Department of Health and Human Services 

OFFICE OF 

INSPECTOR GENERAL 

CLIA’s IMPACT ON THE AVAILABILITY OF 

LABORATORY SERVICES 

JUNE GIBBS BROWN 

Inspector General 

JUNE 1995 

OEI-05-94-00130 
OFFICE OF INSPECTOR GENERAL 

The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, as 

amended, is to protect the integrity of the Department of Health and Human Services’ (HHS) 

programs as well as the health and welfare of beneficiaries served by those programs. This 

statutory mission is carried out through a nationwide network of audits, investigations, and 

inspections conducted by three OIG operating components: the Office of Audit Services, the 

Office 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 Office 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 

carrying 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 efficiency throughout the Department. 

OFFICE OF INVESTIGATIONS 

The OIG’s Office of Investigations (01) conducts criminal, civil, and administrative 

investigations of allegations of wrongdoing in HHS programs or to HHS beneficiaries 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 Office of Evaluation and Inspections (OEI) conducts short-term management and 

program evaluations (called inspections) that focus on issues of concern to the Department, 

the Congress, and the public. The findings and recommendations contained in these inspection 

reports generate rapid, accurate, and up-to-date information on the efficiency, vulnerability, 

and effectiveness of departmental programs. 

This report was prepared in the Chicago Regional Office, Region V, under the direction of 

William C. Moran, Regional Inspector General and Natalie A. Coen, Deputy Regional 

Inspector General. Project staff: 

CHICAW HEADQUARTERS 

John M. Traczyk, project leader Linda Moscoe 

Suzanne G. Johnson Brian Ritchie 

Thomas F. Komaniecki Barbara Tedesco 

Christine Esteban Hugh Hetzer 

Timothy J. O’Driscoll 

For additional copies of this report, please call the Chicago regional office at (312) 353-4124. 
EXECUTIVE SUMMARY 

PURPOSE 

To determine whether the Clinical Laboratory Improvement Amendments of 1988 

have restricted the availability of laboratory services to Medicare patients. 

BACKGROUND 

In February 1992, the Health Care Financing Administration (HCFA) issued 

regulations implementing the Clinical Laboratory Improvement Amendments of 1988 

(CLIA). These amendments extended Federal regulation to all sites, including a 

significant number of physician office laboratories (POLs) and other sites that had 

previously been exempt from Federal regulation. The passage of CLIA has raised 

concern that laboratory sites, especially POL sites, might cease operations and thus 

restrict patient access to certain types of laboratory tests. Concerned about this 

possibility, HCFA requested that we conduct this study. 

FINDINGS 

Since passage of CLIA in 1988, the volume, number of tests per patient and 

expenditures have increased rapidly. Growth seems to have slowed after 

implementation in 1992, but data is incomplete. 

The number of laboratory tests used in patient care has risen consistently since 1983. 

In 1983, Medicare paid for an estimated 139 million laboratory tests. In 1988, the 

year in which CLIA was passed, Medicare paid for 232 million laboratory test; today, 

Medicare pays for more than 403 million tests annually. The number of laboratory 

tests provided to Medicare Part B enrollees has more than doubled from five tests per 

enrollee in 1985 to an estimated 12 tests per enrollee in 1993. 

The CLIA appears not to have affected physician ability to secure laboratory services 

for their patients. 

None of the 232 physician practices, including the rural practices, contacted during this 

study indicated that they had any trouble securing laboratory tests for their patients. 

All had access to a laboratory and nearly all (987)o used more than one laboratory to 

perform testing. We found that the number of physicians having access to an in-office 

laboratory has remained unchanged since 1988 even though the actual number of POL 

sites operated by them has decreased. This is, in part, due to the consolidation of 

medical practices that has resulted in larger physician groups. 

i 
Only 38 counties in the United States have no physician medical practices and no 

laboratories. While POL sites are not as common, rural counties have 7.4 hospital 

laboratory sites per 100,OfKlpersons versus 5 such sites per 100,ooO population in 

non-rural counties. Since hospital sites are more likely to perform moderate and high 

complexity testing, persons living in rural areas appear to have available to them 

laboratory sites equivalent to their non-rural counterparts. 

Physicians who changed their in-office laboratory operations were influenced by factors 

broader than CL& these influences include other government regulations and nongovernment factors, such as sales, mergers and managed care. 

Of the 232 physician practices we contacted in our 2 random samples, 18 had closed a 

POL site and 8 had opened new sites. Eleven primarily cited governmental 

regulations as reasons for closure, three cited governmental and non-governmental 

factors, and four cited primarily non-governmental factors. The governmental factors 

included the Stark Amendments, Occupational, Safety and Health Administration 

requirements, CLIA and/or other government initiatives. Physician decisions to close 

an in-office laboratory were often not attributable to a single cause but to the 

cumulative effect of multiple factors. 

Non-government factors have also caused some laboratory operators, including POLs, 

to re-evaluate the kinds of testing they offer and the number of sites they operate. 

Between 1988 and 1994, non-government factors appear to have affected physician inoffice laboratories. Of the 232 practices we contacted, 64 volunteered information 

about the sale, merger, or changes in their practices. Of these, 30 noted nongovernment factors as the major reason for change in their in-office laboratory 

operations. These changes were the primary influence in their decision to close their 

in-office laboratory or to limit the kinds of testing they perform. 

The CLIA appears to have affected the type of testing performed in POLs. Growth in 

the volume of tests billed by POLs appears to have slowed. Shifts from moderate and 

high complexity test procedures to waived testing procedures are evident in glucose, 

sedimentation rates and other areas of testing. While volume for some other 

procedure codes billed by POLs has declined, this decline was also experienced by all 

laboratories billing these codes; thus, indicating that factors other than CLIA may have 

influenced volume. 

ii 
COMMENTS ON THJ3 DRAFI’ REPORT 

We received comments on our draft report from the American Medical Association, 

American Society of Internal Medicine, American Clinical Laboratory Association and 

HCFA. Based on comments we received, we have reordered and reworded the report 

findings. The full text of comments received can be found in Appendix E. 

The HCFA and the American Clinical Laboratory Association concurred with our 

report findings. The American Medical Association and the American Society of 

Internal Medicine pointed out that our study does not address CLlA’s impact on 

patient convenience or the speed and quality of testing afforded by physician in-office 

laboratory testing. While important subjects, these issues were beyond the scope of 

our inquiry which was simply to determine whether CLlA has restricted the availability 

of laboratory services. 

. . . 111 
TABLE OF CONTENTS 

PAGE 

EXE-SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i 

INTRODUCI’ION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 

FINDINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 

�  Volume, number of tests per patient and expenditures have increased . . . . . . . . 6 

�  Physician ability to secure laboratory services appears unaffected . . . . . . . . . . . 7 

�  Multiple government and non-government factors have affected laboratories . . . 9 

APPENDICES 

A: 1988 POL Survey Methodology and Results of 1994 

Recontacts with Physicians Who Participated in that Survey ............. A-l 

B: CLIA Laboratories by Type ..................................... B-l 

C: Tables of U.S. Counties Without Laboratories ........................ C-l 

D: Laboratory Procedure Codes by Place of Service: 19851993 ............. D-l 

E: Comments on the Draft Report .................................. E-l 
INTRODUCTION 

PURPOSE 

To determine whether the Clinical Laboratory Improvement Amendments of 1988 

have restricted the availability of laboratory services to Medicare patients. 

BACKGROUND 

Clinical hbomtoy regulation 

In February 1992, the Health Care Financing Administration (HCFA) issued 

regulations implementing the Clinical Laboratory Improvement Amendments of 1988 

(CLIA). These amendments require HCFA to identify and regulate all sites where 

analysis of blood, urine, tissue and other specimens derived from the human body 

takes place. The passage of CLIA marks the first time that Federal regulation of 

laboratories was extended to all sites, including a significant number of physician office 

laboratories (POLs) and other testing sites that had previously been exempt from 

Federal regulation. 

Initially, the new amendments divided laboratories into three groups based on the 

sophistication of the testing they perform. ’ All laboratory tests are classified as either 

waived, moderate or high complexity. The nine tests in the waived category include 

those that: 

b are approved for home use by the Food and Drug Administration, 

b pose no reasonable risk of harm to patients if performed incorrectly, and 

b employ simple and accurate test methodologies that reduce the likelihood of 

erroneous results. 

Laboratory sites performing tests in the moderate and high complexity categories must 

institute quality assurance programs and meet specific personnel standards and quality 

control requirements. These laboratories are subject to periodic onsite inspections 

and must successfully engage in an approved proficiency testing program. The test 

1 Physician-performed microscopy (PPM) was later added as a separate subcategory of moderate complexity 

testing. While physicians performing tests in this sub-category are not subject to routine inspections, they must meet 

the same standards that apply to moderate complexity testing with the exception of personnel standards. In a final 

rule published April 24, 1995, HCFA expanded the “physician-performed microscopy” subcategory to include PPM 

tests performed by certain mid-level practitioners in addition to physicians. The name of the sub-category was 

changed, accordingly, to “provider-performed microscopy.” 

1 
methodologies in the moderate and high complexity categories are more complex and 

can pose great risk of harm to the patient if not performed correctly. 

All laboratory sites must pay registration fees and must follow manufacturers’ 

instructions to ensure that equipment functions properly and that test results are 

reliable. However, laboratory sites performing only waived tests are exempt from 

CLIA standards including quality assurance requirements. 

Registration and inspection fees are based on the level and volume of testing being 

performed. An inspection fee is charged only if the laboratory undergoes an 

inspection. 

Loboratory specimen co&ction and adysk 

Many physicians collect patient blood, urine, tissue and other specimens for laboratory 

analysis in their office. When the physician has an office laboratory some or all of the 

patient’s specimens will be analyzed onsite. Tests that the physician office is incapable 

of performing are usually picked up by courier(s) and transported to independent or 

hospital-owned reference laboratories capable of performing the desired tests. 

When specimens are not collected in the physician’s office, patients are sent to an 

independent or hospital-owned laboratory or collection site. Nothing requires a 

physician to use the nearest laboratory facility; consequently, the distance a patient 

must travel to obtain laboratory tests varies considerably. Patient preference, urgency, 

the nature of the test, insurance requirements, physician contractual obligations and 

practice affiliations are but a few of the factors that influence how far a patient may 

have to travel to obtain laboratory services. Consequently, patients living in urban 

areas where laboratory testing site density is greatest often travel distances comparable 

to patients living in rural areas to secure laboratory tests.2 

In most cases, laboratory test results are returned to the ordering physician in 24 hours 

or less. Turnaround times greater than 24 hours were usually encountered when 

testing methodologies required longer processing times (i.e., cultures).3 

Other environmental in-m 

Regulations implementing the Clinical Laboratory Improvement Amendments were 

published in February 1992. Between passage of the law in 1988 and its 

implementation in 1992, numerous other changes were also taking place. 

2 “CLIA-88: Clinical Laboratory Improvement Amendments of 1988 Impact Study,” Levine Associates, Inc., 

April 1992, Vol 1, Page A-17. 

3 When physicians need a test result immediately (i.e., to confirm a diagnosis for a potentially life threatening 

situation and to decide whether to admit a patient to the hospital) they will request that a test be done “STAT.” 

Such requests are rare and when STAT testing is required, the closest laboratory capable of doing the testing is 

usually used. In many cases this is a hospital laboratory. 
On the private side, growth of managed care fueled sales, mergers and changes in 

physician business affiliations. Also influencing physicians, hospitals, clinical 

laboratories and other health care entities were Occupational, Safety and Health 

Administration requirements and the “Stark Amendments,” which generally prohibit 

physicians from referring patients to entities in which they have a financial interest. 

While POLs are exempt from the Stark Amendments, many joint ventures and other 

business arrangements between physicians and other laboratory operators are 

prohibited. Awareness of prohibited business ventures and practices increased during 

the 5 year period following passage of CLIA. The number of patients enrolled in 

managed care grew and the number of entities providing managed care services also 

increased. New Federal and State laws, coupled with policy, billing and payment 

reforms, the rise in managed care and increased competition for patients, affected 

nearly everyone involved in providing medical care. 

Implementation of CLIA has raised concern that laboratory testing sites, especially 

POL sites, might cease operations and thus restrict patient access to certain types of 

laboratory tests. Concerned about this possibility, HCFA requested that we conduct 

this study. 

SCOPE AND METHODOLOGY 

The scope of this study was limited to those factors that would enable us to determine 

whether the Clinical Laboratory Improvement Amendments of 1988 had restricted the 

availability of laboratory services to Medicare patients. This study does not address 

CLIA’s impact on patient convenience or CLIA’s impact on the quality of physician 

in-office laboratory testing. 

We assessed three major questions through our methodology: overall trends in 

laboratory usage, physician access to laboratory testing, and influences (both 

governmental and non-governmental) on laboratory testing patterns. To develop 

information on these questions, we accessed a number of data sources. 

Trends in Overall Volume, Tvoe and Freouencv of Testing. We analyzed the volume, 

type and frequency of laboratory tests provided to Medicare patients between 1985 

and 1993, including an analysis of where laboratory testing was conducted. We used 1 

percent samples of laboratory data obtained from HCFA’s Common Working File and 

its predecessor the Part B Medicare Annual Data file. These 1 percent samples have 

been extracted annually, since 1985, by the Office of Inspector General from data 

maintained and collected by HCFA. 

Carrier data in HCFA’s Common Working File for 1992 and 1993 was consistent with 

information collected by the Office of Inspector General in earlier years and with 

other published statistics. However, the Common Working File hospital outpatient 

laboratory data for 1992 and 1993 appears to be inconsistent with other data collected 

3 
during this study. Therefore, we derived our own estimates of hospital outpatient 

laboratory test volume and expenditures and did not use the 1992 and 1993 Common 

Working File data. 

We assumed the hospital outpatient department share of the laboratory marketplace 

to be 40 percent for the years 1990 through 1993. This percentage was reported as 

the 1990 hospital share of the laboratory marketplace by Levine and Associates, Inc. 

in a study released in 1992. Other industry estimates place the hospital outpatient 

market share of laboratory services, in 1994, at 50 percent or more. While some 

evidence exists to support the higher figure for 1994, we used 40 percent for each year 

beginning with 1990 and ending with 1993. .Hospital outpatient data on laboratory 

services for years prior to 1992 is based on estimates published in other studies. 

Phvsician Access to Laboratorv Testing. This indicator involved two parts. -First, we 

assessed trends in the numbers of physician office laboratories. We recontacted the 

200 medical practices that participated in a study we conducted in 1988. We knew 

from our 1988 study which medical practices were operating a POL in 1988. We 

recontacted them to determine what, if any, impact CLIA had on their laboratory 

operations. We were able to contact 176 of the 200 medical practices selected for our 

1988 study. 

Second, we charted the availability of laboratories to physicians. We used HCFA’s 

Online Survey, Certification and Reporting System database to identify Medicare 

certified laboratories. Our analysis was based on CLIA certificates and not sites. 

Therefore, hospitals operating multiple laboratory sites under one CLIA certificate 

were counted as one site. However, if the hospital chose to have a separate certificate 

for every site they operated, each site was included in our analysis. 

Our decision to count as one entity multiple laboratory sites under a single certificate 

reduces the number of sites used in our analysis from the 151,658 reported by HCFA 

to 129,634. The net effect of this decision understates the actual number of 

laboratories available for use by physicians and patients. 

We combined HCFA’s Online Survey, Certification and Reporting System data with 

HCFA provider number information and with 1990 census information. This resulting 

data set enabled us to analyze the number and location of medical practices and 

laboratory sites available to physicians and patients. 

Government and Non-Government Influences on Testing. To understand what factors 

may have affected laboratory testing (both governmental and non-governmental) we 

used the responses of the 176 medical practices that participated in our 1988 study. 

We also used a HCFA file that identified 1,532 medical practices. Each of these 

medical practices had advised HCFA that they would no longer perform laboratory 

tests. Using this file, United States Postal Service zip codes and 1990 census 

information enabled us to identify 658 medical practices that met our definition of 

rural. We selected 112 of these 658 rural practices using simple random sampling, and 

4 
attempted to contact them by telephone to determine the current status of their 

laboratory operations. We also wanted to know whether they were experiencing any 

problems in securing laboratory services for their patients. 

Of the 112 rural practices selected at random, 56 agreed to participate in this study. 

The remaining 56 fell into 2 groups. One group consisted of 12 practices that refused 

to participate in our study and the other consisted of 44 practices that had closed, 

merged or moved outside the rural county in our sample. 

To identify rural counties, we used statistics from the United States Bureau of the 

Census. If the Bureau of the Census classified more than 50 percent of the residents 

in a county as rural, we classified that county as a rural county. Medical practices 

within these counties were considered “rural” for purposes of this study. 

Overall, in our two samples, we spoke to 232 physician practices, the American 

Medical Association, the American Clinical Laboratory Association, the American 

Society of Internal Medicine and the Health Industry Manufacturers Association for 

their views on the impact of the 1988 laboratory amendments. We also reviewed a 

number of other studies and articles about CLIA, physician practice trends and 

laboratory services. 

5 
FINDINGS 

Finding 1: Since passage of CLIA in 1988, the volume, number of tests per patient 

and expenditures have increased rapidly. Growth seems to have slowed after 

implementation in 1992, but data is incomplete. 

year 

Continued growth in the laboratory Estimated Volume 

marketplace indicates that the 1988 6ow 

(in millions) 

wamendments have not impaired the aavailability of laboratory services. The ao- ----letal 

volume of laboratory services provided wo- Pa8q.dCuA 

to Medicare patients has increased each mo2soo- since 1983. The top graph to the 200. HOP0 right shows estimated growth in the l(y1- _>:S==­---z== -

_=::’ volume of laboratory tests experienced 100. --=5 -/-- ---.-. __.... poL -_cczyT_.__... _.-_.

by the Medicare program. In 1983, the p. _________--..& I.... 

Medicare program paid for an estimated 

139 million laboratory tests. In 1988, 

the year CLIA was passed, Medicare 

paid for 232 million tests. By the end of Estimated Number of Tests 

1993, this number had grown to over 403 per Medicare Enrollee 

14 

million tests annually. 1s1 Implm6nt6Uon IP11. 

The middle graph shows the estimated looaverage number of laboratory tests 6-

7- provided to Medicare Part B enrollees. 6. 

This number has more than doubled 6. 

4-

between 1985 and 1993. In 1985, s2- Medicare paid for five laboratory tests 

per Medicare Part B enrollee. In 1988, lJi 62 64 66 W 67 66 W 60 61 62 99 

the year CLIA became law, Medicare 

was paying for approximately seven tests 

per Part B enrollee. By the end of 1993, Estimated Expenditures 

Medicare was paying for nearly 12 tests (in Billions) 

per Part B enrollee. 62 1-M 6-

6.6. 

The bottom graph reflects our estimate 6-

4.6. 

of the total dollars paid by the Medicare 4-

35 

program for outpatient laboratory sservices. In 1983, Medicare expenditures 26. 

2. 

for these services were just over $1 1.6. 

1. billion. In 1988, the year CLIA became 0.6. 

! . . 1 ! law, Medicare was paying $2.8 billion. 0’. W 64 66 66 67 66 66 60 61 62 W 

At the close of 1993 payments had risen 

to $5.9 billion. 

6 
As these graphs show, the number of laboratory tests used in patient care has risen 

consistently since the passage of CLIA in 1988.4 Over the last 10 years, the number 

of Medicare beneficiaries has increased by less than 3 percent a year. Growth in the 

volume of laboratory services provided to them has averaged 17 percent a year. 

The 1993 data appears to show that the rapid growth of Medicare laboratory services 

has slowed and that POL services declined slightly since implementation of CLIA 

in 1992. However, our data is incomplete. Only when hospital outpatient data 

becomes more reliable will we be able to determine whether growth has, in fact, 

leveled off, declined or continues to increase. 

Finding 2: The CLIA appears not to have affected physician ability to secure 

laboratoq services for their patients. 

All of the 232 physician practices we contacted in our 2 random samples indicated that 

they had access to a laboratory and nearly all (226 of the 232 or 98.3%), including 

those operating POLs, used more than one laboratory to perform some of their 

testing. Medical practices that collected their own patient specimens had daily courier 

service(s) that picked up specimens for analysis at other laboratory sites. Physicians 

who did not collect laboratory specimens in their office sent their patients to nearby 

collection sites. 

We found that the number of physicians with access to an in-office laboratory has 

remained unchanged since 1988. In 1988, we projected that 162,100 physicians had 

access to an in-office laboratory (operating a POL). Based on our recontacts with 

these medical offices, we project that 162,300 physicians still had access to an in-office 

laboratory in 1994. This information (obtained from physicians who were in active 

practice in 1988 and who were still in active practice in 1994) indicates that CLIA has 

had little impact on physician access to in-office laboratories. Complete survey 

information can be found in Appendix A. 

Examination of survey results shows that the number of POLs (41,400) operated by 

physician groups remains unchanged, although the number of physicians in the groups 

has increased. The number of POLs operated by physicians in solo practice had 

declined from an estimated 57,000 sites in 1988 to an estimated 44,500 sites in 1994. 

This decline in the number of POLs operated by physicians in solo practice appears to 

reflect the ongoing trend away from solo practice and toward larger group practices.5 

4 Data for POLs and “Other” sites (primarily independent clinical laboratories) is actual billing data. The 

hospital outpatient department (HOPD) data is projected. Totals reflect projected hospital outpatient data and 

actual Part B data for POLs and Other. 

5 Philip R. Kletke, David W. Emmons and Kurt D. Gillis, “The Changing Proportion of Employee Physicians: 

Evidence of New Trends.” (Chicago: American Medical Association, 1994). 

7 
As of January 30, 1995, HCFA had issued CLIA certificates to 151,658 laboratory 

sites.6 On average, there are nearly 51 clinical laboratory sites for every 100,000 

persons and nearly 1 site for every 4 physicians. All but 66 of the 3,140 counties in 

the United States have at least 1 medical practice site and at least 1 laboratory site. 

Of the 66 counties without a single laboratory, 38 have no physician medical practices 

and no laboratory sites. Additional information about the types and numbers of CLIA 

certificates and counties without laboratories can be found in Appendices B and C, 

respectively. 

Adjusting for population density, rural counties compare favorably with non-rural 

counties. While rural counties have fewer POL sites and independent laboratory sites 

they make up for this shortage with other laboratory sites. For example, rural 

counties have 7.4 hospital laboratory sites per 100,000 persons versus 5 such sites per 

100,000 population in non-rural counties. Since hospital sites are more likely to 

perform moderate and high complexity testing, persons living in rural areas appear to 

have available to them laboratory sites equivalent to their non-rural counterparts. 

However, rural POL sites are not as common as in non-rural areas. Table A provides 

additional information on how rural counties compare to their non-rural counterparts. 

Table A 

1 RURAL I NON-RURAL 1 TYPE 1 RURAL I NON-RURAL II 

II 0therLabtxatories I 4.4 I 25.6 [ OtberIAmmtories 26.5 I 19.1 11

’ For analysis purposes we eliminated multiple certificates issued to laboratories located at the same site. This 

reduced the number of laboratory sites used for analysis to 129,634 sites. 

8 
Finding 3: Physicians who changed their in&fke laboratory operations were 

influenced by factors broader than CLIA; these influences include other government 

regulations and non-government factors, such as sales, mergers and managed care. 

POL closzu~ 

Of the 232 physician practices we contacted in our 2 random samples, 18 had closed a 

POL site and 8 had opened new sites. Eleven primarily cited governmental 

regulations as reasons for closure, three cited governmental and non-governmental 

factors, and four cited primarily non-governmental factors. The governmental factors 

included the Stark Amendments, Occupatidnal, Safety and Health Administration 

requirements, CLIA and/or other government initiatives. ’ Physician decisions to close 

an in-office laboratory were often not attributable to a single cause but to the 

cumulative effect of multiple factors. Government related reasons given for closing an 

in-office laboratory include: 

b Management or other arrangements for procuring laboratory services that 

might violate Federal or State statutes enacted since 1988. (2 of the 1988 sites) 

b Increased cost of doing business to comply with personnel, quality control and 

proficiency testing regulations and/or the cost to comply with CLIA regulatory 

requirements. (4 of the 1988 sites and 6 rural sites) 

b Red tape, hassle and inability to show a profit due to non-specified Federal or 

State regulations. (2 rural sites) 

b Low reimbursement. (4 rural sites) 

Information collected during this study indicates that some medical practices may have 

closed their POL prematurely. More than half of all the practices in this study that 

reported closing their POL due to CLIA did so during the period between passage of 

the amendments in 1988 and publication of the final regulations in February 1992. 

This indicates that their decision to close was not based on the final regulations as 

published by HCFA. 

Between the passage of the Amendments in 1988 and the implementation of the final 

regulations in 1992, there was much speculation as to what the final regulations would 

be and what the effect of regulation would be on POLs. The final regulations actually 

allowed more laboratory tests into the waived category than were originally 

anticipated. The final regulations governing personnel standards and other 

controversial aspects of CLIA were also considerably different than first proposed. 

7 As noted earlier, POLS are exempt from requirements of the Stark Amendments. Despite this, respondents 

did note this as a factor in their decision to close their POL. 
Additional evidence that some POLs may have prematurely closed can be found in the 

number of POLs that advised HCFA that they were closing operations due to CLIA 

and subsequently did not do so. In our rural sample, we found 33 of 56 physician 

practices that had advised HCFA that they would close their POL due to CLIA had 

reconsidered this decision and were still operating their in-office laboratory. 

Non-government influences may have had a greater impact on physician in-office 

laboratory testing than did government influences. Of the 232 physician practices 

contacted during this study, 7 of 18 POLs that closed indicated that their decision was 

influenced in part, or totally, by non-government factors. 

Sixty-four told us in unsolicited discussion that the organization of their practice had 

changed since 1988. About a third of the 64 practices indicated that they had 

downsized. The rest indicated that their affiliation with other physicians or institutions 

had resulted in a larger medical practice organization. Many had become employees 

of a hospital, others had merged with other physician practices and some had become 

more involved with health maintenance organizations and other managed care entities. 

Of the 64 practices that volunteered information about the sale, merger or changes in 

their practice, nearly half (30 practices) indicated that the change had affected their 

in-office laboratory testing. Respondents provided anecdotal information about what 

happened to their in-office laboratories. Several indicated that, after their practice 

was sold to a hospital, testing at the office was reduced to waived tests or eliminated 

altogether. Several respondents mentioned that, following the hospital acquisition of 

their practice, an in-office laboratory was established to perform waived tests. In 

virtually all cases involving hospital acquisition of a physician practice, the hospital 

required that tests of moderate and high complexity be sent to the hospital. Other 

physician respondents indicated that their affiliation with a managed care entity 

required them to use a specific laboratory and that they subsequently closed their 

in-office laboratory because the managed care entity would not pay them for in-office 

laboratory testing. 

At this point in time, information about physician business practices and alliances is 

available. However, without reliable hospital outpatient laboratory data and managed 

care laboratory data the impact of the changing business environment on POLs is 

unclear. Information obtained from study respondents suggests that sales, mergers 

and other changes in physician practice have influenced the number of POL sites in 

operation and the types of tests performed at those sites. 

POL Testing 

To assess the extent to which CLIA may have limited the kinds of tests being offered 

by POLs, we analyzed 60 laboratory procedures billed to Medicare carriers between 

January 1, 1985 and December 31, 1993. Analysis of billing data for these 60 

laboratory tests shows POL volume for chemistry tests has increased each year since 

10 
the passage of CLIA. s The increase in POL chemistry test volume indicates that 

POLs continue to provide this testing and the volume continues to increase. 

The 1988 amendments dictated that billers differentiate waived testing procedures 

from moderate and high complexity testing procedures. This differentiation is seen in 

certain procedure code volume data. The volume of tests billed by POLs for 

quantitative glucose, a moderate category test under CLIA, have decreased sharply. 

On the other hand, there has been a corresponding increase in glucose testing by 

reagent strip (82948), which falls in CLIA’s waived test category. Similar shifts in POL 

volume from moderate to waived testing procedures is evident for sedimentation rate 

tests and other tests. Tables containing the information used for this analysis can be 

found in Appendix D.’ 

The CLIA appears to have had some effect on the volume and types of tests being 

billed by POLs. Shifts from moderate and high complexity test procedures to waived 

testing procedures are evident in glucose, sedimentation rates and other areas of 

testing. Volume for some other procedure codes billed by POLs has also declined. 

However, volume decreases experienced by all types of laboratories for these codes 

indicate that factors other than CLIA have influenced volume and where laboratory 

tests are performed. 

8 Policy, billing and processing changes initiated by HCFA have resulted in a decline in the volume of some 

chemistry, hematology and other procedures performed by all laboratories. For example, change in policy has 

resulted in a decline in procedure code 80012, used to describe a 12 chemistry tests, and in declines for other 

chemistry tests codes (i.e., 84132 potassium, 82465 cholesterol). The change in policy is reflected in increases in 

procedure codes 80002 through 80019. 

9 Our analysis took into consideration all of the procedure codes used that might be used by laboratories having 

a certificate of waiver. Some codes with no volume or extremely low volumes were not used in our analysis, since 

including them would have had no impact on the analysis or conclusions drawn from the data. 

11 
COMMENTS ON THE DRAFI’ REPORT 

We would like to thank the American Medical Association (AMA), American Society 

of Internal Medicine (ASIM), American Clinical Laboratory Association and HCFA 

for responding to our request for comments on the draft of this report. Based on 

comments we received, we have reordered and reworded three of the report findings. 

The full text of comments received can be found in Appendix E. 

The HCFA and the American Clinical Laboratory Association concurred with our 

report findings. The AMA and ASIM expressed concern that our study does not 

address CLIA’s impact on patient convenience or the speed and quality of testing 

afforded by physician in-office laboratories. While important subjects, these issues 

were beyond the scope of our inquiry which was simply to determine whether CLIA 

has restricted the availability of laboratory services. 

The AMA suggests that we have not estimated correctly the number of physicians in 

active practice in 1988, and hence questions the accuracy of other estimates in the 

report. We believe the difference in OIG and AMA estimates of physicians in active 

practice is largely due to differences in definition and does not affect the accuracy of 

other estimates in this report. 

Our estimate of the number of physicians in active practice in 1988 reflects physicians 

who made themselves available to the general public. We realize that our definition is 

a more restrictive one than the common definition used by the AMA. We considered 

a physician to be available to the general public if they were listed in the yellow pages 

or listed with telephone directory assistance. The AMA definition of active practice 

includes physicians who do not make themselves available to the general public. 

These physicians are employed by health maintenance organizations, hospitals, 

government, community clinics or other entities. While the organizations for whom 

they work may advertise for patients, the individual physicians employed by them do 

not solicit patients by advertising in the yellow pages or other means. Given this 

difference in definition, and other factors, the magnitude of discrepancy between the 

AMA’s data and our data should not affect our projections, since the excluded 

physicians generally do not operate in-office laboratories. 

12 
APPENDIX A 

1988 POL Survey Methodology 

and results of 1994 recontacts with physicians 

who participated in that survey 

Note: The information presented on the following pages was used to determine what, if 

any, impact CLLA had on physicians in active practice in 1988 who were still in active 

practice in 1994. The data provided does not reflect the number of POLs in operation 

today. It does not take into consideration physicians entering into medical practice since 

1988 and their access to POLs. 

Projections are based on information obtained from States in 1988. Today, more 

accurate information as to the number of physicians in active practice is available. Using 

this information and the experience gained during our 1988 and 1994 surveys suggests that 

the current universe of laboratory sites that could be considered POLs ranges somewhere 

between 97,000 and 114,000 sites. 

A- 1 
..................................................................................... 

.................................. 

. 

POL SURVEY METHODOLOGY 

The 1988 and 1994 physician surveys both used a two-stage cluster sample to estimate 

the number of physician office laboratories (POLs) nationwide. In 1988, the States 

were selected at the first stage with probability proportional to size, where the size of 

the State was determined by the total number of laboratory procedures billed under 

Medicare Part B during 1985. This data does not include hospital outpatient data. 

The information on the total number of laboratory services was obtained from the 

Health Care Financing Administration’s 1985 Part B Medicare data file. Ten States 

were selected for inclusion in the survey. Table 1 gives the States selected, the 

corresponding estimated total number of laboratory services and the proportion that 

total is of all laboratory services for 1985. This proportion represents the probability 

of selection associated with each State. 

........... ................. ........ ................................................................. ....... ........ ....................................................... .............. ....... ....... .............................................................. ......... ............... ................................... .............................................................. .............................................................. ........................................................................................ .............................................................. ,,,,,,,,,,,,,_,,,,,,,,,.,,,,,,,,,,,.,,,,,,,,.,,,,.,,,,,,,,,,,, ...................................... :.:........................... ............................................................................. : .............................................................. :.. ................ :, .A.. At the second stage of ............................................................................ .............................................................. .............................................................. . ................................................................ ,.,.,.,.,.,.,.,.,.,.,.,.,.,.,.,.,.,.,.,.,.,.,.,.,.,., .:.:.:.:.:.:.:: . .:::$,g-$$$jj .iiiiiiiiiiiiii~~~~~~~~~~~~ ............................................................... ..................... ................. ................... .............. :;::. ......................... .............................. : :::::,:; ;;;,:....~.... :.:.:.:.>:.:.:.:.:.:...........:.y.>:.: :.:.>:.:.:.>:.: .............................. .............. ......... .:......................>:.p:.:...y...: .:... ............... ::: >:.:........................ .................::.::::::::.: .......... :~:::::.~~~~~ ~~~~ ::::::::::: ....................>>..............

.y........... .

......... 

..................

::::: ....I~,~,~,‘~‘~.~.~.~.~.~‘:‘~ ............. .......... sampling, each selected :.:.:.:.:.:.:.:.:.:.:,~::::.:.:.:.:.:.:.:.:.:.:. .................... :_..................................................... ......... .............................................................. ............................................ ................. ................................................................... :::::::::: .............................. ......................................... :::: :::: :................................... .............................. ...... ................ . ....... ............................w.:... : : .................... I:iais~~:i:~~:~ ~~~~~~ ...................

..................... .~:.:.:.:.:.:...::.:.:.:.:..:.:.~.:.:.:.:.:.:.:.:...::

................... 

.................... .. ..:....::.:.:.:.: ..

....................

.................... 

.

...................

................... 

............................... ................... ....... .............. ..:.:.:.:...: State was contacted and ..................... ......... :.:.:.:.:.:.:.;.:.::.:.:...:.:.:.:.: ....................................:............................................ 

I 1 requested to provide a 

12$i51 .................................................................................. 

Aetna Oregon ............................................ 1.09 ................ listing of all physicians .,:,,,,,,,:,,,‘.:.:.:,:,:.:.~:,:,:,:.:~:~~~:~:~:~:~~,:,:~~:~:~:~:~:~:~:~:~~.:~.,:~:~:~:~:;~~:~:~~:~, ........................................ :,:::j:;:;:;:;:;:j:::::: .............. :.:,:.:.:.:.:.:.:.:.~~.~:.:.~:.:.::.:.:.:.:.:.:.~:.:.: ................... ....... .............. ..iii:i.i’ii.i:j.~~~~~~ ............................................................ ...................... licensed in that State. ~~~~~~~~~,~ 

............................................................................................................................................. :.............

Aetna oklahoma 12,516 1.08 

Prudential NC 33,908 292 

Sample Total 365,913 3153 

+Numberspcesentedarefi-oma1%randomsampkofaU 

laboratory services in calendar year 1985 

Table 1 

Three of the selected 

States were unable to 

provide this listing. Each 

of these 3 States were, 

instead, asked to provide a 

listing of the name and 

address for approximately 

45 physicians selected at 

random. This approach 

was considered acceptable 

due to the independent 

nature of the sampling 

within each State. From 

the listings for the seven 

remaining States, 

physicians were selected 

within each State using 

simple random sampling. 

The only criteria for 

selection of a physician 

was that the physician’s 

mailing address be within 

A-2 

I 
the selected State and that the physician be licensed as a medical doctor (MD). All 

other physician groups, such as doctors of osteopathy, podiatrists, and chiropractors, 

were excluded from this survey. 

Each State in the sample was also asked to provide a count as to the number of 

licensed physicians with addresses in the State. This enabled us to identify the 

universe of physicians within each State and to exclude out-of-State licenses from the 

State universe. All of the selected States were asked to provide this count as of the 

date of our inquiry. 

It was felt that sampling 20 physicians in active practice, per State, was sufficient for 

purposes of this study. We attempted to secure a telephone number from directory 

assistance for each physician selected for study contact. 

Aetna 4,794 32 a!= 

OkhhOttW I I I 

Prudential NC ll~OO* 53 

7,081 II 

I I 

�  ���������  �������  �� ��� ������  II � * Adjustment is based on 20 physicians per State in the final sample. II

Table 2 

Telephone calls were made 

to all physicians with listed 

telephone numbers until 

we reached 20 physicians 

in active practice. 

Physicians with unlisted 

telephone numbers and 

those with listed telephone 

numbers who could not be 

reached, or whose 

answering service could not 

be reached after three 

attempts, were assumed 

not to be in active practice 

or not holding themselves 

out to the general public. 

We realize that our 

definition is more 

restrictive than the 

common definition used by 

the American Medical 

Association. 

Each of the physicians (or 

office staff) contacted were 

asked to confirm whether 

or not the physician was in 

active practice. The universe for each State was adjusted to eliminate those physicians 

not considered to be in active practice. 

When we had located 20 active practices, they were asked to participate in our study. 

Approximately 10 percent refused. Those that agreed to participate were asked if 

A-3 
..(.....,.,.....,.,..., ;:;::. 

. . . . 

they performed laboratory tests in their office. If they responded yes, they were asked 

if laboratory testing exceeded 5,000 tests a year. Our wording of these questions was 

consistent with the language of the Omnibus Budget Reconciliation Act of 1987 

provision. 

The results of the 1988 sampling process and the final adjusted estimates of the 

number of active physicians in each State are displayed in Table 2 on the previous 

page. 

This methodology allowed us to estimate the number of physicians who use a POL. In 

order to estimate the number of POLs, we also asked each interviewed physician if 

any other physicians used this same laboratory, and if so, how many. From this 

information we were able to estimate the number of POLs used by a single physician 

and, using the mode of the distribution from the responses indicating more than one 

physician used a given POL, we estimated the number of POLs used by more than 

one physician. Using the proper weight, based upon the sampling design, we were 

able to produce the national estimates given in Table 3. Included in this table are the 

lower and upper bounds for the 90 percent confidence interval. All values in this 

table are rounded to the hundreds position. 

., ,.,. ,.,.,.,. :f(:‘(:.:.(:’‘I.‘..:.:.:.:/:.....:.:...:::.~..:.:.:.:.: .~::::::::j:::::~:~:~~:~~~:~:~:~~~~~~~:~:::::::::::::::::::::::::~:~~:~:~:~:~:~:~:~:~:~:~~~~::...:.:.:.:.:.:.:.:.:::::::.::::’~:::~:::: i.i.i.i.i.i.i.i.i.::ii:;-:::::l:::I:I:::::~:~:~:::::~:~:::::~ ~~~~~~~~~~~ :.;.f:i:;:i:::::::::::::::::.:.:.:.:.> ....>:,......:;..~..:::::::::::::::‘.:~. :.:.,>>>:.>>>>: ,.j,.,.,.,.,.,.,.,.,.,.,.,.,...,.,.,.,., ,:,:,:,::::::::::::::::::::j::::::::::::::::::::::::::::::::::::::::::::::: .,..,. .,.,.,.,.,..,. .,.,.,.,. .,.,.,.:::.:.::-:.:-:.‘.:.:.:.’ ..,...., .A....: .,., .,.,.,.,.,.,. ,.,..,.,.,.,.,.,. :.:.v::::::: :;::.:.,. ..........,.,./,.,.. 

:::::::::,: ...... ..:.:.:.::::::y:::: ~:.:.:,..:: :.y:.:.A.:.:....i...:.:.:.:.:.:.:.:.:.:.::~ ... ......:..... ..>:.: ,.,.,, :...:,:. ,.,..,., :,,, .:::::::::“‘:~~ IA;:,::;&,:i.:.1:i.l.I.;.I.::~:~:~,:~.~,~,~~~~:~~~.~~~~:~~~~:~~~~~~~~~:~~~~~~~~~~~~~~~~~~~~~~~:~~~~~~~~~~~~~~~~~~~: :.: ..:...; .,.,(.,.,.i,.....,.,...,.,.,... :I ,................ ::y:::::::‘::::.:::::::::::::::.:.:.:..\\ ... ......:... ., .. ............... .:.:y:‘.‘: ;: :.....:.:....:.:.:.:.:.:.:.:.:.:..,. ~: ........ ...).................... . 

. 

. 

. 

. 

. 

. 

. 

.................. 

: ::y::I’.‘.‘:‘.‘.:.............................................................. .:,:.:,:.:,:.: .,:...:.:.:.:.:.:.: 

i:i~:i:ii\iiiiii;~~~~~~~~~~~~~~~~~~~~~~~~ ‘;i’!:~~ iil;i;~,,.i:-::;~~~;:i:li~~~~~~ 

# of Iicensed PhysiciaDs 567m 42890 705,400 

# P0I.s > 5,m Laboratories/Yeaf 

# with Multiple Physic&m 16,900 

Table 3 

A-4 
Results of 1994 Physic&n OJice Laboratory Survey 

The 1994 survey was designed to determine what happened to the 299,500 medical 

practices that were active in 1988. Using data derived from recontacting the 200 

physicians who participated in 1988, we were able to make the following projections 

about the 299,500 physicians in active practice in 1988. 

1) Projected number of medical practices that have closed POL operations since 

our 1988 survey. Includes practices that have ceased testing altogether and 

those that have consolidated sites:* 

Estimated # of POL Closures 90% Confidence Interval 

17,170 12,470 - 21,870 

2) Projected number of new POL sites:* 

Estimated # of POL Openings 90% Confidence Interval 

14,900 6,500 - 23,300 

3) Projected number of physicians operating POLs based on the 1994 survey:* 

.

44 Projected number of physicians in solo practice and group practice in 1994. . 

Physicians per Practice Type 

in 1994 Estimate 90% Cotidence Interval 

# of physicians in solo 

practice 81,000 59,200 - lo2$oo 

# of physicians in group 

practice 195,000 148,600 - 241,400 

* Based on physicians in active practice in 1988 who were still in active practice in 1994. 

A-5 

I 
9 Projected number of POLs being operated in 1994 by physicians who were in 

active practice in 1988 and who are still in active practice in 1994. This 

number has been broken down to show the number of POLs being operated by 

physicians in solo practice and to show the number of POLs being operated by 

physicians in group practice: 

Estimated # of POLS in 1994 8WoO 

# of POLS by Practice Type in 1994 Estimate 90% Confidence Interval 

POLs operated by solo practices 4Wo 29,800 - 59,400 

POLS operated by group practices 41,400 27,300 - 55,500 

W Percent of practices using national reference laboratories, local independent 

laboratories, hospital-owned laboratories or no reference laboratories 

(N= 176):* 

Laboratory Type Estimated percent 90% ConfIdeme Interval 

National reference laboratory 42.1% 34.8% - 49.4% 

Local independent laboratory 23.7% 16.7% - 30.7% 

Hospital-owned IaboratoIy 32.0% 20.4% - 43.6% 

None 2.2% 0.4% - 4.0% 

* Based on physicians in active practice in 1988 who were still in active practice in 1994. 

A-6 
5b) Percent of practices using national reference laboratories, local independent 

laboratories, hospital-owned laboratories or no reference laboratories by 

Practices With or Without POLs in 1994:* 

II No POL I 21.0% I 113% - 30-7% II 

II POL I 643% I 532% - 75.4% II 

No POL 69.8% 49.4% - 902% 

POL 

II +NumbexstoosmaUtoreport. II 

* Based on physicians in active practice in 1988 who were still in active practice in 1994. 

A-7 
APPENDIX B 

CLIA Laboratories by Type 

B-l 
II Type of Laboratory 

IIHome Health Agencv 

IIHospital 

II Industrial 

Frequency % CLIA Applications 

I 6,907 1 4.6% 11 

I 8,789 I 5.8% 11 

I lJfj5I 0.8% 11 

IIIntensive Care/Mental Rehabilitation Facility 

11SEIM Nursing/Nursing Facility I 13,157 I 8.7% 11 

II Other Practitioner I 2,194 I 1.4% II 

Blood Banks 

IIuIlknown* I 34 I 0.0%11 

II* Not validated by HCFA Based on how laboratories classified themselves on HCFA’s 

CLIA application. II 

B-2 
APPENDIX C 

Tables of U.S. Counties 

Without Laboratories 

The information presented on the following pages was derived using information from the 

United States Bureau of the Census, HCFA’s Online Survey, Certification and Reporting 

System and from HCFA’s Unique Physician Identification Number (UPIN) file. We used 

1990 census information. The HCFA data reflects information in file at the end of 

February 1995. 

C-l 
. . 

Table 1 

Yelkneone National Park MT 52 Hartley, TX 3,634 . . ~, ...‘.? ‘.’‘.> .,.‘,.’ ‘,&&+&.< ,:,... ., ,,,: : #... .,l[tma,+& ,:,:,’ .,, ‘,, ,.,... .y .?’&& 

Banner, NE 852 

Hages,NE: ::’ 

McPherson, NE 

Wheeler, NE 

c-2 

460 
. 

Table 2 

County, State Population # of Physicians 

3 

Qnitman, GA 1 

4 

675 1 

1 

:.:,..::::,_,. ; L:j.,:,.: :,,,g.:,~ 

I Falls Church, VA 9,578 4 

. .. j&&&y;yA “,:“,., .y. ‘,: ,.,;:(:“:..~&@ ,j,:f,‘.’ ..,..;‘:,,: ‘..,,. .l 

King and Queen, VA 6339 1 

c-3 
Table 3 

County, State I Population 1 # of Physicians II 

Fredericksburg City, VA 19,027 19 

c-4 
APPENDIX D 

Laboratory Procedure Codes 

by Place of Service 

1985 - 1993 

D-l 
The following tables were used to determine if changes in where testing takes place 

have occurred since the passage of CLIA. The tables span the period beginning 

January 1, 1985 through December 31, 1994. 

The data used from this analysis was first collected by the Office of Inspector General 

in 1985 and has been collected each year since that time. The data represents a 1 

percent sample. The samples were drawn annually from HCFA’s Common Working 

File and its predecessor the Part B Medicare Annual Data (BMAD) file. 

The procedure codes represented on the following pages were initially identified for 

use in our report entitled Quality Assurance in Physician Ofice Labs. At the time 

these procedure codes were selected they represent procedure codes most often billed 

as being performed in POLs. 

We compared the volume data for 1987 with the volume data for 1993 to determine if 

the billing for a particular procedure code had risen or fallen since the passage of 

CLIA in 1988. The volume for some procedure codes has vacillated from year to 

year. For purposes of this analysis, reasons for such vacillation was not taken into 

consideration. A change was considered to have occurred if the volume for a 

procedure code in 1993 was lower than the volume in 1987. 

D-2 
. . . . . . . . .._...........~...~.......................................................~....~.......................... 

i......................................lf!!. ..................................... 

/--1985 ( 1986 1 1987 1 1988 1 1989 1 1990 1 1991 1 1992 1 1993 . ..+-.......+........+.......-+........+........+........+........+........ 

~SERVICES~SERVICES~SERVICES~SERVICES~SERVICES~SERVICES~SERVICES~SERVICES~SERVICE~ 

I........ + . . . . . . . . + . . . . . . . . + -....... + . . . . . . . . + . . . . . . . . + . . . . . . . . +........+........ 

, SUM 1 SUM 1 SUM 1 SUM 1 SUM 1 SUM 1 SUM 1 SUM 1 SUM 

. . . . . . . ..-..-..................+........+ . . . . . . ..+........+-.......+........+........+........+........+........ 

I 1 HCPCS ; PLACE 

. . . . . . . . . . . . . ..+..........-..-.I 

I 

I i I 

I I I I 

I 

BOO02 ;OTH I 4406; 3835; 5089j 6477j 6842: 7285: 8456: 9831; 14015 I...............+........+........+........+........+........+........+........+ . . . . . . ..+........ 

’ POL I 4682; 5609; 5879; 7018; 7381; 8171; 8799; 9992; 1085e ,..-............+........+........+........+ I . . . . . . ..+........+ . . . . . . ..+........+........+........ 

:ALL I 9088; 9444; 10968 1 13495 1 14223; 15456; 17255; 198231 24873 . . . . . . . . . . . . . ..+...............+........+........+........+........+........+........+........+........+........ 

80003 . . . . . . . . . . . . . . . I I I i I i I 

j I 

IOTH I 25233 3017: 3753; 3849; 4180: 4361: 5055; 5079; 5314 ,.--....-.......+..-....m+ . . . . . . ..+......-.+ ..-....-+........+ . . . ..-..+........+........+........ 

’ POL I 3268; 3748; 40581 47171 4226; 4650; 5201; 5427; 5612 ,...............+--......+ . . . . . . ..+......--+ . . . . . . ..+........+ . ..-....+--......+....-...+........ 

;ALL I 

I 5791: 6765: 7811: 8566; 8406; 9011; 10256; 10506; 10926 . . . . . . . . . . ...-.+.. -............+........+ . . . . . . ..+........+ . . . . . . ..+........+ . . . . . . ..+........+........+........ 

BOO04 ; PLACE I 

~...............~ i I 

I 

I I I I 

i i 

;OTH 1 65021 66061 69381 77171 7618; 82491 8575; 83111 7997 I...............+........+........+........+........+........+........+........+........+........ 

1 POL I 

I 2776; 2672; 2425; 2653; 2740; 2749; 3100; 3377; 3531 I..........-....+........+........+........+........+........+........+........+........+........ 

;ALL I 

I 9278; 9278; 9363; 10370; 103581 10998: 11675; 11688: 11528 .-............-+...............+........+........+........+........+........+........+........+........+........ 

‘PLACE I I I I I I 

BOO06 I I I I 1 I I 

i!YE .......... 1 I I I i I I I I I I I I 

‘OTH 

I . . . . . . . . . . . . . . . i . ..- 3601j . . . . 4y . . . . 41y . . . . 521!! .-.. 1235i . . . . 5y . . . . 73?1.... 761!! . . . . 8115 

IPOL I . . . . . . . . . . . . . . . i . . . . 1549j . . . . 1437j . . . . 2466j . . . . 112:; . . . . 1141j . . . . 1765j . . . . 22T; . . . . 3!55j . . . . 3583 

jALL I 5150; 5703; 6174; 6778; 67761 7592; 9587; 10673; 11698 . . . . . . . . . . . . . ..+...............+........+........+........+........+........+........+ . . . . . . ..+.....-..+........ 

BOO12 ; PLACE I I I I I I 0 I 

~............... i 

PT! ............i.... 3104j ....3333j ....3461j ....3?$ ....3236j ....f??j ....TT76j ....T5?1.... ?28 

jPOL I 

I 3547; 3258; 3188; 3703; 4022; 4311; 3902; 3129; 2608 ~............... +........+........+........+ . . . . . . ..+........+........+........+ . . . . . . ..+....-... 

;ALL I 

I 6651; 6591; 6649; 6962; 7258; 7286; 6678; 5654; 5236 . . . . . . . . . . . . . ..+...............+........+........+........+........+........+........+........+ . . . . . . ..+........ 

BOO16 I I I I I I 

iYY .......... 1 I I 

I II 

I i I 

I 

I 

I 

I 

1 1 I !OTH 61701 4761; 4897; 4928; 50433 5180; 5494; 5310; 6535 I . . . . . . . . . . . . . . . j... ..-..+........+ . . . . . . ..+........+........+........+-.......+ . . . . . . ..+........ 

IPOL I 

I 4152; 4720; 6198; 7535; 8933; 9646; 11705; 13659; 15585 ,...............+........+........+ . . . . . . ..+........+ . . . . . . ..+........+..------+ . . . . . . ..+........ 

;ALL 1 10322; 9481; 11095; 12463; 13976; 14826; 17199; 189691 22120 . . . . . . . . . ...-..+.- . . . . . . . . . . . ..+........+........+........+.... . . ..+........+........+ . . . . . . ..+........+........ 

50018 ~PLACE I 

I I ;...............; I 

I I I I I I 

I I I I i I 1 I I I ;OTH I 4385; 5085; 5593: 69431 6772; 7067; 7804: 80531 8805 I...............+........+........+........+ . . . . . . ..+......-.+ . . . . . . ..+........+........+......-. 

1 POL I 

I 2655; 3178; 3525; 4055; 4291; 4592; 5841; 6799; 7905 I...............+........+........+ . . . . . . ..+........+........+........+........+ . . . . . . ..+........ 

;ALL I 7040; 8263; 9118; 10998; 11063; 11659; 13645; 14852; 16710 . . . . . . . . . . . . ...+. . . . . . . . . . . . . ..+........+........+........+.... . . ..+........+........+........+........+........ 

90019 I PLACE I I I I I I I I I I I I I i I I ~...............~ I 

jo~"~~~~~~~~~...~.~~"M38!...594981 70183; 84082: 981651 1069891 1213981 1203241 126095 .+........+........+........+...-....+ . . . . . . ..+........+........ 

7454; 6111; 6713; 8363; 9209; 105661 13516 24727; 25320 I!?.-...- . . . . ..+........+.......e t +........+...--..-+ . . . . . . ..+...-....+........ . . . . . . ..+........ 

i ALL I 54092; 65609; 76896; 92445; 107374; 117555; 134914 145051; 151415 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..~.............................~............................... 

D-3 
----------------- ---- 

-- 

---------------------------------------------------------------------------------------------------------------- 

I 

____________________---------------------------------------------------------

i------ ------- ------- ___----- __-------- !E”“- __------------_ 

i 2985 I 1986 ; 1987 1 1988 ; 1989 ; 1990 ; 1991 I 1992 1 1993 -----+--------+--------+--------+--------+--------+--------+ --------+--------

~SERVICES~SERVICES~SERVICES~SERVICES~SERVICES~SERVICES~SERVICES~SERVICES~SERVICES 

I,--------+--------+--------+--------+--------+-------- +--------+--------+--------

; SUM I SUM ; SUM ; SUM ; sun ; SUM ; SUM I SUM ; SUM -------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------

HCPCS I I I 

_______________ i!!!! __________ i i i i i i 

BIOOO !OTH ,-_.-------_.---!---~~~~~~-- 25379; 28961! 314553 33259j 36867j 41632; 41565j 43007 ------+--------+ --------+--------+ --------+--------+--------+-------­

,_--------.-----i__l~~6~~ IPOL 116330; 106154; 124286; 129331; 134665; 142747; 138712; 132458 ---+--------+--------+ --------+--------+ --------+--------+ ------e-+-e-----­

iALL 1 132792; 141709; 135115; -155741; 162590; 1715321 184379; 180277; 175465 

-----------*---+---------------+--------+--------+ --------+--------+--------+--------+--------+--------+--------

81002 I I I I 

I I i i i i I 

8881 1719; 1927; 2377; 4122; 5007; 4924j .5476! 4603 

I---------------+--------+ --------+--------+ --------+--------+ --------+--------+ --------+--------

13333; 14706; 14364; 15577; 20163 

i!? ____________ i____!?Oi ____91?1____ ?j- --123o71 -----+--------+--------+ --------+--------+--------

iALL I 8628; 11289; 11631; 14684; 17455; 19713; 19288; 21053: 24766 ---------------+---------------+--------+--------+--------+--------+--------+--- -----+--------+--------+--------

81005 I I I 

iP?!E __________ i i i i i I i 

---------------+---------------+--------+ --------+--------+--------+--------+--------+--------+--------+--------

81015 

---------------+---------------+--------+--------+--------+--------+--------+ --------+--------+--------+--------

82270 

; 26016; 27688; 29024; 37443; 41980; 46281; 49831; 45771; 46777 ---------------+---------------+--------+--------+ --------+--------+--------+--------*----------+--------+--------

82465 ;PLACE I I I I I I I I 

~---------------;I I I i I I 1 I 

;OTH I 1593: 24571 4391; 7422; 8376; 7196; 6867; 6381: 4960 

I---------------+--------+--------+--------+--------+--------+ --------+--------+ -m-----m+-------­

!POL I 33391 4335; 6690; 12598; 15064; 13268; 12645; 10505~ 7466 

I---------------+--------+--------+ --------+--------+--------+--------+ --------+--------+-------­

fALL I 4932; 6792; 11081; 20020; 23440; 20464; 19512; 168861 12426 ---------------+---------------+--------+--------+-------- +--------+--------+--------+--------+--------+--------

82565 PLACE I I I I I I I I 

;_______________;I I 1 I i I I I 

I I I 1 

;OTH I 21451 2901; 3114; 3022: 30931 32481 3293; 3191; 2681 

I---------------+--------+ --------+--------+--------+--------+ --------+--------+--------+--------

I iPOL I 2231; 2421; 3029; 3359; 3476; 3540; 4013; 4109; 3593 t---------------+--------+ --------+--------+--------+--------+ --------+--------+--------+--------

I ;ALL I 4376; 5322; 61431 63811 6569; 6788; 7306; 7300 1 6274 

D-4 
---- 

---------------------------------------------------------------------------------------------------------------- 

I YEAR 

I_________--------_--------------------------------------------------------------

I 1985 ; 1986 1 1987 ; 1988 1 1989 ; 1990 ; 1991 ; 1992 1 1993 ----w-m-+-------- +--------+--------+--------+--------+--------+--------+-------­

~SERVICES~SERVICES~SERVICES~SERVICES~SERVICES~SERVICES~SERVICES~SERVICES~SERVICES 

--------+--------+-------- +--------+--------+--------+--------+--------+--------

j SUM ; SUM , SUM , SUM 1 SUM 1 SUM 1 SUM ; SUM 1 SUM .------------------------------+--------+----- ---+--------+--------+--------+--------+--------+--------+--------

KPCS ~PLACE I I I I I I I 

---------------+---------------I i I I I i I 

I 

32643 'OTH I 92601 11911; 13635: 152221 16931; 189861 21885j 21843; 11558 I,---.-----------+--------+--------+ --------+--------+--------+--------+--------+--------+--------

1656; 2045; 2453; 2705; 3130; 3720; 4904; 2202 

i!? ____________ i ____2!1?+--------+--------+--------+--------+--------+--------+--------+-------­

iALL I 11407; 13567; 15680; 17675; 19636; 22116: 25605; 26747; 13760 ---------------+---------------+--------+--------+-----*--+--------+--------+ --------+--------+--------+--------

32756 'PLACE I I I I I I 

--m------------I I I I i I 

!OTH i 3557; 5283; 7183: 81963 9469; 10995; 11793; 136461 8877 

,---------------+--------+--------+--------+--------+ --------+--------+--------+--------+--------

i? ____________ i____!!63i- -----+--------+ 9691

1335; 1446; 1562; 1641, 

--------+--------+--------+--------+ 

1951; 3404; --------+--------1478 

;ALL I 4720; 6252; 8518; 9642; 11031; 12636; 13744; 17050; 10355 ---------------+---------------+-- ------+--------+--------+--------+--------+ --------+--------+--------+--------

52947 ;PLACE I I I 

I 

I I I I I 

,_______________; I 

I 

I 

I 

I 

I I

I i I I I 

;OTH ( 22165; 24460: 24661; 24135; 23688; 24261j 26151: 25629; 24889 I---------------+--------+--------+--------+--------+--------+--------+--------+--------+--------

iW\-s------- 1 503561 529871 508851 561391 572961 569601 550461 504671 43919 ---+--------+--------+--------+--------+--------+ --------+--------+--------+--------

iALL f 72521; 77447; 75546; 80274; 80984; 81221; 81197; 76096; 68808 ---------------+---------------+--------+--------+--------+--------+--------+-------- +--------+--------+--------

52948 I I I I I I I

I Pf __________ 1 I I I i I 

ROTH I 1078: 132; 271; 345; 408: 909j 17553 1874; 1377 I---------------+--------+--------+--------+ --------+--------+--------+ --------+--------+--------

8684; 9132; 11384; 119991 13436; 14609; 14873; 15348 

iY ___________ -+-I _------+--------+-------- 8o091 +--------+------ --+--------+--------+--------+--------

I [ALL I 9087; 88161 9403; 11729; 12407; 14345; 16364; 167471 16725 ---------------+---------------+--------+ --------+--------+ --------+--------+--------+ --------+--------+--------

33036 'PLACE I I I I I 

I _______________, i i I i I f 

1 I 

IOTH 4426; 5748; 7631; 9758; 121481 127961 14372 

I_--___----_---- i 525+ ----9 +--------+--------+--------+--------+--------+--------+-------­

lPOL 2369; 2907; 3437; 4706; 8503; 9963 

I__---__---__--- i--__ 1144: ___-13?j ---_ 1817i --+--------+--------*--------+ --------+--------+--------

I IALL I 3401; 4644; 6243; 8117; 10538; 13195; 16854; 21299; 24335 -------------------------------+-- ------+--------+--------+--------+--------+ --------+--------+--------+--------

53718 IPLACE I I 1 I I I 

+--------------- I 

I I i I I I 

I I 

4490; 82711 19786: 27174; 342381 45888; 487241 50464; 60396 

i?!- -----------+--------+--------+--------+--------+-------- +--------+--------+--------+--------

!POL 33191 6257; 8671; 9713; 12940; 18493; 16815 I -__----_-----_- i ---- 1566j ---_ !895i- - - -----+--------+--------+--------+--------~--------+--------

1 jALL I 6056; 101661 23105; 33431; 42909; 55601; 61664; 68957; 77211 ---------------+---------------+--------+--------+--------+--------+--------+--------+--------+--------+--------

I I I I I I I I 54132 1 I I iYF __________ j 1 I t I I I I 

I I I 

ROTH , 10007; 9668; 8973; 8240; 8423; 8052; 84411 8104; 7250 I---------------+--------+--------+--------+--------+--------+--------+--------+--------+--------

IPOL ; 14783; 15683; 16879; 18927; 18670; 17331; 16747; 13999; 11134 

I---------------+--------+--------+--------+--------+ --------+--------+--------+--------+--------

;ALL ; 24790; 25351; 25852; 27167; 27093; 25383; 25188; 22103; 18384 -------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------

34295 !PLACE 

;--------------- 1 

I ;OTH I 

I 

I I 

1967; 1944; 

I 

1574: 

I I 1 I I 1 

1637; 1788; 1480; 

i 

12521 

I

I 

1238; 823 I---------------+--------+--------+--------+--------+ --------+--------+--------+--------+--------

'POL I 2924; 2818; 3225; 4024; 4122; 3932; 3468; 2709; 1896 I‘--------------+--------+ --------+--------+-------- +--------+--------+----*---+---+--------

;ALL I 4891; 4762; 47991 5661; 5910; 5412; 47201 3947; 2719 

I , I I I I I I 

D-5 
------ 

------ 

---- 

---- 

-- 

---- 

i_____________________________________-Y!- ___________________________ __________ 

1985 ; 1986 I 1987 1 1988 ; 1989 i 1990 1 1991 I 1992 ) 1993 

i.-------+--------+--------+ --------+--------+--------+ --------+--------+--------

~SERVICES~SERV~CES~S~RV~~ES~~E~~~~~~~~E~~~CES~SERVIC~S~SE~V~~~~~S~~~~~~~~~~~V~~~~ 

I--------+--------+--------+--------+--------+--------+--------+--------+-------­

; SUM ; SUM I SUM 1 SUM 1 SUM ; SUM ; SUM ; SUM 1 SUM -------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------

HCPCS I I I I 1 I 

i”!? __________ / , I ---------------I-- i i I

84420 'OTH I 1843; 2674; 2888; 35281 4005: 45571 5007j 4220; 2198 ---------------+------ --+--------+--------+--------+ --------+--------+--------+--------+--------

IPOL I 1147; 1549; 2197; 2618: 2739; 3028; 2981; 3068; 1204 I ---------------+--------+--------+----------+--------+-------- +--------+--------+--------+-------­

iALL I 2990; 4223; 5085; 6146; 6744; 7585; 7988; 7288; 3402 ---------------+---------------+--------+--------+--------+--------+--------+--------+--------+--------+--------

84435 I I I 

i!!? __________ j i i I i i i 

IOTH 4241 i 37161 35401 27361 2787: 2905: 33501 3132: 1518 I---------------+----- I ---+--------+--------+--------+--*----+--------+--------+--------+--------

!POL I 1740; 1826; 20331 2205; 2849; 3617; 4666; 5421; 2419 I---------------+------ I --+--------+--------+--------+ --------+--------+--------+--------+--------

1ALL I 5981; 5542; 5573; 4941; 5636; 6522; 80161 8553; 3937 ------------------------------+-----------+--------+--------+--------+--------+--------+--------+--------+--------

84436 'PLACE I I I

I I I I I 

I --------------_ 1 I i i I I I t I 

!OTH i 12991: 20432; 24704: 30188; 328901 35555; 40635; 40749; 38428 I---------__----+--------+--------+--------+ --------+--------+--------+--------+ -e------+-------­

iPoL I 2520; 2270; 2935; 3431; 3848; 4083; 4817; 7786; 8442 I ---------------+--------+--------+--------+--------+--------+ --------+--------+--------+-------­

iALL I 15511~ 227021 276391 33619; 36738; 39638; 45452; 48535; 46870 ---------------+-- -------------+--------+--------+--------+-- ------+--------+--------+--------+--------+--------

84443 ~PLACE I I I I I I 

(--------------- j 

I I i i I I 

'OTH I 42161 63541 88591 13008j 171481 229171 32139: 376641 38066 I---------------+--------+--------+--- -----+--------+--------+--------+ --------+--------+--------

!POL I 1763; 1854; 2755; 3712; 4826; 6252; 8932; 14606; 14816 

I__-------------+--------+--------+--------+--------+ --------+--------+--------+--------+--------

I /ALL I 5979: 8208; 11614; 16720; 21974; 29169; 41071; 52270; 52882 +---------------+--------+--------+--------+--------+--------+--------+--------+--------+--------

84478 1 I I I I 

I I I 8 I I I i"""'-_-------- j 1

I I I I

I 1 

/OTH I 3598; 3480; 4702; 6554; 7686: 78721 8517; 90791 7432 I---------------+--------+--------+ --------+--------+--------+ --------+--------+--------+--------

2620; 2776; 3632; 5072; 5799; 5731; 6182; 6043; 4799 

iP?- _------+--------+ I --------+--------+--------+--------+-------- +--------+--------+-------­

jALL I 6218; 6256; 8334; 11626; 13485; 136031 14699; 15122; 12231 +---------------+--------+--------+--------+--------+--------+--------+--------+--------+--------

I I I I I I 84479 ;PLACE I ;_______________I I i i i I

I 

169OOj 206821 22504; 19719 

i?! ____________ i____5764j ____893o~--YO~~- ------+--------+--------+ 125731 138151 --------+--------+--------

!POL 3656 I _______________i ____1336! ____!366! ____1647j ___- lPPZl---- 18Z4j ---- ??fi 2125’- --+ -------+-------- 41301 

jALL I 7100; 10296; 12952; 14565; 15689; 188601 23207: 26634; 23375 +---------------+--------+--------+--------+--------+--------+--------+--------+--------+--------

84520 

iY’i __________ 1 I 

I I I I 

I I

I I II I

I 0 1 1 I I I !OTH I -_-_-_---__-__- j___- fI66j ---_ 2’112j____2860i 2785; 3177; 4013; 58211 5245; 4026 ---+--------+--------+--------+--------+--------+-------­

jPOL 1 3906; 4249; 4686; 4801; 4643; 4239; 40951 3703; 3100 I---------------+--------+--------+--------+--------+ --------+--------+--------+--------+--------

;ALL I 6472; 7161; 75461 7586; 7820; 8252; 9916; 8948; 7126 _--_-- ---‘-+‘--------------+--------+--------+--------+--------+--------~--------+--------+--------~--------

84550 

i!K __________ j I I i I I I I 

IOTH 1060; I---------------' +--------+--------+-----

12641 12591 1121 j 12631 ---+--------+--------+--------*--------+--------+--------1176: 1170j 9251 780 

I jPOL 1 2190; 2173; 2100; 2316; 2214; 1849; 1838; 1527; 1215 I---------------+--------+--------+--------+--------+--------+--------+--------+ --------+--------

I ;ALL I 3250; 3437; 3359; 3437; 3477; 3025; 3008; 2452; 1995 

1 1 I I I I I 

,

I 

D-6 
________________________________________--------------------------------------------------------------------------

i______________________________________ !?! ______________________________________ j 

+pB'lmi--~pf6 1 1987 I 1988 ; 1989 ; 1990 1 1991 1 1992 1 1993 I 

---+--------+--------+ --------+--------+--------+--------+--------

~SERVICES~SERVICES~SERVICES~SERVICES~SERVICES~SERVICES~SERVICES~SERVICES~SERVICES 1 

--+--------+--------+--------+-------- +--------+--------+--------+--------I 

i-----­

, SUM ; SUM 1 SUM 1 SUM ; SUM ; SUM 1 SUM , SUM 1 SUM I 

-------------------------------+--------+----- ---+--------+--------+--------+-------- +--------+--------+--------i 

I I I I I I HCPCS 

---------------I--------------- I i I i I 

85007 66761 5533; 51301 53021 50961 4404; 5031; 5337; 50321 --+--------+--------+--------+-------- +--------+--------+- -------+--------+--------

IPOL I 4100; 3905; 4605; 5403; 5432; 5318; 53531 5417; 46561 I ---------------+--------+---- ----+--------+--------+--------+--------+--------+--------+--------, 

/ALL I 10776; 9438; 9735; 10705~ 10528; 9722; 10384; 10754; 9688' ---------------+---------------+--------+----- ---+--------+--------+--------+--------+--------+--------+--------, 

85014 I I I I I

I I I I I I I i i I 

I I I I 

1337; 1521; 1760; 1896: 2364; 2706; 3413: 4382; 3620; I __- - - - - ___- - - _ -+--------+--------+--------+--------+--------+--------+ --------+--------+--------I 

[POL ; 10689; 10513~ I---------------+--------+--------+--------+--------+-------- +--------+--------+--------+--------,

9347; 9820; 9380; 8908: 8085; 6855; 5104: 

jALL 1 12026; 12034; 11107; 11716; 11744; 11614; 11498; 11237: 8724; ---------------+---------------+-- ------+--------+--------+--------+ --------+--------+--- -----+--------+--------I 

85018 I I I I I I I 

1 I i i I I 

1298; 1441; 16451 1837: 23261 25421 3105; 3872; 3509; -----+--------+--------+--------+--------+--------+--------+ --------+--------+--------I 

!POL 1 13323; 13115~ 11382; 13020; 12766; 12477; 11857; 9588: 7705j ,---------------+--------+--------+-------- +--------+--------+-- ------+--------+--------+--------, 

!ALL ; 14621; 14556: 13027; 14857; 15092; 15019; 14962; 13460; 11214; 

---------------+------------ ---+--------+--------+--------+--------+ --------+--------+--------+ --------+--------, 

85021 1 PLACE I I I 

I 

1 I I 

I 

I I 1 

I I I I 1 

I 

____--__--_----_---------------

85022 

------------+--------*--------+--+---+--------+--------+- -------+--------+--------+--------

iPOL I 20235; 22885; 23212; 240851 217341 18301; 15486; 12101; 86111 l---------------+--------+------*--+--------+--------+ --------+--------+--------+--------+--------, 

;ALL I 45165; 58893; 560431 46058; 37100; 290421 24512; 17683; 123181 

---------------+---------------+--------+ --------+--------+--------+--------+--------+--------+--------+--------

85027 ; PLACE I 

I 

I 

I I 

I 

I 

I 

I 1 I 

~--------------- 1 I 

I 

I 

I 

I 

j I I I I 

;OTH I 1717; 2907; 43891 52941 5627; 6078; 6480: 6933: 73121 I---------------+--------+--------+--------+--------+--------+ --------+--------+--------+--------

1 POL 1 

I 1929; 2921; 4802; 7115; 8203; 88061 9754; 9762; 91721 I---------------+--------+--------+--------+--------+--------+ --------+--------+--------+--------

;ALL 1 

I 3646; 5828; 9191; 12409; 13830; 14884; 16234; 16695; 16484/ ---------------+---------------+--------+--------+--------+--------+--------+--------+--------+--------+--------, 

85028 I 1 I 

i i I 

I I i 

I 

I 

I 

t 

99371 656; III 0; 01 0: 01 O/ 

,---------------+--------+--------+--------+--------+--------+--------+--------+--------+--------, 

i POL f 3934; 23221 404; 11; ‘I 01 0: 01 01 --------------+--------+--------+--------+--------+--------+--------+--------+ --------+--------; 

/ALL I 14982; 12259; 1060; 22; ‘I 01 01 01 01 ---------------+---------------+--------+ --------+--------+--------+--------+--------+--------+--------+--------l 

85031 

; 36340; 309781 27691: 26008; 22331; 17290; 14208; 10737; 7348; 

D-7 
---- 

I I I 

I I YEAR I I---_---------_-----____________________-----------------------------------------I 

I 1985 1 1986 ; 1987 1 1988 ; 1989 ; 1990 ; 1991 1 1992 ; 1993 i 

I_-------+--------+ --------+--------+ --------+--------+ --------+--------+--------

~~ERV~~E~~~ER~~~E~~~ER~~~E~~~ER~~~E~~~ER~~~E~~~ER~~~E~~~ERV~~E~~S~RV~CES~SERVICES~ 

I-----_--+--------+--------+--------+--------+ --------+--------+--------+--------

' SUM I SUM I SUM ; SUM ; SUM ; SUM ; SUM ; SUM ; SUM I 

---------------+---- -----------L--------+--------+--------+--------+--------+--------+--------+--- ---W-+-W------

I I I I I HCPCS ;PLACE 

---------------+--------------- I i i i I 

85048 ;PLACE I I I I 1 0 1

1---------------l I i i I I i I 

!OTH Slli 3421 371: 3191 414I 5441 7871 987‘I I----------_----i ----+--------+--------+ 371i --------+--------+--------+--------+--------+-------- I

IPOL I ----------__--- i ---- 633flj _-_- 6133j _--- 5411j ---- 1879; ---- 1267; ---- SZSOi-_-- 3944j ---_ 3!(13j ---- 236: 

iALL I 6709; 66441 5753; 6250; 5586; 56941 44881 3850; 3353 ---------------+---------------+--------+--------+--------+ --------+--------+--------+ --------+--------+--------

85580 I I i!E __________ i i i i i i i 

I --------------_ 1- - ?80i-+--------+--------+ --------+--------+ --------+--------+ --------+--------

jPOL I 88161 9244; 9607; 9474; 8844; 7614; 6470; 5666; 1658 

I---------------+--------+--------+--------+--------+ --------+--------+--------+--------+--------

;ALL 1 14196; 15326; 17620: 17144; 12169; 10574; 9287; 8172; 3116 ---------------+---------------+--------+--------+--------+--------+--------+--------+--------+--------+--------

85595 IPLACE I 0 I I I I 

f I I 

I I 

I ,_______________; I I I 

I 1 I I I I 

i?! ____________ 34331 3983; +-I _------+--------+--------+ 

3203: 3363; 2954; 30041 --------+--------+--------+--------+--------+--------

2918: 2525: 2832 

jPOL 1 

I 4249; 4925; 5459; 61611 5960; 5603; 4857; 3997; 3595 )---------------+-..-----+ --------+--------+ --------+--------+--------+--------+--------+--------

fALL I 7682; 8908; 8662; 9524; 8914; 8607; 7775; 6522; 6427 ---------------+---------------+--------+--------+--------+--------+--------+--------+--------+--------+--------

85610 !PLACE I I 

I 

I I I I 

I I 

I 

;_______________ 

!OTH 6082; 80131 76701 33251 29601 28171 25061 1458 

-

85650 j 

I I i II ;OTH 157251 19711; 22691; 23844; 27052; 330361 42137; 47669; 58800 I---------------+--------+ --------+--------+ --------+--------+ --------+--------+ ------m-+-------e 

i!OL I 13153; 13178; 13883; 16099; 18487; 19926; 23862; 28827; 31441 --------------+--------+--------+--------+--------+--------+--------+--------+--------+--------

/ALL I 28878; 32889; 365741 39943; 45539; 52962; 65999; 76496; 90241 ---------------+---------------+--------+--------+--------+--------+--------+--------+--------+--------+--------

i!Yf __________ I

I i i I 

I 

I 

I 

1

I

I 

I 

I I 

i0T~ I 5418; 55571 5937j 6096; 6331; 6550; 6500: 5850; 2615 I---------------+--------+--------+--------+--------+--------+--------+--------+--------+-------­

!POL 1 11096; 11491; 10486; 10960; 10974; 10630; 10418; 9997; 4220 I---------------+--------+--------+--------+--------+--------+--------+--------+--------+-------­

;ALL , 16514; 17048; 164231 17056; 17305; 171801 16918; 15847; _____- ---------------------+--------+--------+--------+ --------+--------+--------+--------+--------+-------- 6835 

/ 85651 i!!? __________ I

I I

I I

I I 

f 

1 

I I 

I 

I 

I I

1 

I 

ROTH I 3769; --------+--------+--------+ 95301 11152j 13216; 13720; I---------------+--------+ 5526; 6693; 8369; --------+--------+--------+--------+--------17077 

----+--------+--------+ 10456; 11289; 12333; 13986: 15999; 20630 i!? ____________ i ____62521 7174; 8556; --------+--------+--------+--------+--------+--------

---___ [ALL , 10021~ 12700; -----+---------------+--------+--------+---- 15249; 18825; 20819; 234851 27202; 29719; ----+--------+--------+--------+--------+--------+-------- 37707 

87060 ~PLACE I 

I I I 

I 

I 1 I I I I 

I I ,_______________~ I I I 1 I I I I I I ;OTH 1

+--------+--------+--------+ 745; 693; 811; 992; 947; 1041 ;_______________ 651; 521; 614; --------+--------+--------+--------+--------+-------­ iPOL I 

I 1311; 1507; 1375; 1520; 1531~ 1491; 1430; 1157 I---------------+--------+--------+--------+--------+--------+ 14931

--------+--------+--------+-------- ;ALL I 

I 1962; 2028; 1989; 2265; 2186; 2342; 2483; 2377; 2198

_-----------------------------------------------------------------------------------------------------

D-8 
----- 

---------- ---- ---- 

I 

I I 

---- 

________________-___----------------------------------------------------------------------------------------------

t YEAR ,_______________________________________-----------------------------------------

t 1985 ; 1986 ; 1987 ; 1988 1 1989 ; 1990 ; 1991 1 1992 1 1993 

I,--------+--------+--------+--------+--------+--------+--------+--------+--------

~SERVICES~SERVICES~SE~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~V~~~~ 

1--------+--------+--------+--------+--------+ --------+--------+--------+--------

; SUM 1 SUM ; SUM ; SUM ; SUM 1 SUM ; SUM 1 SUM ; SUM -------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------

I I I HCPCS ;PLACE I I I I ---------------+--------------- I i i I 

87070 ‘OTH 3094/ 46011 51471 5915j 7002; 79151 88511 9191; 8685 ,---------------+--------+--------+--------+--------+--------+--------+--------+--------+--------

i____2603i____ 16901 1758; 16181 1662; 1603; 1719; 153c i!? ____________ 1636j-------+--------+--------+ --------+--------+ --------+-------­

jALL I 4697; 6237; 6837; 7673; 8620; 9577; 104541 10910~ 10215 ---------------+---------------+--------+--------+--------+--------+--------+--------+--------+--------+--------

87081 1PLACE I I I I I I I 

;_______________; I i i I /OTH- I 391: 488; 514; 3431 572; 479; 555; 5541 59E __- -----------+--------+--------+ --------+--------+--------+-- ------+--------+--------+--------

IPOL I ---------_----_ i ---- Y!i -_-_ 1024: -__-- 863; ----_ 95:; 9955--__- 94Oj _--- 1OZli ---__ 888; -____ 79f I jALL I 1504; 1512; 1377; 1300; 1567; 1419; 1576; 1442; 1396 ---------------+---------------+--------+--------+--------+--------+ --------+--------+ --------+--------+--------

87086 i I I I i i I i I i!!!! __________ 1

!OTH I -----! Ir?!! 8444l---~rUrSli-.-ll~~~~-- ~!2856j-1162~~- !8943!- -20!49j-Et 

!POL l----------_----i ---- 61335 88251 9304; 9845; 10720; 11506; 10571 ---- 6698!---- 7985j- ------+--------+ --------+--------+ --------+-------­

iALL I 12393; 15142; 18466; 20742; 22160; 25472; 29663; 31655; 34427 --------------------___________ +--------+--------+--------+--------+--------+--------+--------+--------+--------

87088 i!YY __________ I i I

I 

I f

f II 

I I1 I

I I I 

I 

ROTH I 2265: 3608; 4797; 5964; 6479; 73831 8771; 97131 8442 ;_______________ +--------+--------+--------+--------+--------+--------+--------+--------+--------

i ____ ____ 25021____ 34111 4152; 4500; 4961; 4601 i!! ____________ 151Oj 5063i____ 5?1j ____----+--------+--------+ --------+--------

1 /ALL I 3775; 5671; 7299; 89551 9890; 11535~ 13271; 14674; 13043 ---------------+---------------+--------+--------+--------+-------- +--------+--------+--------+--------+--------

87101 j I 

I 

I 

I I I I i i I

I i!!? __________ I 

ROTH I 121; 133: 154; 197: 205; 204: 2493 238; 161 I---------------+--------+ --------+--------+ --------+--------+--------+--------+--------+--------

i!OL____________ !YY!____ 248!!____ -+--------+--------+--------+-------- 1553 i____!663!____ f!!?i ____ Es1 3217; 3009; 2512; 

jALL I 1784; 2030; 2184; 2678; 3010; 34211 3258; 2750; 1714 ---------------+---------------+--------+--------+--------+--------+--------+ --------+--------+--------+--------

87184 1PLACE I

I_______________l I 

I I

I i I 

I I I I 

I 

I 

I 

1

I 

I 

;OTH 1 4335; 5583; 6237j 6470: 62631 6481; 7139; 61601 5344 I---------------+--------+--------*----------+--------+--------+ --------+--------+--------+--------

;POL I 35171 4164; 5141; 5765; 6004; 6397; 6828; 6439; 5745 I---------------+--------+--------+--------+--------+--------+--------+--------+--------+--------

I IALL I 7852; 9747; 11378; 12235; 12267; 12878; 13967; 12599; 11089 ---------------+---------------+--------+--------+--------+ --------+--------+--------+--------+--------+--------

87205 i I

I 1 I I

I I I I

I I i!?? __________ I I I I 

!OTH 1854; 2316; 27231 2911; 3298 i---__----------j l!“‘“i__-_ 117pj ___- 1324j _--- !549i ---+--------+--------+--------+--------+--------

I ’POL 1 1514; 1521; 14381 1664; 1763; 1885; 1969; 1962; 1951 ,---------------+--------+ --------+--------+--------+--------+----- ---+--------+--------+--------

I ;ALL I 2536; 27001 2762; 3213; 3617; 4201; 4692; 4873; 5249 ---------------+---------------+--------+--------+--------+--------+--------+--------+--------+--------+--------

87210 ‘PLACE I I I I I I I 

---------------f I I I 

I I i I I 1 I

:OTH I --------_---__- i ---__ I?! _____1? 146; 209; 226; 2433 231; 197; 245 - +--------+--------+--------+--------+--------+--------+--------

I jPOL I 1590; 1750; 1715; 2111; 2298; 2394; 2657; 2384; 2247 ;_______________ +--------+--------+--------+--------+--------+--------+--------+--------+--------

I ;ALL I 1717; 1907; 18611 2320; 2524; 2637; 2888; 2581; 2492 

D-9 
I 

I 

________________________________________--------------------------------

I YEAR I 

I_______________________________________-----------------------------------------~ 

j--~~f'--~ss~~f~- I_ 1987 f 1988 f 1989 1 1990 1 1991 1 1992 1 1993 / -+ -------+--------+--------+--------+--------+--------+--------

ISERVICES:SERVICESISERVICESlSERVICESlSERVICES~SERVICES~SERVICES~SERVICES~SERVICES~ 

j --_-_--- ;.- ------+--------+--------+--------+--------+--------+--------+--------

, SUM f SUM ; SUM , SUM f SUM i SUM f SUM 1 SUM 1 SUM I 

-------------------------------+---- ----+--------+--------+--------+--------+--------+--------+--------+--------, 

I I I I HCPCS ; PLACE I ---------------+---------------I I i i i i I i i 

88150 ‘OTH I 3390; 3583! 4248; 44561 49073 58471 56133 5132; 4452/ I ---------------+--------+--------+ --------+--------+--------+--------+--------+--------+--------

IPOL l

I 3095; 2956; 2068; 2561; 2774; 3017; 2519; 2277; 1754/ I--- ------------+--------+--------+--------+--------+ --------+--------+ --------+--------+-------­

iALL I 6485; 6539; 6316; 7017; 7681; 8864; 8132; 7409; 6206/ ---------------+---------------+--------+--------+ --------+--------+--------+--------+--------+ --------+--------

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8 ;OTH 1 55401 4961; 4834; 4790; 4435; 43911 4281; 32241 2886/

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i ____ 181l n21 697; 810; 7191 656; 384; i!? ____________ 107flj_____ + -------+--------+-------- +--------+--------+--------+--------2931 

jALL t 66181 5742; 5566; 5487; 5245; 5110; 4937; ---------------+---------------+--------+--------+--------+--------+--------+--------+- -------+--------+--------3608; 31791 

88304 1 PLACE I t I I 

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,_______________, I I I I I I 

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/ALL 1 21624; 23955; 27438: 29085; 32142; 35202; 38976; 19747; 16364; ---------------+---------------+--------+--------+------ --+--------+--------+--------*--------+--------+--------~ 

89205 1 PLACE I I I I I I I I I I I I I---------------, I I I

I I

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i!! ____________ i _____ 1’105 _____ TZbj_____ 3221_____ 513j_____ 244j_____ 282j_____ 26Oj_____ 152!_____Illi 

I jPOL I 2975; 3118; 2089; 2196; 2055; 1760; 1620; 1152; 8521 

I---------------+--------+--------+--------+--------+--------+--------+--------+--------+--------I 

;ALL I 

I 3165; 3344; 2411; 2409; 2299; 2042; 18801 1304; 969: 

D - 10 
APPENDIX E 

Copies of Comments Received on the Draft of this Report 

E-l 
May l&l995 

Amer’ican 

Clinical I,abor*atory 

A!%VK!ial.i~n 

June Gibbs Brown 

Inspector General 

5250 Wilbur J. Cohen Building 

330 Independence Avenue, S.W. 

Washington, DC. 2020 1 

Dear inspector General Brown: 

As President of the American Clinical Laboratory Association (“ACLA”), I am writing to 

thank you for the opportunity to comment on the Office of Inspector General’s recent draft report, 

“CLIA’s Impact on the Availabiiity of Laboratory Services.” As you know, ACLA is an 

association representing independent clinical laboratories located throughout the United States. 

All ACLA members were directly affected by the passage of CLIA’88 and the subsequent 

regulations implementing that law. 

ACLA has always believed that all patients should be assured that their clinical 

laboratory testing was being performed in a facility that met certain basic quality and personnel 

requirements, regardless of whether that testing was being performed in an independent clinical 

laboratory, a hospital laboratory, or a physician’s office laboratory. For that reason, ACLA 

members strongly supported the enactment of CLIA ‘88, and have continued to support the 

enforcement of its provisions. 

As a result of our concern about these issues, we read with great interest the OK’s recent 

report. We believe its basic--and most important--conclusion is stated al the bottom of page 7 of 

the report. The report notes: 

Despite changes in POL [Physician O&e Laboratory] testing 

capabilities, none of the practices that participated in our study indicated 

that they have any trouble in securing laboratory services for their 

patients. The availability of POLs, independent clinical laboratories and 

hospital laboratories appears to be adequate to meet the needs of 

physicians and patients. 
June Gibbs Brown 

Inspector General 

May 15,1995 

Page Two 

In short, the repot-t concludes that CLIA’s imposition of basic quality and personnel 

standards has not limited patients’ access to laboratory services. We believe this conclusion is an 

impottant one to bear in mind as consideration is given to proposals to modify the law. 

Thank you for the opportunity to comment on this report. If we can be of any fizrther 

assistance, please do not hesitate to contact me. 

Sincerely yours, 

David N. Sundwall, M.D. 

Resident 

E-3 
-- 

American Medical Association 

Physicians dedicated to the health of America 

James S. Todd, MD 515 North State Street 312 464-3000 

Executive Vice President Chicago, Illinois 60610 312 464-4184 Fax 

May 15, 1995 

June Gibbs Brown 

Inspector General 

Department of Health and Human Services 

330 Independence Avenue, S.W . 

Washington, DC 20201 

Dear Ms. Brown: 

The American Medical Association (AMA) appreciates the opportunity to comment on 

the Office of Inspector General’s draft report entitled “CLIA’s Impact on the Availability 

of Laboratory Services. ” Clearly, no other regulation has caused more concern, anxiety, 

and unrest in the physician community than has CLIA. We are, therefore, pleased that 

the Administration has made the request that your office study CLIA and its effects on 

the medical profession especially on those physicians who have opted to perform 

laboratory testing in their office. 

In requesting the study, HCFA had raised concerns that testing sites, especially physician 

office laboratory (POL) sites, might cease operations and thus restrict patient access to 

certain types of laboratory tests. The study concludes that CLIA has had little or no 

impact on the availability of laboratory services. What the study fails to address is the 

effect CLIA may have had on the availability of In-office testing, regardless of whether 

outside laboratory services were available, and what such a decrease in the availability of 

In-office testing may mean to patient convenience and quality of carei 

Certainly, lab closure was one possibility that POLs had to consider when faced with 

volumes of regulatory requirements. Other possibilities include the higher costs 

associated with the provision of laboratory services brought about by compliance with 

CLIA, costs associated with inspections of private physician office practices, and 

excessive administrative requirements. As the study indicates a number of physicians 

did opt to close their laboratories. However, we would challenge a number of the 

study’s other conclusions. 

For example, we maintain that it is questionable, as the draft study suggests, that the 

reduction in the number of POLs from 57,000 in 1988 to 44,500 in 1994 can be 

attributed primarily to physicians moving from solo practices to group practices. While 

group practices are growing in number, many physicians may have closed their labs due 

to multiple factors such as the cost of complying with CLIA requirements, lower 

reimbursements for lab services, OSHA requirements, and managed care requirements. 

E-4 
2 

In addition, we believe that the report does not provide enough evidence to support its 

conclusions concerning the underlying reasons for the apparent shift on the part of 

physicians from solo practitioners to group practices. Specifically, the report does not 

provide enough evidence of this shift as it only accounts for 1994. According to AMA’s 

Socioeconomic Monitoring Survey, it is a fact that the percentage of physicians in solo 

practice has fallen (from 35% in 1990 to 29%) in 1994. What is less certain, however, 

is that the reduction in POLs operated by solo physicians can be necessarily associated 

with the decrease in their numbers without evidence that would specifically link POL 

closures to the trend of physicians merging practices. Thus, it would be more accurate 

to conclude that some, but not all, of the lab closures are the result of physicians joining 

groups. 

We also find it troubling that the study does not differentiate between employee and selfemployed physicians. Surely, self-employed physicians are more likely to respond to 

CLIA’s cost implications because they bear the financial risks directly. The study 

ignores the fact that although physicians are able to maintain necessary laboratory 

services, they may also incur additional costs. 

In addition, it should be noted that some of the numerical projections in the study utilize 

magnitudes that may be questionable. For example, the study shows an estimated 

299,500 of 567,200 licensed physicians in active practice in 1988. Our records indicate, 

however, that in 1988 there were approximately 567,587 licensed physicians, of which 

521,328 were in active practice (According to the AMA’s Phvsician Characteristics and 

Distribution in the U.S.). These estimates, which are in our view inaccurate, make the 

other projections used in the study suspect. 

We agree with the study’s fourth finding where it states, “The CLIA appears to have had 

an impact on the kinds of testing performed by physician office laboratories.” Clearly, 

most physicians have chosen to restrict the variety of laboratory testing they perform for 

their patients. Tests that had been routinely and safely performed for’ their patients 

benefit pre-CLIA were subsequently considered highly complex or moderately complex 

and became subject to stringent and costly requirements that made it no longer 

economically practical or feasible to continue to perform those same tests in the POL 

setting. POLs that did restrict their “menu” of tests were ultimately compelled to use 

either hospital or independent labs to provide the complimentary additional needed 

diagnostic data necessary to compile the treatment regiment for their patients. Reducing 

the menu of tests routinely performed in a POL has resulted in disruptions in both 

patient and physician access to immediate essential services. The draft study results do 

not address this problem in particular. 

The AMA maintains that the study would be enhanced if it could assess the hardship on 

patients in having lab testing performed elsewhere other than in a POL. The 

convenience to the patient and/or physician in having the full regiment of diagnostic 

services readily available is an important issue. If the costs associated with performing 

E-5 
critical and fundamentally essential testing are so high that physicians must curtail their 

menu of laboratory testing, then the patient, the physician and the Medicare program 

loses. The patient is forced to delay the initiation of a drug program or other medical 

services until lab results are returned from an outside lab. Subsequent patient visits may 

be necessary to convey the results and establish an appropriate treatment regime. The 

patient and physician must adjust busy schedules to accommodate the additional visits. 

For the physician the convenience of being able to perform essential lab tests that 

complement his or her practice can mean that a more conservative course of treatment 

can begin as quickly as possible. Waiting even twenty-four hours for lab results can 

mean the difference between conservative treatment or surgery, patient anxiety or patient 

satisfaction, professional autonomy or unnecessary government oversight. 

The study should also recognize that the increase in the utilization of lab services per 

patient and in expenditures has occurred, in part, due to the availability of sophisticated 

automated lab equipment. That equipment is now being used safely and effectively by 

hospitals, independent labs and physician office labs. 

It is ironic that the regulation being examined by this study was enacted into law to 

improve the quality of patient care by assuring the accuracy of laboratory testing, and 

yet, the study draws no conclusions about the impact of the law on quality. If lab work 

is delayed, quality is not improved. If a physician is unnecessarily restricted from being 

able to practice medicine due to excessive costs and regulations, quality is not improved. 

The study should attempt to correlate the benefits (improvements in the quality of 

medical care) that accrue to physician office practices that are able to provide a full 

array of necessary, in office lab testing to their patients, where access is not a problem. 

The AMA appreciates the opportunity to comment on the draft report. Should you have 

questions about these comments please contact Jack Emery in our Wa$ington Office at 

(202) 789-7414. 

Sincerely, 

James S. Todd, MD 

E-6 
american society of internal medicine 

President 

KATHLEEN M. WEAVER. MD May 15, 1 395 

The i-iono able June Gibbs Brown PW3l&nt-NOd 

WILLIAM E. GOLDEN. MD Inspector 3enerai 

Liflfe Rock, Arkkanres Departme It of Health & Human Services 

Sacralsry- Treasurer 200 lndep sndence Avenue, SW 

J. LEONARD LICHTENFELD. MD 

Battlmow Maryland Washingtc n, DC. 20201 

/mm&ate Past President 

YANK D. COBLE Jr, MD Dear Ms. 3rown: 

Jaciwxwll(s, Florida 

TRUSTEES Thank yo! I for giving the American Society of Internal Medicine (ASIM) the opportunity 

LOUIS Ii. DIAMOND, MD to provide comments on the Office of Inspector General’s draft report entitled “CLIA’s 

Washington. D.C. Impact on the Availabliity of Laboratory Services.” In general, we find that this study 

CYRIL M. HETSKO, MD does not rddress the true impact of the CLJAlaw on physician office laboratorles. 

Madison, WlacorWn 

E. RODNEY HORNBAKE 111,MD The stud) concludes that CLIA has had little or no impact on the availability of 

Rochester, New York laborator], services. This conclusion Is based on the findings that there has not been 

ISABEL V, HOVERMAN, MD a signlfic; nt decrease In the number of physicians operating in-office laboratories 

Aistln, Texas since CLI, 4was enacted in 1988 and that none of the physicians contacted during the 

ROBERT D McCARTNEY MD study ind :ated that they had trouble securing laboratory tests for their patients from 

Denver, Cdorado outside SIIurces. The study fails to address whether CL/A has restricted the availability 

PHILIP T. RODILOSSO, MD of in-officl ! laboratory services to Medicare patients and how such a change, if any, 

Arhngton,Vlrglnla may have impacted patient convenience and quality of care. 

BERNARD M. ROSOF, MD 

Hunllnglon. New York The stud!, finds that CLIA has had an effect on the kinds of testing performed by 

RONALD L. RUECKER. MD physician office laboratories. Specifically, the study concluded that CLIA contributed 

Decalur. lllinols 

to a sharl 1decline in the volume of 12 tests out of a sample of 80 procedures M. BOY0 SHOOK, MD 

Oklahoma City, Oklahome performel I by physician offlce laboratories between 1987 and 1993. For example, the 

volume o quantltative glucose and sedimentation rate tests--both moderate 

LAURENCE 0. WELLIKSON MD 

Orange, Callamla complexi! j tests--performed by physician office laboratories has dropped sharply. 

There ha! been a corresponding increase in the volume of the waived versions of 

CECIL B. WILSON, MD 

Winter Park, florlda these tes s. ASIM believes that a large number of physicians have discontinued all 

but waive:d testlng in order to avoid the costs associated with complying with the CLIA ExecufWe Vice Pmsldenf 

ALAN R. NELSON MD regulatior s for moderate- or high-complexity laboratories. This would explain both the 

sharp de, :rease in offlce laboratory test volume for some procedures seen in this 

ThlRy-ninthAnnual Meeting study, an j the fact that over 50 percent of physician office laboratories now fall into 

Washqmn. D.C. 

October 18-22. 1995 the waive d or physician-performed microscopy categories. it also would explain why 

this stud! did not find a significant decrease in the total number of physicians 

REPRESENTING operatinc office laboratories. 

Internists.and 

All SubspecIalists 

of lntemal Medlcine We belle ‘8 that this study may actually underestimate the impact CLIA has had on 

patient aI :cess to moderate- and high-complexity testing in the office laboratory 

setting. ‘he study compares pre-CLiA data from 1987 with 1993 data. We believe 

the most significant changes in testing volume dld not occur until the period from 

1991 to - 993. Feedback from our members indicates that the majority of them waited 

until after regulations were published before changing their test menus. Many walted 

2011 PENN’ tYLVANIA AVENUE, NW � SUITE 800 � WASHINGTON, DC 20006-1606 

TELEPHON i (202) 6352746. FAX (202) 635-0443 

E-7 
even longer until the regula ions were implemented in September of 1992 before discontinuing 

tests for which no aftemativ I waived method exlsted. 

The study concludes that th 3 apparent change in offfce laboratory testing capability is not 

Important, suggesting that tile physicians contacted during the study had no problems securing 

laboratory work for their pat ents from outside sources. We believe this conclusion is misleading 

and ignores the special ber sflts of having laboratory services performed where care is being 

provided. Office laboratorie z allow physicians to obtaln test results while patients are still in the 

office so that they can begir immediate treatment of their medical problems. Afthough moderateand high complexity tests ci n usually be obtained from outside sources, there often Is a 

substantial delay in reoeivin f the results of those tests. At best, outside laboratories can get 

results back in a few hours. in some cases, It may take days to obtaln test results from 

commerclat laboratories. Tr Is means unnecessary delays in test results that may require revisits 

to the physician’s offfce or c ianges In treatment. At the least, this greatly inconveniences the 

patient. At worst, such dela rs In dlagnosls may have serious consequences for the patient, e.g., 

unnecessary hospitalization!. 

Another consequence of the apparent change in the kinds of tests performed by office 

laboratories is that patients I lay be sent to outside laboratories for routine tests that were 

performed for them at their f hysiclan’s offfce pre-CLIA. This may pose a hardship for elderly, sick 

and dlsabled patients who p 9ve difficulties in arranging transportation to other sites. As a result, 

some patients may forgo ob aining necessary tests altogether. For working patients, this may 

mean that they must take mcIre time off from work to get test work, resulting in lost wages for the 

employee and decreased pr rductfvfty for the employer. 

ASIM is also concerned abo tt the possible impact WA has had on quality of testlng. The study 

fails to address the possible quality implications ff CLIA has indeed caused a large number of 

physicians to switch to less effabfe, but lower category tests rather than use more reliable, but 

more regulated methods. A: noted above, the study also fails to address whether CLIA has 

caused delays in diagnosis i nd if patient care has been adversely impacted as a result. 

Finally, the study data show :hat 12,500 office laboratories operated by solo practitioners have 

closed since CLIA was enad 3d. We question the assumption made by the study that all these 

closures can be explained b’ the move away from solo practice toward larger group practices. 

In conclusfon, ASIM rejects tl te overall conclusion of the study that CUA has had no impact on the 

availability of tests. lmmedia e availability of many routine tests in a manner that is convenient to 

patients and facilitates prom1 t dlagnosis and treatment decisions has been adversely affected by 

CLIA. Patients no longer ha\ e the same access to moderate and high complexity in-office 

laboratory services as they h Id pre-CLIA. The study does not adequatefy address this concern. 

Thank you ,for the opportunlb to review and comment on the 010’s report on the impact of CUA 

on the availabillty of faborato y testlng. ASIM looks forward to working with you and your staff on 

this issue in the future. 

Sincerely, 

Alan R. Nelson, MD 

Executive Vice President 

2 

E-8 
DEPARTMENT OF HEALTH & HUMAN SERVICES Health Care Flnanctng Admlnlstratlon 

The Admlnlstrator 

Washington, D.C. 20201 

DATE MAY 22 1995 

TO June Gibbs Brown 

Inspector General 

FROM Bruce C. VIadec 

Administrator 

SUBJECT Office of Inspector General Draft Report: “CLIA’s Impact on the 

Availability of Laboratory Services,” (OEI-05-94-00130) 

We reviewed the subject draft report which examined whether the Clinical Laboratory 

Improvement Amendments of 1988 have restricted the availability of laboratory services 

to Medicare patients. Our comments are attached for your consideration. 

Thank you for the opportunity to review and comment on this report. Please advise us 

if you would like to discuss our comments. 

Attachment 

E-9 
Comments of the Health Care Financing Administration (HCFA) 

on Office of Insnector General Draft Renort: 

“Clinical Laboratory Improvement Amendments of 1988 

fCLIA) Impact on the Availabilitv of Laboratory Services” 

(OEI-05-94-00130) 

HCFA Comments on the Report Findings 

Page i - We recommend rewording the first finding as follows: “CLIA appears not to 

have affected physician ability to secure laboratory services for their patients.” The 

statement as it is currently written implies that physicians refer all laboratory services 

which is not the case. This statement is also on page 5 of the report. 

Page ii - We recommend replacing the wording of the last finding with the language 

contained in the original draft document we reviewed, “Changes in the marketplace have 

affected where some laboratory tests are performed.” The discussion concerning the 

change in billing codes does not take into account that, until CLIA, waived tests did not 

have unique codes but were billed under existing billing codes that were not as specific. 

Stating that coding changes show a shift in physician testing may not be a reliable factor 

as these unique codes did not exist prior to CLIA. The present wording of the last 

finding also fails to consider the other factors that are elaborated on in the discussion on 

page 9. It might be helpful to expand the discussion on page ii to include these other 

factors. (This finding statement is also on page 9.) 

Another factor that should be mentioned in addition to the “Stark Amendment” should 

be Occupational, Safety, and Health Administration requirements. These came into 

place around the same time and there is concern in the medical community about these 

requirements as well. This is also mentioned on page 9. 

Page 3 - The discussion in the second paragraph concerning multiple sites is incorrect. 

Since multiple sites are permitted under one certificate, the total number of laboratory 

sites should be larger than 151,658, not smaller (129,634). This should also be corrected 

on page 6. 

Appendix C - It would be helpful to know the timeframe from which this information is 

taken (currently, based on 1990 census , . . .). As it is presented we are unsure of the 

time period involved. If this is current information is there similar information available 

so that pre- and post-CLIA comparison could be made? 

E - 10