Department of Health and OHumFan S ervices 
OFFICE 
INSPECTOR GENERAL

OUTPATIENT SURGERY

MEDICAL NECESSITY

AND QUALITY OF CARE

UWICES. 
Richard P. Kusserow 
INSPECTOR GENERAL 
FEBRUARY 1991 
1-
qYd:m  OFFICE OF INSPECTOR GENERAL

The mission of the Office of Inspector General (OIG), as madated by Public Law 95-452, as 
amended, is to protect the integrty of the Deparent of Health and Human Services ' (HHS)
programs as well as the health and welfare of beneficiares served by those programs. This 
statutory mission is cared out through a nationwide network of audits, investigations, and 
inspections conducted by three OIG operating components: the Office of Audit Services
, the
Offce of Investigations, and the Office of Evaluation and Inspections. The OIG also informs the 
Secretary of HHS of program and management problems and recommends courses to correct 
them. 
OFFICE OF AUDIT SERVICES 
The OIG' s Offce of Audit Services (OAS) provides all auditing services for HHS, either by 
conducting audits with its own audit resources or by overseeing audit work done by others. 
Audits examine the performance of HHS programs and/or its grantees and contractors in 
caring out their respective responsibilities and are intended to provide independent 
assessments of HHS programs and operations in order to reduce waste
, abuse, and 
mismanagement and to promote economy and effciency throughout the Deparment. 
OFFICE OF INVESTIGATIONS 
The OIG' s Offce of Investigations (01) conducts criminal, civil, and administrative 
investigations of allegations of wrongdoing in HHS programs or to HHS beneficiares and of 
unjust enrichment by providers. The investigative efforts of 01 lead to criminal convictions 
administrative sanctions, or civil money penalties. The 01 also oversees State Medicaid fraud 
control units which investigate and prosecute fraud and patient abuse in the Medicaid program. 
OFFICE OF EVALUATION AND INSPECTIONS 
The OIG' 
s Offce of Evaluation and Inspections (OEI) conducts short-term management and 
program evaluations (called inspections) that focus on issues of concern to the Deparment, the 
Congress, and the public. The findings and recommendations contained in the inspections 
reports generate rapid, accurate, and up-to-date information on the effciency, vulnerability, and 
effectiveness of departmental programs. The report was prepared under the 
diection of 
Kaye D. Kidwell, Regional Inspector General, and Paul A. Gottlober, Deputy Regional Inspector 
General, Office of Evaluation and Inspections, Region IX. Paricipating in this project were the 
following staff: 
Deborah Harvey, 
 Project Leader  Brad Rollin 
Mollyann Brodie Lead Analyst  Alicia Simon 
Ruth Carlson  W. Mark Krshat Headquarters 
Robert Gibbons  Wayne Powell  Headquarters 
Corrnne Harol  Renee Schlesinger Region II 
Cynthia Lemesh 
Medical review was completed by Forensic Medical Advisory Service under a contract with the 
OIG.  Department of Health and Human Services

OFFICE OF

INSPECTOR GENERAL

OUTPATIENT SURGERY

MEDICAL NECESSITY

AND  OF CARE 
QUALITY 
f,RVICES' 
Richard P. Kusserow 
INSPECTOR GENERAL 
1- OEI-
'0  09-88-01000 
~qYd:m  EXECUTIVE 
SUMMARY

PURPOSE 
This report compares the medical necessity and quality of care of selected outpatient surgeries 
rendered to a 1988 sample of Medicare beneficiares in ambulatory surgical centers (ASCs) and 
hospital outpatient deparments (OPDs). 
This report is the second in a series on outpatient surgery. The first report, issued December 
1989, discussed beneficiar satisfaction. 
BACKGROUND 
Over the past 8 years, the most common setting for surgery has shifted from the inpatient 
department of the acute care hospital to the OPDs and ASCs. In par, this shift has resulted from 
advances in medical technology (which have made the ambulatory setting a safer surgical 
environment), improvements in anesthesia techniques and decreases in the length of 
postoperative care. 
Although most outpatient surgery continues to be performed in OPDs, the number of ASCs and 
their share of the outpatient surgery market are increasing. From 1984 through 1989
, the number 
of ASCs increased over 300 percent. Between 1988 and 1989 alone, the number of free-standing 
ASCs increased by 27 percent. As of April 1990, there were 1 177 Medicare-certified ASCs. 
The rapid ASC growth presented hospitals with a business challenge, to which they responded 
by increasing the number of OPDs providing outpatient surgery. Although the hospitals perform 
more outpatient than inpatient surgeries, they are losing their outpatient surgery market share to 
ASCs. The hospital share has decreased from 89 percent in 1984 to about 76 percent in 1989. 
Prior to 1985, outpatient quality of care was not under review by peer review organizations 
(PROs). Subsequently, several legislative bils expanded the PRO authority to include outpatient 
quality of care review. In April 1989, the PROs completed implementation of 100 percent 
pre procedure and 5 percent retrospective review of at least 10 nonemergency inpatient or 
outpatient surgical procedures. The surgeries selected for this inspection were performed before 
the national implementation of PROs ' preprocedure review. 
METHODOLOGY 
For this inspection, we selected 4 high-volume Medicare outpatient surgical procedures from 
10 States and reviewed the appropriateness of setting, medical necessity and quality of care for 
each surgery. We selected cataract surgery with intraocular lens (IOL) implant
, upper 
gastrointestinal (GI) endoscopy, colonoscopy and bunionectomy. We identified the 10 States 
that had the highest number of ASCs and selected a random sample of 1 170 Medicare  beneficiares, hal of whom had their surgeries in ASCs and half in OPDs. Since there were only 
eight bunionectomies in our sample, we excluded them from the analysis and have not included 
any information about them in this report. All procedures were performed between 
Januar and 
March 1988. We collected the medical records from both the surgeons and the facilities and 
used an independent medical review contractor to review the records. The contractor used 
physician specialists to develop the procedure-specific criteria. The physicians then reviewed 
each record for appropriateness of outpatient setting, medical necessity and quality of care. 
addition, we interviewed several professional medical associations and a sample of ASC and 
OPD physicians in each specialty to identify currently acceptable standards for medical necessity 
and quality of care. 
Based on information we received from Medicare carers, we identified 84 ophthalmologists 
who received more than $1 milion in 1987. We compared the medical necessity and quality of 
care for their patients with the patients of non-high volume ophthalmologists. 
FINDINGS 
The Outpatient Setting Was Appropriate. 
The medical reviewers determned that the outpatient setting was appropriate for 99.5 percent of 
the surgeries and inappropriate for only 0.5 percent. 
While Most Surgeries Were Medically Necessary, Reviewers Questioned More Than 
23 Percent Of Upper GI Endoscopies.

The reviewers determined that 23.3 percent of the upper GI endoscopies, 7.7 percent of the 
colonoscopies and 1.7 percent of the cataract cases were medically unnecessar. 
Percent Of The Beneficiaries Had Poor Or Questionable Care. 
Approximately  14 
The reviewers determined that 85.6 percent of the beneficiares had adequate care 
7 percent had poor care and 11.7 percent had questionable care. 
High Volume Ophthalmologists Are More Likely To Provide Medically Unnecessary 
Services And Render Poor Or Questionable Care. 
High volume ophthalmologists (i.e., those who earn at least $1 milion annually) have almost 
twice the rate of medically unnecessar surgery and questionable care as non-high volume 
ophthalmologists.  RECOMMENDATIONS 
The HCF A Should Add Upper GI Endoscopies To The PRO Review List Of 
Recommended Procedures. 
Our study revealed that more than 23 percent of the upper GI endoscopies were medically 
unnecessar and almost 6 percent of the endoscopy patients had poor care. Therefore, we 
recommend that HCFA should add upper GI endoscopy to the PRO preprocedure review list of 
recommended procedures. 
The HCF A Should Intensify Review Of High Volume Ophthalmologists. 
By intensifying review of high volume ophthalmologists, HCFA could more easily identify both 
questionable practice patterns and ophthalmologists who are providing unnecessar services or 
render poor quality cataract surgery. 
AGENCY COMMENTS 
The HCFA disagreed with the draft report s recommendations to (1) include upper GI endoscopy 
on the mandatory PRO preprocedure review list and (2) intensify the review of high volume 
ophthalmologists. According to HCFA, it would not be cost effective to mandate PRO review of 
upper GI endoscopies. The HCFA suggested adding the procedure to the recommended review 
list rather than the mandatory review list. According to HCFA, intensified review of high 
volume ophthalmologists is not necessar because the current preprocedure mandatory review of 
cataract surgery is sufficient. 
The complete text of the comments is contained in appendix D. 
OFFICE OF INSPECTOR GENERAL RESPONSE 
Based on HCFA's comments, we have modified our recommendation concerning upper GI 
endoscopies. Our recommendation now states that upper GI endoscopies should be included on 
the recommended preprocedure review list rather than the mandatory list. 
We continue to be concerned about high volume ophthalologists and believe that a more 
intensive review of their services is waranted. This could be accomplished in any of a number 
of different ways, including (1) a preprocedure PRO review that is more intensive than currently 
conducted, (2) a postprocedure PRO review, (3) establishment of carer screens that trigger pre-
or postprocedure carer review or (4) a combination of any of the above or similar methods.  ...... ........... ...................... . . ............ ... ... .......... ......... ........ . ............ ..................  .............. ... .....................  ........... ...................... ........ . ...... .............. ......... .......... ..... ............... ........ .. .................... ... ......  ............ ........... .............................. .. ........ ....
TABLE OF CONTENTS

EXECUTIVE SUMMARY 
INTR  0 D U  CTI  0 N 
.................................................................................................................. 4 
FIND  IN G S 
The Outpatient Setting Was Appropriate ................................................ 
While Most Surgeries Were Medically Necessary, Reviewers Questioned 
More Than 23 Percent of Upper GI Endoscopies.......................................

Approximately 14 Percent of the Beneficiaries Had Poor 
or Q uesti onabl e Care .. 
High Volume Ophthalmologists Are More Likely to Provide

Medically Unnecessary Services and Render Poor

or Q uesti onabl e Care .. 
REC 0 MMEND A TI 0 NS ........ ................ ........ ........ ...... 
ENDNOTES........................................ .............. ........... 
APPENDICES 
Appendix A:  Methodology .... ................................................................ .... ..  - 1

Appendix B: Medical Review Criteria ...............................................B - 1

Appendix C:  C - 1

B i bliogra phy ........................................................................ 
Appendix D: Agency Comments ............................................................... D - 1

Appendix E: American Society for Gastrointestinal 
Endoscopy Letter ................................................................. 
- 1  INTRODUCTION

BACKGROUND 
Over the past 8 years, the most common setting for surgery has shifted from the inpatient 
deparent of the acute care hospital to the outpatient deparment of the hospital (OPD) and 
ambulatory surgical center (AS C). In par, this shift has resulted from advances in medical 
technology (which have made the ambulatory setting a safer surgical environment), 
improvements in anesthesia techniques and decreases in the length of postoperative care. The 
1983 changes in Medicare inpatient reimbursement under the prospective payment system (PPS) 
also contrbuted to the shift to the outpatient setting. 
Although most outpatient surgery continues to be performed in OPDs, the number of ASCs and 
their share of the outpatient surgery market is increasing. Since the Health Care Financing 
Administration (HCFA) first certified ASCs to receive Medicare reimbursement under the 
Omnibus Budget Reconciliation Act (OBRA) of 1980, the number of ASCs increased 
300 percent from 1984 through 1989. Between 1988 and 1989 alone, the number of 
1 As of Apri 1990
free-standing ASCs increased by 27 percent.  , there were 1 177 certified ASCs 
in the Medicare program. The rapid ASC growth presented the hospitals with a business 
challenge. They responded by increasing the number of OPDs providing outpatient surgery. 
Although the hospitals perform more outpatient than inpatient surgeries, they are losing their 
outpatient surgery market share to ASCs. The hospital share has decreased from 89 percent of 
the market in 1984 to 76 percent in 1989. 
Medicare regulations do not specificaly define medical necessity or quality of care. The 
concepts are characterized as providing adequate care accordig to the practices of the medical 
community. Section 1862(a)(1)(A) of the Social Security Act states that no payment may be 
made under par A or par B for services that are not reasonable and necessar. In recent years, 
many professional organizations, such as the American Academy of Ophthalmology, have issued 
guidelines to their members outlining medical necessity criteria and suggesting standards of care. 
Prior to 1985, the peer review organizations (PROs) were not responsible for reviewing 
outpatient qualty care. Several legislative bils expanded the PRO authority since that time 
includig the Consolidated Omnibus Reconciliation Act (COBRA) of 1985 and the Sixth 
Omnibus Budget Reconciliation Act (SOBRA) of 1986. The COBRA authorized PROs to deny 
payment for questionable care while SOBRA mandated PROs to review quality care in postacute 
and ambulatory care settings, including OPDs and hospital-affiliated ASCs. In April 1989, the 
PROs completed implementation of 100 percent preprocedure review of at least 
10 nonemergency inpatient or outpatient surgical procedures. The PROs were given this 
authority under Section 9401 of Public Law 99-272. Cataact extraction is one of two 
mandatory procedures. The PROs can choose 8 other procedures from a recommended list of 
11 surgeries, or they can select other procedures based on historical data. In addition, HCFA 
requires the PROs to review retrospectively the medical records for 5 percent of their 
preprocedure requests on a quarterly basis. The purpose of retrospective review is to verify their 
page 1
 determnations of medical necessity. The surgeries selected for this inspection were completed 
before the national implementation of PRO preprocedure review. 
PURPOSE 
This report compares the medical necessity and quality of care of selected outpatient surgeries 
rendered to a 1988 sample of ASC and OPD Medicare beneficiares. This report is the second in 
a series on outpatient surgery. The fIrst report, issued December 1989, discussed beneficiary 
satisfaction. 
METHODOLOGY 
For this inspection, we selected four high-volume Medicare outpatient surgical 
procedures--ataract extraction with intraocular lens (IOL) implant, upper gastrointestinal (GI) 
endoscopy, colonoscopy and bunionectomy. Cataract extraction, the highest volume Medicare 
outpatient procedure, is the surgical removal of a lens that has become cloudy or opaque. The 
lens is most commonly replaced by an arificial lens (the IOL). Upper GI endoscopy is the 
visual inspection of the esophagus, stomach and small intestine using a flexible, fiberoptic tube 
inserted through the mouth. Colonoscopy is the visual inspection of the colon
, which is a par 
the large intestine, using a flexible, fiberoptic tube insened though the 
rectum. A bunionectomy 
corrects the great toe displacement generally by surgically removing a bone wedge and 
realigning the toe. 
The universe consisted of 172 615 outpatient surgeries that were performed in 10 States between 
Januar and March 1988. These were the States with the highest number of Medicare-certified 
ASCs in February 1988. 
page 2  10 STATES WITH THE MOST ASCs

We selected a random sample of 1 170 Medicare beneficiares, half of whom had their surgeries 
in ASCs and half in OPDs. We chose this sample size to satisfy specific statistical testing criteria 
which are detailed in appendix A. Due to the smal number of bunionectomies, we excluded 
these cases from all analyses leaving a universe of 1, 162 cases. Appendix A includes the details 
of the sample selection. 
We collected the medical records from both the surgeons and the facilities and used an 
independent medical review contractor to review the records. The contractor used physician 
specialists to develop the procedure-specific criteria for appropriateness of setting, medical 
necessity and quality of care. Members of the American Academy of Ophthalmology and the 
American Society for Gastrointestinal Endoscopy reviewed these criteria, and their suggestions 
were incorporated. The criteria for each procedure are included in 
appendix B. The medical 
reviewers then utilized the criteria and completed a 
narative assessment for each record. In 
addition, we interviewed representatives of several professional medical associations and a 
sample of ASC and OPD physicians in each specialty to 
identiy currently acceptable standards 
for medical necessity and quality of care. 
Based on infonnation we received from Medicare carers, we identified 84 ophthalmologists in 
our sample who received more than $1 milion in 1987. We compared the medical necessity and 
quality of care of their patients to the patients of non-high volume ophthalmologists. 
page 3
 FINDINGS

THE OUTPATIENT SETTING WAS APPROPRIATE 
For the 90. 1 percent (1,047 of 1 162 cases) that included documentation, the reviewers assessed 
the outpatient setting as appropriate for 99.5 percent (1 042 of 1 047 cases) of all procedures and 
inappropriate for 0. 5 percent (5 of 1 047 cases). (See appendi A for detail concerning 
documented and undocumented records.) Physicians are not required to document in the 
medical record why they chose the ASC or OPD. However, the patient s history and physical 
test results wil be the basis for determning if a patient should be hospitalized. For our sample 
the medical reviewers determined if the outpatient setting was appropriate using objective 
criteria for each surgical procedure. The criteria included assessing the anesthesia category and 
the patient s level of illness. 
The outpatient setting was inappropriate for five beneficiares (0.5 percent)--ne cataract and 
four upper GI endoscopy patients. The medical review comments included the following: 
The patient has numerous medical problems. She was advised to discontinue her 
aspirin and Persantine, whether that was done with medical consultation is not 
clear from the chart, and this could have been dangerous in a person who has had 
carotid surgery three times. It is likely that this is not a good candidate for an 
outpatient setting. (ASC cataract patient) 
I am not certain that this outpatient setting, if the patient was this fragile
, was 
correct, particularly since she was transferred to a hospital after the procedure.... 
(ASC upper GI patient) 
Overall, there was no statistically significant difference between the ASC and OPD sites for the 
inappropriate cases. 
There were no major differences between OPD and ASC patients in sex and average age. The 
breakdown by sex for each site was similar-35 percent male and 65 percent female in ASCs 
and 36 percent male and 64 percent female in OPDs. The average age was 75. 8 years for ASC 
patients and 76.0 years for OPD patients. 
The OPD patients in our sample were no sicker than the ASC patients. Sicker patients frequently 
have concomitant conditions, such as diabetes, hypertension or arhythmias. If such conditions 
exist, physicians exercise additional medical precaution when determining if the patient is a good 
outpatient candidate. Even though 31 percent of all sampled patients had concomitant 
conditions, the medical reviewers found no differences in the outcomes for these patients. Of the 
five patients who should have been inpatients, only two of them had concomitant conditions. 
There has been much publicity and concern expressed by the American Association of Retired 
Persons (AARP) and others that patients were being forced to the outpatient setting when they 
page 4  ..." ."' '..' ..'. ..... ....... ..-.-.. .... .... .... .... .... .... .... ..... .... ..... .... .... .... .... .... . .. .... .... .... . ... ... -... -...... .... ....... ..... ..... .-..-. . .-.. .-... ....... ..... ." . -. ." . ". . '. .. ". -" . ." . ". . ". .. ." . ." . ". - '-. ." - ." . ". . ". .. .' .- . ". '.. .' -" . .. . . . .
preferred to b  hospitalized or should have been admtted because of their medical condition. In 
our telephone surey, 72 of 837 beneficiares told us they would have preferrd to stay in the 
hospital overnight. Of the 72 cases, 22 were ASC patients and 50 were OPD patients. 
Accordig to the medical reviewers, none of the patients ' physical conditions warted their 
admssion as inpatients. 
WHILE MOST SURGERIES WERE MEDICALLY NECESSARY, REVIEWERS 
QUESTIONED MORE THAN 23 PERCENT OF UPPER GI ENDOSCOPIES 
For the 96.6 percent (1 122 of 1 162 cases) with documentation, medical reviewers deemed 
93.9 percent (1,053 of 1 122 cases) of the surgeries medcaly necessar and 6. 1 percent (69 of 
122 cases) unnecessar. The medical reviewers analyzed the cases and determned whether the 
need for surgery was appropriately and adequately substatiated. The reviewers based their 
decisions on such factors as (1) the decrease in visual acuity caused by the presence of an 
opacity for cataact surgery, (2) upper GI distrss which persists despite an appropriate tral of 
therapy for upper GI endoscopy or (3) an abnormity identied by barum enema for 
colonoscopy. 
Reviewers determned that 23.3 percent (44 of 189 cases) of the upper GI endoscopies, 
7 percent (12 of 155 cases) of the colonoscopies and 1.7 percent (13 of 777 cases) of the 
cataract cases were not medically necessar. 
MEDICALLY UNNECESSARY SURGERIES

Distribution by Procedure

PERCENT 
20 
15 
1 0 
Cataracts  Upper GI  Colonoscopy

PROCEDURE

_ASC  t?OPD 
page 5
 The 44 unnecessar upper GI endoscopies were evenly divided between ASCs and OPDs. The 
usual symptoms which would necessitate the procedure include upper GI bleeding, 
diffculty in 
swallowing, persistent vomiting, persistent hearbur or a history of growths (polyps). The most 
common reasons why the surgeries were found to be medicaly unnecessar were 
(1) substantiation for surgery was inadequate (29.5 percent) and (2) symptoms did not justify the 
procedure (15.9 percent). Inadequate substatiation included cases where the patient did not 
have a tral of medical therapy prior to the procedure. Inappropriate symptom cases included 
ones where the endoscopy was used as a routine follow-up for a previously documented 
noncancerous condition. Our fmding of more than 23 percent unnecessar endoscopies is higher 
than the 17 percent reported in a Rand COrPoration study of Medicare patients who had 
3 Approximately 77 percent of the cases were 
diagnostic upper GI endoscopies in 1981.
performed by gastroenterologists and 23 percent were performed by general surgeons and 
internists. 
The 12 medically unnecessar colonoscopies were alost evenly divided between ASCs and 
OPDs. Common reasons for performng a colonoscopy include rectal bleeding (technically 
called occult bleeding), chronic bowel disease, a history of chronic polyps or unexplained 
anemia. In our sample, the most common reason for medically unnecessary colonoscopies was 
that the symptoms did not justify the procedure (66.7 percent). For example, if the patient did 
not exhibit occult blood in a stool sample and there were no other symptoms, the reviewers 
deemed the procedure as medically unnecessar. 
While the overall rate for unnecessar cataact surgery was low (1.7 percent), the rate for the 
13 medically unnecessar cases vared between the sites- 7 percent for ASCs and 0.5 percent 
for OPDs. While this difference is statistically significant, the numbers are too small for any 
further analysis which adjusts for other factors such as age, sex or initial visual acuity. 
We found that medical necessity could not be determined solely on the beneficiary s reported 
symptoms. Of 113 upper GI endoscopy patients who reported symptoms such as heartburn and 
ulcers, medical reviewers determined that only 86 of their endoscopies were medically 
necessar. For the cataract cases, 3 percent of the beneficiares did not report symptoms, yet 
medical reviewers found that their surgeries were necessar. In addition, of 179 beneficiares 
who said that their cataracts did not hinder their daily activities, the reviewers found that 177 of 
the surgeries were medically necessar. 
APPROXIMATELY 14 PERCENT OF THE BENEFICIARIES HAD POOR OR 
QUESTIONABLE CARE 
For the 93.4 percent (1,085 of 1 162 cases) of surgeries with documentation, 85.6 percent of the 
beneficiares (929 of 1 085 cases) had adequate care, 2.7 percent (29 of 1 085 cases) had poor 
care and 11.7 percent (127 of 1 085 cases) had questionable care. Poor care is defined as care 
which does not meet the acceptable standards of the medical community. Two examples of poor 
care for cataract surgeries include (1) a case where the surgery was performed on the 
beneficiar s better eye and the surgery caused worse vision in that eye, and (2) a case where 
more than 2 months after surgery, the beneficiar had poor vision (Snellen test of 20/100). In the 
page 6  latter case, the medical record indicated no reason for the poor vision, and no tests were 
performed to assess the cause of the problem. Questionable care was defined as some aspect of 
care which the reviewers did not find within acceptable standards, e.  , if a cataract patient did 
not have the basic preoperative screens or if follow-up care was not rendered in a timely manner. 
Although ASCs had more cases of poor and questionable care than the OPDs, the difference 
between the sites was not statistically significant. The qualty of care rates for each procedure 
follow: 
Qualiy of Care Rates by Procedure 
ASC  OPD  OVERALL
PROCEDURE 
CATARACTS 
poor  1.3  1.8 
questionable  16.  12.  108  14. 
adequate  299  81.3  324  86.  623  83. 
SUBTOTAL  368  100.  376  100.  744  100. 
UPPER GI ENDOSCOPY 
poor  7.4  4.4 
questionable  8.4 
adequate  84.  88.  161  86. 
SUBTOTAL  100.  100.  187  100. 
COLONOSCOPY 
poor 
questionable  1.3 
adequate  96.  92.  145  94. 
SUBTOTAL  100.  100.  154  100. 
TOTAL  540  49.  545  50.  1085  100. 
The upper GI endoscopies had the highest rate of poor care in both sites, 7.4 percent of ASC and 
4.4 percent of OPD cases. 
page 7
 ..................................-.. ...--.--.-..--.................................,........
 .....................__...-...
. . - . . . .. . . . . . . . . - . -- - -- . - . . . . . . . -. . . -.  . . - . . . . . . - -
Intraoperative and Postoperative Complications 
The overal OPD intraoperative complication rate for the sample was over twice the ASC rate 
(2.4 percent versus 1.0 percent), which is statisticaly signcant Catarct intraoperative 
complications in our sample included vitrous loss from a posterior capsule tear and iris prolapse 
from the patient moving on the operating table. Complications durng cataract surgery occured 
in 3. 1 percent of ASC and 6. 1 percent of OPD cases. All introperative complications in both 
sites were resolved appropriately. 
Postoperative complication rates raged from 0.5 percent (1 of 202 cases) for upper GI 
endoscopies to 6. 1 percent (49 of 802 cases) for cataacts. There were only 2 endoscopy 
complications out of 360 upper 01 and colonoscopy cases. Durng the cataract postoperative
period, reactions may occur which range from the expected (e.g., mid pai) to the severe 
(e.g., extreme pain from germ infection). The patient can minimze the expected 
reactions by
using nonprescription pai medication. The severe reactions can lead to serious 
infection or 
permanent loss of eyesight, if they are not treated in a timely manner with antibiotics or other 
medications. Medical literature does not contan many well-established or 
accepted cataract
complication rates for different reactions. A few studies cited rates of 0.
04 to 5.7 percent for the
retention of large amounts of fluid in the cornea (corneal edema), less than 2 percent for 
inflamation of the eye cavities (endophthaltis) and 2 to 3 percent for separation of the thin 
lining at the back of the eye from the hard shell (retinal detachment). 
CATARACT COMPLICATION RATES

By Si te 
PERCENT 
6 ...........  A"',_,-,"""'"

2 -.... 
Intraoperative 
Postoperative 
COMPLICATION TYPE 
_ASC 
OPD 
page 8
 In our study, 6. 1 percent of 
cataact cases had postoperative complications, including protrusion 
of the colored part of the eye through a corneal wound (irs prolapse), hemorrhage within the 
anterior chamber (hyphema) and elevated ocular pressure. We found that the postoperative 
complication rate for the sampled ASC patients was 8.5 percent for cataract cases, while the rate 
for sampled OPD patients was 4.2 percent, which is statistically significant. Adjustments for 
age, sex and initial visual acuity had no effect on the complication rate. 
Cataract Cases Involving Questionable Care 
There were 127 questionable care cases. The highest number (108 of 127 cases) involved 
cataract surgeries. There are two main reasons why cataract cases were considered questionable: 
Inadequate preoperative tests-About 44 percent (48 of 108 questionable care cases) of 
surgeries were questioned because the medical record did not include documentation of 
basic preoperative tests, e.  , A-scan, fundoscopy or tonometr. 
60-day preoperative screening-About 35 percent (38 of 108 cases) of questionable cases 
did not have preoperative ophthalmic screens completed within 60 days prior to surgery. 
The medical review criteria specified 60 days as the outside limit in order to have the most 
current data before surgery. In one case, the biometrc data used to measure the IOL 
power was documented to have occurred 5 years b fore the surgery. 
Of 32 patients who had surgery in both eyes, 17 had the surgeries within 30 days. Surgeons 
generaly do not operate on both eyes within such a short time span. The waiting period should 
allow healing in the fIrst eye and suffcient time to rule out complications, such as infection. An 
ASC patient is 3 times more likely to have both cataract surgeries within 30 days than an OPD 
patient (6 percent versus 2 percent). This practice was prevalent among a few physicians. These 
cases did not have higher rates of medically unnecessar surgery or quality of care problems 
than the rest of the sample. 
About 9. 1 percent of beneficiares did not have visual acuity improvement. We found that 
patients with poor or questionable care were less likely to have visual improvement than the 
patients with adequate care. There is a significant difference by site in the visual 
acuity 
improvement of the beneficiares. This difference may be accounted for by the difference in age 
and initial visual acuity. As the patients ' age increases, they were 1.4 times more likely to have 
the same or worse postoperative visual acuity. Older patients were almost five times as likely to 
have the same or worse postoperative vision if the initial visual acuity was 20/40 or better. 
In our beneficiary survey, 11 percent (55 of 522 cases) of cataract patients reported their vision 
was the same or worse after surgery. The medical reviewers, however, found that 25 percent of 
this group (14 of 55 cases) had no improvement in visual acuity. 
page 9
 HIGH VOLUME OPHTHALMOLOGISTS ARE MORE LIKELY TO PROVIDE 
MEDICALLY UNNECESSARY SERVICES AND RENDER POOR OR 
QUESTIONABLE CARE 
About 22 percent (178 of 802 cases) of our sampled cataract patients had their surgery 
performed by high volume ophthalmologists, or ophthalmology groups. These providers 
received at least $1 millon from Medicare in 1987. Of the 255 ophthalologists the OIG 
identified as high volume providers nationally, 84 were in our sample. Sixty-four percent of the 
84 physicians are solo practitioners, and 36 percent are group practitioners. We conducted 
further analysis to determine whether the quality and medical necessity of the surgeries 
performed by high volume ophthalmologists differed from non-high volume ophthalmologists. 
While high volume physicians do not affect the differences between OPDs and ASCs, they do 
have a higher percentage of medically unnecessar, poor and questionable 
care cases. Within the 
OPD sample, they have a higher percentage of poor and questionable care than non-high volume 
ophthalmologists. Within the ASC sample, they are responsible for a greater percentage of 
medically unnecessar surgeries. In addition, ASC high volume ophthalmologists operate on 
patients with better preoperative visual acuity. 
Compared to non-high volume ophthalmologists, the surgeries performed by high volume 
ophthalmologists were:

twice as liely to be medically unnecessar (2.9 percent versus 1.3 percent-not 
statistically significant), 
twice as likely to be of poor quality (3.0 percent versus 1.4 percent-not statistically 
significant), 
more likely to be of questionable quality (19.
9 percent versus 13.0 percent-statistically 
significant), 
less likely to have intraoperative complications (2.9 percent versus 5.3 percent-not 
statistically significant), 
more likely to have postoperative complications (8.6 percent versus 5.7 percent-not 
statistically significant), 
twice as likely to be performed on patients with a visual acuity of 20/40 or better 
(21.4 percent versus 10. 1 percent-statistically significant) and 
based on changes between pre- and postoperative visual acuity only, more likely to have 
the same or worse visual acuity (15.6 percent versus 7. 3 percent-statistically significant). 
page 10
 ......................................................................................................................................................... ............. ................ ............................
..................................... .--.............. ... 
COMPARISON OF CATARACT PROVIDERS

High Volume versus Non-High Volume

PERCENT 
100 
80 
60 
40 
20 
Questionable  ) 20/40 
Improved
QOC  Vision  Vision 
MEDICAL REVIEW FINDINGS 
High Volume  Non-High Volume 
NOTE: QOC. Quality of Care 
page 11
 RECOMMENDATIONS

THE HCFA SHOULD ADD UPPER GI ENDOSCOPIES TO THE PRO REVIEW LIST 
OF RECOMMENDED PROCEDURES 
Currently, the peer review organizations review 10 inpatient or outpatient surgical procedures on 
a preprocedure and retrospective basis for quality of care. Cataract surgery is one of two 
mandatory procedures. Our study revealed that more than 23 percent of the upper GI 
endoscopies were medically unnecessar and almost 6 percent of the endoscopy patients had 
poor care. Therefore, we recommend that HCFA add upper GI endoscopy to the PRO review list 
of recommended procedures. 
THE HCFA SHOULD INTENSIFY REVIEW OF HIGH VOLUME 
OPHTHALMOLOGISTS 
By intensifying review of high volume ophthalmologists, HCFA could more easily identify both 
questionable practice patterns and ophthalmologists who . are providing unnecessar or poor
quality cataract surgery. 
AGENCY COMMENTS 
The HCFA disagreed with the draft report s recommendations to (1) include upper GI endoscopy 
on the mandatory PRO preprocedure review list and (2) intensify the review of high volume 
ophthalmologists. According to HCFA, it would not be cost effective to mandate PRO review of 
upper GI endoscopies. The HCFA suggested adding the procedure to the recommended review 
list rather than the mandatory review list. According to HCFA, intensified review of high 
volume ophthalmologists is not necessar because the current preprocedure mandatory review of 
cataract surgery is sufficient. 
The complete text of the comments is contained in appendix D. 
OFFICE OF INSPECTOR GENERAL RESPONSE 
Based on HCFA's comments, we have modified our recommendation concerning upper GI 
endoscopies. Our recommendation now states that upper GI endoscopies should be included on 
the recommended preprocedure review list rather than the mandatory list. 
We continue to be concerned about high volume ophthalologists and believe that a more 
intensive review of their services is waranted. This could be accomplished in any of a number 
of different ways, including (1) a preprocedure PRO review that is more intensive than currently 
page 12
 review, (3) establishment of carer screens that trgger pre-
conducted, (2) a postprocedure  PRO 
or postprocedure carer review or (4) a combination of any of the above or similar methods. 
page 13
 , " 
ENDNOTES 
, 1990, p. 99. 
John A. Henderson  Surgery centers continue makng inroads,  Modern Healthcare, 
May 21 
Ibid., p. 99. 
Abstracts-Upper GI Endoscopy: Is It Overused?"  Geriatrics,  Februar 1989, p. 98. 
page 14
 APPENDIX A

METHODOLOGY 
The purpose of the study was to compare the medical necessity, qualty of care and cost of 
selected Medicare outpatient surgical procedures in two settings-ambulatory surgical centers 
(ASCs) and hospital outpatient deparments (OPDs). We identified the 
11 States that had the 
highest number of ASCs-Arzona, California, Florida, Illinois, Louisiana, Marland, North 
Carolina, Ohio, Pennsylvania, Texas and Washington. These States had 61 percent of the ASCs 
certified by the Health Care Financing Admnistration (HCFA) in Februar 1988. We identified 
several high volume outpatient procedures on the basis of (1) the 1985 
Par B Medicare Annual 
Data (BMA), (2) HCFA's 1986 ASC surey, (3) interviews with ASC administrators and 
(4) input from the academic community and several medical societies. We selected four 
procedures--ataract extraction with intraocular lens (IOL) implant, upper gastrointestinal (GI) 
endoscopy, colonoscopy and bunionectomy.

To establish the universe of outpatient surgeries performed between Januar 1 and 
March 31, 1988, we requested procedure code printouts from the 12 Medicare carers that 
process Par B claims for the 11 States. (We chose the first quarer of 1988 to allow the 
intermediares, which pay OPD claims, sufficient time to convert their claims processing systems 
to incorporate the same billng codes used by the carers, which pay ASC claims. ) We manually 
counted ASC and OPD surgeries for the four procedures from the printouts. We eliminated 
Washington from the sample because the carer 
printouts did not distinguish the specific 
outpatient site (ASC or OPD) for three of the four 
procedures-upper GI endoscopy, 
co1onoscopy and bunionectomy. The universe of surgeries for the selected quarter are 
distrbuted by site as follows: 
TABLE 1 
Universe of Surgeries - January-March 1988 
PROCEDURE  ASC  OPD  TOTAL 
Cataracts  44299  85.  74121  61.5  118420  68. 
Upper GI Endoscopy  4093  25712  21.3  29805  17. 
Colonoscopy  3287  19938  16.  23225  13. 
Bunionectomy  357  808  1165 
TOTALS  52036  100.  120579  100.  172615  100.
 sample size, we used HCFA's 5-percent threshold for peer review organization 
To determne  bur 
(PRO) review of outpatient quality of care. We assumed the same threshold and set a power of 
80 percent to determne a two-fold difference between ASCs and OPDs. We had an 80 percent 
chance to determine if significant positive or negative diferences existed, e.g., if poor ASC 
quality of care exceeded 10 percent or if it fell below 2.5 percent when the OPD rate for poor 
care was 5 percent. Using this criterion, we selected 585 surgeries in each site. We used a 
computer program to generate random numbers and identified a total of 1 170 surgeries. We 
selected a proportionate number of surgeries from each State based on the summed distrbution 
of all outpatient surgeries in that State. Table 2 includes the State sample distrbution. 
TABLE 2 
Distribution of Procedures Among States 
PROCEDURE GROUP 
Upper GI 
Cataracts  Colonoscopy  Bunionectomy  TOTAL 
Endoscopy 
STATE 
Arizona 
1.3 
California  160  20.  33.  40.5  75.  298  25. 
Florida  170  21.2  13.  25.  206  17. 
Ilinois 
Ohio 
Louisiana 
Maryland 
North 
Carolina 
Pennsylvania 
14.  15.  118  10. 
Texas  158  19.  12.  10.  200  17. 
TOTALS  802  100.  202  100.  158  100.  100.  1170  100. 
A- 2
 We requested beneficiar payment histories from the carers to (1) identify the surgeons and the
facilties where surgeries were completed and (2) determne all procedures associated with the 
entire episode of care, including preoperative tests and postoperative services rendered by 
September 30, 1988. We then requested medical records from both the surgeons ' offices and the 
facilities (ASCs or OPDs). The medical data included, at a minimum, a record of both pre- and 
postoperative care rendered by physicians durg office visits, preoperative test results, copies of 
the operative reports, anesthesia reports, x-ray interpretations and any related paperwork 
completed durng the surgery. 
We identified al services associated with the surgeries, e.g., preoperative ophthalmic tests, and 
entered the frequencies and costs into a dBase 111+ progr for further SAS statistical analysis. 
For those OPD surgeries where IOLs were not biled to Par B through the carer, we contacted 
fiscal intermediares to obtan copies of the 
claims submitted by the hospitals. When the IOLs 
were included in medical supplies or sterile supplies rather than a separate cost center
, we called 
the hospitals to obtain the 
biled and allowed amounts. 
An independent medical review contractor used physician specialists to develop 
procedure-specific criteria. Members of the American Academy of Ophthalmology and the 
American Society for Gastrointestinal Endoscopy reviewed the criteria, and their suggestions 
were incorporated. The medical reviewers utilized the criteria and completed a narative 
assessment for each record. The reviewers assessed each record for medical necessity, 
appropriateness of the outpatient setting and quality of care. 
First, we eliminated the bunionectomies from all analyses due to the small number included in 
the sample. For some of the remaining cases, assessment 
was impossible when the medical 
records were (1) incomplete due to missing information from the surgeon or the 
facilty or 
(2) inadequate due to ilegible or poor documentation. For these undocumented records, the 
medical reviewers were unable to assess 9.9 percent (115 of 1 162 records) for appropriateness 
of the outpatient setting, 3.5 percent (41 of 1 162 records) for medical necessity and 6.6 percent 
(77 of 1 162 records) for quality of care. 
Based on infonnation we received from Medicare carers, we identified ophthalmologists who 
received more than $1 milion in 1987. Out of 255 ophthalmologists, 84 performed 178 
surgeries in our sample. We analyzed this subset further to identify any differences between the 
surgeries completed by the high volume ophthalmologists versus the non-
high volume 
ophthalmologists in our sample. Table 3 describes demographic data about the sampled ASC and 
OPD patients. 
In addition, we interviewed representatives of several professional medical associations and a 
sample of ASC and OPD physicians in each specialty to identify currently acceptable standards 
for medical necessity and quality of care. 
A- 3
 Table 3 describes demographic data about the sampled ASC and OPD patients. 
TABLE 3

Demographic Information for Sample

CHARACTERISTIC  ASC  OPD 
AVERAGE AGE (years)  75.  N/A  76.  N/A 
AGE GROUP 
64 years  2.4

65-69 years  14.
 15.

70-74 years  167  28.
 136  23.2

75-79 years  142  24.
 156  26.

80-84 years  122  20.
 120  20.

85+ years
 11.3

TOTAL  585  100.
 585  99.

SEX

Female  380  65.
 375  64.

Male  205  35.
 210  35.

TOTAL  585  100.
 585  100.

RACE

White  130  22.
 357  61.0 
Black  1.0

Asian

Other
 2.4

Not documented  444  75.
 180  30.

TOTAL  585  99.
 585  100.
 APPENDIX 
MEDICAL REVIEW CRITERIA  APPENDIX 

BffLIOGRAPHY 
Abstracts-
February 1989, pp. 98 and 100. 
Upper GI Endoscopy: Is It Overused?"  Geriatrics, 
Agreed: Outpatient PPS by 1991  May 14, 1990, p. 3.
Health Policy Week, 

AHA Voices Concerns about HCFA' s Severity Index  October 5, 1988, pp. 26-28.
Hospitals, 
Ambulatory Surgery-Conducting a Feasibilty Analysis for Free-Standing Ambulatory

Surgical Centers,  AORN Journal,  December 1986, pp. 1026-1033.

American Academy of  March 1988.
Ophthalology,  Dry Eye, 

March 1984. 
American Academy of Ophthalmology,  Glaucoma, 
Laser Surgery of the Eye  April1987. 
American Academy of Ophthalmology, 

American Academy of Ophthalmology,  Macular Degeneration, 
 Februar 1988. 
May 1988. 
American Academy of Ophthalmology,  Seeing Well, 

American Academy of Ophthalmology, "Policy Statement-An Ophthalmologist s Duties 
Concerning Postoperative Care 
" September 27, 1987. 
American College of Surgeons, Socioeconomic Affairs Deparment,  Socio-Economic Factbook 
1988, 1988.

for Surgery 

Appropriate Use of Gastrointestinal 
American Society for Gastrointestinal Endoscopy, 

Endoscopy,  June 1986. 
Preparation of Patients for Gastrointestinal 
American Society for Gastrointestinal Endoscopy, 

Endoscopy,  January 1988. 
Some Answers to Questions about 
American Society for Gastrointestinal Endoscopy, 

Colonoscopy and Polypectomy,  June 1987.

Standards of Practice of Gastrointestinal 
American Society for Gastrointestinal Endoscopy, 

March 1986. 
Endoscopy, 
Therapeutic Gastrointestinal Endoscopy-An 
American Society for Gastrointestinal Endoscopy, 

Information Resource Manual  no date. 
C - 1  , "  , " ,,  "" , "

Are Some Surgical Procedures Overpaid,  Summer 1987, pp. 124-130.
Health Affairs, 

Beneficiares Happy with Outpatient Surgery-Study,  Februar 12, 1990 
Modern Healthcare, 
pp. 18, 22. 
Berler, David K., M.  , and Robert Peyser, M.D., "Light Intensity and Visual Acuity Following 
Cataract Surgery,  August 1983, pp. 933-936.
Ophthalmology, 
Betz, Robert, "Hospita Outpatient Payment Policy: Beginnings and Endings,  Federation of 
American Health Systems Review, 
 November/December 1989, pp. 12-17. 
Brook, Robert H. , M.D., and Kathleen N. Lohr, Ph.D., "Monitoring Quality of Care in the

Medicare Program-Two Proposed Systems,  lAMA  December 4, 1987, pp. 3138-3141.

Capital Digest: Ambulatory Surgery Rates May Rise Only 5.  Modern Healthcare

June 3, 1988, p. 18.

Classen, M. and K. Knyrm  Electronic Endoscopy-The Latest Technology,  Endoscopy, 
1987, pp. 118-123. 
Committee Claims PRO Data Show Drop in Quality,  Hospitals  November 20, 1987, p. 36.

Complexities Likely to Delay Enactment of PPS System for Outpatient Services,  Modern

November 25, 1988, p. 16.

Healthcare, 
Competition Helps Cap Costs Study,  November 11, 1988, p. 5.

Hospitals, 
CPT 4 System Puts Additional Burden on Hospitals,  May 5, 1987, p. 30.
Hospitals, 
Customer Perception Counts in Quality Assurance,  Hospitals  January 20, 1989, p. 84. 
Davis, James E., M.D., "The Future of Major Ambulatory Surgery,  Surgical Clinics of North 
August 1987, pp. 893-901. 
America, 
Davis, James E., M.D., and Kenneth Sugioka, M.  Selecting the Patient for Major 
Ambulatory Surgery-Surgical and Anesthesiology Evaluations,  Surgical Clinics of North 
August 1987, pp. 721-732. 
America, 
Surgical Evaluation  Surgical CZinics of North America  August 1987, pp. 721-731. 
DHHS, Office of Inspector General  National DRG Validation Study, Quality of Patient Care in 
Hospitals," July 1989, #OAI-09-88-00870. 
DHHS, Offce of Inspector General  The Utilzation and Qualty Control Peer Review 
Organization (PRO) Program: Quality Review Activities," August 1988, 
#OAI-01-88-00570. 
C  pp.  , "  , " 
Droste, Therese, "Quality Care: Elusive Concept Deserves Defining,  Hospitals,  June 5, 1988, 
pp. 58-59. 
EPA Should Get Guidelines for Medical Wastes-AH 
Modern Healthcare, 
August 12, 1988, p. 29. 
Expert in Error Over Medicare Payment, 
July 22, 1988, p. 126. 
Modern Healthcare, 
Farber, M.A. and Lawrence K. Altman 
A Great Hospital in Crsis,  The New York Times

Magazine,  Januar 24, 1988, pp. 18-21, 38, 40, 50 and 57.

Foulds, Wallace S., Chapter I-Tests of Visual Function  The Eye in General Medicine, 1983, 
12. 
A Comparison of VA and HCFA Methods 
General Accounting Offce, 
 for Analyzing Patient 
June 1988, pp. 1
Outcomes, 
Improved Patient Outcome Analyses Could Enhance Quality 
General Accounting Office, 

Assessment 
June 1988. 
Improving Quality of Care Assessment and Assurance 
General Accounting Offce, 
 May 1988. 
Limited State Efforts to Assure Quality of Care Outside Hospitals, 
General Accounting Offce, 

Januar 
1990. 
Medicare Preliminary Strategies for Assessing Quality of Care 
General Accounting Offce, 

July 1987.

Medicare Reviews of Quality of Care at 
General Accounting Office, 
 Participating Hospitals, 
September 1986. 
Goes, F., M.D.,  Modern Trends in Ophthalmology-roceedings of the 18th European Congress 
of Ophthalmology ECLSO/SOBEVECO: Personal Complications After I.
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1989, pp. 179-189. 
Graney, Marshall J., Ph.D., "A Clinical Index for Prdicting Visual Acuity After Cataract 
Surgery,  American Journal of Ophthalmology, 
 May 1988, pp. 460-465.
Hamilton, Jon  Specialized Minicenters-Shopping-Mall Medicine,  American Health 
March 1988, pp. 106-111. 
HCFA: Ambulatory Surgery Rates May Hurt Hospitals, 
Hospitals,  July 5, 1987, p. 26. 
Health Policy Week  November 28, 1988, pp. 1
C - 3  , ," p"p.  , "  , " 
Hedden, Michael and K. Donald Wolfe, "Experience from a New Wave Ambulatory Surgery

Center  June 1987, pp. 411-416.

Florida Medical Association, 

Henderson, John A., "Freestanding Centers Gaiing on Surgical Suites,  Modern Healthcare

June 3, 1988, pp. 84-87.

Surgery Centers Continue Makng Inroads,  Modern Healthcare  May 21 , 1990 
pp. 98-100. 
HHS Inspector General Report- 6% of Medicare Patients Said to Receive Poor Care at Costs 
of $1.2 Bilion  August 10, 1988, pp. 1
Health Daily, 

Holloway, James J. et al.  Clinical and Sociodemographic Risk Factors for Readmission of 
Medicare Beneficiares,  Health Care Financing Review Fall 1988, pp. 27-36. 
Jaffe, Norman S., M.D.,  Symposium on Cataract SurgeryTransactions of the New Orleans 
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Surgery, 
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The Decision to Operate, 
Complications,  1990, pp. 3-11. 
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Ophthalmology,  1987, (71), pp. 112-115. 
Jennings, LTC Bonnie M. and MAJ Richard A. Sherman, "Anxiety, Locus of Control, and 
Satisfaction in Patients Undergoing Ambulatory Surgery, 
Miltary Medicine April 1987 
206-208. 
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Annals of Ophthalmology, 
Kahn, Katherine et al.  Indications for Selected Medical and Surgical Procedures-
A Literature 
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May 1986. 
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C  ,,  ,,""  ""pp.  , ," " , "  , " 
87. 
Koska, Mar T.  HCFAExamnes Ambulatory Payment Options  July 20, 1988 
Hospitals, 
pp. 86-
HCFA Monitors Outpatient and Home Care Growth 
Hospitals,  December 20, 1988 , p. 27.
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September 20, 1988, p. 66.
Hospitals, 
Krentz, Susanna E. and Maran C. Jennings, "Prcing Strategies for Hospital-Based Ambulatory 
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Annals of Ophthalmology, 
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266-268. 
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American Journal of Public Health,  February 1986 
pp. 150-
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C - 5  .,,,    """p.  , " , " , " 
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C  ,,,,    """"pp.  , "  , ", "  , "  ,,  "" , " 
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Ware, John E. Jr., Ph.D., and Ron D. Hays, Ph.  Methods for Measuring Patient Satisfaction 
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C  Weiner, Jonathan P. , D.  H., et al., "Elective Foot Surgery: Relative Roles of Doctors of 
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AJPH, 
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The Journal of Foot Surgery, 

C - 8  APPENDIX D

AGENCY COMMENTS

D - 1
 APPENDIX 

AMERICAN SOCIETY FOR GASTROINTESTINAL ENDOSCOPY LETTER

E - 1