95th Congress I COXXITTEE PRINT C CONMMI T TEE
2d Session j I PRI-NT 95-71
SURGICAL PERFORMANCE: NECESSITY AND QUALITY
TOGETHER WITH ADDITIONAL VIEWS
SUBCOMMITTEE ON OVERSIGHT AND
COMMITTEE ON INTERSTATE AND
HOUSE OF REPRESENTA
SECOND SESSION (JN P
U.S. GOVERNMENT PRINTING OFFICE
36-855 WASHINGTON: 1978
For sale by the Superintendent of Documents, U.S. Government Printing Office Washington, D.C. 20402
COMMITTEE ON INTERSTATE AND FOREIGN COMMERCE
HARLEY 0. STAGGERS, West Virginia, Chairmnan
JOHN E. MOSS, California SAMUEL L. DEVINE, Ohio
JOHN D. DINGELL, Michigan JAMES T. BROYHILL, North Carolina
PAUL G. ROGERS, Florida TIM LEE CARTER, Kentucky
LIONEL VAN DEERLIN, California CLARENCE J. BROWN, Ohio
FRED B. ROONEY, Pennsylvania JOE SKUBITZ, Kansas
JOHN M. MURPHY, New York JAMES M. COLLINS, Texas
DAVID E. SATTERFIELD III, Virginia LOUIS FREY, JR., Florida
BOB ECKHARDT, Texas NORMAN F. LENT, New York
RICHARDSON PREYER, North Carolina EDWARD R. MADIGAN, Illinois
CHARLES J. CARNEY, Ohio CARLOS J. MOORHEAD, California
JAMES H. SCHEUER, New York MATTHEW J. RINALDO, New Jersey
RICHARD L. OTTINGER, New York W. HENSON MOORE, Louisiana
HENRY A. WAXMAN, California DAVE STOCKMAN, Michigan
ROBERT (BOB) KRUEGER, Texas MARC L. MARKS, Pennsylvania
TIMOTHY E. WIRTH, Colorado PHILIP R. SHARP, Indiana JAMES J. FLORIO, New Jersey ANTH 'ONY TOBY MOFFETT, Connecticut JIM SANTINI, Nevada ANDREW MAGUIRE, New Jersey MARTY RUSSO, Illinois EDWARD J. MARKEY, Massachusetts THOMAS A. LUKEN, Ohio DOUG WALGEEN, Pennsylvania BOB GAMMAGE, Texas ALBERT GORE, JR., Tennessee BARBARA A. MIKULSKI, Maryland
W. E. WILLIAMSON, Chief Clerk and Staff Director KENNETH J. PAINTER, First Assistant Clerk ELEANOR A. DINKINS, Assistant Clerk WILLIAm L. BURNS, Printing Editor
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS JOHN E. MOSS, California, C'hairman JIM SANTINI, Nevada JAMES M. COLLINS, Texas
THOMAS A. LUKEN, Ohio NORMAN F. LENT, New York
DOUG WALO HEN, Pennsylvania MATTHEW J. RINALDO, New Jersey
AL13ERT GORE, JR., Tennessee DAVE STOCKMAN, Michigan
CHARLES J. CARNEY, Ohio MARC L. MARKS, Pennsylvania
HIENR1Y A. WAXMAN, California SAMUEL L. DEVINE, Ohio (ex offi lo)
PHILIP R. SHARI", Indiana ANTIION Y TOB Y MO FFETT, Connecticut AND)REW MAGUI RE, New Jersey ROBERT (BOB) KRUEGER, Texas
HIARLEY 0. STAGGERS, West Virginia (ex officio)
ELLIOT A. SEGAL, Health Task Force Director KATHERINE C. MEYERS, Special Assistant PATRICK M. McLAIN, Counsel B ERNARD J. W UNDER, Jr., Minority Counsel QiI)
LETTER OF TRANSMITTAL
HOUSE OF REPRESENTATIVES,
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS,
COMMITTEE ON INTERSTATE AND FOREIGN COMMERCE,
Washington, D.C., December 1973.
Hon. HARLEY O. STAGGERS,
Chairman, Committee on interstate and Foreign Commerce, Washington, D.C.
DEAR MR. CHAIRMIAN: Attached is a report entitled "Surcical Performance: Necessity and Quality" approved by the Oversight and( Investigations Subcommittee. As you well know the Subcomminittee has been investigating the cost and quality of the health delivery system in this country and has published previous reports and hearing on these issues.
This particular report examines the current status of unnecessary surgery and also the quality of surgery performed. The Subcommittee finds that the public remains at risk and that unnecessary surgery remains a major national problem which requires urgent and[
accelerated attention. The scope of the problem remains enormous, namely that there were approximately two million unnecessary procedures wasting over four billion dollars and over 10,000 lives in 1977.
In our previous Subcommittee report, the American ?Me(lical Association (AMA) took issue with our conclusions concernin' the extent of unnecessary surgery. At that time they in(i1eat(t that unnecessary surgery was not in the magnitude of 17 percent but rather between 0 and 1 percent. The evidence presented by the AMA for their conclusions was examined by the Subcommittee and was determined to be faulty in methodology and imprecise in execution. When that study was examined carefully, the rate of unnecessary sur rery was in the same range of the Subcommittee's.
The Subcommittee also examined the quality issues of su:ti-ery. It found that an individual may have twice the chance of d(yinw from an operation simply by having the procedure performed at one hospital rather than another. The Subcommittee also found that many surgeries end up with unexpected adverse events (misadventures). The surgical community themselves determined(I that a nialority of these misadventures were judged to be surgeon related and preventable. We believe the public should be informed of the hospitals. that present them with a much greater risk.
Based upon this study, the Subcommittee recommends that Congress consider legislation that would require pre-admission certification using present criteria for elective proce(lures such as hystereetomies, and tonsillectomies. We do not believe that Meliears and (IIm)
Medicaid should be paying for unnecessary procedures. The Subcommittee also recommends that a national program be established to monitor the critical incidents (misadventures) that take place in hospitals and that the public be given information about the performance standards of these hospitals.
JOHN E. Moss,
Chairman, Subcommittee on Oversight and Investigations.
I. Introduction and methodology --------------------------------- I
III. Recommendations ------------------------------------------- 3
IV. Current 4
A. Unnecessary 4
B. Surgical abuses and 6
1. Abuses and 6
a. Institutional Differences Study------------ 9
b. Critical Incidents 10
C. Examination of 12
D. Examination of hysterectomies------------------------- 14
E. Dr. Emerson's 16
V. Second 19
VI. Cost of unnecessary 20
VIL Professional standards review organizations 20
VIII. Board 23
IX. Other issues ------------------------------------------------- 24
X. Conclusions ------------------------------------------------- 25
Separate views of the Honorable James M. Collins, M.C --------------- 26
Digitized by the Internet Archive in 2013
SURGICAL PERFORMANCE: NECESSITY AND QUALITY
I. INTRODUCTION A-ND METHODOLOGY
During the 94th Congress, the House of Representatives Committee on Interstate and Foreign Commerce, Subcommittee on Oversigrht and Investigations undertook a major study into the costs and quality of the health care delivery system in this country. That set of investigations including hearings resulted in a report entitled "Cost and Quality of Health Care: Unnecessary Surgery," published in January 1976.'
That investigation and report examined aspects of surgical care. Several problem areas were identified and a series of recommendations were presented based on findings that unnecessary surgery existed to
a age degree and that very little was being (lone b h eat
ment of Health, Education, and Welfare (HEW) to reduce and eliminate such abusive practices.
In the previous report 2 the Subcommittee concluded] that unnecessary surgery has deleterious effects upon the American public. It was estimated that there were approximately 2.4 million unnecessar surgeries performed in 1974 at a cost to the American public ofalmost $4 billion and that~ unnecessary surgeries led to approximately 11,900 deaths during 1974.
Specific recommendations were made for the establishment of indlependlent second professional opinions to confirm the need for surgrery- under Medicare and Medicaid and that the major existing~ statutor-y sections concerning the utilization of surgical care be improved. Particular areas d esig'nated as requiring improvement include Professional Standards Review Organizations (PSROs) and the Medicaid Utilization Review sections.
Subsequent to this report, there were several issues identified and contested by organized medicine. The American Medical Association (AMA) took issue with the conclusions concerning the extent of unnecessary surgery, the costs, and the determinations of mortality. The Subcommittee received material from the AMA and several other sources and examined it with an eye toward refining, if necessary, the findings and conclusions of the previous study. In addition, the Subcommittee identified for further scrutiny many of the issues, particularly those concerning quality of care that were touched upon but not examined in-depth.
One such issue is Professional Standard Review Oroganizations (PSRO). The Subcommittee had a study (lone on its behalf by a Yale University Study Group concerning the implementation of
"Cost and Quality cf Health Care: Unnecessary Surgery," report by the Subcommittee on Oversights and investigations, Committee on Interstate and Foreign Commerce. U.S. House of Representative, 94th Cong., 2d sess.. January 1976. [Hereinafter cited as Unnecessary Surgery Report"].
2 Unnecessary Surgery Report, supra note 1 at 5-9.
PSROs. That investigation led to a "Backgr ound Report on Professional Standards Review Organizations" published in July of
The Subcommittee also obtained comments and evaluations of that report from HEW, Blue Cross Association, Health Insurance Association of America, the American Medical Association, the American Hospital Association, and the American Association of Professional Standards Review Organizations. Those comments are included in the background report.
The Subcommittee also sent a questionnaire to all fifty-three Medicare agencies throughout the country. The questionnaire sought data on surgery reimbursed under Title 19 of the Social Security Act (Medicaid Program). The compilation and findings of that questionnaire were collated into a staff report entitled "Background Report on Surgery in State Medicaid Programs," 4 published by the Subcommittee in July 1977.
In September, 1977 a third survey of the States was undertaken. That survey as well as the two previous ones found States reporting signmificantly more surgery than the general population. The quality of the data submitted by the states was found to be so poor as to make all conclusions tentative. (Report forthcoming.)
In addition, the Subcommittee held seven days of hearings on April 25, 29, May 2, 9; October 6, 28; and November 1, 1977 in order to gather more information about the quality of surgical care. The Subcommittee also held hearings on March 21, 22 and April 5, 6, 7, 1978, on issues primarily relating to the costs of surgical care.,' The cost issues will be the subject of a separate report of the Subcommittee.
This report will explore the evidence that has accumulated subsequent to the 1976 report. The report will focus upon the existence and extent of unnecessary surgery, as well as, surgical abuses and standards for judgment. Specifically, tonsillectomy and hysterectomy data will be discussed. Finally, existing programs including PSROs and second opinion consultations will be examined.
The Subcommittee finds that:
1. Unnecessary surgery remains a major national problem which requires urgent and accelerated attention. The Subcommittee believes that contentions by organized medicine that unnecessary surgery cannot be defined are diversions and obfuscations which serve to be counterproductive.
The Subcommittee finds that the public remains at risk and unnecessary surgery continues to waste lives and dollars. The Subcommnittee believes that there were approximately two million unnecessary procedures costing over $4 billion and over 10,000 lives in 1977.
3 "Background Report on Professional Standards Review Organizations," Report of a Yale University Study Group, prepared for the use of the Subcommittee on Oversight and Investigations, Committee on Interstate and Foreign Commerce, U.S. House of Representatives, 95th Cong., 1st Sess., July 1977. [Hereinafter cited as "PSR 0 Report".]
I "Background Report on Surgery In State Medicaid Programs," Staff Report prepared for the use of the Subcommittee on Oversight and Investigations, Committee on Interstate and Foreign Commerce, U.S. House of Representatives, 9.5th Cong., 1st Sess., July 1977. [Hereinafter cited as "Medicaid Surgery Report".] 5 "4Skyrocketing Health Care Costs: The Role of Blue Shield," hearings before the Subcommittee on Oversight and Investigations, Committee on Interstate and Foreign Commerce, 95th Cong., 2d Sess., March 21 and 22; April 5, 6, and 7, 1978.
2. The evidence available from studies by the National Academy of Sciences and the surgical community are compelling and demonstrate extensive variations in the quality of surgery being performed in this country. An individual may have twice the chance of dying from an operation simply by having the procedure performed at one bos ital rather than another. The Subcommittee finds that the information now being made available to the public concerning quality of care is not adequate.
3. Many surgeries end in misadventures (unexpected adverse events). One third of the misadventures are preventable and a majority of these are surgeon related.
4. There has been a f allure on the part of State licensing agencies and medical societies to take appropriate steps to curb the performance of unnecessary or incompetent surgery.
5. Professional Standard Review Organizations, which have a mandate to measure care for individual institutions are not fulfilling their responsibility. The Subcommittee is disturbed at the evidence of incompetent surgery and.beli.eves that PSROs and other public protection units are functioning inadequately. HEW has been tardy and ineffective in its administration of this program.
6. With respect to tonsillectomies, the evidence supports the contention that many tonsillectomies could be avoided with little hazard to the child. It appears likely that a majority of tonsillectomies performed in 1977 need not have been done. The Subcommittee believes that a program of requiring prospective preset criteria is obviously needed.
7. Many hysterectomies are being performed for reasons of birth control and for cancer prevention. Responsible medical experts believe that these are inappropriate indications for a hysterecton y and the procedure should not be performed if these are the only indications present. The Subcommittee finds that the criteria delineated by American Medical Association's (AMA) experts are not being followed and are not even a policy of the AMA's chief spokesperson.
S. The major basis of the claim by organized medicine that there is between zero to one percent unnecessary surgery is without foundation. The evidence presented by the AMA for this conclusion was determined to be faulty in methodology and imprecise in execution. When the population of that study was examined carefully, the rate of unnecessary surgery was in conformity with the Subcommittee's previous findings.
9. With respect to board certification, evidence is lacking concerning increased effectiveness of board certified physicians. We believe such evidence should be obtained.
10. There is a need for developing protective legislation that would guarantee the confidentiality of research and educational studies so that there can be increased opportunities for improving quality and quantity of medical care.
Based upon these findings, the Subcommittee recommends that:
1. Consider legislation that will require preadmission certification based upon pre-set criteria for federal payment for elective
procedures such as hysterectomies and tonsillectomies.
2. Consider legislation that will require HEW to develop minimum standards for competency for physicians performing
surgical procedures. t
3. Consider legislation that will provide for the confidentiality
of research and educational studies on the quality of surgical care anti provide immunity to participants when appropriate, exceptincr Concgress and HEW.
~4. Provide sufficient appropriations for PSROs to establish a
program of concurrent review, medical care evaluation studies,
and profile analysis that is comprehensive anti coordinated.
a. Consider legislation that will increase public representation
on PSROs. n
B. Department of Health, Education, and Welfare
1. Establish a national program to monitor critical incidents,
their rates anti their causes; and make public the data from this
2. Establish a program for measuring morbidlity anti mortality
differences by procedure for hospitals that participate in Medicare
anti Medicaid; anti make public the data from this program.
3. Require aggressive review of surgical services by PSROs.
4. Establish a program of independent mandatory second consultations for elective procedures such as hysterectomies and
5. Take steps to rectify the Department's appalling data gatherering capabilities, particularly with respect to Metdicaid. At the very least that program should be able to report the number of
surgical procedures paid for and the dollar amounts.
IV. CURRENT SITUATION
A. UNNECESSARY SURGERY
Prior to the Subcommittee hearings and report of the 94th Congress concerning unnecessary surgery, there was a general lack of public discussion about this issue.
The Subcommittee report defined unnecessary surgery using the categories delineated by the Study of Surgical Services in the United States. (SOSSUS).6 Subsequent to that report there was heated rhetoric by the American Medical Association (AMA) concerning the definition of what is unnecessary surgery. The AMA in a letter to Chairman Moss on February 6, 1976 stated "the report is unsound in concept, for it seeks to measure a phenomenon (namely unnecessary surgery) for which no criteria have been established." 7
Dr. Eugene McCarthy, one of the principal investigators of the necessity of surgical services, particularly in relation to second opinion programs, testified before the Subcommittee on May 2, 1977 "we have consciously tried to avoid a phrase surplus surgery." When pressed by Congressman An drew M aguire (D-N .J.) for elaboration on the semantic dlifferences, Dr. McCarthy testified thatI will be quite candid with you. The nuances between the two are extremely difficult to pick-up and perceive.
Unnecessary Surgery Report, supra note 1 at 9.
7 "Vo~lume I Quality of Surgical Care," Hearings Before the Subcommittee on Oversight and Tnvesti-alions. Committee on Interstate and Foreign Commerce, 9J5th Cong., 1st Sess., April 25 and 29; May 2 and 9, 1977. [Hlereinafter cited as Volume I Surgery Hlearinigs) at 194-195.
1 d feel in terms of our own study the question of unneces:iry surgery hzo- had an inflammatory reaction, particularly among surgeons around tie cti ntrv.s
On May 9, 1977, Dr. James 11. Sammons, ExecutiveX ice Preshiolnt of the AMA, testified before the Subcommittee. At that poini, Congressman iMarks (R-Pa.) pursued the definitionn issue.
Mr. MARKS. Dr. Sammons, how would you or the AMA speaking th r-igh you this morning, define unnecessary surgery.
Dr. SAMMONS. I cannot Mr. Marks. I read through a great deal of nteril t hat has been presented before this Committee including the report of a yeir' gHl1 I have not found a (efinition of unnecessary surgery and I have not seen oln that has been promulgated by the Committee. ..
Mr. Marks pursued the issue.
Mr. MARKS. Could you lay down some criteria for us this morning as to what you consider to be "unnecessary"? 10
Dr. Sammons replied to that question:
You've asked about criteria. There are indications for surgery that are taught beginning in medical school, they are taught right on through residenc- training programs, they are in fact taught in continuing education programs anI by the development of new technology and techniques. "
Dr. Sammons then goes on to describe that the AMA in conjunction with thirty specialty organizations, developed the PSRO manual which provides parameters that measure applicability and accuracy of diagnoses resulting in a given treatment.
In preparing this document, the AMA and its thirty specialty groups established indications for performing a procedure. One can assume that when a procedure did not meet any of those criteria and was carried out that procedure was not necessary.
In fact, Dr. William Ruhe testifying for the AMA on the issue of unnecessary surgery statedI wrote down a number of them (phrases) which have been used-"unnecessary', 'surplus', 'unconfirmed', 'inappropriate', 'unwarranted', 'contraindicated', 'unjustified', also the terms elective, optional, selective, discretionary, deferrable, and each one of these has a different set of connotations to the person using them.12
Dr. Ruhe, on May 7, 1977 in speaking before the American College of Obstetricians and Gynecologists in Chicago, Illinois statedOf course there is unnecessary surgery. We know that there is. Physicians are human beings. There are people within the medical profession, I am quite certainI can't name them but I am quite certain-that there are individuals within the medical profession who perform surgery for the wrong reasons, for inappropriate reasons, perhaps pecuniary gain; we are all aware that that is the case.
When pressed by Chairman Moss with that quotation at the Subcommittee hearings Dr. Sammons indicated thatIf you put the caveats on it that Dr. Ruhe put on it when he was on the panel on Saturday, then we can probably use it for purposes of (iscussion.4
With that acknowledgement by Dr. Sammons, it would appear that
everybody concerned with the issue is willing to accept the premise that there is unnecessary surgery and that it is a topic for discussion. Perhaps Under Secretary of Health, Education, and Welfare, Hale
6Id. at 171-172.
9 Id. at 320.
10 Id. at 321.
11 Id. at 322.
12 Id. at 322.
13 Transcript of Ruhe speech is available at Subcommittee files. 14 Vol. I Surgery Hearings, supra note 7 at 321.
Champion summed up the issue best when he testified on November 1i 1977. Champion stated:
For three years the Subcommittee has tried to point out that there is too much unnecessary or inappropriate surgery in this country and that much of it is paid for by governmental programs.
For three years this Subcommittee has been right. The indicators that I have examined clearly support the Subcommittee's positions. Comparisons with prepaid delivery systems, geographic variations in rates of surgery, and historical trends all point to the fact that there is more surgery in the United States today than there ought to be. While experts may argue over some of the data and exactly what it means, the evidence seems clear to me.15
The Subcommittee reaffirms its previous findings that unnecessary surgery can be defined and deserves continuing attention whatever it is called.' The Subcommittee believes that attempts to use related terms appear to be only, diversionary and counterproductive.
The important point is to move toward determining the extent of unnecessary surgery and to take steps toward eliminating useless procedures which lead to wasted dollars and in some cases, needless deaths.
B. SURGICAL ABUSES AND STANDARDS
The Subcommittee hearings concentrated on gathering information and evidence concerning standards that are utilized in judging surgical abuse, negligence, and quality.
1. Abuses and negligence
On April 29, 1977, Chris 0. Stern, Executive Secretary of the Board of Registration and Discipline in Medicine for the Commonwealth of Massachusetts, testified concerning the case of a physician performing sur gery in Massachusetts. Following up a complaint from the Medical Division of the Department of Public Welfare, the Board of Registration and Discipline determined that the physician had committed gross misconduct in the practice of medicine, gross negligence on a particular occasion, and negligence on repeated occasions.'17
Eleven patient files were examined which involved both unnecessary andl incompetent surgery.
The unnecessary surgery was categorized as follows:
a. Surgery performed without appropriate medical treatment
having been tried first.
b. Two separate operations performed within days of each
other on the same patient when it appeared that there was no medical justification for not performing the second procedure
(luring the first operation.
c. An excessive number of surgical procedures performed on
The incompetent surgery involved:
a. The performing of five dilation and curettages (D&C)
when the physician had reason to believe that an infection existed
in the same area in which the operation was performed.
b. Four instances of possibly spreading infection by inserting
an IUD or performing a tubal irrigation when there was reason to
believe that there was an infection in the vagina.
is "Volume I1 Quality of Surgical Care," hearings Before the Subcommittee on Oversight and Investiga. tions. Committee on Interstate and Foreign Commerce, 95th Cong., 1st sess., October 6 and 28; November 1, 1977 at 227. [1 lereinafter cited as Volume 11 Surgery Hlearings.] Is Unnecessary Surger Report, supra note 1 at 39. 17 Volume I Surgery HEearings, supra note 7 at 82.
c. The repeated failure to obtain a pap smear prior to an opera,tion on the uterus and repeated failure to conduct a thoroughU physical examination prior to an operation or to record the results
of a physical examination in the hospital record.
The allegations concerning in competence and unnecessary su rgery on the part of Dr. Robert Breed at Revere M'\emorial Hospital were known as early as April 5, 1976.19 The Medicaid investigratingr unit and the Commonwealth Health Agencies M\onitoring Prorram
(CHAMP) had determined that cases by Dr. Breed "exhibit practice patterns that fall outside the accepted stand ardls of surgical and patterns that fall outside the accepted standards of surgical and medical practice." 20 Dr. Breed had his license revoked by the Massachusetts Board of License on February 17, 197821
Several issues are raised by this case. One is- the length of time needed to resolve such a situation. The Subcommittee believe's it is excessive to allow a physician, who was determined in April of 1976 to be operating outside the bounds of accepted medical practice, to continue to practice medicine a year or~ two beyond that determination.
A related issue concerns the existing mechanisms f or bringing matters of this type to the attention of officials who may be in a position to deal with them. A key question is whether or not judgements or suggoested disciplinary actions by responsible physicians acting in an official capacity can be accomplished without fear of professional reprisals. This issue will be discussed in greater detail relative to the Critical Incidents Study.
A third issue is the need for developing measures of outcome of care that will highlight deviations from the normal practice of medicine or surgery. This question will be discussed in detail under the sections relating to the Critical Incidents Study and the Institutional Differences Study.
Another series of examples of incompetent and unnecessary surgery was presented to the Subcommittee by Mr. William Gaines who performed undercover work for the Chicago Tribune.
He had himself hired as a j anitor at Von Solbrig Memorial Hospital in Chicago, Illinois. In that capacity he encountered cases of families of public aid recipients being subjected to tonsillectomies all on the same day. Two families of five children each had their tonsils removed within a period of two weeks.3 On May 15, 1975, five brothers had their tonsils and adenoids removed and among them were three circumcisions, repair of an umbilical hernia, and the removal of a cyst..
This same physician, Dr. E. 3. Mirmelli scheduled the six children of Mrs. Canary Fipps for tonsillectomies after she had refused permission for him to go ahead with these operations. She related that Dr. Mirmelli got angry and said "you don't care nothing about your children if you don't have their tonsils out." 24
Mr. Gaines in his testimony pointed out that the costs of the hospital stays of patients of Dr. Mirmelli were often increased by many tests. One unexpected test was that children were always given electrocardiograms (EKGs) when they came in for tonsil surgery.
1"Id. at 89.
21 Telephonic communication to Subcommnittee, October 25, 1978. 22 Vol. I Surgery Hearings, supra note 7 at 3.
23Id. at 4.
Id. at 4-6.
Mr. Gaines testified, "Our experts laughed at the idea of giving six
year olds EKGs." 25
Again, the question was raised concerned the ability of an existing state ao'ency to deal effectively with the problems of practitioners performing in an incompetent manner or beyond the bounds of conventional medical practice. It should be pointed out that John M. Fultz, M.D., Medical Coordinator for the Illinois Department of Registration and Education, wrote to the Subcommittee concerning the status of Dr. Mirmelli as of May 17, 1977. At that time, he indicated that the investigation was currently in active status.'
Also noteworthy is that Dr. Mirmelli performed these questionable procedures in 1975 and subsequently, during 1976, Dr. Mirmelli was reported to have received $119,000 from the Medicaid program. This certainly raises questions about the monitoring activities and utilization review activities performed by the State Medicaid Agency. Questions of peer review activities are raised because at Von Solbrig Hospital the 3 person Tissue Committee was headed by Dr. Von Solbrig along with his wife and secretary. Quality control review must also be examined since the hospital was accredited by the Joint Commission on Accreditation of Hospitals in 1973 for a period of two years.7
Congressman Henry Waxman (D-Calif.) questioned state actions in revoking the license to practice medicine of an individual such as Dr. Mirmelli. He noted that the Board of Medical Examiners in the State of California had never revoked a license of a physician for incompetence. He pointed out the case of Dr. Nork who had been involved in over $30 million of medical malpractice cases and was determined to have performed surgery under alcoholic and narcotic influences. Even Dr. Nork continues to retain his license to practice medicine.
The actions taken by Boards which have the ability to license and discipline physicians, based upon these cases in Massachusetts, Illinois, and (alifornia, suggest that the entire process of reviewing the continuing competence of physicians is time-consuming and insufficient.
Chairman Moss questioned the powers of the medical societies to discipline a physician. He pointed out that such organizations are relatively powerless, their only recourse being censure and the removal from the local medical society. Dr. Claude Welch in his testimony corroborated that position.
The Subcommittee found the evidence in the Mirmelli and Breed instances reinforced evidence of cases in Florida and California presented to the Subcommittee during the 94th Congress.2 (e.g. Valenzula and O' Grady).
Beyond negligence and abuses, the Subcommittee focused upon acceptable standards.
One example of standards of care is the open heart surgery program that existed at Malden (Massachusetts) Hospital. In a study con(lucted by the American Association for Thoracic Surgery (AATS) all
2, Id. at 7.
2 1(. at 9.
'1 1 d. at 34.
2 1d. a? 13.
23; iPv Ready for National health Insurance: Unnecessary Surgery," hearings before the Subcom,iee i ( OVersight and lIv 1s, figaltionl s, (ommit Tn i e on 1n11erst ate and Foreign Commerce, 14th Cong., 1st sess., Ju ly 15, 17, 18, and September 3, 1975. 11 Lercinalter cited as Unnecessary Surgery Hearings.]
cases of open heart surfer from 1968 to 1975 were examinile ." It was determined that 49 percent of thie open heart surgery cases resueltd in patient deaths.1
The AATS concluded* * the results do not compare favorably with average reported results of comparable cases in the United States for the same period of time.
Meanwhile, in nearby M\ount Auburn Hospital in ('ambri(lge, Massachusetts mortality rates were approximately 22 percent awl open heart surgery at major medical centers in Boston, Massachlsetts were described by Dr. Claude Welch to be close to or slightly lower than 10 percent The Malden situation led the Massachusetts Board of Registration and Discipline to consider the option of limiting the scope of licenses of med(lical pracittioners.
A broad policy issue that emerges is how much the public should know about the quality of care given by practitioners and institutions. It would seem that a person living in the greater Boston area nee(ling open heart surgery might like to know that within a 10 mile area are three hospitals that have death rates for that procedure of 49, 22, and 10 percent respectively. Solutions relate to requiring profiles in the PSRO program or some other program and will be discussed in
greater depth in the PSRO section.
A. Institutional differences study
Dr. William Forrest, Associate Professor of Anesthesiology at Standford University School of Medicine, identified through the Institutional Differences Study that there were several factors that correlated strongly with differences among hospitals and these
correlations can be matched with patient outcomes."
That endeavor under the auspices of the National Academy of Sciences consisted of two major studies. The first study examined variations in post surgical deaths and morbidity among short term hospitals in the United States. Data abstracted from patient records after discharge were used to compute indirectly standardized mortality rates for 314,000 patients in 14 surgical categories from 1224 hospitals. The second study collected more intensive data from 8593 patients in 15 surgical categories from 17 short stay hospitals.34
The objectives of this work included developing a method for measuring the quality of surgical care in individual hospitals. Post operative morbidity and mortality were used as outcome criteria and a comprehensive set of patient variables to compensate for differences in patient mix in the individual hospitals.
Dr. Forrest, Director of these studies, summarized one of the aspects of the individual hospital analysis in response to questioning from Congressman Albert Gore (D-Tenn).
Mr. GORE. * as I also understand it your investigation indicates that if I am a patient and I need a particular kind of operation my chances of dying from that operation may be two to three times greater depending upon the hospital I choose to go to, is that correct?
Dr. FORRECT. "That is correct-two times." 35
a0 Volume I Surgery Hearings, supra note 7 at 64.
a3 Id. at 65.
32 Id. at 69.
a Id. at 37 -41.
34 Id. at 43.
35 Id. at 39.
In the extensive study portion of the National Academy of Sciences work, significant differences were found for certain operations. These significant differences include, "~ * the ranking of hospitals for biliary tract surgery, fractured hip with no trauma, surgery of the large bowel involving cancer, amputation of the lower limb,*** and for surgery of major abdominal arteries." 36
The study found that 17.8 percent or 218 of the 1224 hospitals involved in this study had standardized ratios greater than two; meaning that they had at least twice as many deaths for a certain procedure than would be expected given their mix of patients .
Dr. Forrest concludedIt is obvious from previous testimony we heard today that we must look for a monitoring system which hopefully is not too costly and that will give us a guage of what is going on in acute care hospitals in the Ujnitedl States. I would like to suggest that we consider as a national policy issue the question of a national monitoring system for acute care hospitals tailored after our methodology.38
B. Critical incidents study
Dr. Charles Gardner Child, at the time of the hearings Professor of Surgery at the University of Michigan, served as chairman of the National Academy of Sciences' study. Dr. Child also chaired a subcommittee concerning quality that was part of the American College of Surgeons and the American Surgical Association's major work the "Study of Surgical Services in the United States" (SOSSUS)39
That portion of the SOSSUS study evaluated the quality of surgical services in this country.4' A critical incident was defined by Dr. Child as "tany surgical misadventure which occurred during the course of one patient's hospitalization. This could vary all the way from death to a bad cold after having your tonsils taken out."1 41 Judgments were made on identifying whether a critical incident was surgeon related-such as technique, post-operative care, preoperative care, judgment, etc. Other cat-egories included hospital related and community-related. One hundred and fifty-three hospitals joined the study with ninetyfive hospitals finally reporting. During the period of this study close to 1,500 critical incidents were reported. These included 245 deaths; of this number, 160 were judged non-preventable and 85 were judged preventable."
Dr. Child testified that when the etiology of 576 preventable incidents was examined, it was found, "~ * that surgeons themselves believe that 78 percent of their misadventures were probably related to some attribute which we have labeled surgeon ratedd" "
The study concluded that all States should support a program of professional quality assessment by providing protective legislation which would permit hospitals and surgeons to participate in studies of this kind without fear of ~itigation. Dr. Child concluded that he believed that a broad studyy,,f this sort could serve as a base upon
3S Id. at .10_40.
8Id. at 19.
4Id. at 20.
4Id. at 20-21.
43 Id. at 21.
44 Id. at 22.
which American surgery can begin to build methods of critical analysis of the products it makes available to the American public.
The Subcommittee is impressed with the significance of the results of this study and concur with the findings and conclusions reached by this surgical group.
The study further suggested that surgical reporting of critical incidents could be made a requirement for a hospital's accreditation by the Joint Commission on Accreditation of Hospitals. The Subcoinmittee not only believes this to be a suggestion of merit but that such a program should also be considered as a requirement for the PSRO program.
The testimony presented to the Subcommittee concerning quality of surgical care leads to the following conclusions and recommendations:
1. The Subcommittee believes monitoring is inadequate, and
the public is unaware of the risks.
Effective monitoring would allow for the measurement of
quantitative outcome differences among institutions. The Subcommittee recommends that such data be collected and made
2. Monitoring of care can identify surgical procedures that
end in misadventures.
Currently PSRO's have a mandate to measure care for in(lividual institutions within specific geographic areas. However, there is no mandate to improve performance by some specific amount or proportion nor is it a requirement to measure baseline and post-implementation performance to see whether any change, favorable or unfavorable, was achieved.4' The Subcommittee
recommends that this deficiency be corrected.
3. Quality of surgical care is diminished by the extent of unnecessary surgery that has been catalogued. The Subcommittee believes that unnecessary surgery leads to unnecessary disabling
injuries and deaths, and this is inexcusable.
Also, the Subcommittee finds that critical incidents (misadventures) are judged to happen with frequency. Surgeons themselves believe that a third of these misadventures were preventable, with 78 percent of the preventable misadventures "surgeon related." Such misadventures also caused prolonged
4. The SOSSUS study of critical incidents did not present
morbidity and mortality rates. The Institutional Differences Study did and found significant differences between hospitals sometimes in the range of twice as many deaths at institution A as at institution B after appropriate adjustments for differences in patient mix. The Subcommittee finds these rate variations to be a substantial problem. Unfortunately, the SOSSUS study did not present the rates of advers outcomes.46 (p. 22) rhis was a deficiency in the portion of the SOSSUS (C'ritical Incidents Study) dealing with the quality of care but it nevertheless points
out the need for such information.
46 Id. at 4"-46.
Id. at 23.
3-855---7 8- 3
There 1oire, ti e Subcommittee recommends that Congress consider legislation and HEW establish programs that willa. Call for professional quality assessment programs;
b. Establish a national data bank to record critical incidents
and their causes;"
c. Require establishment of a program for measuring mortality
and morbidity differences by procedure for those hospitals
which choose to participate in Medicare and/or Medicaid; and
d. Establish immunity for institutional evaluations and
critical incident studies (Massachusetts has recently passed
C. Examination of Tonsillectomies
One of the surgical operations identified as particularly susceptible to unnecessary procedures during the first set of hearings by this Subcommittee was tonsillectomies.*4
The Subcommittee therefore endeavored to examine this procedure in gr-eater detail. Dr. Charles D. Bluestone, Director, Department of Otolaryngology, Childrens' Hospital of Pittsburgh and Professor of Otolaryngology, University of Pittsburgh School of Medicine testified before the Subcommittee on April 29, 1977 that 786,000 tonsillectomies were performed in 1975. Dr. Bluestone testified that "the majority of children who are subjected to tonsil and adenoid surgery have problems or findings whose favorable response to surgery is at best uncertain and controversial."1 49 Dr. Bluestone described the prospective controlled clinical trials being carried out under the auspices of Childrens'
Hosptalof Pittsburgh, Pensyvania. Of the group involved in this study, 60 percent of the children (10 not initially fulfill the criteria for either tonsillectomy or adenoidectomy. In addition, the Pittsburgh study followed 102 referred children.50 Each of these children would have satisfied the criteria for entering the clinical trial portion of this study except that medical histories were not readily available to be documented. This group was therefore followed closely and, during a full year of observation, 80 percent failed to dlevelol) enough illness to satisfy the tonsillectomy criteria.
Based upon these results, Dr. Bluestone concluded] that in most of the conditions for which tonsillectomy or adenoidectomy are carried out, the efficacy of these operations remains uncertain.5' He indicated that preliminary findings have shown that tonsillectomy should not be recommended or undertaken on the basis of recurrent throat infect ion if the history is not well dlocumnentedl.5
Dr. Bluestone further elabor-ated on the population group that was included within the study. This was a group of approximately 850 patients who had been seen previously andl were sent specifically to Childrens' Hospital to have the operation or to be evaluated for the operation. The study of that group found that 75 lpercenlt never had enough diseasee to warrant the p)Focedlure.54
47 I. ut, 2-5.
48 Unnecessary Surgery lfeariiis, supra note 29 at t8. 4V Volume I Sm,,vir Iieat i,_-, ttpra n t 7 at 101-102.
5 1(1. at 106-107.
51 Id. at 112.
~A Ud ut 2
When asked if the evidence acquired by the Pittsburgh stndly could be applied nationally, Dr. Bluestone opined:
If we were to extrapolate the information we see in out stu(dly probably half of them (400,000 of 800,000) may not be beneficial but we have no idea why the operation is being done throughout the whole country.
On our own service it seems half of them we used to do are no)t inecessary at the present time.55
In many ways this study confirms the testimony of Dr. George Zuidema in the previous hearings of the 94th Congress. At that time, Dr. Zuidema testified that tonsillectomies as a routine smlrgical procedure have become highly questionable and should( be categorized as "operations where indications are a matter of difference in judgment and opinion among experts." Dr. Zuideina further testifiedSome segments of informed otolaryngological opinion would hold that a number of tonsillectomies could be avoided with little hazard to the child or the young adult many of which are performed by non-certified otolaryngologists.0
The Bluestone evidence supports the contention that many tonsillectomies could be avoided with little hazard to the child. The efficacy of performing such operations should also be questioned. The Subcommittee believes this conclusion leads to the need(1 for requiring that prospective pre-set criteria be utilized in highly questionable surgical procedures. The Subconmmnittee believes that the federal government should not pay for surgical procedures that (o not meet established pre-set criteria.
Dr. Julius B. Richmond, Assistant Secretary for Health of HEW and Surgeon General, testified before the Subconmmittee on November 1, 1977. Dr. Richmond indicated that he hoped there would be movement toward pre-performance review rather than post-operative review. He testified: "This needs to be coupled with a much clearer definition of criteria." 58
Congressman Doug Walgren (D-Pa.) pressed both Under Secretary Champion and Dr. Richmond on the issue of precertification based on criteria for tonsillectomies.
Congressman WALGREN. * when you have a procedure like tonsillectomies which account for millions of dollars for surgery each year and there are strong indications that they may be done much more routinely than they should be, isn't that one of the first priorities of HEW to conduct a study that would get at that question?
Mr. CHAMPION. I would think that kind of study is essential.
Dr. RICHMOND. Mr. Walgren as a pediatrician, I have been particularly sensitive to the tonsillectomy issue of over three decades. I think we would have a good basis for establishing criteria on the basis of, not only the work of Drs. Paradise and Bluestone, but other people who have worked in this field, going way back to the 1930s. . .
I think we do have the basis on which to look very very critically at the pcifor mance of this procedure.
Mr. WALGREN. I would only like to encourage you to conduct the kind of studlics at HEW that will not be conducted by the medical profession, foi example, those that go behind commonly accepted medical practice. I think it is important that you bring into effect controls at present to get the whole country to commonly accepted medical practice.
Mr. CHAMPION. We agree with you on that.59
56 Unnecessary Surgery HIearings, supra note 29 at 33-34. 57 Volume II Surgery Hearings, supra note 15 at 247. s58 Id.
5 Id. at 249-250.
The information presented by Dr. Bluestone, and acknowledged by Dr'. Richmond, concerning regional variations further reinforced the points raised in the previous Subcommittee report. At that time the area-wide variations presented by Dr. John E. Wennberg showed the probabilities of tonsil removal within geographic areas of Vermont to be from 8 percent to 62 percent.60 Further, the Federal Employees Health Benefit Program Utilization Study in January 1975 showed that tonsillectomy data varied from the probability of having a tonsillectomy being 41.3 percent for Blue Cross subscribers to 10.5 percent for prepaid group subscribers.*6
Dr. Bluestone presented national aggregated data that showed the rate of operations per 100,000 population to range from 84.6 in the South to 1:37.5 in the North Central part of this country.62 The Subcommittee finds that these small area and national variations are inexplicable in relation to medical needs. The magnitude of the problem, of tonsillectomies and adenoidectomies requires immediate governmental attention. The Subcommittee recommends that the Department undertake a baseline minimum of pire-set criteria to be implemented immediately and documentation of such criteria be a precondition for federal reimbursement.
D). Examination of Hysterectomies
The Subcommittee also examined another controversial procedure, hysterectomy. Testimony was received from Dr. John P. Bunker, Director of the Division of Health Services Research at Stanford University, and President of the Division of Licensing for the Board of Medicine Quality Assurance for the State of California. Dr. Bunker testified that, in this country, something on the order of 40 percent of women will have had a hysterectomy by age 65.631 Dr. Bunker has in the past published comparisons showing significantly more hysterectomies in this country compared to England.
Dr. Kenneth J. Ryan, Chairman of the Department of Obstetrics andl Gynecology, Harvard University School of Medlicine, and Chief of Staff, the Boston Hospital for Women, testified on May 9, 1977, that the number of hysterectomies (lone in this country at the rate of 647 per 100,000 females of all agres, is "staggering.") 65
Dr. Ryan described the standards by which one judges the need for a hysterectomy:
The judgment or need for hysterectomy need not be ambiguous or complex. I think most responsible physician specialists competent to judge the health impli(ations to the patient would agree on indications which include involvement of, the uterus with cancer of the womb, severe infection, large fibroid tumors, and severe endometriosisA61
He then went on to testify as to when hysterectomy is -not indicated:
I think removal of the uterus for. contraception alone or for prophylaxis against future disease in the absence of uterine pathology is an excessive treatment. I do not think it can be considered superior to other measures on medical, social,' humanitarian, or economic groun(1s. That goes for the prophylaxis of cancer ,IS We11.17
60 Unnecessary Surgery Report, supra note t at. 12.
6Volume I Surgery Hearings, s~upra note 5 at 114,
63 Id. at 138S.
64 J1. P. Bunker, ",-urgieul Manpower, A ('omup~idoi of O1perat ions auid Surgeons iii the United States, Fngland, artd Wells," Newx bn:glaid Journail of Med (icinie. 285: No. 3 (.January 1970 at 1.3.5-44). 65 Vlm iSreyHaigsir oe5a 19
66 Id. at 2"Ao
,- I d.
Dr. Ryan further testified that the number of surgical procedures performed in an institution where there was insufficient pathology to justify the procedure should be a guideline to the quality of the care provided in that institution.68
Dr. James Sammons, Executive Vice President of the American Medical Association testified that two factors are responsible for the growth of hysterectomies in recent years: 69
1. the use of hysterectomy as a means of sterilization; and
2. the use of' hysterectomy as a cancer prophylatic.
He states that if a woman wants such a l)rocedure and,
* is happier for having it, is it necessary or an unnecessary operation? Clinically that is approached on a pathological basis, it is not necessary, medically
-that is approached on a patient b)asis with the patient fully informed of all of the consequences, I would say that it is beneficial and therefore is necessary.70
It is difficult to comprehend the logic of this position of the American Medical Association, particularly in comparison with testimony presented by medical experts. Such description raises further questions because of the document prepared under the auspices of the American Medical Association itself, namely the criteria to be used by PSROs in relation to the indications for hysterectomy.
That document, "Sample Criteria for Short Stay Hospital Review," is intended for use by medical audit and utilization review personnel in a hospital. For female surgical sterilization, hysterectomy "with no other indication for hysterectomy" has a screening benchmark of zero. Thus, the American College of Obstetricians and Gynecologists developed a standard whereby they believe hysterectomy for sterilization alone should never be done.7"
The testimony of Dr. Sammons, himself, discusses the issue of criteria where he states: "There are indications for surgery that are taught beginning in medical school." 72
Cong.essnian Andrew Maguire (D.-N.J.) questioned Dr. Ryan
concerning the performance of hysterectomies for prevention of cancer. Dr. Ryan replied: "It is not something I woul teach medical students I do not believe that it is practiced in our institution." 71
Dr. Sammons answered Congressman Albert Gore (D.-Tenn.) on the use of hysterectomies for sterilization:
* it has been my experience that women who truly have 'pregnaphobia' and thank goodness that that is a very small percentage but people who truly have it even knowing that their uterus is in place and that a piece of tube may still be present, albeit well ligated at the ends or even tucked into the broad ligament, that simply does not relieve sometimes their anxieties." 7
Dr. Sammons then goes on to indicate that in Los Angeles County a study demonstrated that 20 percent of the hysterectomies were (lone for sterilization purposes.70 In that study, however, Dr. Lester T. Hibbard wrote in the "American Journal of Obstetrics and Gyne68 Id. at 351.
69 Id. at 265.
70 Id. at 265-266.
71"Sample Criteria for Short Stay Hospital Review," American Medical Association. Chicago. iW., .une 1976, at M1.
72 Id. at 322.
73 Id. at 352.
7 Id. at 309.
75 Id. at 310.
cology," that over a third of the patients receiving a hysterectomy had originally requested tubal sterilization. He further wrote that:
Many patients requesting tubal sterilizations had been persuaded to accept hysterectomy either because of the enthusiasm of the attending physician or because of coexisting minor degrees of pelvic relaxation or a stress incontenance which might benefit from additional operative procedures to be done at the time of hysterectomy.76
Dr. Hibbard further wrote in that article that by any yardstick, hysterectomy is significantly more hazardous than tubal sterilization.
In terms of time and money an elective hysterectomy is an expensive luxury as compared to tubal sterilization. The direct surgical and hospital expenses of an average patient are four to five times greater. To this must be added the costs of convalescense, and lost income.77
Dr. Hibbard concludes his paper with the following sentence: "In our experience, the case for routine elective hysterectomy for sterilization has not been made."'78
The Subcommittee agrees with this conclusion. It believes the position of Dr. Sammons representing the American Medical Association is arbitrary, capricious, and out of synchronization with the appropriate and conventional practice of medicine. The position is unsupported by any studies and is further unsupported in light of the AMA's own expert group of obstetricians and gynecologists. Use of hysterectomy solely for sterilization or for cancer prophylaxis must be deemed unnecessary. This conclusion further lends support to the previous Subcommittee report which recommended the need for second opinions before such elective )rocedures.
E. Dr. Emerson's study
In a letter dated May 10, 1976, from Dr. Sammons to Chairman John E. Moss, Dr. Sammons attached a critique79 of the Subcommittee's 1976 report. As part of his refutation of the Subcommittee's figures, Dr. Sammons cited "The Study the Subcommittee chose to Ignore." 80 That study was done under the auspices of Dr. Ralph S. Emerson, President of the Medical Society of the State of New York. That study reported: "the incidence of unjustified surgery in the 833 consecutive cases was less than one percent." 81
It should be noted that the Emerson study was published subsequent to the first Subcommittee report. Upon receiving this study by the New York State Medical Society, the Subcommittee endeavored to examine the validity of the data since it v s at such variance with other testimony andstudies.
Dr. Ralph Emerson was invited to testify before the Subcommittee at the request of the Minority Members. In addition, the Subcommittee asked two respected physicians with expertise and previous work of their own in tonsillectomies and hysterectomies, to review portions of the Emerson data.
Dr. Emerson testified before the Subcommittee on October 6, 1977. He reiterated his findings that the overall incidence of unjustified
76 L. T., Iibbard, "Sexual Sterilizat iou by Elective vst erec y," A uerivau .Jotrtal of Obs el rics and Gynecology, Vol. 12, No. 8 (April 15, 1972) 1076-1083.
77 Id. at 1078-1079.
78 Id. at 1083.
79 Volume I Surgery Hearings, supra uiote 7 at 212-255.
0 Id. at 229-231.
0, Id. at231.
surgery was less than 1, percent wliii irieWs;ured I against, soun I p~re-set standards." 12
The Subcommittee applied the pi-e-set Emerson criteria in ot(Ier to
evalate he ethooloy and. results of the Emerson study. Congr-essman Toby Moffett (D.-Conn) questioned Dr. Einerson on the use of his criteria. One hospital, inlcludled in the study, LongIsland Jewish, submitted data on January 11, 1 977.8: Congressman Moffet t asked Dr. Emerson whether Long lIsland Jewish Hospital use(l1 the Emerson p~redlictor's or other criteria. Dr. Emerson replied: "* * can I verify that they used the specific indications for hysterectomies? I can't."
Dr'. Emerson was asked specifically to reconcile the findings reported by him in his New York Medical Society study with the findings of Dr. Frank J. Dyck, thie Saskatchewan gynecologist who evaluated the medical records for the Subcommittee. Dr. Dyck has studied hysterectomies extensively in Canada. Dr. Dyck reviewed the records of five of the twenty-eight hospitals covering 190 of' the 1900 hysterectomies in the Emerson study. 85 86
Dr. Emerson acknowledged that the review of the medical records at these hospitals was not done by a physician but by the medical data analyst. The results for the five hospitals as used in the original Emerson report were zero unnecessary hysterectomies. These five hospitals accounted for more than 10 percent of the entire population of hysterectomies studijed. When presented with this information at the hearings, Dr. Emerson testified:
* This is the first I heard of it last night, I was shocked because I thought from the people who were there and all the time that we had talked that we would get the message across that there would be the screening and that the physicians would then carry it through the normal procedure of the medical care evaluation committees.87
Chairman Moss also w as shocked at these r-evelations, however, from a different -prospective.
Doctor may I join you in expressing shock that you come before a Committee of the Congress and charge that "in addition the reports from your subcommittee * are also not valid because these statistics were based on the false premise and conclusion"~ in other words you rebut our study which was based on several studies and several sets of conclusions with a rather imperfect study of your own with a lack of attention to the components that went together to make-up the whole. There was a lack of supervision on your part to know that your report reflected accurately what you recite as the conclusions that should pr operly be drawn from the data.
I do not treat lightly the strong denunciations made of the Subcommittee report when the fabric against which you place it appears to be rather faulty itself.851
Emerson upon reviewing specific cases from the five hospitals agreed with. the Dyck assessment that certain operations were unjustified-8 Chairman Moss in questioning Dr. Emerson pointed out that the Dyck report found 16 percent of the procedures w~ere classified as not justified.90 Also Dyck concluded that up to 43 percent of the procedures
82 Vol. 11 Surgery hearings supra note 15 at 15.
8Id at 27.
84 id. at 28.
55 Id. at 37.
B6 Id. at 41-63.
87 Id. at 39.
98 Id. at 39-40.
sQ Id. at 108.
00 Id. at 110-113.
could not be justified based upon the criteria established by the New York State Obstetricians and Gynecologists. Dr. Emerson interpreted the 43 percent to mean those cases which did not pass through our screen, "these are the cases that are subject to review." "They are not unnecessary surgery until they have been reviewed by the physicians and the medical care evaluation system." 91 Physicians and the medical care evaluation system did not in fact review the 43 percent, hence, the Emerson protocol was again not fulfilled.
Based upon the concurrence of Dr. Emerson that his study was indeed faulty and that unnecessary surgery within his program for hysterectomies was at least 16 percent rather than the zero percent that he reported, the Subcommittee concludes that there are no scientifically valid studies of unnecessary surgery that are in the zero to one percent range as reported by the AMA and Dr. Emerson.92 Rather, unnecessary procedures are again found to be in the magnitude of the original Subcommittee report of 17 percent. In fact, for a procedure such as hysterectomies, seventeen percent would appear to be conservative.
The other major area of investigation by the Subcommittee for replication of the Emerson study was tonsillectomy and adenoidectomy This review was done by Dr. Charles Bluestone and is summarized on Table 2 of the hearings.93
Dr. Bluestone found that 54 percent of the patient records were insufficient, for a decision to be made concerning the necessity of the procedure and for an ad(litional 23 percent of the cases there was insufficient information for either tonsillectomy or adenoidectomy. when one of the procedures was reasonably indicated. In 15 percent of the procedures, there was a reasonable assumption of need for the procedure and in 8 percent the operation was clearly not indicated as derived from the patient recordIs.94
Looking only at those procedures that were (eemed reasonable and those that were not indicated, there were eleven of which seven were reasonable and four were not indicated. Hence, of those cases where there was sufficient documentation, over 30 percent of the procedures were found not to be indicated.5
It is clear that there needs to be greater emphasis on the problems of unnecessary surgery. The Subcommittee finds sufficient evidence for tonsillectomy, adenoidectomy, and hysterectomy to determine that the public is not sufficiently infoImed nor protected from unnecessary procedures.
The Subcommittee concludes that the evidence it has gathered warrants intensive action for these proce(lures. We therefore recommend that HEW institute a programm wherein payment is not male
for these procedures under Medicare or Medicaid unless patient medical records demonstrate the procedure has met the appropriate pre-set criteria. Further ore, the Subcommittee recommends that the Department of Health, Education, and Welfare establish a muandatory second opinion progi-aIi for these elective procedures.
92 Id. at 113.
9 Id. at 71.
V. SECOND CONSULTATIONS
During the hearings of the 94th Congress and subsequent report extensive examination took place concerning the concept of providing second consultations to a patient before elective surgery. Several witnesses suggested that surgical abuse could be reduced by additional consultation. Physicians including Dr. George Zuidema, Dr. Sidney Wolfe, Dr. Eugene McCarthy, and others all endorsed the need for second consultations.96 The result of that investigation led the Subcommittee to recommend that HEW promptly mandate second professional opinions to confirm the need for elective or non-emergency surgery under Medicare and Medicaid. Secondly, the Subcommittee recommended that such a program be carefully evaluated to determine the impact upon quality of care, containment of health care costs, percentage of surgical procedures deemed to be unnecessary, and cost of administering such a program compared with the cost paying for unnecessary procedures.97
Hale Champion, Under Secretary of Health, Education, and Welfare, in testifying before the Subcommittee this year, acknowledged that the Subcommittee has been urging HEW to adopt an aggressive policy of second opinions and announced the establishment of an effort to encourage the American public and especially government beneficiaries to seek second opinions8 The Department indicated that the State of Massachusetts would begin requiring Medicaid patients to obtain second opinions for selected conditions before surgery. HEW indicated it would monitor this progress and if voluntary second opinions were proving ineffective in reducing high levels of surgery, the Department "... will be prepared to require second opinions for selected non-emergency procedures such as tonsillectomies, hysterectomies, and cholecystectomies." 19
The Massachusetts mandatory second opinion program under Medicaid has been operating since March 1977. As of June 1978, 2,720 patients were reviewed for surgical procedures under this program. Of those involved in the consultation program, the rates of denial for elective surgery ranged from 3 percent for cholecystectomy to 20 percent for meniscectomy. Except for cholecystectomy all other procedures exceeded 10 percent for denials for the surgical procedure.'00
Subsequent to the testimony by Under Secretary Champion, the Department has initiated steps to advance the second opinion program. In May 1978, HEW provided program guidance for the development of local voluntary second consultation programs. The program includes public information activities, a nationwide referral mechanism, demonstration projects, and an evaluation project.'0'
The second opinion surgery programs have also grown within the private health care financing sector. Reimbursement for second opinions for elective surgery is now offered through twenty-seven Blue Cross and Blue Shield plans, reaching about 9 million subscribers.02
Unnecessary Surgery Report, supra note 1 at 12-13 07 Id. at 6.
Is Volume II Surgery Hearings, supra note 15 at 228.
100 Material supplied by HEW to Subcommittee.
101 HEW Initiating Steps To Enhance Second Opinions on Elective Surgery in May, 1978 (press release)& 102 Hospitals, Vol. 52 (October 16, 1978) p. 21.
Under these plans all charges related to the second opinion, including the consulting specialists fees, X-rays, and laboratory tests, are covered. Blue Cross and Blue Shield Associations have thus far reported that few patients have taken advantage of the free second opinions which they claim can save from $750 to $1500 in hospital costs for each operation not performed.
To date, the utilization of second opinions has been low and the time in which they have been in existence has been too short to establish any useful evaluations. The Subcommittee is concerned about this low utilization and believes HEW should examine the factors contributing to this situation.
VI. COST OF UNNECESSARY SURGERY
In spite of the potential impact on the number of unnecessary surgeries that may have resulted from publicity steming from the orig-inal Subcommittee work and specific follow-up activities that have been promulgated by the HEW, as well as private insurance carriers; the overall reduction in the rate of unnecessary surgeries appears to be small. Thus, unnecessary surgery~ remains a monumental problem for the American public. For example, even if unnecessary surgeries for 1977 are in the 12 to 15 percent range rather than the 17 percent level, then unnecessary surgeries for 1977 would still be between 1.9 million to 2.4 million procedures.
Usiny an estimate of $1,900 for 1977 ($1,650 was used for 1974), the public again spent close to $4 billion dollars for unnecessary procedures. If mortality rates for these procedures remains close to 5 per 1,000 then these unnecessary procedures led to over 10,000 deaths in 1977.
The Subcommittee continues to find this magnitude of unnecessary surgery to be intolerable. We recommend that HEW undertake immediate steps to require second consultations in those areas that are most highly elective for surgery such as tonsillectomies, and adenoidectomies, hysterectomies, and cholecstectomies.
VII. PROFESSIONAL STANDARDS REVIEW ORGANIZATIONS
TJhle Subcommittee in its report of January 1976 concluded that "PSROs are not a viable substitute for mandated utilization review programs."1 103 The report suco ested that the impact of these functioning PSROs upon unnecessary surgery needed to be examined fully before being accepted as a substitute for requirements under Medicaid utilization control.0 The Subcommittee recommended that, since PSROs were being implemented at a pace far slower than Congress intended, H-EW submit a revised timetable for implementation and that the lack of emphasis by HEW in requiring PSROs to dIevel op qu allity control programs from non-hospital care be corrected immed intely.05 In add(it ion, the Subcommittee recommended that HJEW require all designated PSROs to submit a plan for determining that care be provided in the most cost effective manner.00
103 Utiiaicossary Surgery Report, supra note 1 at 40,
104 Id. at, 6.
105 Id at 7.
106 1d. at 8.
Following the Subcomnmittee's report, ain atteml)t was in:a le to determine oil a detailed basis how well PSlt)s imlacte(l ipolli I llnnec(ssary procedures. The Siubcommittee soli ite a(nd recoivI a
report fiom a Study Group at Yale university Scllool of M\ediie entitled "Background Report on Professional Standards Review Organizat ion." 10?
In the process of this study, Prolfessor John D. T'llompson, et al., uncoveredi( a major flaw in the adinitM*,ration of the PSRO() review. The PSRO, when it determined( that a hospital stay was uinnccessary or inappropriate, place(l a hospital at risk for payinent deli al. l1owever, the l)physician who initiated such a stay was not at risk for his )payment. HEW (did not believe this to be the situation, but, upon investigation, d(letermined the finding to be accurate. Under Secretary Champion testified that when a 1)procedure was determined to be unnecessary, under Part B of Medicare, HEW had no evidence that the carrier would stop payment to the physician.10s
Mr. Robert Derzon, Administrator of Health Care Financing Administration testified:
I think that your information (the Subcommittee's) is essentially correct. I can tell you that that situation is one in which I personally feel a great sense of unfairness. I think it is unfair to essentially penalize the hospital and not penalize the physician who has made these inapprop iate decisions.
My plan is to take a look at both, that is to look at this situation to find out whether or not there are ways in which we can coordinate the denial process and in fact we have the authority to no longer pay an extra benefit to a physician if we have deemed his work to be unnecessat y.09
The Thompson study focused on the present or potential effect of PSROs on unnecessary hospital admissions and unnecessary surgery. Specifically the Study Group examined the major programs for quality assessment used by PSROs; first, activities in concurrent and preadmission review; second, medical care evaluation studies (MNICE); and third, profile analysis."0
The Thompson group recommended that pre-admission certification be required for all elective surgical admissions of federal patients and that denial of coverage be applied equally to physicians as well as hospital services delivered in cases where excessive or inappropriate care has been detected."'
The Study Group examined MCE's which are to evaluate current local practice. Thompson found that none of the PSROs surveyed used the results of MCE's as a basis for setting priorities for concurrent review activities. The Study Group recommended 1) that PSROs become involved in the selection of MCE study topics for delegated hospitals, 2) that PSROs require surgery related studies, and 3) that these studies be used to focus and evaluate concurrent review efforts. 112
The third component of the PSRO review system is profile analysis. Such analysis can be used as a means of evaluating the impact of PSROs on utilization by identification of atypical patterns of care.
107 PSRO Report, supra note 3.
10s Volume II Surgery Hearings, supra note 15 at 267.
i0 PSRO Report, supra note 3 at 5.
M Id. at 22.
The Thompson study found that PSROs had been discouraged from performing profiles pending establishment of national guidelines. It recommended that profile analysis be given a high priority, that, profiles be generated in a manner which allows an epidemiological perspective so that utilization and costs of services can be related to the population served, and that data for cost analysis be developed in order to give priority to the cost benefit aspects of the review system."13
The Subcommittee concurs with the findings and recommendations. of the Thompson report concerning PSROs. It is apparent that the PSRO program has still not moved toward the status and goals, intended when enacted by Congress in 1972. Z
With respect to the specific focus upon reduction of unnecessary surgery the Yale Study Group suggested examination of four api& oaches:
1. Elimination of fee-for-service in the surgical specialties.
2. Clustering of surgeons into group practice.
3. Recertification of surgeons on a periodic basis; and
4. Reduction in surgical training programs.'"4
The Subcommittee believes that these suggestions extend beyond the current statutory provisions of PSROs. However, such recommendations should be considered within the Medicare and Medicaid programs as well as within the context of a more comprehensive national health insurance program.
Appearing before the Subcommittee on November 1, 1977, UnderSecretary Champion described PSROs as a component of HEW's, strategy to deal with unnecessary surgery. He testified: "we now want them (PS ROs) to move aggressively into review of surgical sevcs" 1',
He indicated that virtually everyone agrees that we need an effective, utilization review system and that we want physician participation. PSROs contain these necessary elements. Champion further testified that HEW intended to have review mechanisms in place for 1978 so. that 75 percent of the most common surgical procedures will have criteria established for review by PSROs. Regulation for hospital review for non-emergency surgical procedures occurrig prior to theprocedure would take place when high surgical rates or other inappropriate practices are found."'
The Subcommittee finds this approach meritorious but is concerned that the Department is falling behind the time schedule that UnderSecretary Champion laid out for Departmental action."' The Subcommittee believes that the problem is of sufficient magnitude that these delays are not warranted. The program should commence forthwith. These programs must be implemented and evaluated before one, determines whether the proposed actions are app ropriate or more stringent action is necessary. However, for. this evaluation the frame-work must be established and the program implemented expeditiously..
The Subcommittee believes it is timely to examine reasons why PSROs continue to limp along as slowly and as ineptly as they have t&~ (late. It may be that there is insufficient participation by payers and consumers of care and too much control by providers. This should be113 Id. at 23.
I1is Volume HI Surgery Hlearings, supra note 15 at 228.
116 Id at 229J.
,explored. The Subcommittee recommends that the legislative committees of the Ways and Means Committee and Interstate and Foreign Commerce Committee consider the need for legislation to strengthen the public membership and accountability of PSROs.
VIII. BOARD CERTIFICATION
In the course of the investigation by the Subcommittee numerous references were made to board certification of physicians. Under this system, physicians receive specialty training in a given discipline such as surgery and are certified by an American College of Surgeons specialty group to signify that they have completed certain additional training in that specialty. With respect to who should perform surgery, there have been many diverging opinions on the matter. For example, the American Medical Association has stated that all physicians should be entitled to provide all medical services "I including surgery. Under current state licensure procedures a physician once having passed a state examination is legally eligible to perform all such
-services. However, many expert witnesses testified that board certification should be taken into consideration in the performance of
-specialized surgical procedures. There appears to be increasing debate on limiting licenses for physicians and for requiring board certification
-or board eligibility as a prerequisite for certain types of practices. The Massachusetts State Board of Registration now has statutory authority to limit physicians from performing certain procedures."'
However, the evidence available for measuring differences in the quality of care provided by board certified versus non-board certified of physicians appears limited and not conclusive. If one uses measures of outcome to determine whether or not board certified suro eons perform at a higher level than non-board certified surgeons the evidence is lacking. This question is of major concern to the government not only in terms of quality protection but also because of costs. For example, are differential rates of reimbursement for services based upon one's board certification appropriate? In addition, should the Federal Government continue to support manpower training programs and reimburse under Medicare and Medicaid for residency training?
The American College of Surgeons, in testifying before the Subcommittee, indicated that they believed only qualified surgeons should perform surgery.110 In fact, the American College of Surgeons has delineated a statement oil qualifications for surgeons. 121 They suggested the qualifications of a surgeon include in addition to gTaduation from medical school, education leading to qualification as a surgical. specialist. Dr. C. Rollins Hanlon, Execu tive Director of the American College of Surgeons, testified that, "all other things being', equal, someone who is well educated in his background is less likely to carry ,out a procedure on casual or misapplied indications than someone who is less well educated." When pressed as to whether or not he had any ,evidence that surgeons perform better including any measurements relating to lower morbidity rates or lower mortality rates, Dr. Hanlon
indicated that he did not have such evidence.
11 Volume I Surgery Hearings, supra note 7 at 330.
119 Amendment to chapter 623 of the Massachusetts Code, effective January 9, 1978. 120 Volume 1I Surgery Hearings, supra note 15 at 130-137. 121 Id. at 136.
122 Id. at 139.
Witha respect to studies that~ have been (lone relating to procedures, leading to questionable surgery, the studies done by Dr. Child, Dr. Forrest, and Dr. McCarthy showed no major discernible difference in performance measures between board certified and non-board certified. surgeons in the performance of surgery.
Although this was not a major area of inquiry by the Subcommittee, it is nevertheless an important directionall finding. The Subcommit tee believes this question has both cost and quality implications and, therefore, recommends that the Department of Health, Education, and Welfare determine all current information available on this topic and undertake studies to measure outcome differences between board certified and non-board certified surgeons in the performance of such surgical procedures.
IX. OTHER ISSUES
Other important issues emerged in the course of the Subcommittee. inquiry that merit further examination. For example, information was gathered by the Subcommittee concerning pr-2-payment which in-(licates significantly less surgical procedures than under f ee-f or-servicearrangements. 23 The Subcommittee believes this findings is of considerable importance and should be the basis of a comprehensive studyto (determine not only surgical rates between salaried surgeons and feefor-service surgeons but dlifferences in measurements of health amongthe respective populations.
The Subcommittee obtained further information on the inadequacies of data that are kept by the government programs, particularly Medicaid. The Subcommittee therefore recommends that HEW' immediately undertake steps to improve its data collection system. At a minimum, major categories such as the number of surgical procedures should be enumerated. Variations and differences regionally and within given areas should be profiled and those areas of high utilization should be examined.
Another important issue identified was the potential need for national licensure. Chairman Moss questioned Dr. Claude Welch concerning the degree of control currently exercised by States over the licensing of physicians.24 He questioned the need for national minimum standards. Dr. Welch indicated that all State licensing boards, all colleges of surgeons, and the AMA are all against it very much. Yet, he testified "I have to recognize that there could be advantages in the national licensing." 125 The Subcommittee believes that this question deserves additional examination and recommends that a study ber undertaken by HEW to provide the Congress with information con-cerning the advantages and disadvantages of national licensure and whether HEW believes legislation at the national level is necessary and desirable.
The issue of immunity for physicians doing evaluations was raised in the hearings. Dr. Child indicated that of 153 hospitals first joiningr, his study, 95 reported (lata while several hospitals indicated that they had to be careful about participation because of potential liability.1 In fact, Dr. Child testified participation initially was limited to States in which there was protective legislation for research or investigation.27
123 Unnecessary Surgery Report, supra note 1, at 6.
124 Volume I Surgery Hearings, supra noteo 7 at 77.
120 Id. at 21.
127 1Id. at 20.
The Subcommittee is impressed thlat the neel for stch 1rotective legislation Aoult(I guartit ee tie conlfilenti ity ol't S reliiii If I (Ii tional studies that (In be (lone for the purpose of' inijloviig (*lilv and quantity of inedical care. However, the t' at ii a!rIe k p1t
confidential must be carefully consi(ere(l as well as '\ N%(1 iherl 'olet is to be exempt front the confi(lentiality requiireflleilts. 1lence, tile Subcommittee recommends the consideration of national legislation toward this goal.
The Subcommittee believes that the evidence gathered in the investigation for this report serves to reinforce the previous findings that there is too much unnecessary surgery.
Unnecessary surgery wastes lives an(l dollars. In measuring the extent of unnecessary surgery, the Subcommittee is foce(l to conelel (le that the magnitude for 1977 is essentially equivalent to the deterninations made for 1974.
Total operations for 1977 were approximately 21 million compared to 18.4 in 1973. Hence, elective procedures were close to 16 million compared to 14 million.
In spite of the potential impact on the number of unnecessary surgeries that may have resulted from publicity stemming from the original Subcommittee work and specific follow-up activities that have been promulgated by HEW, as well as by private insurance carriers; the overall reduction in the rate of unnecessary surgery appears to be small. Thus, unnecessary surgery remains a monumental problem for the Ameican public. For example, even if unnecessary surgeries for 1977 are in the 12 to 15 percent range rather than at the 17 percent level, then unnecessary surgeries for 1977 would still be between
1.9 million and 2.4 million procedures.
If approximately $1900 was spent per unnecessary surgery then the public wasted over $4 billion in 1977 for unneeded operations. If death rates for these procedures remain approximately 5 per 1000, then unnecessary procedures caused over 10,000 deaths in 1977.
The Subcommittee is convinced that second consultations before surgery could cut down significantly on unnecessary procedures. The Subcommittee believes HEW should promptly institute a program of mandatory independent second opinions to confirm highly elective
procedures such as hysterectomies and tonsillectomies when paid for by the federal government.
The Subcommittee is appalled at the amount of evidence of incompetent as well as unnecessary surgery. There appears to be a lack of desire or ability on the part of the states, organized medicine, or existing PSRO's to take corrective action. The Subcommittee believes this situation must be resolved.
SEPARATE VIEWS OF HON. JAMES M. COLLINS
M-,uch attention has been recently focused on the issues of "unnecessary surgery" and the quality of surgical care. It has been alleged that a substantial portion of surgery performed is either "unnecessary" or of poor quality. On the basis of the evidence before this Subcommittee, I conclude that the case has been overstated. The medical profession has made great efforts to insure that the quality of medical care is high and that overutilization of surgical services is small.
Throughout the 95th Congress, the Subcommittee held hearings on the quality of surgical care. These hearings were part of the Subcommittee's continuing review of the health care- system in the United States, its strengths and weaknesses.
Similar hearings were held by this Subcommittee during the 94th Congrress, culminating, in the issuance of a report entitled "Cost and Quality of Health Care: Unnecessary Surgery".
This nation is fortunate in having the finest medical and health care in the world. This achievement is largely the result of private efforts, although from time to time important collaborations have existed between the private sector and government. In the main, however, the quality of health care provided in this country is a monument to the benefits of private enterprise. While I recognize that government can sometimes have a proper role in health care, governmental activity should never become the dominant factor, stiflingi the continuation of private efforts to build on the achievement already attained.
I especially believe that in the area of quality control of medical services the role of government should be limited. Bureaucratic oversight can never be a substitute for professional peer review of the quality of medical care.
Testimony before the Subcommittee has particularly impressed me with the efforts of physicians to curb improper behavior within the profession. 'While more can always be accomplished, the strides made by physicians in self-regulation are noteworthy, and the profession shows no signs of relaxing its vigilance. If anything, practitioners have become more sensitive to the need to demand the highest levels of competence in themselves. The government should encourage this trend, not (lef eat it by substituting its j udgment for that of professionals.
These hearings have focused on the quality and necessity of surgery peCrformned in the United States. TIhe medical profession has a long and successful history of improving the quality of surgery. Unfortunately, recogTnition of these gains seems to have been submerged in the atmosphere of sensationalism that has surrounded this Subcommittee's work. All too often, what should be a search for an improved partnership between government and medicine has bogged down in acrimony an(1 mistrust.
I hope these views may spread oil on the troubled waters. I propose to analyze the testimony before this Subcommittee with a view to. building toward a mutually satisfactory relationship between medicine and government.
DISCUSSION OF HEARINGS
The testimony received by this Subcommittee is interesting not so. much for the answers it provides, but for the questions it raises. I propose to look at these questions carefully and to present some ideas that may provide answers to some of them.
Two fundamental issues confront the Subcommittee, (1) is too much surgery being performed in this country, and (2) how does one monitor the quality of surgical performance to insure high standards of care?
1. Evaluation of rate of surgery
A number of witnesses, including Drs. Eugene McCarthy and Charles Bluestone, have presented evidence that may indicate that too, much surgery is being performed in the United States.
I perceive a more fundamental issue in the area of "unnecessary" surgery and that is "What is the basis for comparison" or "Too much surgery compared to what?" .
A frequently made comparison of surgical rates is that between the United States and Great Britain. It is said that for certain surgical procedures, our rate is twice that of Great Britain.
I believe that such international comparisons are invalid. The bald statement that "we do twice as much of this as the English" (or Germans, French, Italians) simply ignores too many variables to be reliable. The comparisons do not consider access, societal traditions or expectations of medical care. Payment mechanisms might also be an unaccounted factor. Too many undetermined factors are at work here for any valid comparisons to be made.
I ajain come to the question-Too much surgery compared to what?
Some might argue that "too much surgery" is any surgery performed that costs too much for the benefits derived. Approaching the problem of "unnecessary" surgery on a cost/benefit basis, however, does not really answer the question. The benefits of surgery are diverse and a patient's perceptions of the benefits may be a decisive factor.
Often a procedure does not save or prolong life but does contribute significantly to an individual's physical or emotional comfort or quality of life. Doctor James Sammons, of the American Medical Association (AMA), in his testimony, pointed out that many factors, both physical and emotional, enter into a decision by a physician to recommend surgery. This nation should decide whether high-quality health care, or rationing of health care in accordance with available national resources, is to be accorded to our population in the future.
No one knows what quantum of surgery. is necessary to protect the physical and emotional well being of patients. Our current techniques for evaluating surgical care are not yet sophisticated enough to provide an answer in numerical terms. Dr. William Forrest testified that at present there is no proven methodology for evaluating and controlling the quality of health care.
There is no evidence to indicate that most physicians do not have their patients' best interests in mind when they prescribe a course of treatment. I believe that most of the "surplus or unnecessary surgery"
is nothing more than honest differences in professional opinion as to the appropriate mode of treatment, ste A.ML..- -g from the fact that there is a liaitimate basis for a difference in medical opinions.
In conclusion, I believe that there is some surgery performed that should not be, just as any. human endeavor includes'the questionable acts of some; however, neither we, nor anyone else, knows how much. I recognize that the studies of Doctors McCarthy, Bluestone, John Morris and others raise questions about the rationale for. the performance of some surgery. However, other witnesses have questioned their findinos.
Clearly whatever questions are raised as to the amount of "Unnecessary" surgery are still only questions. No final judgment has been reached. Further, I do not believe that those raising the questions have adequately solved the puzzle of how to prevent such unneeded procedures, regardless of the percentage.
This brings us to the second part of this question-how do we find out how much surgery is unwarranted?
Let me be clear from the outset-no testimony before the Subcommittee has answered the question of "bow much". The estimates made in the Subcommittee Report cannot be taken seriously for they are massive extrapolations of unrelated data to the national population. Doctor Charles Child warned that the results of his study on surgical incidents was not a rate study, nor could it be extrapolated to a national population. HEW in its testimony also observed the erroneous nature of such extrapolation. Doctor McCarthy testified that "deferred" surgery did not equal "unnecessary" surgery and that further study was needed to determine how much, if any, of the deferred surgery was truly surplus.
A common thread in all the testimony was the need for the developnient of a broad surgical data base before any accurate determinations could be made about potential surplus surgery. While I hesitate to recommend a "wait and see" attitude, I have seen enough ill-advised and ill-informed solutions coming from government to be very wary of leaping before looking.
Therefore, as a beginning, I would recommend that the medical profession and the government jointly undertake an effort to compile the statistics needed to make accurate determinations of surgical rates in this country.
This could be followed by determining and accounting for the factors that affect individual hospital's surgical rates. In this way comparisons of rates by hospitals would be possible.
As I perceive the thrust of much of the testimony, it is only af ter reliable statistics on surgical usacre have been compiled that efforts can tn.
begin to determine the appropriateness of an individual hospital's surgical rate.
Several witnesses testified about their efforts to review the appropriateness of surgical procedures. Doctor McCarthy and. the Subcommittee Majority are vigorous advocates of second opinion programs as a means of reducing the quantity of surgical procedures. I believe that a second opinion is just. that-anotber professional opinion. I agree that patients and physicians should seek consultations whenever there is any question as to the medical necessity of surgery; however, I do not view a second opinion program as the panacea to all problems related to surgical care. As so far presented,
second opinion programs contain too many variables and unresolved questions for me to endorse them unreservedly.
A technique discussed by Doctors Bluestone and Emerson, which I believe should be studied further, is the use of pre-set criteria for surgical proce(lures. As I understand it, these criteria would not be absolute, but would be revisedd to guide the physician's thinking and to assist, him in the decision making process an(I provide a basis for reviewing the appropriateness of his treatment recommendations. I believe this can definitely have a salutary effect, and I encourage government and physicians to collaborate on these projects in order to test this hypothesis.
2. Quality qf surgery
Experiments such as the one discussed above will, I believe, eventually reveal the methods that can lead to a substantial diminution and perhaps a virtual elimination of "unnecessary" surgery. However, this and related proposals do not answer the question of how the quality of surgical cate can be evaluated. Clearly, reducing the amount of "unneeded" surgery will contribute to the quality of medical care, but I believe that some means must be developed that will permit satisfactory determinations of the quality of care. The testimony before the Subcommittee is unanimous in stating that this is an area where much work remains to be done.
SECOND OPINION PROGRAMS
Much has been made recently, especially by this Subcommittee, of the use of surgical second opinion programs as both a means of reducing unnecessary" surgery and of containing health care costs. I believe that patients and physicians should have the option to seek a second opinion in surgical cases, but they should not be required to do so. As I noted earlier, physicians seem unanimous in urging patients to have another opinion, particularly in difficult cases.
As I have discussed, I am not convinced that mandatory second opinion programs are appropriate or beneficial. The second physician is to(lay faced with the same handicaps in making a decision as is the first one. The variables that affect one person's judgment are not necessarily absent from the second equation.
I note with approval the announcement of HEW's plan to institute a second opinion program in Medicare for elective surgery, for this is exactly the approach that Congressman Devine and I recommended( to then HEW Secretary Matthews several years ago. I join the Department in encouraging states to adopt this policy in their Medicaid progi ares. I believe it is appropriate for the federal government to pay for a second opinion sought by the patient. I am pleased that so far the program is a voluntary one, and I believe it should remain so.
I would also encourage the pilot development of second opinion programs using the pre-set criteria discussed above. I believe that the elimination of many of the variables now inherent in second opinion programs could go a long way toward making them more effective.
SETTING OF THE SURGERY
Testimony before the Subcommittee made it clear that a certain percentage of surgery now done on an inpatient basis could be per-
formed on an outpatient one without adversely affecting the qualityof the care or the health of the patient.
To the extent that changing the surgical site to an outpatient facility would help hold down costs without sacrificing the quality of care, I would encourage e the change. However, I believe that the final determination should be based upon a physician's assessment of the patient's needs.
There are some indications that current third-party payment policies may discourage outpatient surgical procedures. If this is true, I would urge that the insurers change their policies so that outpatient surgery could be encouraged. If state insurance laws need amendment to accomplish this, I would encourage that also. If any adjustments. would be needed in Medicare and Medicaid to accomplish this, they.should also be made.
It is valueless to tie uR surgical beds at great expense with patients, who do not need extensive care. I urge that all necessary steps be taken to encourage that surgery be done on an outpatient basis where medically appropriate.
MEDICAL DISCIPLINARY PROCEDURES
Dr. Claude Welsh and Ms. Chris Stem in their testimony pointed out many of the problems that currently exist in state medical licensure and disciplinary procedures. Their own State of Massachusetts is. exploring new and varied ways to improve this situation.
Although there are many unresolved issues at the state level, I stronalv discourage a federal effort to nationalize licensure and discipliary proceedings. I believe that these activities are uniquely within the purview of the states and should remain so.
I believe each state should enact legislation enabling medical disciplinary boards to use a range of penalties, in addition to license revocation, for disciplinary problems. I think that a range of penalties other than revocation will encourage these boards to act against physicians whose behavior is improper but may not warrant license revocation. Bar Associations use this type of approach in Attorney disciplinary proceedings.
The issues of immunity for those who report physicians' misbehavior to disciplinary boards is related to the previous discussion. However, because it is a complex issue, I am treating it separately.
A current problem in present medical disciplinary procedures is the fear of lawsuits by those who would report infractions to the dis. linarv body. This fear, made quite real by legal actions in some states
has ke t many physicians and medical organizations from reporting misconduct to the appropriate state agency.
A number of witnesses suggested that immunity statutes would allay these fears and permit the disciplinary process to proceed more effectively.
However immunity should not (rive rise to situations resulting in the denigration of a person's reputation without good cause. To prevent undesirable results, there should be proper safeguards in the statute and within the disciplinary process itself so that innocent people will not be harmed.
To the extent that these safeguards are include(] nn iunmuiiity law ma be an effective way to encourage more effective medical (1iscipline than now exists in some states. I would encourao'c the states which have not done so to experiment with this concept along with ,other innovations.
SURGEON I S TRAINING
Another issue raised at these hearings was surgical training. The medical profession has taken many steps to upgrade the qualifications .of surgeons and other practitioners, and I applaud the results and support their continuing efforts.
During the hearings before this Subcommittee, questions were raised concerning the setting of national standards for the qualifications of surgeons. I believe that such a step by the federal government would be inappropriate. The natural evolution of medical training and specialization will, I believe, result in even higher standards for surgeons than now exist. 1 perceive no weakness in the present system of specialty training that calls for federal intervention. The federal role should only be to make is easier for the medical profession to develop better training and certification methods.
PSRO SCREENING CRITERIA
The Majority uses the AMA-developed "Sample Criteria for ShortStay Hospital Review" as evidence that hysterectomies performed for sterilization purposes should be considered unnecessary. I believe this displays a misunderstanding of the criteria.
The introduction to the "Criteria" makes it clear that they are not intended for use as rigid standards of quality nor should they supplant the physician's judgment based on the needs of the patient. They are guidelines only and are to be used only to indicate cases where further investigation would be appropriate.
Dr. Sammons of the AMA is taken to task by the Report on this issue, but nowhere in his statements does Dr. Sammons flatly recommend the widespread use of hysterectomy for sterilization, absent other clinical indications for performing the procedure. He states only that each patient must be evaluated independently by her physician and that in some few cases, hysterectomy for sterilization may be the appropriate procedure. Dr. Sammons also noted for instance that if a patient insists on a hysterectomy when no clinical need is shown, then a psychiatric consultation could be in order.
I do not find his attitude nor that of the AMA arbitrary or capricious at all. I believe these statements are the essence of good medical practice-thorough evaluation of each patient with that patient's physical and emotional well being taken into consideration and consultation wlth other physicians whenever necessary.
I share with the Subcommittee Majority a deep concern that all citizens have available the best possible medical care from competent physicians. I firmly believe that the medical profession shares this conviction and, in fact, that it has always believed this to be its prime goal.
I am encouraged in this belief by the accomplishments of the profession in setting its own standards and qualifications. I know that the efforts of the medical profession will continue, and I encouracre the federal government to be supportive, not combative. I do not believe, however, that the government should begin to substitute its judgment for that of the physician. "D
It is the patient's interest that is the key to the equation. The patient is the final arbiter on the quality of care. Any federal action must be looked at closely to determine the effect on patient care.
I believe that a balance may be found among these sometimes conflicting ideas; however, any such determination will come about only after exhaustive study. Hasty actions and ill-conceived solutions should be avoided. To do anything less would be a disservice to idl people in this country. JAMES M. COLLINS.
UNIVERSITY OF FLORIDA 3 1262 09119 2483