Department  of Health  and Human  Services 
OFFICE  OF 
INSPECTOR  GENERAL 
CLIAs  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  OIGs  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  OIGs  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  OIGs  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.  ODriscoll 
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 non-
government  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  in-

office  laboratories.  Of the  232 practices  we contacted,  64 volunteered  information 

about  the  sale,  merger,  or changes  in their  practices.  Of these,  30 noted  non-

government  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  CLlAs  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 
INTRODUCIION  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  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: 
are  approved  for  home  use by the  Food  and  Drug  Administration, 
b 
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 
patients  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  physicians  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 
CLIAs  impact  on  patient  convenience  or CLIAs  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  HCFAs  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 HCFAs  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  HCFAs 
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  HCFAs  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. 
Continued  growth  in the  laboratory  Estimated  Volume 
marketplace  indicates  that  the  1988  (in millions) 
6ow  w-
amendments  have  not  impaired  the 
a-
availability  of laboratory  services.  The  ao- ----letal 
volume  of laboratory  services  provided  wo- Pa8q.dCuA 
to Medicare  patients  has  increased  each  mo-
year  since  1983.  The  top  graph  to the  2soo-
right  shows  estimated  growth  in the  200.  HOP0
---z== -
l(y1- _>:S==
volume  of laboratory  tests  experienced  _=::
by the  Medicare  program.  In  1983, the  1p0.0.   _________--.-._&c cz-y-T_=.5_-I._./..-..-.  ---._-..- __._....  poL 
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 
million  tests  annually. 	 141    Implm6nt6Uon 
1s
IP-
11. 
The  middle  graph  shows  the  estimated  lo
o-
average  number  of laboratory  tests 	
6-
provided  to Medicare  Part  B enrollees.  7-
6. 
This  number  has  more  than  doubled 	 6. 
4-
between  1985 and  1993.  In  1985, 	
s-
Medicare  paid  for  five laboratory  tests  2-
lJi 
per  Medicare  Part  B enrollee.  In  1988, 
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-
of the  total  dollars  paid  by the  Medicare  4.6. 
4-
program  for  outpatient  laboratory  35 
s-
services.  In  1983, Medicare  expenditures  26. 
for  these  services  were  just  over  $1  2. 
1.6. 
billion.  In  1988, the  year  CLIA  became  1.
0.6. 
law, Medicare  was paying  $2.8 billion.  0.  !  .  .  1  !
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 0therLabtxatorieIs   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) 
Increased  cost  of doing  business  to comply  with  personnel,  quality  control  and 
b 	
proficiency  testing  regulations  and/or  the  cost  to  comply  with  CLIA  regulatory 
requirements.  (4 of the  1988 sites  and  6 rural  sites) 
Red  tape,  hassle  and  inability  to show  a profit  due  to non-specified  Federal  or 
b 	
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 CLIAs  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  CLIAs  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 
AMAs  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  Administrations  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. 
....,...::...........:......:..~........:...:.,.  ........:...:.......:....,:.........:........... ....,::.........:...:...........,.:>..........:...............,::..........:...:...........,.:.:.........:...............,:,............:...:...........,.:.:..........:...............,:;...........:...:...........,. ...........:..;.............,:..... ...... ..;.:...........,..............;.............._:.............,.:.........................:..,...........................:,............................,...........:................:,...........:................,..............~..... .....:.,.........:........ ...,.,........ ................~.,.........:...............,.....................>..............::..............,...........:.......... :..,.........::...w..........,..........:..........p..,........................,.........::...:........:..,.........................,:.........:.... .:.....:...,.......................... ..,~...........:......:......... ,.........................,..........:......>y:.......>............: . .........,..........:....:.........,........ ..:............y,.........:......>........,..........:...::........,....... .:..... ......:...,.........:.............,........:....:......:...,.........:..:...................:....:......:...,.........: ..:..:.........,........:........_.....:.....,........,..:..:.:.............,......................:...............,..:..:..........:... ...,.............. ......::.....,........,:....:.............. ,....... ...........:.....,.......,...:........:......,........:.........:.....,.......,............:.... ..,.....................:....,.......,............. .:...... ,......................:...,.......,.:............:.....,.......:..:..............., ...,.:.......  ..:.... y. ..:......... ....,.:.............. .. .........>...,..I.............~......... .....:,... ...............,....... ....:~,............ ...............,..,.:................~.............,..:...............,.... ........,..>.... .~..... . .. ...,.:........~... ., ::............,::~.......... ,>:...........:I..:..:~ .~:.....:..::.,:..i........:..:...a.......:..::.:,::..~:........:... .:i :.....:..::.,s ..:........:...:.~:.....:..::.,~:..........:....:~......:..:;.,.~..~....... .:....~ ....:..:,.:.:.............i.:..~....:..:,.:............:.:~.~....~......,....... ..... .:~ ...:.~... .
....  ......::....... ..~.. .............. .......::.................:...... ..........:...................:...................:.......... ....................................... ....................:......... ............:. :..........:.......;: :........:.$.........:..........,.... .... g ..............-.. . ..$..........$..........$..........j...j .... ......................~.~..........i.........i....~.~...:..i............i......~.~i...:.......i..........i....~.~...:.i..........i...... .~i...:......i.......i...:..~....i............i....... ~...:...................~ .....................~.... ...
............~....:........,....~...... ...............~.A....................~......................~ ........ .......~............~ ....
....~......~...... .... ................  ASsattam tteph leiwn gsa,es c oecnaocdnh ta scsttaeegldee c teaodnfd
I  I  1  requested  to provide  a 
Aetna Oregon  12$i51  1.09 
....,..:..,..,..,..,..,..,..,..:..,..,..,.......:.....:.....:..,..:..,...:.....:.....~....:..,..:..,..:..,..:.....:. ~..:.~...~:.,.:~:..:..j:..:~..;..:.:.;.~.:...;...:.:....~.;....:.:......;:....:.:~....,.j....:.:~ .....:...:.:,.....::...:.:,.....::...:. ~..........:.....~........:......:....:~.........:.:.....~...~.......:..~~...........:. ~~..:.:..~:...:~.~. ::.~:.::~:.~:.:..:~:.:..,::.~:.:~~::l.~i:.s::~ti:n;~g~ :o~f: ~a~l:l~ ,physicians
~~~~~~~~~,~  ..iii:i.iii.i:j.~~~~~~  licensed  in that  State.
.........................................................................................:.................................................. ................................. ................................................................ 
Three  of the  selected 
Aetna oklahoma  12,516  1.08 
States  were  unable  to 
provide  this  listing.  Each 
Prudential NC  33,908  292  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 
Sample Total  365,913  3153 
within  each  State.  From 
the  listings  for  the  seven 
remaining  States, 
+Numberspcesentedarefi-oma1%randomsampkofaU 
physicians  were  selected 
laboratory services in calendar year 1985 
within  each  State  using 
simple  random  sampling. 
Table 1 
The  only  criteria  for 
selection  of a physician 
was that  the  physicians 
mailing  address  be within 
A-2 
 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. 
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 
Aetna 
numbers  who  could  not  be 
I  4,794  32  a!= 
OkhhOttW  I  I  reached,  or whose 
answering  service  could  not 
be  reached  after  three 
Prudential NC  ll~OO*  53  attempts,  were  assumed 
not  to be  in active  practice 
or not  holding  themselves 
out  to the  general  public. 
We  realize  that  our 
II definition  is more 
7,081 
restrictive  than  the 
common  definition  used  by 
I  I 
II  the  American  Medical 
        

 * Adjustment  is based on 20 physicians per State in the final sample.  II
 Association. 
Each  of the  physicians  (or 
Table  2  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. 
.~::::::::j:::::~:~:~~:~~~:~:~:~~~~~~~:~:::::::::::::::::::::::::~:~~:~:.~, :,~.,.: ~,.,:.~,.:,~.i ::.~fi.(:i:.~i(.::i~..:i:..~i(.:i~I..i~..:~.::i:.i:::.;..-:..::::./::::..::.l.:.::..:.:I:.:.:I:.:.::..:.:::.:::~::.::~:~:.::.:~:..:~:::.::~::::.~::~~.~::::~:~~~:::~::::~::~~~~ 
::...::A;:..::.f:y.:::.i:::.::..;::::.: ,:. iy:. :  ::..:.:..:::.:.:..::.::.:...::;..:.. ..::..::  ::..::..:.:>::.::::::.....:.:,.:::... .:>:,:::(.:,::.::.:,.:.:..::.:,,.:.y..:>:.,:i;::. ,..:. :...:,...~:.:.:. ,..,,.~::.:......:,.,.:.:.. ..\::.,,\:....., ::..,.:, ,..:.., :.......:,:,...:: .,).: , :....:(.,.:.::......:..... y:,:........:.. ,..>.::.,:~....>...,A....>  .....::......>.::.,,.I..> . ...,..i..,> ........ .j>...  .,...,  ...:.   :.  .,.. ..:....,....:....,....:....,....:... .,.;,.:.:..,. ,.:....., ,:..:., ,::..:.,,,:,:.,...y..,,,,.:.,.:...:  ,.:,~....I.,:,.,:. ....,.:,..,:,:.....,.:,,.,:,::....,.:,,..,:,:....,.:,.::,;..,.:..:::..,::.,;.: ..~: .:.., :,:.: .~:,...: .: .: :.:.- .::.:...::.:.- .::.:...:.:...::.:..:.::..j..:.::.:...:.v.: .::..::.::..::.::..::.::.. :.:..:.:..:.:..:.:..:.:..:.:..:.:.: ::I.:;::A:,::::;..:::::,.,::,:::..;: :&:,.::.,:.::...:i.:.:.. .::..:..::1.:..::.::.i.,....l:,...I:/..,;.:.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.I 
. . 
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 
 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 
II +NumbexstoosmaUtoreport. 
*  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  Frequency  % CLIA Applications 
II 1 
Home Health Agencv 
 I  6,907  4.6%  11 
II
Hospital 
 I  8,789 I  5.8%  11 
II Industrial 
 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  I  0.0%11 

34 
II* Not validated by HCFA  Based on how laboratories classified themselves  on HCFAs 

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, HCFAs  Online Survey, Certification and Reporting 
System and from  HCFAs  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[.t>m a,+&  ,:,:,  .,,  ,,  .,,..,.,...  .y .?&& 
Banner, NE  852  460 
Hages,NE: :: 
McPherson, NE 
Wheeler, NE 
c-2  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 
I 
County,  State  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  HCFAs  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 
. . . . . . . ..-..-..................+........+  . . . . . . ..+........+-.......+........+........+........+........+........ 
H. C. P.C S.  . . . . . . . . . ..+....;. ..P..L.-A..-C.IE   I  1 II   i I  I  I  I  II  
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  P.L A.C E.  . . . . . . . . . . . .  II   II   II   i  II   i  I  II  
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  II   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  II   2776;  2672;  2425;  2653;  2740;  2749;  3100;  3377;  3531 
I..........-....+........+........+........+........+........+........+........+........+........ 
;ALL  II   9278;  9278;  9363;  10370;  103581  10998:  11675;  11688:  11528 
.-............-+...............+........+........+........+........+........+........+........+........+........ 
BOO06  i!YE  ..........1 	 II   II   II   i  I  I1   II   II  
I  I  I  I  I 
OTH 
I . . . . . . . . . . . . . . . i  . ..- 3601j  . . . . 4y  . . . . 41y  . . . . 521!!  .-..  1235i  . . . . 5y  . . . . 73?1....  761!!  . . . . 8115 
IIP .O L. . . . . . . . . . . . . . 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  II   3547;  3258;  3188;  3703;  4022;  4311;  3902;  3129;  2608 
~...............  +........+........+........+  . . . . . . ..+........+........+........+  . . . . . . ..+....-... 
;ALL  II   6651;  6591;  6649;  6962;  7258;  7286;  6678;  5654;  5236 
. . . . . . . . . . . . . ..+...............+........+........+........+........+........+........+........+  . . . . . . ..+........ 
BOO16  II   II   I  I  II   II   II  
iYY  ..........1  I  II  1  i  I  I  I
1 
!IO .T H.  . . . . . . . . . . . . . j...  61701  4761;  4897;  4928;  50433  5180;  5494;  5310;  6535
..-..+........+  . . . . . . ..+........+........+........+-.......+  . . . . . . ..+........ 
IPOL  II   4152;  4720;  6198;  7535;  8933;  9646;  11705;  13659;  15585 
,...............+........+........+  . . . . . . ..+........+  . . . . . . ..+........+..------+  . . . . . . ..+........ 
;ALL  1  10322;  9481;  11095;  12463;  13976;  14826;  17199;  189691  22120 
. . . . . . . . . ...-..+.- . . . . . . . . . . . ..+........+........+........+....  . . ..+........+........+  . . . . . . ..+........+........ 
50018  ~;..P..L..A..C...E.. ..;  I  III    II   II   II   i  III    I1  III    I 
;OTH  I  4385;  5085;  5593:  69431  6772;  7067;  7804:  80531  8805 
I...............+........+........+........+  . . . . . . ..+......-.+  . . . . . . ..+........+........+......-. 
1 POL  II   2655;  3178;  3525;  4055;  4291;  4592;  5841;  6799;  7905 
I...............+........+........+  . . . . . . ..+........+........+........+........+  . . . . . . ..+........ 
;ALL  I  7040;  8263;  9118;  10998;  11063;  11659;  13645;  14852;  16710 
. . . . . . . . . . . . ...+.  . . . . . . . . . . . . ..+........+........+........+....  . . ..+........+........+........+........+........ 
90019  I~ .P..L..A..C...E.. ...~  II   II   III    I  II   II   i  II   II  
jo~"~~~~~~~~~...~.~~"M38!...594981  70183;  84082:  981651  1069891  1213981  1203241  126095 
.+........+........+........+...-....+  . . . . . . ..+........+........ 
7454;  6111;  6713;  8363;  9209;  105661  13516  24727;  25320 
I!?.-...- . . . . ..+....t....+.......e+........+...--..-+  . . . . . . ..+...-....+........  . . . . . . ..+........ 
. . . . . . . . . . . . . . . . .i  A.L .L  . . . . . . . . . . . . ..~I .....5..4..0.9..2..;. ......6..5..6.0..9.~; .......7.6..8..9.6..;.. ......9.2..4..4..5.;   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  !,O-T_H.-------_.---!---~~~~~~-- 25379;  28961!  314553  33259j  36867j  41632;  41565j  43007 
------+--------+ --------+--------+ --------+--------+--------+-------
,I_P-O-L- -----.-----i__l~~6~~  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- --1-2-3-o-7-1+ --------+--------+ --------+--------+--------
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  II   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  II   I  I  II   I  I  II   II  
;_______________; I  1  i  I 
I  I  1 
;OTH  II   21451  2901;  3114;  3022:  30931  32481  3293;  3191;  2681 
I---------------+--------+ --------+--------+--------+--------+  --------+--------+--------+--------
iPOL  II  2231;  2421;  3029;  3359;  3476;  3540;  4013;  4109;  3593 
t---------------+--------+ --------+--------+--------+--------+  --------+--------+--------+--------
;ALL  II  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 
.------------------------------+--------+----- ---+--------+--------+--------+--------+--------+--------+--------
K-P-C-S- -----------+-~-P-L-A-C-E- --------I I  i  II   I  I  II   II   i  II  
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  I  I 
--m------------I I  I  i 
!OTH  i  3557;  5283;  7183:  81963  9469;  10995;  11793;  136461  8877 
,---------------+--------+--------+--------+--------+  --------+--------+--------+--------+--------
1335;  1446;  1562;  1641,  1951;  3404;  1478 
i?  ____________ i____!!63i- -----+9--6---9---1+  --------+--------+--------+--------+  --------+--------
;ALL  I  4720;  6252;  8518;  9642;  11031;  12636;  13744;  17050;  10355 
---------------+---------------+-- ------+--------+--------+--------+--------+  --------+--------+--------+--------
52947 	 ;,P_L_A_C_E_ __________; I  III    II   III    III    III   i  II   III   
;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  Pf  __________ 1  I  II  I  II   I  II   i  II 
I 
ROTH  I  1078:  132;  271;  345;  408:  909j  17553  1874;  1377 
I---------------+--------+--------+--------+  --------+--------+--------+  --------+--------+--------
8684;  9132;  11384;  119991  13436;  14609;  14873;  15348 
iY  ___________ -+-I _------8+-o---0---9-+1-------- +--------+------ --+--------+--------+--------+--------
[ALL  II  9087;  88161  9403;  11729;  12407;  14345;  16364;  167471  16725 
---------------+---------------+--------+  --------+--------+  --------+--------+--------+  --------+--------+--------
33036  I' _P_L_A_C_E_ _________, I  i  i  II   i  II   f  I  I 
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 ---_181--+7--i--- ---+--------*--------+  --------+--------+--------
IALL  II  3401;  4644;  6243;  8117;  10538;  13195;  16854;  21299;  24335 
-------------------------------+-- ------+--------+--------+--------+--------+  --------+--------+--------+--------
53718 	 +I-P-L-A-C-E- --------- III    II   i  I1   II   II   I  II  
4490;  82711  19786:  27174;  342381  45888;  487241  50464;  60396 
i?!- -----------+--------+--------+--------+--------+-------- +--------+--------+--------+--------
!POL  6257;  8671;  9713;  12940;  18493;  16815
I -__----_-----_- i ---- 1566j ---_  !895i- - 33191 
- -----+--------+--------+--------+--------~--------+--------
jALL  1I  6056;  101661  23105;  33431;  42909;  55601;  61664;  68957;  77211 
---------------+---------------+--------+--------+--------+--------+--------+--------+--------+--------+--------
54132  1I   II   II  I  II   I  I  II 
iYF  __________ j  t  I  I 
1  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  ;!-P-L-A-C-E- --------- 1I   ,  II   II   II   II   1I  i  II 
I  I  I  I  1  I 
;OTH  II  1967;  1944;  1574:  1637;  1788;  1480;  12521  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 
---------------------------------------------------------------------------------------------------------------- 
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 
-------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------
I  I  I  I 
HCPCS  I  1 
---------------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 
II-O-T--H- ----------+----- I  42--4-1+ -i- ------+37--1--6-1-- -+----3--5-4-+01-- *----+2--7-3--6--1- +-----2--7-+87--:- -----+-2-9--0-5--:-  33501  3132:  1518
!I-P--O-L- ----------+------ II   174--0+;- -------1+8--2-6--;- --+---2--0--3-3+1   2205; -------2-+84--9-;-- ---+--3--6-1--7-;+ -------4-+6-6-6--;- --- 5421;  2419
1ALL  I  5981;  5542;  5573;  4941;  5636;  6522;  80161  8553;  3937 
------------------------------+-----------+--------+--------+--------+--------+--------+--------+--------+--------
84436  'I -P-L-AC-E- ---------_ I1   II   II  i  I  i  II   I  II 
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 	 ~(P-L-A-C-E- ---------- II   II   i  I  I  i  II   II  
j 
'I-O--T-H- ----------+--------+I- ------4-+2-1-6-1  63541  --8-8--5+9-1-- -----+13--0--0-8--j- +----1-7--1-+48 1  229171 -----3--2-1+3--9-:-- ---+-3-7--6-6--4-1  38066
!POL  I  1763;  1854;  2755;  3712;  4826;  6252;  8932;  14606;  14816 
I__-------------+--------+--------+--------+--------+  --------+--------+--------+--------+--------
/ALL  II  5979:  8208;  11614;  16720;  21974;  29169;  41071;  52270;  52882 
+---------------+--------+--------+--------+--------+--------+--------+--------+--------+--------
84478  i"""'-_-------- j  11I   III    II   III   II   II   81I   I
/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 
------  ----  +---------------+--------+--------+--------+--------+--------+--------+--------+--------+--------
84479  ;;P_L_A_C_E_ __________I II   I  II   i  I  i  i  I  II
I 
169OOj  206821  22504;  19719 
i?! ____________ i____5764j ____893o~--YO~~- --1-2-5-7-3+1- ----1-3-8-1+5-1-------+  --------+--------+--------
!I _PO_L_ ____________i ____1336! ____!366! ____1647j ___-lPPZl---- 18Z4j ---- ??fi  ----  212--5+- ----4-1-3-0+1- -----3-6-56
jALL  I  7100;  10296;  12952;  14565;  15689;  188601  23207:  26634;  23375 
------  ----  +---------------+--------+--------+--------+--------+--------+--------+--------+--------+--------
84520  I  I  I  I  II  I1   II  II
iYi  __________ 1  I  0  1  I 
I  I  I 
!OTH 2785;  3177;  4013;  58211  5245;  4026 
I -_-_-_---__-__- j___- fI66j  ---_ 2112j____2860i 
---+--------+--------+--------+--------+--------+-------
jPOL  1  3906;  4249;  4686;  4801;  4643;  4239;  40951  3703;  3100 
I---------------+--------+--------+--------+--------+  --------+--------+--------+--------+--------
;ALL  I  6472;  7161;  75461  7586;  7820;  8252;  9916;  8948;  7126 
_--_--
----+--------------+--------+--------+--------+--------+--------~--------+--------+--------~--------
84550  1  1  I  I  I  I  I 
i!K  __________ j  I  I  i  I  I  I  I 
IOTH  1060;  12641  12591  1121 j  12631  1176:  1170j  9251  780 
I---------------' +--------+--------+----- ---+--------+--------+--------*--------+--------+--------
jPOL  I1  2190;  2173;  2100;  2316;  2214;  1849;  1838;  1527;  1215 
I---------------+--------+--------+--------+--------+--------+--------+--------+  --------+--------
;ALL  II  3250;  3437;  3359;  3437;  3477;  3025;  3008;  2452;  1995 
,
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 
H-C-P-CS- -----------I--------------- I  II   I  I  i  I  I  I i
I 
85007  66761  5533;  51301  53021  50961  4404;  5031;  5337;  50321 
--+--------+--------+--------+-------- +--------+--------+- -------+--------+--------
IIP -OL- -------------+--I -----4-1+0-0-;- - 3-9-0-5-+;- ----4-6--0+5-;- -----5-4+0-3-;- -----5+4-3-2-;- ----+5-3-1-8-;- ---+-5-3-5-3--1- -+---5-4-1-7-;- ,  46561
---------------+--/A-LL- -----------+----I ----1+0-7-7-6--;  94-3-8-;+ -----9-7-3-+5-;- ----1-0-7+0-5-~- ----1-0+5-2-8-;- ----+9-7-2-2-;- ---+1-0-3-8-4-;-- -+-1-0--7-5-4-;- ,  9688' 
85014 	 II   II   II   II   II  i  I  i  II 
I  I  I  I 
1337;  1521;  1760;  1896:  2364;  2706;  3413:  4382;  3620;
I __-----___---_- +--------+--------+--------+--------+--------+--------+  --------+--------+--------I 
I[P-O-L- ------------+--------+; ------1--0+6-8-9--;-- --+-1--0-5--1--3+~- -------9347;  9820;  9380;+ -------8-+90--8-:-- ---+--8--0--8-5-+; --------6,855;  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  II   1  I  I  I  I  I  1I  
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  II   II   I  II   II   1  I  I  II  
~--------------- 1  I  I 
j  I  I  I  I 
;OTH  I  1717;  2907;  43891  52941  5627;  6078;  6480:  6933:  73121 
I---------------+--------+--------+--------+--------+--------+  --------+--------+--------+--------
1 POL  1I   1929;  2921;  4802;  7115;  8203;  88061  9754;  9762;  91721 
I---------------+--------+--------+--------+--------+--------+  --------+--------+--------+--------
;ALL  1I   3646;  5828;  9191;  12409;  13830;  14884;  16234;  16695;  16484/ 
---------------+---------------+--------+--------+--------+--------+--------+--------+--------+--------+--------, 
85028  i  i  III    1  II   i  II   It  
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  YEAR  II 
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------
HCPCS  ;PLACE  I  II   I  i  i  I  i  II 
---------------+---------------
85048 	 ;1PL-AC-E- ------------l  II   i  i  II   II   I  i  1  0I   1
!IO-T--H- ------_----i  ----  371i  Slli  3421  371:  3191  414I  5441  7871  987I
----+--------+--------+  --------+--------+--------+--------+--------+-------- I
IIP -O-L--------__--- i ---- 633flj _-_-6133j _--- 5411j ---- 1879; ---- 1267; ---- SZSOi-_-- 3944j ---_ 3!(13j ---- 236: 
iALL  I  6709;  66441  5753;  6250;  5586;  56941  44881  3850;  3353 
---------------+---------------+--------+--------+--------+  I --------+--------+--------+  I--------+--------+--------
85580  i!E  ________i__  i  i  i  i  i  i 
I!O -T-H- -----------_  1- ?80i 6082;  80131  76701  33251  29601  28171  25061  1458 
- - -+--------+--------+  --------+--------+  --------+--------+  --------+--------
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  f  II   II   I  II   I 
,_______________;  I  I  I 
I  1  I  I  I  I 
i?! _________I_ ___ 34331  3983;  3203:  3363;  2954;  30041  2918:  2525:  2832 
+- ------+--------+--------+  --------+--------+--------+--------+--------+--------
jPOL  1I   4249;  4925;  5459;  61611  5960;  5603;  4857;  3997;  3595 
)---------------+-..-----+  --------+--------+  --------+--------+--------+--------+--------+--------
fALL  I  7682;  8908;  8662;  9524;  8914;  8607;  7775;  6522;  6427 
---------------+---------------+--------+--------+--------+--------+--------+--------+--------+--------+--------
85610  !;_P_L_A_C_E_ _________  I  III    I  III    I  II   i  III  
;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  I  I  I  I 
85650  i!Yf  ________j __  I i  i  I  I  I I 
I  I  I  1 I 
iI0-T~- -------------+--I- -----5+41--8-;- ----+55--5-7-1- ---+5--9-3-7-j- --+-6--0-9-6-;- -+---6-3-3-1-;- +----6-5-5-0-;+ -----6-5-0-0+:- -----5-850;  2615
!IP-O-L -------------+--1- ----1-10+96;- -------1+149-1-; ------+10--4-8-6-;- --+1--0-9-6-0-;- -+-1--0-9-7-4-;- +---1-0-6-3-0-;+ ----1-0-4-1-8+;- -----9-997;  4220
_____- -------;A-L-L ------------+---,- ----1+6-5-1-4-;- ---+1-7-0-4-8-;- --+ 164231 ----1-7-0--5+6;- ----1-7--3+05-;- ----1--7+18-0-1- ----1-+69-1-8-;-- ---+15-8-4-7--;- -- 6835 
I  I  1  I  I  I
85651 	 i!!?  ________/__  I II  I I  I  I  I  1 
f  I 
RI-OT-H- ------------+--I- -----3+76 9; -----5-5-2-+6;- -----6-6-+93-;- -----8-3+6 9; -----9-5-3-+01- ----1-1--1+52-j- ----1--3+21-6-;- ----1-+37-2-0-;-----17077 
i!? _________i ______ 6-_-2--5+2-1-- ---7-1-7+4;- ------8-5+56 ; ----1-0-4--5+6;- ----1-1--2+89-;- ----1--2+33-3-;- ----1-+39-8-6-:-- ---+15-9-9-9--;- -- 20630
---___  -----+[A-L-L -------------+---, ----1-0+021-~- ------1+2-7-0-0-; 15--2-4-9+; ----1--8-8-2+5;- ----2--0-8+19-;- -----2-3+48-5-1-- ----2+72-0-2--;- ---+29-7-1--9-;--- 37707 
87060  ~PLACE  II   I  II   II   1  I  I  I  II  
,_______________~  I  I  I  1 
I  I  I  I  I 
;;O_TH_  _________+_I1-_-_--_-- 6-5-1+;- ------5-2+1-;- ------6+1 4; ------7--4+5;- ------6-+93-;- ------+81-1-;- -----+9-9-2-;-- ---+-9-4-7--;- - 1041
iIP-O-L -------------+--II-  -----1+3-1-1-;- ----+1-5-0-7-;- ---+-1-3-7-5-;- --+--1-5-2-0-;- -+  14931-----1--5-3+1~- ------1-4+91-;- ------1+43-0-;-- ----1157
_-----;A-L-L -----------------II-  -----1-9-6--2-;- -----2-0-2-8-;-- -----1-9-8-9-;-- -----2-2-6-5-;- -----2--1-8-6-;- -----2--3-4-2-;- -----2-4--8-3-;-  2377;  2198
D-8 
 ________________-___----------------------------------------------------------------------------------------------
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 
-------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------
HCPCS  ;PLACE  I  II   I  I  I  i  I i
---------------+--------------- I 
I 
87070 	 OTH  3094/  46011  51471  5915j  7002;  79151  88511  9191;  8685 
,---------------+--------+--------+--------+--------+--------+--------+--------+--------+--------
i!? _________i______ _2603_i__1_6 36j- 16901  1758;  16181  1662;  1603;  1719;  153c
------+--------+--------+ --------+--------+ --------+-------
jALL  I  4697;  6237;  6837;  7673;  8620;  9577;  104541  10910~  10215 
---------------+---------------+--------+--------+--------+--------+--------+--------+--------+--------+--------
87081 	 1;P_L_A_C_E_ __________; I  I  II   i  I  I  i  I  I 
/OTH- II  391:  488;  514;  3431  572;  479;  555;  5541  59E 
__- -----------+--------+--------+  --------+--------+--------+-- ------+--------+--------+--------
IPOL
I ---------_----_  i ---- Y!i  -_-_ 1024: -__-- 863; ----_  95:; -----  9955--__- 94Oj _--- 1OZli ---__ 888; -____ 79f 
jALL  II  1504;  1512;  1377;  1300;  1567;  1419;  1576;  1442;  1396 
---------------+---------------+--------+--------+--------+--------+  --------+--------+  --------+--------+--------
I  I  I  I  I
87086  i!!!!  ________i __  i  i  i  1
!OTH
I ----------  -----!  ----  Ir?!!  ----  8444l---~rUrSli-.-ll~~~~-- ~!2856j-1162~~- !8943!- -20!49j-Et 
!l-P-O-L-
------_----i  ----6133-5- --6698-!---7985j- 88251  9304;  9845;  10720;  11506;  10571 

------+--------+  --------+--------+  --------+-------
iALL  I  12393;  15142;  18466;  20742;  22160;  25472;  29663;  31655;  34427 
--------------------___________  +--------+--------+--I- -----+--------+-----I ---+------1- -+-------I- +--------I+ -------- I 
87088  i!YY ________I__  i  II  ff  II  I I I 
ROTH  I  2265:  3608;  4797;  5964;  6479;  73831  8771;  97131  8442 
;_______________ +--------+--------+--------+--------+--------+--------+--------+--------+--------
i!!  _________i ______ 1_5 1O_j_ _5_0 63_i__2_5 021__5_?_1 j ___3_4111  4152;  4500;  4961;  4601
----+--------+--------+  --------+--------
/ALL  1I  3775;  5671;  7299;  89551  9890;  11535~  13271;  14674;  13043 
---------------+---------------+--------+--------+--------+-------- +--------+--------+--------+--------+--------
I  I 
87101  i!!?  ________j __  I  I  I  I  I  i  i  II
I 
ROTH  I  121;  133:  154;  197:  205;  204:  2493  238;  161 
I---------------+--------+  --------+--------+  --------+--------+--------+--------+--------+--------
i!OL_________i_______ !663!___!_Y Y!___f_!! ?i ___2_4 8!!___E_ s1  3217;  3009;  2512;  1553
-+--------+--------+--------+--------
jALL  I  1784;  2030;  2184;  2678;  3010;  34211  3258;  2750;  1714 
---------------+---------------+--------+--------+--------+--------+--------+  --------+--------+--------+--------
87184 	 1IP_L_AC_E_ ________I___l  II   II  i  II   II   I  II   1I 
I  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---------------+--------+--------+--------+--------+--------+--------+--------+--------+--------
IALL  II  7852;  9747;  11378;  12235;  12267;  12878;  13967;  12599;  11089 
---------------+---------------+--------+--------+--------+  --------+--------+--------+--------+--------+--------
I  1  I  I I  I  I 
87205  i!??  ________i __  I I  I  I  I I
I  I  I  I 
!OTH  1854;  2316;  27231  2911;  3298 
i---__----------j  ---- l!i__-_ 117pj ___-1324j _---!5-4-9-i+--------+--------+--------+--------+--------
POL  1  1514;  1521;  14381  1664;  1763;  1885;  1969;  1962;  1951 
I, ---------------+--------+  --------+--------+--------+--------+----- ---+--------+--------+--------
;ALL  II  2536;  27001  2762;  3213;  3617;  4201;  4692;  4873;  5249 
---------------+---------------+--------+--------+--------+--------+--------+--------+--------+--------+--------
87210  -P-L-A-C-E- ---------f I  II   1II    II   II   I  i  II   III  
:OTH 146;  209;  226;  2433  231;  197;  245 
I --------_---__- i ---__  I?!  _____1-? +--------+--------+--------+--------+--------+--------+--------
jPOL  II  1590;  1750;  1715;  2111;  2298;  2394;  2657;  2384;  2247 
;_______________ +--------+--------+--------+--------+--------+--------+--------+--------+--------
;ALL  II  1717;  1907;  18611  2320;  2524;  2637;  2888;  2581;  2492 
D-9 
 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 
-------------------------------+---- ----+--------+--------+--------+--------+--------+--------+--------+--------, 
H---C--P--C--S-- ----+---------------I  ; PLACE  I  III    i  i  i  i  II   I i  i 
88150 	 IO -TH- -------------+-I -----3-3-9+0-;- ----3-5-8+3 ! -----4-2-4-8+;- ----4-4-5-6+1- -----4-9-0+7-3- ----5-8-4+7-1- -----5-6+1-3-3- -----5+1-3-2-;- ----4452/
IIP-O-L-  ------------+-lI -----3-0-9+5-;- ----2-9-5+6-;- -----2-0+6-8-;- ----2-5+6 1; -----2-7-7-4+;- ----3-0-1-7+;  -----2-5-1-9+;- ----2-2-7-7+;- -----1-754/
iALL  I  6485;  6539;  6316;  7017;  7681;  8864;  8132;  7409;  6206/
---------------+---------------+--------+--------+  --------+--------+--------+--------+--------+  --------+--------
88302  ; PLACE  I  i  II   I  II   I  I  II  II   II  
;---------------;  I  t  I 
;OTH  81  55401  4961;  4834;  4790;  4435;  43911  4281;  32241  2886/
I---------------+--------+--------+--------+--------+--------+--------+  --------+--------+--------
i!? _________i ______ 1_0 7fl_j___1_8 1l  n21  697;  810;  7191  656;  384; 2931 
+ -------+--------+-------- +--------+--------+--------+--------
jALL  t  66181  5742;  5566;  5487;  5245;  5110;  4937;  3608;  31791 
---------------+---------------+--------+--------+--------+--------+--------+--------+- -------+--------+--------
88304  1, _PLA_CE_ _________I ___,  tI   II   II   I  I  I  II   I  I 
I  I  I 
,;O_T_H ____________+_I -----1-5-7-06+1 --------+17-3-83-;- ----+---1-9-8-43-;- +- 210721 ---2--2-8-+64--1- -----2+4-8--6-9--;- -+--2--7-4--7-4+;- -----1--5~4 92:  13809; 
i!? _________i-___-59181  6572;  7595;  80131  9278;  10333;  11502;  4255;  2555;
- ----+--------+--------+--------+--------+--------+--------+--------+--------~ 
/ALL  1  21624;  23955;  27438:  29085;  32142;  35202;  38976;  19747;  16364; 
---------------+---------------+--------+--------+------ --+--------+--------+--------*--------+--------+--------~ 
89205  1I- -P--L-A--C--E-- ----,  II   III    III    III   III   III   I1I   II   i  III   
i!!  _________i ______ _1_1 0_5_ __T_Z b_j___3_2 21___5_1_3 _j ___2_4 4_j ___2_8 2_j ___2_6 O_j___1_5 2_!___I_lli 
jPOL  II  2975;  3118;  2089;  2196;  2055;  1760;  1620;  1152;  8521 
I---------------+--------+--------+--------+--------+--------+--------+--------+--------+--------I 
;ALL  II   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  American 
May l&l995 
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  Generals recent  draft report, 
CLIAs  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  CLIA88  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 physicians  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 OKs  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  CLIAs  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  Generals  draft  report  entitled  CLIAs 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 
studys  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 AMAs 
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 self-
employed  physicians.  Surely,  self-employed  physicians  are more  likely  to respond  to 
CLIAs  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 AMAs  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 studys 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 
 May  15,  1 395 

KATHLEEN M. WEAVER. MD 
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 

Washingtc n, DC.  20201 

Battlmow Maryland 
/mm&ate  Past President 

YANK D. COBLE Jr, MD  Dear Ms.  3rown: 

Jaciwxwll(s, Florida 

Thank yo! I for giving  the American Society of Internal Medicine  (ASIM) the opportunity 
TRUSTEES 
to provide  comments  on the Office of Inspector Generals  draft report entitled  CLIAs 
LOUIS Ii. DIAMOND, MD 
Washington. D.C.  Impact on the Availabliity  of Laboratory Services.  In general, we find that this study 
does not  rddress the true impact of the CLJAlaw on physician  office laboratorles. 
CYRIL M. HETSKO, MD 
Madison, WlacorWn 
The stud)  concludes  that CLIA has had little or no impact on the availability  of 
E. RODNEY HORNBAKE  111M,D 
Rochester, New York  laborator], services.  This conclusion  Is based on the findings  that there has not been 
a signlfic;  nt decrease In the number of physicians  operating  in-office  laboratories 
ISABEL V, HOVERMAN, MD 
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  performel I by physician  offlce laboratories  between  1987 and 1993.  For example, the 
Oklahoma City, Oklahome 	
volume  o  quantltative  glucose  and sedimentation  rate tests--both  moderate 
LAURENCE 0. WELLIKSON  MD  complexi! j tests--performed  by physician  office laboratories  has dropped  sharply. 
Orange, Callamla 	
There ha!  been a corresponding  increase  in the  volume  of the waived  versions  of 
CECIL B. WILSON, MD 
these tes s.  ASIM believes that a large number of physicians  have discontinued  all 
Winter Park, florlda 	
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.  the waive d or physician-performed  microscopy  categories.  it also would  explain  why 
October 18-22. 1995 
this stud!  did not find a significant  decrease in the total number  of physicians 
operatinc  office laboratories. 
REPRESENTING 
Internists.and 

All SubspecIalists 

We belle 8 that this study may actually underestimate  the impact CLIA has had on 

of lntemal Medlcine 
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  moderate-
and 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 physicians  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 hysiclans  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 010s  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:  CLIAs  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