator. Unlike Dr. Pierce, I
have worked in all settings, one of which was I was a sole
anesthetist in a rural community working under the direction of
the surgeon alone, the surgeon alone, just me and the surgeon
doing anesthesia and I was the only provider in that care and
that is a model that is prevalent in the vast majority of rural
hospitals in this country. The issue that I have heard over and
over again is we want to remove supervision. I thought the
issue was we wanted to defer supervision to State law so that
States that have different demographics can look at need of
their populus and serve that need appropriately.
Senator DeWine. Dr. Silber, do you want to, while it is
fresh in your mind, I will give you the chance if you want to
to respond to anything about the study.
Dr. Silber. Let me respond. I have to say, it is a bit
unfortunate that the paper is not out yet. It will be out in 3
weeks, and almost--in fact, all of the comments that you have
raised are addressed in that paper.
The first matter, on the high death rates, that the death
rates in our study showed 2.5 per 1,000 whereas it is often
stated that the mortality rates in anesthesia are only one in
250,000. I want to state that it is comparing apples to
oranges. The anesthesia death rate statistics are talking about
deaths during the operation or within the first 24 hours of the
operation. They are very restrictive. So of course the rates
will be low. Any time you restrict the death to right during
the operation, you will have less of them. Health services
researchers know that those are biased numbers and that is why
we used the unbiased figure of 30-day mortality.
So our study is not inconsistent with the studiestracking
anesthesia mortality over time, but we are talking about all the
different effects that can happen during the operation that later can
lead to death, not death within 24 hours, and I think that can explain
that.
In terms of the question about more than one procedure, we
did a number of analyses in the paper coming out looking at
whether multiple procedures makes a difference. Our results
were unchanged when we put in a variable for multiple procedure
or not. We also, and you have to read the paper and I apologize
for just having an abstract, but it will be out in 3 weeks, if
you had any direction by an anesthesiologist during any day
during the hospitalization, that day would be considered a
directed day. So many of the situations that have just been
brought up would not apply.
The concept that complications were the same and,
therefore, there is really no difference between providers, I
just do not think is correct. The definition of complications
that we used was not a definition that talked about direct
anesthesia complications because you cannot do that with
Medicare data. What you can do with Medicare data is get a
rough idea about what complications occurred and we used that
as a severity adjustment. Please do not look at the equal rates
of complications in this study as a statement for equivalence
in quality. Look at the mortality rates. The data is very good
on mortality and it shows a considerable difference.
Finally, the comment about who funded the study. Again, we
started this line of work well before we knew anything about
regulatory changes that might occur with anesthesiologists and
nurse anesthetists. We have had a history of doing research in
this area and it was natural that we were funded from a group
that was interested in this same topic. I think the study will
stand for itself and I look forward to the time when everyone
can read it, which will be in about 3 weeks, and then I do not
think these questions will be brought up.
Senator DeWine. Your study, of course, did not measure
outcomes for unsupervised CRNA's, correct?
Dr. Silber. If a CRNA was unsupervised, they might have
fallen into the undirected group. Remember, we do not have data
on unsupervised versus supervised. Our data was directed versus
not directed. So it is possible in the not directed group, that
group that had higher death rates, that could possibly include
unsupervised cases.
Senator DeWine. Dr. Pierce, let us go to you. Tell us what
this study means.
Dr. Pierce. Yes. I have not read the study. I did read the
abstract and I think I am not qualified to comment on that
subject until after I read the study.
I wanted to emphasize a little bit more, though, about my
own practice in a very large hospital attached to the Harvard
Medical School, that indeed at night and weekends during
emergency surgery, all of the anesthesia was provided by the
anesthesiologist. Only during the daytime did we work in the
nurse care team with the nurse anesthetist. What I am trying to
do is emphasize the variability, enormous variability in
methods of practice across this country. Again, this is not an
area in which I keep up with particularly.
I would say somewhere between--I can be corrected--30, 40
percent of all anesthesia is administered by an
anesthesiologist by him or herself; some 8 or 10 percent is,
largely in rural hospitals, but still some 8 or 10 percent is
administered by a nurse anesthetist alone; and the in between
30 to 40 percent and the 10 percent are various combinations of
nurse anesthesia care teams, anesthesiologists working with
residents and what have you. So it is extraordinarily variable.
Senator DeWine. Any other comment about that study, what it
means? I understand you want to read it, but----
Dr. Pierce. Well, epidemiology, outcome studies, are the
most difficult thing that is on the face of the earth, and
everybody years before and especially since the IOM study is
insisting on outcome evaluations for everything. But they are
extraordinarily difficult to do. They are extraordinarily
expensive to fund. And even though I have worked in standards
for 25 years, I am not sure these outcome studies are going to
be very numerous, so I just want to wait and read the paper
when it comes out.
Senator DeWine. That is fine. That is fair enough. Ms.
Stewart, do you want to comment?
Ms. Stewart. Sure. I would just like to reiterate that the
proposal under consideration for this hearing is the
elimination of supervision under Part A, and lest anyone think
that that has anything to do with the anesthesia care team, I
would just like to restate that this provision lies in Part A
of Medicare for facilities to be paid. Most likely, if this
provision comes into play, it is when a nurse anesthetist is
being, ``supervised'' by a surgeon and there are not any
anesthesiologists around.
This proposal is not going to remove the anesthesiologist
from the place where they are already working. That is not the
design, that is not the intent, and that is not going to be the
outcome of what will happen. That is really not--it is off-
point to discuss medical direction because that is not what
this is about. Anesthesiologists and nurse anesthetists are
going to continue to work together in the operating room like
they do now. This is not going to change that.
As I said earlier, if those facilities who have both
providers in their operating rooms delivering care wanted to
change that, they could have done that at any time. There is no
requirement anywhere to have anesthesiologists to deliver
anesthesia except by the facility standards, and that is not
going to change. Facilities are going to be free to keep their
standards as they are. States are going to be free to impose
supervision or not as they see fit. This is not an issue about
complete lack of oversight or collaboration with nurse
anesthetists. That is not what this is about in the least.
And when we talk about safety standards, the nurse
anesthetists, just to let you know, have been active in safety
and quality for the entire duration of our lifetime as an
organization. It was why we were put together. We were the
first group to publicly accept the prestigious Harvard safety
standards. We wrote OB guideline standards and we were the
first group to write standards for office-based anesthesia. We
have been in the forefront of leading education and safety ever
since the inception of our organization. It is a very on-point
concern for us.
Dr. Pierce. I do not think we know what the result will be
after this rule is removed, if it is removed. I am unable to
predict relationships in hospitals between nurse anesthetists
and anesthesiologists 2 to 3 years down the road. I think that
is impossible to do. What I do know is that you do not regulate
aviation State by State, and if you turn this over to State by
State regulation of this issue, and I have already stated why I
believe it should be not changed until the studies are
available, you are going to end up with 50 more similar
contests to what we are going through now with both
organizations making claims and statements. Certainly what the
ASA has said is no worse, in my view, than what the AANA said.
It is just not a fortunate situation.
Mr. Fallacaro. Senator, if I may, again, being in academia,
if somebody had asked me ahead of time, why are you opposed to
a study, I am not opposed to studying things and phenomena when
they deserve to be studied, when they are phenomena that raise
their heads, when there are problems and issues at hand. And up
until just a few minutes ago, I had always thought, along with
many of my colleagues, that the Joint Commission on Hospital
Organizations standards of complications of anesthesia were
those things that were within 48 hours of the procedure or
things that were linked to us.
What Dr. Silber asks us to buy is that things out to 30
days, deaths out to 30 days that we may be associated with, I
do not think our malpractice insurance carriers want to hear
this. I do not think we want to see that our death rates are
now 200 times what is predicted. Again, I just think that this
is out of the blue from all traditional studies I have seen in
the area, and as Dr. Pierce has said, to do kinds of outcome
studies are very expensive, very, very difficult to control
because of the different practice settings.
And again, with respect to Dr. Silber, no amount of
statistical control can account for flaws in design. And again,
if we are looking at a nurse anesthetist versus
anesthesiologist, then why were anesthesia complications not
the ones that we would want to consider the most in looking at
these things?
So again, I look forward, as well, to reading the paper,
because again, I also feel there may be trouble in Pennsylvania
that I want to look at, as well, if there are that many deaths.
Dr. Pierce. I would say that the JCAHO Joint Commission
attempts over the last 10 years to look at anesthesia mishaps
and morbidity have not been successful. They have had a
reporting system now for 2 or 3 or 4 years and they do not get
any reports because the hospitals are afraid of legal factors.
That is another major issue with the IOM report. How that is
going to turn out, no one knows. But my summary is that we
simply do not know the incidence of anesthesia morbidity and
mortality. We can only take an educated guess.
Senator DeWine. Dr. Silber, do you want to comment? Then I
am going to move on to some other questions.
Dr. Silber. We did a study. We have data and we are going
to present that data. It is going to be published in 3 weeks. I
hope everyone reads it and then they will make their own
conclusions. But there are not many other studies out there. I
think there needs to be more studies done on this issue. Mine
is not the final study. It should not be considered the final
study on this issue. There should be more studies. There should
be studies that look at the actual chart and review the charts
in patients who had directed and undirected care, look at the
deaths and the survivors in those different groups. More
research is needed. Mine is not the definitive study.
But I just have to say that the use of 30-day mortality is
absolutely the gold standard in health services research. The
use of anesthesia-related deaths, which my colleague on my
right has stated, is a statistic that is good for following
anesthesia practice over time, but it does not get at the true
amount of deaths that are caused by variations in anesthesia
practice. We did it the right way and we did it the way that my
colleagues in health services research would say would be the
right way and I stand by that.
Senator DeWine. Ms. Stewart, let me move, if I could, back
to the rural area again. You state in your testimony that the
proposed HCFA rule will increase access to anesthesia care in
those rural areas. My understanding is that under current
rules, the only requirement is that CRNA's be supervised by a
physician and that in rural areas, then, that physician is
certainly often the operating doctor or the attending
physician.
Even if the HCFA rule goes into effect and supervision is
not required, it seems clear that a surgeon or attending
physician will still need to be present to perform the
procedure, so the patient will be faced with the exact same
requirements, a doctor and a CRNA. Is that correct? And if that
is correct, then how does removing the supervision requirement
increase access to these services?
Ms. Stewart. Thank you for asking, Mr. Chairman. The
problem that we have seen with the supervision requirements in
those underserved areas is that the surgeon erroneously
believes in some instances that they assume the liability of
the actions of the nurse anesthetist--we refer to that as
vicarious liability--because they have been named the
supervising physician.
Now, in the vast majority of situations, the operating
practitioner does not know as much about the anesthesia as the
nurse anesthetist, and if they perceive that they are then
liable for the actions of the nurse anesthetist, thereis worry
that since they do not really know how to direct anesthesia, or would
they want to, they worry that they are then going to be liable for
something that the nurse anesthetist may do. Now, we have been able to
show in case law that surgeons are no more liable working with nurse
anesthetists than anesthesiologists, but the problem that we find is
that there is some disincentive in those underserved areas for those
places to bring CRNA's in because the surgeons object to working with
them because of the perception of liability on their part, if you
followed that long track.
Senator DeWine. No, please explain it again.
Ms. Stewart. OK. When a nurse anesthetist and a surgeon
work together, the surgeon may have concerns that if the nurse
anesthetist does something that causes an adverse outcome, the
surgeon could be held liable for that because he is the
supervisor.
Senator DeWine. OK.
Ms. Stewart. OK, and we refer to that as vicarious
liability.
Dr. Pierce. This concept----
Senator DeWine. Let her finish.
Ms. Stewart. What we find is that in some areas, surgeons
have wanted to bring in either--they either will not do their
cases because there is no anesthesiologist or they want to hire
an anesthesiologist in for themselves. There are all sorts of
permutations about that. What we found is a disincentive for
nurse anesthetists to be utilized in those underserved areas.
Senator DeWine. So what then actually happens? There is
this disincentive to get this CRNA in there, so as a practical
matter--I am the patient--what does that mean to me? What
happens? Do I get operated on or not?
Ms. Stewart. You may or you may not.
Senator DeWine. OK.
Ms. Stewart. You may have to drive to a major regional
medical center to have your surgery done, which may be quite
removed from your home.
Senator DeWine. All right. So the options are, what your
testimony is, I may have to go someplace else, a big city, to
get operated on----
Ms. Stewart. Or a larger city.
Senator DeWine [continuing]. Or a larger city, or if the
operation takes place, then who is there? The surgeon is there
and an anesthesiologist is brought in?
Ms. Stewart. It could be a nurse and anesthesiologist or an
anesthesiologist that is there to oversee the care. There are
all sorts of different ways that could happen. There is no one
answer to that. But it does cause some impediment to the
delivery of anesthesia care in some of those underserved areas.
Senator DeWine. OK. We will take that and I will come back
to you in a minute. Comments on that? Dr. Pierce, you had
started to talk, so I am going to let you go first.
Dr. Pierce. I think the vicarious liability concept has
changed dramatically in the last 20 or 25 years in my
understanding in that surgeons are no longer found liable for
the acts of the nurse anesthetist. So I do not think it will
affect the number of nurse anesthetists in rural areas at all.
Senator DeWine. Well, I think what you are both saying,
though, is it is not a question of law, it is a question of
perception.
Ms. Stewart. With all due respect, Dr. Pierce, we do still
see it happening in the rural areas. Unfortunately, the surgeon
colleagues of yours and mine have not quite gotten the message
that the rules have changed.
Senator DeWine. Dr. Silber, you were next.
Dr. Silber. I think the three main results from my study
have relevance to this question. We found, first of all, that
direction reduced the death rate. We also found that the higher
the nurse-to-bed ratio, the lower the death rate. And we found
that the larger the hospital, the lower the death rate. All
three had independent effects. If you think about----
Senator DeWine. Give that to me again. The larger the
hospital----
Dr. Silber. The larger the hospital, the more nurses per
bed and direction by an anesthesiologist were the three factors
that influenced mortality.
Senator DeWine. So you are telling us those are the three
things that, as a consumer, if I could, I would check?
Dr. Silber. That is right. So now if you think about a
regulation that might make it easier for one to get their
procedure out in the periphery at that hospital that cannot
afford an anesthesiologist, that probably, if they cannot
afford an anesthesiologist, probably is not going to have as
high a nurse-to-bed ratio and is not going to be as large, my
study would be--the results from my study would make one
somewhat concerned. So I think we have to look at the whole
picture when we think about these regulations.
Senator DeWine. Mr. Fallacaro.
Mr. Fallacaro. I think ease of access is something that we
can talk about, but I think taking care of a major rural
population of this country is of utmost importance, those who
cannot travel to large medical centers. Again, I work in a
small community hospital where there was no anesthesiologist
and this was in New York State and the medical liability,
Mutual Insurance Company, at that time said that because of the
supervision--quote, because the nurse anesthetist needed to be
supervised, that that may indeed add added liability to the
surgeon. The surgeons were nervous and frightened.
Anesthesiologists are willing to supervise nurse
anesthetists and take added liability because they are
compensated for it. Surgeons are not. If they were, they might
be a different story. But they are not, so therefore the
surgeon says, ``Mike, you are doing great anesthesia, but boy,
oh boy,'' you know, and the surgeon knows nothing about
anesthesia. Again, you are doing great anesthesia, there is
nothing wrong, but we may want to get an anesthesiologist down
here or in here, and then they had tremendous trouble trying to
find somebody to come down because, again, even Dr. Orkin, an
anesthesiologist researcher, has cited over and over that to
get anesthesiologists to move to these areas is very difficult.
It is an access issue.
Senator DeWine. Dr. Pierce, let me go back to you, if I
could. As I mentioned at the beginning of the hearing today,
the antitrust analysis that must be done when examining if
standards are anticompetitive is a very fact-based analysis.
Specifically, one must examine all the facts and circumstances
to determine if the standards set are reasonable to assure
quality and consumer confidence.
In your testimony, you discuss the voluntary standardsfor
pre-anesthesia care, basic anesthesia monitoring, post-anesthesia care,
and then you conclude that they are all reasonable under that test. Let
me ask you, though, what about the current HCFA rule that requires
physician supervision of CRNA's? Is that reasonable or, in your
opinion, does it unfairly exclude CRNA's from the market? I will give,
the rest of you a chance to respond. Dr. Pierce?
Dr. Pierce. Well, I am the only anesthesiologist speaking
today, and again, I have spent my last 20 years in the safety
side of anesthesia, but I guess I should take the opportunity
to point out the difference in education between an
anesthesiologist and nurse anesthetist. It is really not 10
years versus 12 to 14 years. It is a very different background
of education. Anesthesiologists go to medical school, or
college for 4 years, medical school for 4 years, internship,
which in many ways is the same as being an ICU nurse, and then
3 to 4 years as a resident. So we are talking about 4, 8, 9,
10, 11, 12, 13, 14.
And my view is that anesthesia is the practice of medicine.
We are medical doctors. We make decisions about the illness the
patient has. Most of the patients now come into surgery at age
75 or 80, are severely ill in other systems, renal, lungs,
heart, and I just think the physician approach to these
patients is safer. That is simply all I can tell you about that
question.
Senator DeWine. Who else wants to comment?
Mr. Fallacaro. I have been practicing anesthesia for 20
years. I am not practicing medicine. If I were practicing
medicine, you should charge me as doing so, as a legally
practicing--I am not. This scope of practice issue, I served
several years on the New York State Board for Nursing. This
scope of practice issue, should I charge Dr. Pierce with
practicing nursing if he comes in and takes a blood pressure?
Again, anesthesia is a body of knowledge unto itself and for
100 years, it has been within the scope of practice of nurses
to be able to administer anesthesia, as has been many
professionals.
And I agree with Dr. Pierce that we do need--OK, hear this
now--we do need a medical expert in the operating room. We do
not practice anesthesia independently. And again, I am prepared
as a nurse, the physician is prepared as a physician, and if I
need consultation on a medical condition, I can choose to get
that consultation from an anesthesiologist, from a surgeon,
from a cardiologist or whatever. We are not practicing without
medicine in an intercollaborative manner.
Senator DeWine. Dr. Silber, any comment on that, or Ms.
Stewart?
Dr. Silber. I just think that we should go back to looking
at data and we need to study this problem with more study--we
need to look at this problem with more studies and look at it
carefully and that my study raises concerns.
Senator DeWine. Ms. Stewart.
Ms. Stewart. I am sorry, I got derailed by that last
comment. I agree with several comments here today, but what we
cannot ignore is that anesthesia is incredibly safe today and
it has only gotten safer in the last couple decades. I think
that is because of a lot of things that have been mentioned
here. Our educators are educating us better. Our clinicians are
learning more. The drugs are better. Our safety monitoring is
better. It is ludicrous to think that this one line in the
Federal Register that has to do with paying the facility is
going to jeopardize the safety of what has been being delivered
to our patients. The quality and safety is not going to change
because of facility payment.
Dr. Pierce. I would comment that anesthesia is much safer
apparently than it was 25 years ago, but it is far from
guaranteed to be totally safe. I hear of anesthesia mishaps
several times a month across the country. So we have a long way
to go to make it absolutely safe. I did not understand the
comment by HCFA that anesthesia is so safe, it does not matter
anymore. That is simply not true. There are plenty of
anesthesia complications.
Mr. Fallacaro. Senator, the one question that I have in my
mind is, again, I am glad that Dr. Silber's study is going to
be published soon and the issue here would seem to be whether
or not you believe or your committee believes that States have
the competence and the ability to read his study and make a
decision based upon that study. I believe States do. They have
done this in other areas, and I speak from experience as
working on a State board.
Senator DeWine. Let me ask all of you a question, and maybe
we will start with Dr. Pierce on this one. One concern raised
about the proposed rule is that the CRNA's may be allowed to
administer anesthesia without supervision by a physician, but
even if the proposed rule is enacted, surgeons will still be in
the operating room with the CRNA's as they administer the
anesthesia. So, how will that be different from the situation
that exists today? What will happen out there? Get out your
crystal ball. What is the difference? What will we see in 2 or
3 years because of this change, anything?
Dr. Pierce. That is what I said a few minutes ago. I do not
know that any of us has an idea what is going to happen. It may
change considerably. There may be far fewer anesthesiologists
at major teaching hospitals. I simply do not know. There is
speculation about what direction this will go, but it is
anybody's guess, Senator.
Senator DeWine. You are not in the speculation business
today, I guess, Doctor. I think some of the other witnesses
maybe have a better crystal ball.
Mr. Fallacaro. I think there is a difference in philosophy,
and with all due respect to my colleagues on the panel, they
believe that nurse anesthetists should be supervised by a
physician, but I am going to go out on a limb a little bit,
because what I have heard here is less that they believe nurse
anesthetists should be supervised by a physician and more that
they believe that that physician must be an anesthesiologist,
and I will say that there is a bias and a self-interest in
there to state that. I, having worked in these environments, I
do not believe that is necessary. I believe certainly a surgeon
is necessary. I believe medical consultation is necessary.
Dr. Pierce. Well, I do not think I am really biased, but
maybe. However, I go back to the educational qualifications,
full medical school, ability to diagnose and treat all
diseases, and that is what is necessary in the sick patient. In
the healthy young patient, not much difference. I mean, they
are not sick. They do not have multiple system diseases. But my
mother, your mother, anybody in their 80's have multiple
diseases and I think you need the most well-trained and
educated diagnosis and treatment of medical illnesses that you
can have during your anesthesia.
Senator DeWine. Dr. Silber.
Dr. Silber. You know, I study outcomes research so that I
can try to improve medical care through identifying factors
that can be changed to reduce mortality and I have identified a
factor and that is that if you have direction from an
anesthesiologist, you have less chance of dying. It seems to me
that this regulation is not going to help the situation, it is
not going to in any way foster more anesthesiologists
practicing in hospitals. It is going to, if anything, decrease
them, and so, therefore, that would be my concern, that this
legislation is not going to help and it could possibly hurt.
Senator DeWine. Ms. Stewart.
Ms. Stewart. I would like to comment on a couple of issues,
if I might.
Senator DeWine. Well, if you could, I would like you to try
to address my question. I mean, say anything you want to. We
have gone on here an hour and a half and we want to make sure
everybody has their say today. But what is your prediction in
regard to the question that I asked?
Ms. Stewart. As I said in my testimony, I think that the
practice of anesthesia will remain as it is for the vast
majority of situations. I think that----
Senator DeWine. And the changes will be what?
Ms. Stewart. The changes would be in those underserved
areas where surgeons have concerns about their liability for
the anesthesia.
Senator DeWine. Now go ahead.
Ms. Stewart. OK. I have been doing what we call locum
tenens anesthesia for the last couple years and I am licensed,
have been working in five different States in all regions of
this country delivering anesthesia in literally every
situation, working in surgeon's offices where the only
physician is the surgeon himself and I am the only anesthesia
provider. I work in community hospitals. I worked in Indian
health hospitals. I worked in giant tertiary care centers where
I work in a very close collaborative relationship with
anesthesiologists. I have to say that if you can name some
permutation of how anesthesia is delivered, I have probably
seen it.
It is not like this rule is going to somehow remove
anesthesiologists from those underserved areas. They are not
there now and the patients are receiving very good care out
there. It is not like removing supervision for facility payment
is going to take away an anesthesiologist where there was not
one to begin with, and it is not going to take away the
anesthesiologists where they are now. As I said a few times,
they are there in those situations because of the choice of the
facility and some ethic that underlies that choice and how it
is made. I think all areas that deliver safe quality anesthesia
care are going to continue to do that. That is not the thrust
behind this.
And the other thing that I would say is I have heard a
couple allusions to the fact that when I go to sleep, I want an
anesthesiologist. Well, maybe we should ask some of the other
anesthesiologists who have asked me personally to give their
anesthesia to them or their family or their children. The most
critical person I have ever worked with in an anesthesia
department asked me personally to deliver her anesthesia.
Dr. Pierce. I did not quite----
Senator DeWine. I am sorry.
Dr. Pierce. I did not understand that last statement.
Senator DeWine. Do you want to repeat it, Ms. Stewart?
Ms. Stewart. If nurse anesthetists----
Senator DeWine. I think maybe the last part is what he did
not understand, your examples.
Ms. Stewart. I am getting there.
Senator DeWine. OK.
Ms. Stewart. If nurse anesthetists do not deliver safe
care, then why would an anesthesiologist who really understands
what needs to be done in anesthesia and what it takes to
deliver it, why would they ask me personally to deliver their
anesthesia if I was not safe?
Dr. Pierce. I am not sure that is relative. I have had
anesthesia 5 times in the last 3 years and 3 or 4 of the 5
times, I had a nurse anesthetist with medical direction by an
anesthesiologist and that was my choice. I think that is
straightforward.
Ms. Stewart. The instances I am referring to were without
medical direction.
Senator DeWine. Let me say, I think this has been a very
good hearing, a very helpful hearing. I will be more than happy
to let any of you make one additional comment, if you would
like to.
Mr. Fallacaro. Sure. Again, I want to tell you that I work
very closely with anesthesiologists and I have a lot of respect
for them as physicians and as my colleagues. This, Senator, is
a copy of the Richmond Times Dispatch. There is a full-page ad
in there that says, ``Medicare wants to take this doctor away
during your surgery.'' Now, which doctor are they referring to?
They are not referring to the surgeon, otherwise nobody can
operate. So what they are implying is that Medicare wants to
take away the anesthesiologist. Number one, Medicare has never
required that an anesthesiologist be there.
Number two, it says, ``Your life may be in danger. Medicare
says that it will no longer require a doctor to supervise
during surgery.'' That is not what Medicare issaying. Medicare
is saying it will defer to State law on that issue.
I think this is intolerable. It is a scare tactic to scare
our senior citizens into calling Senators, like Senator Robb's
name here, to force them to make an action. I think this action
is intolerable.
Senator DeWine. Dr. Pierce.
Dr. Pierce. I urge the committee, subcommittee, to look at
the advertising and comments on both sides. I do not want to
get into a contest.
Senator DeWine. Dr. Silber, one last shot.
Dr. Silber. Again, what our study has shown is there is a
benefit to direction and it seems to me that that should lead
us to worry about what would happen if there was less
supervision. If we see that more training and direction by an
anesthesiologist is beneficial, then taking away that influence
in the supervision category might be problematic and I would
urge more research on this subject.
Senator DeWine. Ms. Stewart, you get the last word.
Ms. Stewart. Wow. Thank you. Although I have appreciated
Dr. Silber's comments and the depth of his research, it is
really not to the point of the discussion of supervision.
Supervision for the purposes of our discussion here and for the
vast majority of its application has to do with surgeons being
the supervising physician for nurse anesthetists who are
working without anesthesiologists. That does not take away the
merits that Dr. Silber is offering in his research, but it is
really not on point to today's discussion. It feels a little
like a smokescreen to the discussion because there were not
anesthesiologists in these areas that we are discussing, and
they are not being taken away. They were never there.
Senator DeWine. I want to thank all of you, and actually,
Ms. Stewart, I get the last word because this is the Senate.
Ms. Stewart. That seems appropriate. It is your house.
Senator DeWine. I will make a few comments. Let me thank
all of you for being here. I think it has been a very good
hearing. As we can tell from this hearing, as we knew before we
came into it, this is a very contentious issue. I do think,
though, that today's hearing has been helpful and has allowed
us a good opportunity to explore a number of very important
issues. Most importantly, it has allowed us a chance to
consider the impact of the proposed HCFA rule on the market for
anesthesia delivery and on the health of our seniors. We have
heard a wide range of opinions on a number of competition in
health care issues and it is clear that there is a great deal
of dispute on some of the basic facts of the anesthesia
delivery controversy.
I do think that this hearing has made clear that the Silber
study does shine some light on the topic, but as pointed out by
several witnesses, including Dr. Silber himself, the study
clearly has some limitations. The information generated by the
study and its limitations have further convinced me that we
need a national comparative outcomes study conducted by the
Department of Health and Human Services to more fully examine
this issue.
As I have said before, this issue is too important to
ignore, and that is why we held this hearing. We must not take
any chances with the safety and the health of Medicare
patients. Before we take any steps as a country to alter the
delivery of anesthesia, we must be sure that we protect the
health and the safety of our seniors.
Again, I would like to thank our witnesses very much for
your testimony. It has been very helpful to us. The committee
will stand adjourned.
[Whereupon, at 3:40 p.m., the subcommittee was adjourned.]
A P P E N D I X
----------
Additional Submissions for the Record
----------
Prepared Statement of Hon. Harry Reid, a U.S. Senator From the State of
Nevada
Good afternoon Mr. Chairman, members of the Committee and
distinguished guests. I appreciate the opportunity to share my views
with the Committee about the practice of anesthesiology and related
safety issues.
On December 19, 1997, the Health Care Financing Committee (HCFA)
issued a proposed rule to eliminate its long-standing rule requiring
physicans supervision of nurse anesthetists in Medicare and Medicaid
cases. In March of this year, HCFA announced its intention to finalize
this rule. The proposal has now been finalized by the agency and sent
to the Office of Management and Budget for review.
Senator DeWine and I have introduced legislation (S. 818) that
states that before HCFA changes its policy, the Secretary of Health and
Human Services should conduct a study that looks at the outcome rates
of Medicare patients who are cared for by different anesthesia
providers. The bill would require the Secretary only to take the
results of this study into consideration when issuing a final
regulation.
While some contend there is no difference in outcomes between nurse
anesthetists and physician anesthesiologists, we must be certain this
conclusion is reached based on sound and reliable data, before making
changes to our current procedures. Senior citizens have overwhelmingly
stated their preference for physician involvement in any necessary
anesthesia. If we are to eliminate this requirement, we owe them our
careful attention to objective data showing whether or not a change in
policy would be safe.
In 1992, HCFA considered the same change and rejected it. After
reviewing the then available studies of anesthesia outcomes, HCFA
concluded, ``In consideration of the risks associated with anesthesia
procedures, we believe it would not be appropriate to allow anesthesia
administration by a non physician anesthetist unless under supervision
by an anesthesiologist or the operating practitioner.'' HCFA also noted
that, ``the conditions of participation are intended to be minimum
requirements that promote health and safety. We do not believe it would
be practical to adopt as a national minimum standard for care a
practice that is allowed only in some states.''
HCFA now proposes to reverse itself on both of these grounds,
without offering any evidence that developments since 1992 make the
change appropriate, consistent with HCFA's obligation to protect the
health and safety of Medicare and Medicaid patients. Factors
contributing to HCFA's 1992 conclusions have not changed at all since
1992, and if anything, there exists even more compelling evidence today
to support the wisdom of HCFA's 1992 action.
The one new anesthesia outcomes study since 1992, performed by
Jeffery H. Silber, M.D. at the University of Pennsylvania and to be
published next month, demonstrates the importance of anesthesiologist
involvement. The study found that when an anesthesiologist is not
directly involved, there are more deaths than when an anesthesiologist
is directly involved in the case. In light of the findings of the
Silber study, it is critical that this issue is further studied so that
we can ensure that Medicare and Medicaid patients will not be exposed
to unnecessary life-threatening and other adverse outcomes.
Members of Congress are ill-prepared to judge the merits of this
issue without a scientifically based study of the outcomes of patients
who receive anesthesia services from the two different types of
providers. To act without such advice would be premature and
irresponsible.
Although the rate of adverse anesthesia outcomes has dropped
steadily over the past quarter-century, the provision of anesthesia
remains inherently dangerous and sometimes unpredictable. We must
ensure that the quality of anesthesia care being provided to our oldest
and most vulnerable population is the very best available.
__________
Prepared Statement of the American Society of Anesthesiologists
The American Society of Anesthesiologists (ASA), a national medical
specialty organization of some 35,000 physicians and other scientists
engaged or especially interested in the practice of anesthesiology, is
pleased to offer written testimony on the issue of competition and
safety currently before the Subcommittee.
Competition generally compels markets participants to respond to
the needs of consumers. Often, however, regulation must protect the
public from the dangers of unchecked market forces. Thus, courts allow
government to regulate competition in the interest of public safety.
Similarly, trade associations may implement standards that restrict
unlimited access but promote the quality of service. Whether self-
imposed or governmental, such regulations implement beneficial
standards to protect the public, while arguably limiting competition.
The benefits of regulation are evident in the standards promulgated
by professional associations such as ASA. Quality standards impose a
minimum threshold to preserve the integrity of the market for
professional activities. Instead of dismissing such standards as
anticompetitive, the Supreme Court has recognized that such restraints
may actually improve the market for professional services. Indeed, the
Court has adopted a less stringent antitrust analysis when a challenged
activity seeks to promote a public interest. Professional self-
regulation is always subject to review under the ``Rule of Reason,''
under which the benefits of the regulation are weighed against any
incidental restrains on competition. This rule recognizes that other
interests must often be balanced against any preference for
unrestrained competition in the market for professional services.
Protecting public safety is, of course, a paramount concern in the
medical services market. Quality treatment requires shielding patients
from unrestricted competition that may threaten a patient's well-being.
the antitrust laws recognize the obvious importance of such regulation.
For example, hospital peer review groups can restrict competition by
denying hospital privileges to some doctors due to patient care issues.
Despite the fact that such decisions may be viewed as anticompetitive
in the short run, the courts recognize that peer review is necessary to
protect patients. Although competition remains in the public's
interest, regulations promoting safety and quality care are often
necessary to strike the proper balance.
The Conditions of Participation applied by the Health Care
Financing Administration (HCFA) to hospitals and ambulatory surgical
centers are examples of governmental quality restraints that may impede
unfettered competition, because they apply standards to which those
facilities must adhere in order to participate in the Medicare program.
As discussed in Dr. Pierce's testimony before the Subcommittee today,
ASA's House of Delegates has approved numerous standards related to
anesthesia care which, although not technically binding on and ASA
member, as a practical matter restrain member's conduct because of the
threat that non-adherence would increased the prospects of legal action
in the event of an adverse incident.
One such ASA safety standard is that calling for physician
supervision on non-physician practitioners, a standard that is also
reflected in HCFA's current Conditions of Participation for hospitals
and ambulatory surgical centers. As is well known, ASA vigorously
opposes HCFA's 1997 proposed elimination of this requirement, in place
since the inception of the Medicare program, that a nurse anesthetist
work under the supervision of an immediately-available anesthesiologist
or of the operating surgeon.
HCFA's December 19, 1997 proposed rule addressed numerous changes
to the Conditions of Participation (COPs) for hospitals. In March of
this year, HCFA announced its intention to finalize this single element
of its proposal, and to eliminate its requirement for physician
supervision both with reference to hospitals and ambulatory surgical
centers. That proposal has now been finalized by the agency and sent to
the Office of Management and Budget for review.
To begin to understand the ramifications of HCFA's proposal, it is
necessary to appreciate the nature of and risks inherent in the
provision of anesthesia care. We therefore include a prefatory section,
describing the nature of anesthesia care and the respective training of
anesthesiologists and nurse anesthetists. It is clear, based on
training alone, that the services provided by anesthesiologists and
nurse anesthetists are different services.
I. THE NATURE OF ANESTHESIA CARE--THE PRACTICE OF MEDICINE
The modern practice of anesthesiology is universally recognized as
the practice of medicine, involving a wide variety of diagnostic and
clinical decision-making functions, including the following:
Preventing a patient from feeling pain or emotional stress during
surgical, obstetrical and certain medical procedures.
Evaluating and managing life functions (e.g., breathing, heart
rhythm and rate) under the stress of anesthetic and surgical
interventions.
Clinical management of the unconscious patient.
Pain management (acute and chronic).
Managing patients who need resuscitation because of heart function
or breathing difficulties.
Applying specific methods of respiratory care.
Clinical management of various fluid, electrolyte and metabolic
disturbances.
There are three phases to the provision of anesthesia care in
connection with most surgical and obstetrical procedures: the
preoperative, intraoperative and postoperative periods. Each phase,
involves the exercise of medical judgment and decision-making. The
planning and management of an anesthetic must integrate the patient's
preexisting medical condition, the nature and extent of surgical
stress, and a method for providing, as much as possible, a smooth
stress- and pain-free postoperative course. In many settings, nurse
anesthetists participate in the provision of intraoperative anesthesia
care, but always under the supervision of an anesthesiologist or other
physician.
Nowhere is management of the continuum of anesthesia medical care
more crucial or potentially complex than for the Medicare beneficiary.
More than half of the estimated 40 million surgical procedures done
each year, or about 20 million in-hospital surgical procedures, are
performed on Medicare patients. In this age group, preoperative
evaluation often reveals disorders of multiple organ systems, e.g.,
cardiac, respiratory, renal, musculoskeletal, neurologic. Such
conditions have important ramifications in caring for patients
undergoing coronary artery bypass, aortic or peripheral vascular
surgery, or joint replacement--procedures most often performed in the
Medicare age group. These operations are characterized by the potential
for significant blood loss, often at an astonishing rate, as well as
swift and unpredictable changes in blood pressure, heart rate, heart
rhythm and overall heart function.
If the blood pressure suddenly falls, is the cause exacerbation of
prior heart disease, a sudden change in heart rhythm, surgical
manipulation, inadequate fluid replacement, or some other cause?
Initial diagnosis involves rapid assimilation of data from multiple
sources--pre-existing history, observation of monitoring devices and
the surgical field, etc.--requiring expedited medical decision-making
and, as important, periodic reassessment of the situation. Treatment
for one diagnosis may be contradicted for another (e.g., blood
transfusion for blood loss, fluid restriction for myocardial failure).
If currently available data are inadequate for decision-making, what
more sophisticated devices are required, such as a pulmonary artery
catheter or transesophageal echocardiography?
Obviously, not all operations and anesthetics are characterized by
complications; that possibility, however, is present in each and every
case--even those involving otherwise healthy patients. Especially is
this so in light of the fact that modern anesthesia drugs and
techniques have rendered ever older and sicker patients acceptable
anesthesia risks, where life-extending surgical procedures are
indicated.
Today, anesthesiologists are involved in 90 percent of the
anesthetics delivered in the United States. Thirty-five percent of
anesthetics are administered personally by the anesthesiologist, and 55
percent are administered by a nurse anesthetist, anesthesiologists
assistant (AA),\1\ resident, or student nurse anesthetist under the
medical direction of an anesthesiologist. The ten percent of
anesthetics not involving an anesthesiologist are administered by a
nurse anesthetist who is supervised by the operating practitioner. See
Abenstein, ``Influence of Anesthesia Practice Models on Patient
Outcomes'' (scheduled for publication in September 1998). Supervision
by the surgeon rather than by an anesthesiologist is frequently found
in small, rural hospitals that generally care for less critically-ill
patients. Anesthetics given in rural hospitals account for less than 5
percent of the total.
---------------------------------------------------------------------------
\1\ The services of anesthesiologists assistants (AAs) are payable
under the Medicare Fee Schedule, as are those of nurse anesthetists and
residents, except that AAs must always work under the supervision of an
anesthesiologist. 42 C.F.R. Sec. 410.69. HCFA has not proposed the
elimination of anesthesiologist supervision of AAs.
---------------------------------------------------------------------------
The education and training of an anesthesiologist are vastly
different from those of a nurse anesthetist, and they qualify the
anesthesiologist to provide a radically different, more comprehensive
service than that offered by a nurse anesthetist.
To become an anesthesiologist, an individual must complete 12 years
of education--four years of pre-medical undergraduate education; four
years of medical school in which the individual gains knowledge of the
fundamental science of the human condition (biochemistry, biophysics,
anatomy, pharmacology, physiology and pathology) and receives extensive
clinical instruction and experience in diagnosis and therapy; and four
years of residency training, three years of which are devoted to
clinical training including one year of concentrated study and
experience in connection with the most complicated cases.
Anesthesiologists receive extensive training in pharmacokinetics, which
is the quantitative study of the action of drugs in the body over a
period of time, including the processes of absorption, distribution,
localization in tissues, biotransformation and excretion, and the
factors that affect these processes.
According to published figures from the Journal of the American
Association of Nurse Anesthetists, approximately two-thirds of
practicing nurse anesthetists have a bachelor's degree--one-third do
not. Nursing degrees generally require significantly less science than
corresponding pre-medical or other science-based undergraduate degrees.
Furthermore, many of the science courses taken by nursing students are
survey courses and are not a recognized part of any other science-based
curriculum.
Nurse anesthetist training involves a two-year program of
technique-oriented instruction and clinical experience, with only
modest scientific underpinning. The first year consists of didactic
training in subjects such as anatomy, physiology and pharmacology; the
second year is primarily clinical experience. While nurse anesthetists
study some of the same subject areas as anesthesiologists, the courses
again are generally more superficial than the ones completed by medical
students. Most importantly, CRNAs are trained to make a nursing
assessment of a patient, not a medical assessment.
Nurse anesthetists, who return to school to become
anesthesiologists, have the best understanding of the differences in
the educational programs and the capabilities of nurse anesthetists and
anesthesiologists. In a March 2, 1998 letter sent to HCFA by 64
anesthesiologists who initially trained as nurse anesthetists, the
following statement appears:
``Nurse anesthetists who argue in favor of independent practice can
have no concept of what they are lacking. We do, because we have been
trained both as a nurse anesthetist and then as an anesthesiologist.
The difference is simply profound. In an undertaking where the
patient's physiologic functions are deliberately slowed or stopped, and
where the margin between the routine and the disastrous is literally
measured in seconds and in cubic centimeters of drugs, the capacity
rapidly and correctly to invoke medical judgment is indispensable.''
Nurse anesthetists are not trained to make medical judgments, but
are competent under medical direction by an anesthesiologist or under
supervision of an operating practitioner who has assumed responsibility
for the performance of anesthesia care to:
1. Provide nursing assessment of the patient's health status as it
relates to the relative risks involved with anesthetic management of
the patient during performance of the operative procedure.
2. Based on the health status of the patient, determine, in
consultation with the anesthesiologist or responsible operating
practitioner, and administer the appropriate anesthesia plan (i.e.,
selection and administration of anesthetic agents, airway management,
monitoring and recording of vital signs, support of life functions, use
of mechanical support devices, and management of fluid, electrolyte and
blood component balance);
3. Recognize and, in consultation with the anesthesiologist or
operating practitioner, take appropriate corrective action to
counteract problems that may develop during implementation of the
anesthesia plan;
4. Provide necessary normal postanesthesia nursing care in
consultation with the anesthesiologist or operating practitioner; and
5. Provide such other services as may be determined by the
medically directing anesthesiologist or supervising operating
practitioner.
II. ANESTHESIA CARE SHOULD CONTINUE TO BE PROVIDED BY OR UNDER THE
SUPERVISION OF A PHYSICIAN
In its preamble to the proposed rule, HCFA notes the statutory
provision that a hospital, seeking to participate in the Medicare and
Medicaid programs, must meet requirements that the Secretary of Health
and Human Services finds necessary in the interest of the health and
safety of hospital patients. These requirements are set forth in the
Conditions of Participation (COPs) for Hospitals (42 C.F.R. Part 482)--
the purposes of which ``are to protect patient health and safety and to
ensure that quality care is furnished to all patients in Medicare-
participating hospitals''.
HCFA in its preamble then goes on to state that it proposes to move
from a process-oriented approach to approval of hospitals, to a result-
oriented approach that evaluates performance components as part of the
hospital's ``overall quality assessment and performance improvement
responsibilities''. HCFA thus proposes to include ``process-oriented
requirements only where we believe they remain highly predictive of
ensuring dired outcomes. . . .'' More particularly, HCFA describes a
``fundamental principle'' that guided the development of the proposed
revised COPs as ``Facilitating flexibility in how a hospital meets our
performance expectations, and eliminate process requirements unless
there is consensus or evidence that they are predictive of desired
outcomes for patients'' (emphasis added).
With respect to anesthesia services, HCFA proposes to ``eliminate
current rules on which practitioners can administer anesthesia, and
what level of supervision must be provided to them'', requiring merely
that ``anesthesia be administered only by a licensed practitioner
permitted by the State to administer anesthetics''.
HCFA notes that one effect of its proposed staffing and equipment
requirement ``would be to allow more flexibility to certified
registered nurse anesthetists (CRNAs) without oversight by another
practitioner. Currently, the anesthesia condition (482.52(a)(4))
requires that a CRNA administer anesthesia only under the supervision
of operating practitioner or of an anethesiologist who is immediately
available if needed. . . . We emphasize that CRNAs are allowed to
practice in this way [without supervision] only where doing so is
consistent with State law.''
HCFA then goes on to say that in order to achieve uniformity, it
proposes to eliminate the requirement that nurse anesthetists be
supervised from requirements for ambulatory surgical centers (42 C.F.R.
Sec. 416.42) and critical access hospitals (42 C.F.R. Sec. 485.639). It
notes that as to all three types of institutions, however, State law
may establish a more stringent condition.
HCFA finally states as to anesthesia care its belief that ``it is
critical to the health and safety of surgical patients to have accurate
information on each patient's condition before anesthesia is
administered and a surgical procedure is undertaken. HCFA thus proposes
to require that a comprehensive assessment be performed before surgery
and that ``a preanesthesia evaluation be done by an individual
qualified to administer anesthesia.''
ASA would like to express in the strongest possible terms our
opposition to HCFA's proposal to eliminate the requirement that a nurse
anesthetist be supervised either by theoperating practitioner or by an
anesthesiologist. As is manifest from our prefatory description of
anesthesia practice, anesthesia care involves the practice of medicine.
Simply stated, a doctor of medicine must be responsible for the
provision of all medical and surgical services, including anesthesia,
and available anesthesia outcomes data clearly presents the evidence
HCFA says is necessary for it to retain a process requirement.
A. The wisdom of HCFA's 1992 rejection of a proposal to eliminate
physician supervision of nurse anesthetists
In 1992, HCFA rejected a proposal to eliminate physician
supervision of nurse anesthetists--a proposal identical to the one that
it is now advancing. 57 F.R. 33878. HCFA's rejection was based on two
stated grounds:
``Regardless of whether some State laws allow CRNAs to practice
independently, the laws of most States still require nonphysician
anesthetists to administer anesthesia only under the supervision of a
doctor of medicine or osteopathy. Moreover, the conditions of
participation are intended to be minimum requirements that promote
health and safety. We do not believe it would be practical to adopt as
a national minimum standard for care a practice that is allowed in only
some states.''
``While some of the information [submitted to HCFA] supports the
conclusion that similar results occur under each of the three sets of
circumstances [CRNA alone, anesthesiologist alone, or the two providers
together], we note that . . . existing studies of this issue do not
account for the differences in outcomes caused by differences in age
and in severity of illness among patients. We believe it would be wrong
to conclude from the studies mentioned above that oversight by an
anesthesiologist does not contribute significantly to the safety and
quality of care. In view of the risks associated with anesthesia
procedures, we believe it would not be appropriate to allow anesthesia
administration by a non-physician anesthetist unless under supervision
by either an anesthesiologist or the operating practitioner.''
HCFA now proposes to reverse itself, on both these grounds, without
offering a shred of evidence that developments since 1992 make the
change appropriate, consistent with HCFA's obligation to protect the
health and safety of Medicare and Medicaid patients. The fact is that
the factors contributing to HCFA's 1992 conclusions have not changed at
all since 1992, and if anything, there exists today even more
compelling evidence to support the wisdom of HCFA's 1992 action.
First, there is no greater uniformity of state law on the subject
than there was when HCFA rejected the elimination of physician
supervision in 1992. The American Association of Nurse Anesthetists
(AANA) widely trumpets its ``data'' that the nursing rules of 29 states
permit nurse anesthetists to practice unsupervised. This disingenuous
statement presents less than the whole truth. For one thing, the AANA
claim is based on the assumption that the requirement of
``collaboration'' with a physician--articulated in the nursing rules of
many of the 29 states--somehow may be equated with ``unsupervised''
care. There is no foundation for this conclusion, other than a semantic
one.
More important, nursing rules comprise only one portion of the
health and safety regulations of any given state; also of significance
are the state's medical code, hospital regulations, and restrictions on
the prescription of controlled substances. Attached hereto as Appendix
IV are the results of an analysis of all state laws and regulations
regarding the scope of practice of nurse anesthetists undertaken at
ASA's request by a large private law firm. The analysis discloses the
panoply and diversity of restraints on nurse anesthesia practice that
currently exist in this country. Viewed in this context, it is
difficult to understand how HCFA, in pursuing the proposed rule, could
conclude that it was maintaining the ``minimum standard of care'' that
it, in its 1992 statement quoted above, defines the COPs as
representing.
Nor can HCFA find comfort or justification for its proposed action
in comparative post-1992 anesthesia outcomes studies: There simply are
no new studies showing or even suggesting that anesthesia is as safe,
when provided by an unsupervised nurse anesthetist, as when it is
performed by or under the direction of a physician. If anything has
changed since HCFA's 1992 rule-making, it is the availability of more
recent research indicating that patient outcomes are improved in
hospitals staffed by adequate numbers of board-certified
anesthesiologists. To the contrary, the one new anesthesia outcomes
study since 1992, performed by Silber et al. at the University of
Pennsylvania, demonstrates just the opposite.
J.P. Abenstein, M.D. of the Mayo Clinic, in his article noted
above, states that intraoperative anesthesia-related deaths had
declined from 1:1560 in the early 1950s to fewer than 1:244,000 in
1989. There has been a corresponding decline in morbidity related to
anesthesia. Abenstein found that these improved outcomes could not be
attributed to either pharmacological agents or technology, and that
therefore the improvement must be attributable to anesthesia personnel.
And the most notable change in anesthesia personnel over the last 50
years has been the explosion in the number of anesthesiologists: since
1967, that number has increased by 208 percent, while the number of
nurse anesthetists has increased by only 78 percent.
In support of this conclusion, Abenstein summarized a study from
the University of Pennsylvania. Jeffrey H. Silber, M.D. and colleagues
reported, in 1992 after HCFA's ruling appeared in the Federal Register,
on differences in patient outcomes related to patient and hospital
attributes. The authors examined the outcome of 5972 patients
undergoing elective surgery in 531 hospitals. After exhaustive
examination of numerous factors relating to patients and medical
facilities, only the proportion of board certified anesthesiologists
was directly related to a decrease in mortality rate after elective
surgery (i.e., the higher the proportion of board certified
anesthesiologists, the lower the mortality rate). No other attribute,
including those related to nursing, improved perioperative mortality.
(Silber JH, Williams SV, et al. Hospital and patientcharacteristics
associated with death after surgery. A study of adverse occurrence and
failure to rescue. Med Care 1992;30:615-27.
To the same effect were two studies from 1981 and 1980. In the 1981
study (Bechtoldt AA Jr. Committee on anesthesia study. Anesthetic-
related deaths: 1969-1976. NC Med J 1981;42:253-9), which reviewed more
than 2 million anesthetics and analyzed the 90 anesthetic-related
deaths in that sample, anesthesiologists personally providing
anesthesia and anesthesiologists supervising nurse anesthetists had
significantly better mortality rates than nurse anesthetists supervised
by non-anesthesiologists--15 percent and 26 percent better,
respectively. These results were surprising, since nurse anesthetists
practicing alone generally undertake shorter procedures on healthier
patients.
The 1980 study (Forrest WH. Outcome--the effect of the provider. In
Hirsh RA, Forrest WH, et al, eds. Health care delivery in anesthesia.
Philadelphia: George F. Stickley, 1980; 137-42) showed that nurse
anesthetists had an 11% worse than expected outcomes while
anesthesiologists had as much as a 20% better than expected outcomes--a
31 percent difference between provider groups.
Most importantly, however, researchers at the University of
Pennsylvania (Silber et al) will publish next month a major Medicare
outcomes study, disclosing significantly higher death rates when an
anesthesiologist is not involved in the administration of anesthesia.
This peer-reviewed study covers all Medicare general surgical and
orthopedic cases in Pennsylvania over a recent four-year period. After
factoring out variables based on patient condition and hospital
characteristics, the study shows that when an anesthesiologist was not
involved, there were 2.5 excess deaths per thousand Medicare general
surgical and orthopedic cases without complications; when an
anesthesiologist was not involved and there were post-operative
complications, there were 6.9 excess failures to rescue (deaths) per
thousand Medicare general surgical and orthopedic cases. Dr. Silber is
a witness at this hearing, and his testimony speaks volumes about the
regulatory insanity of HCFA's current proposal; if anything, it appears
that HCFA should be tightening its supervision rule, not dismantling
it.
Contrary to scientific data, the AANA has attempted to claim that
anesthesia care delivered by a nurse anesthetist is safer than the care
delivered by an anesthesiologist. The AANA touts the number of
malpractice claims filed with the National Practitioner Data Bank
against anesthesiologists versus those claims filed against nurse
anesthetists as the only support for such claims. The reality is that
most nurse anesthetists are employed by anesthesiologists within group
practices. The group pays for the nurse anesthetists' insurance.
Malpractice lawsuits are generally filed against the group or physician
employer, not the individual nurse anesthetist. Most malpractice
insurance companies do not write individual policies for nurse
anesthetists when they are employed by a physician group practice. As
such, when a lawsuit is filed, it is filed against the group practice,
not the individual nurse anesthetist. Furthermore, it is important to
point out that there is no obligation for nurse anesthetist malpractice
claims to be reported to the National Practitioner Data Bank when that
nurse anesthetist is employed by the institution or group practice.
There is a reporting obligation for physicians. For these reasons, any
attempt to compare doctor-to-nurse malpractice data as an indication of
patient safety is inherently flawed and irrelevant.
There is a wealth of data demonstrating that the present COP
requirement of physician involvement in the administration of every
anesthetic contributes to patient safety and the quality of care. There
are no studies that would indicate any patient benefit from the
proposed change. To the contrary, to paraphrase HCFA's own words in the
preamble to the proposed rule, this process requirement--that nurse
anesthetists work under the supervision of a physician--is supported by
clear evidence that it is ``predictive of desired outcomes for
patients''. In 1992 HCFA stated, ``we believe it would be wrong to
conclude from the studies . . . that oversight by an anesthesiologist
does not contribute significantly to the safety and quality of care.''
Today, there is even more compelling evidence to support the
requirement of physician supervision of nurse anesthetists.
B. Evisceration of national standard of care for Medicare or Medicaid
The proposed change in the COPs would allow nurse anesthetists to
practice unsupervised only where doing so is consistent with state law.
Only one or two states currently permit nurse anesthetists to practice
without physician supervision. As is apparent from even a casual review
of the summary chart of state regulations appearing in Appendix IV,
however, the state codes and regulations are replete with
inconsistency. New Jersey, for example, requires an anesthesiologist to
supervise a nurse anesthetist. Where collaboration is required instead
of supervision, varying standards exist as to what collaboration
means--ranging from an undefined nominal relationship to a clearly
interactive one. Some hospital codes require physician supervision;
others merely require that a physician oversee the anesthesia
department. Even those states requiring physician supervision or
direction define those terms differently.
As of March 2000, the practice acts of only about half the states
required that a physician direct or supervise a nurse anesthetist in
the administration of anesthesia, or otherwise issue a patient-specific
order for such administration. Eighteen practice acts required mere
``collaboration'' between a physician and a nurse anesthetist; the
remainder of the states were silent on the issue.
Most often, collaboration is defined as ``a process involving two
or more parties working together, each contributing his or her area of
expertise to provide more comprehensive care than one alone can
offer.'' There is rarely a requirement that the collaborating physician
be specially trained in anesthesia or be present during administration
of anesthesia by the nurse anesthetist. There are normally no limits on
the number of nurse anesthetists with whom a physician can collaborate.
It is not uncommon in some states for the collaborating physician to be
retired from active practice or located in a community remote from
where the anesthesia is being administered.
Most state acts requiring physician supervision or direction do not
require, as does the current federal rule, that the physician be
immediately available during the course ofanesthesia. Only one state
practice act requires that such physician be credentialed in
anesthesia.
Hospital regulations in half the states require that a physician
direct or supervise the administration of anesthesia by a nurse
anesthetist. In general, however, these tend to be the same states
which require supervision or direction in the practice acts affecting
nurse anesthetists.
While the vagaries of state law allow for varying standards of
care, as a practical matter, hospitals do not distinguish between
Medicare and non-Medicare patients; as such HCFA's objective of
ensuring a national minimum requirement that promoted health and safety
is met.
For better or worse, the Medicare program is the single most
influential force in this country for establishing health care
standards, and abandonment of the physician supervision requirement
would not only throw Medicare and Medicaid patients into the existing
complex of state regulation, but also send a powerful signal--its
protestations to the contrary notwithstanding--of HCFA's view of the
need for physician supervision. The elimination of this requirement
will be used by the nurse anesthetists to continue the erosion of
physician supervision and physician collaboration requirements until
such time as they are permitted complete independent practice. Nurse
anesthetist advocates are already telling state legislators and
regulators that the federal government approves of unsupervised nurse
anesthetist practice and are arguing that individual states should
allow nurse anesthetists to practice independently. For years, nurse
anesthetists have sought independent practice, including independent
prescriptive authority for all controlled substances, at the state
level for years. It is this effort that has led to the erosion of
strong physician supervision standards in some states.
The bottom line is that adoption of the proposed rule will mean
that Medicare and Medicaid patients will have available a differing
minimum standard of anesthesia care dependent on where they undergo a
procedure requiring that care. HCFA makes much in its proposed rule
about the fact that hospitals are free to establish their own higher
standards of care, but that is not the point: the point is that unless
HCFA maintains a national minimum, Medicare and Medicaid patients will
have no assurance that such a minimum exists.
C. The absence of cost incentives
There is no difference in cost to the Medicare beneficiary or the
Medicare program, whether or not a physician supervises care provided
by a nurse anesthetist. But there is evidence or greater cost
efficiency, and resultant savings to the Medicare and Medicaid
programs, when an anesthesiologist in involved. In a review article
published in the New England Journal of Medicine on October 16, 1997
(Wiklund, RA, Rosenbaum, SH. Medical Progress: Anesthesiology. NEJM
1997;337:1132-1219), the authors noted the growing role of
anesthesiologists in preoperative assessment of patients and cited
research showing that: ``requests for preoperative consultations are
reduced by three quarters when the need for a consultation is
determined by an anesthesiologist in a preoperative screening clinic
rather than by a surgeon. Cancellations of operations due to unresolved
medical or laboratory abnormalities are reduced by 88 percent, and the
costs of laboratory tests are reduced by 59 percent, or $112 per
patient.''
Additionally, anesthesiologists may help to hold down the expenses
of caring for patients post-operatively. Their ability as physicians to
intervene when complex problems occur (e.g., treat heart failure) may
save the Medicare and Medicaid programs the cost of caring for a
catastrophically compromised patient. As noted above, the 1992 study by
Silber et al. showed that the higher the ratio of anesthesiologists to
other anesthesia providers, the greater the likelihood of patients
recovering from adverse events. Also as noted, there have been no
corresponding data indicating that the rate of anesthetic morbidity has
declined at all for nurse anesthetists working alone during the decades
that it has decreased twenty-five fold for anesthesiologists.
D. The misconception of access
Access to rural health care is not improved by the elimination of
the physician supervision requirement. The existing rule permits
supervision either by an anesthesiologist or by the operating
practitioner. Although it is true that some of the smallest rural
hospitals do not have an anesthesiologist on staff, there is always by
definition an operating practitioner available to perform the required
supervision.
This would suggest that if a rural access problem exists, it is due
to a lack of availability of surgeons or other operating practitioners.
Clearly, the proposed rule does not reach that access problem, if in
fact one exists. Whether or not the surgeon supervises the anesthesia
care will not affect the patient's access to surgery. In a recent
survey of rural hospital administrators, Peter J. Dunbar, M.D. and
colleagues found that 85 percent would not do more surgery if they had
more anesthesia staff. (Dunbar PJ, Mayer JD, Fordyce, MA, Lishner, DM,
Hagopian, A, Spanton, K, Hart, LG. Availability of Anesthesia Personnel
in Rural Washington and Montana. Anesthesiology 1998;3:800-808).
Moreover, with the ongoing expansion of the number of
anesthesiologists, which is predicted to continue into the next century
(Abenstein, noted above), anesthesiologists will provide or supervise
more and more of the anesthesia care delivered in rural settings.
Dunbar noted that the numbers of anesthesiologists relative to the
population had increased, between 1970 and 1993, in Colorado, Nevada,
Arizona, Utah, New Mexico, Wyoming, and Montana. In Montana, the number
had more than doubled, from fewer than five anesthesiologists per
100,000 population to eleven per 100,000.
The AANA recently has claimed that surgeons do not want to
supervise CRNAs because of concerns related to increased liability for
the nurse anesthestists' actions, and it is for this reason that access
to care in the rural areas is compromised. The fallacy of this
anecdotal information is revealed by the unanimous support for
continued physician supervision of nurse anesthetists from medical and
surgical specialty societies as demonstrated in a recent letter to
HCFA. We would be remiss if we did not point out that the AANA had a
different view regarding surgeon's willingness to supervise nurse
anesthetists last year. The AANA argued in testimony last year before
the House Judiciary Committee that ``[t]he law governing the liability
of a surgeon for the negligence of a nurse anesthetist is precisely the
same as the law which governs the liability of a surgeon for the
negligence of an anesthesiologist.''
In short, there is simply no basis for the suggestion that
independent nurse anesthesia practice is the solution to increasing
access to health care in rural hospitals and surgical centers.
E. The inappropriateness of an outcomes approach
In its preamble to the NPRM, HCFA explained that it proposed to
revise the COPs consistent with a new philosophical approach to quality
that would focus on ``patient-centered, outcomes oriented standards''
rather than on ``specific, process-oriented requirements for each
hospital service or department.''
ASA has followed the shift in emphasis in evaluating the quality of
medical care, from process to outcomes measures, with great interest.
We agree that outcomes are generally a better guage of performance than
adherence to specific processes. It remains far easier, however, to
establish processes of care that are expected to contribute to good
results than to define and obtain appropriate outcomes data. HCFA
acknowledged the ongoing importance of process requirements when it
stated, in the preamble, that it proposed to include process-oriented
requirements ``where we believe that they remain highly predictive of
ensuring desired outcomes or are necessary to deter or prevent fraud
and abuse.'' At the very least, the 2000 Silber study demonstrated the
need for more comprehensive analysis by HCFA, as called for by the Safe
Seniors Assurance Study Act of 1999 (S. 818/H.R. 632), introduced in
the Senate by Senators DeWine and Reid, and now enjoying wide
bipartisan support in both Houses of Congress.
The requirement that an anesthesiologist or the operating
practitioner supervise nurse anesthetists is one process-oriented
standard that is highly predictive of ensuring desired outcomes. As we
documented above, research has demonstrated that anesthesiologist
involvement is the major cause of the dramatic drop in anesthesia
mortality and morbidity rates. There are absolutely no data suggesting
that unsupervised nurse anesthesia is as safe as medically-directed
anesthesia has become. The outcomes here--discharging a living patient,
promptly and with as little pain as possible, from the recovery room--
are so important that we cannot afford to experiment on Medicare
patients with widely varying state supervision requirements, as HCFA
would have us do.
Accordingly, we respectfully submit that the benefits of continued
involvement of an anesthesiologist or a surgeon in the anesthesia care
provided to every Medicare or Medicaid beneficiary undergoing surgery
far outweighs HCFA's desire to concentrate on outcomes measures.
F. Beneficiary support for retention of supervision
A strong majority of Medicare beneficiaries are unequivocal in
their preference for continuance of the current supervision
requirement. Surveys of senior citizens in 1998 and 1999 by the
Tarrance Group disclosed that 80% opposed eliminating the rule as HCFA
has proposed. (A survey last month by Luntz-Laszlo of all voting
Americans reported that three-quarters of the respondents disfavored
turning the supervision issue over to the individual states, as HCFA
proposes).
In the absence of any countervailing benefit--there being no
relative cost advantages or quality of care or access improvement--
there would seem to be little reason to disregard beneficiaries' and
all Americans voters' clear preference and to deprive beneficiaries of
their right to obtain anesthesia care from or under the supervision of
a physician.
III. CONCLUSION
HCFA's existing rule on physician supervision of nurse anesthetists
is a clear example of a restraint on competition, legally authorized
under the ``state action'' doctrine, maintained in HCFA's own words in
1992 that contributes ``to the safety and quality of care'' for
Medicare beneficiaries. HCFA now proposes to dismantle that rule in the
face of scientific data that the change will lessen, not improve,
patient safety, and in the face of the clear preference of the American
people. Why HCFA is unwilling at least to undertake a more definitive
study, as called for in S. 818/H.R. 632 is beyond comprehension, and
ASA intends to use every resource at its disposal to stop this clear
denigration of anesthesia care.
ASA respectfully requests that a copy of this statement be included
in the record of this hearing.
______
Anesthesia Patient Safety Foundation,
Pittsburgh, PA, February 17, 1998.
Nancy-Ann Min Deparle,
Administrator, Health Care Financing Administration,
HCFA-3745-P, Baltimore, MD.
Dear Ms. Deparle: The Executive Committee of the Anesthesia Patient
Safety Foundation (APSF) wishes to most strongly express its collective
opposition to the Health Care Financing Administration's (HCFA)
proposed rule to eliminate physician supervision of nurse anesthetists.
In 1992, HCFA publicly stated that ``in consideration of the risks
associated with anesthesia procedures, we believe it would not be
appropriate to allow anesthesia administration by a non-physician
anesthetist unless under the supervision of either an anesthesiologist
or the operating practitioner.'' This practice of supervising non-
physician anesthetists has evolved over many years directed toward
optimizing patient safety. There are no data to judge the extent to
which the current level of safety experienced by patients depends on
this supervision.
A basic tenet of medicine is ``first do no harm''. Administration
of anesthesia is a high risk activity. Prior to making any change in
the existing supervision requirement, the burden of proof must be based
on definitive evidence that this change is safe. No such evidence
exists! If the proposed rule is enacted in the absence of evidence that
the change in practice is safe, HCFA will have set a dangerous
precedent by having shifted the burden of proof in the wrong direction.
Such a shift in the burden of proof was a key factor in the ill-
fated decisions leading to the space shuttle Challenger disaster.
Health care should learn from this catastrophe by demanding evidence
that the safety of patients is preserved whenever substantive changes
are introduced in systems with known risks of death and serious injury
from medical interventions.
The Executive Committee of the APSF most strongly urges that HCFA
not enact the proposed rule change.
Sincerely,
Robert K. Stoelting, M.D.,
President.
Burton A. Dole, Jr.,
Vice-President.
David M. Gaba, M.D.,
Secretary.
Casey D. Blitt, M.D.,
Treasurer.
Jeffrey B. Cooper, Ph.D.,
Member at Large.
Robert A. Caplan, M.D.,
Member at Large.
Robert C. Black,
Member at Large.