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[Senate Hearing 106-1008]
[From the U.S. Government Publishing Office]

                                                       S. Hrg. 106-1008

     COMPETITION AND SAFETY IN THE DELIVERY OF ANESTHESIA SERVICES

=======================================================================

                                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
                                 ------                                

      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

                              ----------                              

                    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

                              ----------                              

                        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.

                                
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