U.S. Department of Health and Human  Services  
 
O  ffice of Inspector General  
 
 
 
 
 
Labs  With Questionably High 
Billing for Additional  Tests 
Alongside COVID-19  Tests  
Warrant  Further Scrutiny  
 
Ann Maxwell  
Deputy Inspector General for Evaluation and Inspections   
December  2022, OEI-09-20-00510   U.S. Department of Health and  Human Services  
Office of Inspector General  
 
Report  in Brief  
December  2022, OEI-09-20-00510  
Labs With  Questionably High  Billing for  Additional  
Why OIG  Did This Review  
Tests Alongside COVID-19 Tests Warrant Further  
Medicare Part  B  spending on  
COVID-19 lab  tests  increased   Scrutiny   
steadily  between  spring  2020 
What OIG Found  
when  Medicare first  started 
Key Takeaway   We found that  378  labs  
paying for  these testsand  the  
Certain  labs billed Medicare  Part B for   billed  Medicare Part  B  for  
end  of  that  year.   Preliminary  
questionably  high levels of  add -on tests  add-on  tests  at  
analysis  of  Medicare  Part  B  
alongside COVID -19 tests in 2020.  This   questionably  high  levelsin  
claims  data  indicated  that  some  
significantly increased the payments they  
volume,  payment  amount,  
diagnostic  testing  laboratories  
received for claims that included COVID -19 
or  bothcompared to  the  
billed  for  other  diagnostic   tests.  Such  high  levels of billing for add -on 
19,199  other  labs.   This  
testssuch as  individual  tests raise concern about potential  waste  
includes  276  labs  that  billed  
respiratory  tests (IRTs),   or fraud, suggesting a  need for further 
for  high  volumes  of add-on  
respiratory  pathogen  panels   scrutiny of billing by these labs.  
tests on  claims  for  
(RPPs),  genetic  tests, and allergy  
COVID-19  tests,  and  263  labs  that  billed  for  high payment  amounts  from  
testsalong  with COVID-19  
add-on  tests on  claims for  COVID-19 tests.   Further,  161  of  these  labs 
tests.   We  refer  to  these four  
billed  for  both high  volumes  of add-ons  and  high payment  amounts  from  
types  of  tests  billed  with 
add-ons on  claims for  COVID-19 tests.   We  also  found  a  small number  of  
COVID-19 tests  as  add-on  tests.   
labs  that  had  at  least  10  claims  where  2  labs  had billed for  the same 
Although  it  is  not  unusual for  
enrollee for  the same tests  on  the same day,  which  may  be an  indication 
labs  to  bill for  COVID-19  tests 
of a  fraud scheme involving the  sharing of enrollee information.  
and  other  diagnostic  tests  on the  
On  their  claims  for  COVID-19  tests,  some  of  the  378  labs billed  for  
same  claim,  certain  billing  
add-on tests  in  combinations  that  had  little  if  any  variation across  
patternssuch as  a  high  volume  
patients.   This  may  indicate  that  these  tests  were  not  specific  to  individual 
of  or  high  payments for  add-on 
patients  needs.   The add-on tests  significantly  increased  the per-claim  
testsraise  concerns  of  potential  
amounts  that  Medicare  Part  B  paid  to  these  labs.   For  example,  one  
waste or  fraud.   
outlier  lab  regularly  billed  for  a  combination of five  add-on respiratory  
How OIG Did This Review   tests  on  almost  all of its claims for  COVID-19 tests.  As  a  result,  the  
We  performed  outlier  analysis to  average  per-claim  Medicare  payment  to  this  outlier  lab  was  $666, 
identify  labs  that  billed  for  add-on  covering  both  COVID-19 and  add-on  tests,  compared  to an average  
tests  at  questionably  high  levels   payment  of $89  to  all  other  labs  that  billed  for  COVID-19  tests  and  any 
compared  to  other  labs  that  billed   add-on  tests.  Although  billing  for  add-on  tests  was  generally  allowable,  
for  COVID-19  tests.   We identified  and Medicare  Part  B  pays  for  these tests  when  they  are medically  
two  kinds  of  outlier  labs:  (1) those   appropriate, these  patterns  of  questionably  high billing  raise  concerns  
for  which add-on  tests  constituted   that  some  tests may  have been  wasteful  or  potentially  fraudulent.  
a  high  proportion  of  each  labs 
What OIG Concludes  
total number  of tests, and (2)  those 
Our  analysis  suggests  that  further  scrutiny  of  billing  by  the  378  outlier  
for  which add-on  tests  constituted  
labs  is  needed and, therefore, OIG  has  referred these labs  to  the Centers  
a  high proportion  of  each  labs 
for  Medicare &  Medicaid Services  (CMS)  for  further  review.   Outlier  labs  
total payments  for  tests.    
exceeded the  thresholds  for  one  or  both  measures of  questionable  
We  examined  all  Medicare  Part  B   billing,  raising  concerns  about  potential waste  or  fraud.  
claims  paid  for  COVID-19  tests   
during 2020,  and for  the following   
types  of add-on  tests:  IRTs,  RPPs,     
genetic  tests, and allergy  tests.     
    
TABLE OF  CONTENTS  
 
 
BACKGROUND ................................................................................................................................................  1  
FINDINGS ......................................................................................................................................................... 4  
More than 370 outlier labs billed Medicare Part B for questionably high levels of add-on tests ..............  4  
Individual respiratory tests (IRTs)  and respiratory pathogen panels (RPPs)  accounted for most of the 
payments that outlier labs received for add-on tests ................................................................................................. 7  
CONCLUSION  ................................................................................................................................................ 11  
APPENDIX ......................................................................................................................................................  12  
Appendix A: COVID-19 and Add-On Tests Included in This Analysis ................................................................. 12  
ACKNOWLEDGMENTS AND CONTACT  .................................................................................................  13  
Acknowledgments  .................................................................................................................................................................. 13  
Contact ........................................................................................................................................................................................ 13  
ABOUT THE OFFICE OF INSPECTOR GENERAL ..................................................................................... 14  
ENDNOTES  ....................................................................................................................................................  15  
 
 
   
BACKGROUND  
OBJECTIVE  
To identify labs with  questionably high billing  for respiratory, genetic, and/or allergy 
tests on Medicare Part B  claims  that included  COVID-19 tests   
 
Preliminary Office of Inspector General (OIG)  
analysis of 2020 Medicare Part B claims  data  For  the  purposes of  this report,  we  
raised concerns that some labs may have billed   define add -on tests  as  the  following  
for  unnecessary  diagnostic  tests on their  claims   diagnostic  tests  that  labs  billed  for  
for COVID-19 tests to increase their Medicare  on  their  Medicare  Part  B  claims  for  
reimbursements.   Since billing  for add-on tests  COVID -19 tests:  
alongside COVID-19 tests can significantly 
  individual respiratory  tests  (IRTs),   
inflate Medicares payments to labs, it is 
  respiratory  pathogen  panels  
important to identify labs that billed  for 
(RPPs),   
questionably high levels of  add-on tests.   
  genetic  tests,  and   
Although there can be legitimate 
  allergy  tests.   
patient-specific reasons  to perform such  tests, 
unnecessary or excessive billing of  add-on tests 
could indicate waste or potential  fraud.  For example, the Department of Justice (DOJ)  
brought criminal charges against a  lab owner for bundling COVID-19 tests with more  
expensive, medically unnecessary add-on  tests, including respiratory pathogen panels 
(RPPs)  and genetic tests.1   Another concern involves schemes wherein  labs encourage  
practitioners to order unnecessary tests.   For  example,  a lab paid $256 million to  
resolve  multiple allegations, one of  which  was  that  it  used so-called custom profiles  
that caused physicians to order excessive numbers of  certain  tests.  Rather than 
tailoring  the lab test orders  to individual patients, physicians  ordered  a large number 
of  pre-selected  tests not based on an individualized assessment of each patients 
needs.2    
Medicare Part B Coverage  of COVID-19 Testing and  Other  
Diagnostic Tests  
In 2020, the Centers for Medicare &  Medicaid  Services (CMS) made regulatory 
changes to  Medicare  to respond to the serious threat posed by the spread of   
COVID-19.   These changes expanded  Medicare Part B coverage for  
COVID-19 testing.3   Further, because symptoms associated with COVID-19 can 
present in the same way as respiratory illnesses, such as influenza,  CMS  worked  
quickly to  expand access to  certain  respiratory tests  when needed.4   These actions  
aligned with  guidance from the Centers for Disease Control  and Prevention (CDC)  that  
Labs  With Questionably  High  Billing for  Additional Tests  Alongside  COVID-19 Tests Warrant Further Scrutiny   
OEI-09-20-00510      
  Background |  1     
encouraged  practitioners to consider testing for other respiratory illnesses  alongside 
COVID-19  testing  to confirm or rule out a diagnosis other than COVID-19.5   As more 
information about  COVID-19 became available,  CMS adjusted  its  coverage policies on  
COVID-19  and other respiratory-related  tests.     
Related  Work  
Early in the pandemic, OIG began issuing public alerts about various fraud schemes 
related to  COVID-19, including scams whereby personal information is collected and  
used to fraudulently bill  Federal health care programs and commit medical identity 
theft.6   OIG has also  worked on cases that highlight fraud schemes involving billing  
for COVID-19 tests.7   In these schemes, along with their claims for COVID-19 tests,  
practitioners submitted claims for unrelated, medically unnecessary, and far more 
expensive lab tests, such as cancer genetic tests, allergy tests, and RPPs.  Prior to the  
COVID-19 pandemic, OIG  collaborated with law  enforcement partners in 2019 to  
investigate a pattern of fraudulent genetic tests that were medically unnecessary but  
ordered in exchange for illegal kickback payments to physicians.8  
Methodology  
This evaluation used two measures to  identify labs that billed Medicare Part B for 
questionably high levels of  add-on tests.  We developed these measures based on 
past OIG analysis and fraud investigations of  health  care practitioners, including labs.   
The measures  identified (1) labs for  which add-on tests constituted a high proportion 
of each labs total number of tests, and (2) labs for which add-on tests constituted a  
high proportion of each labs total payments for tests.   This  evaluation is national  in 
scope.   The data that  we used  included  paid Medicare Part B claims for COVID-19 
tests billed  alongside add-on tests from February through December 2020.   
Analysis  
From the claims data, we identified  19,577 labs  that received Medicare Part B  
payments for claims for COVID-19 tests in 2020.  We then determined and calculated  
the percentage of labs that billed for add-on tests (i.e., IRTs, RPPs, genetic  tests, and  
allergy tests) on the same claim as a  COVID-19 test at least  once during the year and  
labs that never billed for add-on tests.  For  the purposes of this study, we use the 
term test to mean one  line of service on a claim.  See Appendix A  for the list  of  
COVID-19 tests and add-on tests that were included in our analysis.9  
We conducted an outlier analysis of labs that billed for add-on tests on claims for 
COVID-19 tests.  Of the 8,582 labs that billed  for add-on tests, we excluded from our 
analysis 2,994 labs that billed  Medicare for fewer than 100 COVID-19 and  add-on  
tests.  We did not include these labs because they billed a relatively low volume of  
tests.  Thus, our outlier analysis focused on 5,588 labs.    
Next, we used a standard  data analysis technique to identify labs that were outliers on 
each of the measures (i.e., labs that  were above the 75th percentile  plus three times 
Labs  With Questionably  High  Billing for  Additional Tests  Alongside  COVID-19 Tests Warrant Further Scrutiny   
OEI-09-20-00510      
  Background |  2     
the interquartile range).10   Exhibit  1 describes the measures we used, the calculations 
for each measure, and the thresholds.  
In addition to the  two  measures, we identified  claims  where an  outlier lab billed for 
the same enrollee  to receive the same tests on the same day  as another lab, which 
may be indicative of  a  fraud scheme  in which two labs agree to share an  enrollees 
Medicare number and bill for tests that only one or neither lab performed to increase  
the payments one or more lab receives  from Medicare.    
Exhibit  1:  Outlier thresholds analysis  
 
Source: OIG calculations of each  labs  Medicare Part B  claims for COVID-19 tests from February through 
December  2020.  
Limitations   
This study is limited  to  an evaluation of  Medicare Part B  lab claims  and does not  
include COVID-19 tests provided by other programs, such as community testing  
efforts, unless they were paid for by Medicare Part B.  COVID-19 tests and add-on  
tests paid for under Part  A and C programs are not included in  this analysis.  
The  outlier analysis does not provide conclusive evidence of wasteful or potentially 
fraudulent billing; rather,  it identifies labs with high levels of  billing for add-on tests 
relative to  all other labs.  Further investigation is needed  to determine whether the 
labs identified through the analysis in fact  billed for any inappropriate or fraudulent  
Medicare Part B claims for COVID-19 or add-on tests.    
Standards  
We conducted this study in accordance with the Quality Standards for Inspection and  
Evaluation  issued by the Council  of the Inspectors General on Integrity and Efficiency.  
Labs  With Questionably  High  Billing for  Additional Tests  Alongside  COVID-19 Tests Warrant Further Scrutiny   
OEI-09-20-00510      
  Background |  3     
FINDINGS  
Of the 19,577 labs that billed  Medicare Part B for  56%  
COVID-19 tests in 2020, more than half  (10,995) did   of labs did  not  bill for any add- on tests 
not bill for any add-on tests.  The remaining labs  on claims for COVID -19 tests in 2020.    
(8,582) each billed  Medicare Part B  for at least one  
44%  
add-on test  (i.e., an  IRT,  an  RPP,  a genetic  test,  or  
an  allergy test)  on the same claim  as  for  COVID-19  of labs billed  for add- on tests on claims  
tests.     for COVID -19 tests in 2020.    
 
More than 370  outlier  labs  billed  Medicare Part  B  for 
questionably high  levels  of  add-on  tests   
We identified  378  outlier labs that exhibited at  least  1  of  2  questionable billing  
patterns.11   More than one-third of these labs (161)  exhibited  both questionable  
billing patterns.  Over the span of 11 months in 2020, Medicare Part  B paid  these 
378  labs more than  $67 million for add-on tests.  On a per-claim basis, whereas 
Medicare paid  an average of  $89  to all other labs for claims for COVID-19 tests, 
Medicare paid outlier labs an average of $227.12   One outlier lab was paid,  on 
average, about $1,000  for each claim.  
 
More than  270 labs billed for a high  proportion of add-on tests  
alongside  COVID-19  tests  
Outlier analysis identified that 276 labs  billed for a high proportion of   24  labs  
add-on tests  relative to  COVID-19 tests.  For these 276 labs, the  
billed  for  add -on  
volume of  add-on tests made up at least 38 percent of the labs billing  
tests on at least  
for COVID-19 and add-on tests.   Twenty-four of  these labs billed for 
90 percent of 
add-on tests on almost all (90  percent  or more)  of their claims for   their claims  for 
COVID-19 tests.  See Lab  Profile  #1 below  for an  example of  a lab that   COVID -19 tests  
billed for a high proportion  of add-on tests on its claims for COVID-19 
tests.   
 
Labs  With Questionably  High  Billing for  Additional Tests  Alongside COVID-19 Tests Warrant Further Scrutiny   
OEI-09-20-00510        
  Findings |  4     
 
 
More  than  260  labs received a high  proportion of their Medicare 
Part B  COVID-19  claim  payments from add-on tests  
When compared to all  other labs, 263 labs received a high proportion 
of their Medicare payments from add-on tests.  For these 263 labs,  
30 labs  
payment for add-on tests made up at least  33 percent  of the total  
payment on claims for COVID-19 tests.  Moreover, 30 of  these labs  received more 
than 80 percent  
received  more than  80  percent of  their payments for these claims 
of payments  
from add-on tests rather than the COVID-19 tests.  See Lab Profile #2,  
from add- on  
on the next page,  for an example of  a lab with a  high proportion of  
tests  
payment  received  from  Medicare Part B for  add-on tests. 1314 
 
 
Labs  With Questionably  High  Billing for  Additional Tests  Alongside COVID-19 Tests Warrant Further Scrutiny   
OEI-09-20-00510        
  Findings |  5     
 
 
Eight  outlier labs exhibited  another concerning billing  pattern  
that may  indicate  a potential  fraud scheme  involving the sharing  
of enrollee information  
We  also identified  eight  outlier labs that billed  Medicare Part B for the same tests for 
the same enrollee  on the same day as another lab.15   Such billing  is  sometimes 
indicative of  a fraud scheme  in which two labs  agree to share an  enrollees Medicare 
number and bill  for tests that only one or neither lab performed to increase the 
payments they recieve  from Medicare.  While there could  at times  be legitimate 
reasons for two  labs to bill  for the same test for the same enrollee  on the  same day, 
repeated  instances of  this type of  billing  could indicate a potential fraud  scheme.   See  
Lab Profile #3  on the next page  for  an example of a lab that exhibited a pattern of  
billing  for the same enrollee  for the same test on the same day as another lab.        
Labs  With Questionably  High  Billing for  Additional Tests  Alongside COVID-19 Tests Warrant Further Scrutiny   
OEI-09-20-00510        
  Findings |  6     
 
Individual respiratory tests (IRTs) and  respiratory  pathogen  panels 
(RPPs) accounted  for  most  of  the  payments  that  outlier  labs  received  
for add-on tests  
The most common types of  add-on tests that drove up volume and Medicare Part B  
payments for COVID-19 tests in 2020 were IRTs and RPPs.  In general, these types of  
tests diagnose respiratory complications and illnesses, such as influenza  and  
pneumonia, which may present similar symptoms to  those of  COVID-19.  Thus, 
practitioners may have legitimately ordered these add-on tests alongside COVID-19 
tests for their patients who had respiratory symptoms, for example, to rule out or 
confirm diagnoses of other respiratory illnesses.  Although far less frequent than IRTs 
and RPPs, other add-on tests billed by outlier labs on the same claims as  for  
COVID-19 tests were for allergy tests and genetic tests.  See the exhibit below for 
information about each type of add-on test billed by outlier labs on claims for 
COVID19 tests.  
Exhibit  2:  Add-on  tests  increased Medicare Part B payments  to outlier  labs  by  amounts  
ranging  from $66 to $237 per  test  on  average  
Average  Payment   Total   Number  of   Number 
Add-On  Test Category  
per  Test   Payment   Tests   of Labs  
IRTs     $66   $48,299,294   728,203   373  
RPPs   $237   $18,611,493   78,672   178  
Allergy Tests   $155   $178,124   1,150   18  
Genetic Tests   $198   $36,123   182   16  
Source: OIG analysis of Medicare Part  B  claims data  from February through December 2020.   See Appendix A for  
the list of add-on tests  we examined.  
Labs  With Questionably  High  Billing for  Additional Tests  Alongside COVID-19 Tests Warrant Further Scrutiny   
OEI-09-20-00510        
  Findings |  7     
Individual Respiratory Tests (IRTs)   
IRTs were the most common add-on tests billed  on claims for 
$48M  
COVID-19 tests.  The  average payment for an IRT was $66.  
Medicare Part  B  
Over 300 outlier labs (373) billed  Medicare Part B for over  
paid to outlier  
700,000 IRTs as add-on tests in 2020, costing Medicare about  
labs  for  individual 
$48 million in total payments.  The most common IRT HCPCS  
respiratory 
code, billed  by about  45  percent of  all outlier labs, was HCPCS  
add -on tests  
code  87798, a general test code used when a more specific code 
billed with  
is not available and  which can be used to indicate tests for 
COVID -19  tests  in 
measles, mumps,  and  norovirus among others.   Other prevalent  
2020  
IRT HCPCS codes that labs billed were HCPCS  code  87581 and  
HCPCS  code  87486,  both of  which tests for a type of pneumonia.  See Exhibit  3  below  
for the top three  IRTs billed by outlier labs.  
Exhibit  3:  Three  most common individual respiratory  tests  that  outlier labs billed  with  COVID-19 tests  
HCPCS   Average  Total  Number  Number of   
Test Description  
Code   Payment   Payment   of Tests   Outlier Labs  
Detection test  by nucleic acid for organism, amplified 
probe technique.  This is a general test code that is used 
87798   when a specific code is not available, and can be used to   $116   $19,172,455   165,861   171  
indicate tests for measles, mumps, norovirus  among  
others.    
Detection  test by  nucleic acid for  Mycoplasma pneumoniae  
87581   $43   $5,187,088   120,151   161  
(bacteria), amplified probe technique  
Detection  test by  nucleic acid for  Chlamydia pneumoniae, 
87486   $40   $4,530,897   113,549   149  
amplified probe technique  
Source: OIG analysis of Medicare Part  B  claims data  from February through December 2020.    
 
One of the concerning patterns  we identified  involved  billing  for the same 
combination  of IRTs with COVID-19 claims.   This billing pattern raises questions  as to  
whether every patient needed the full combination of these tests, or rather, whether it  
was a standard practice for  the labs  or practitioners to routinely bill  for these tests on 
claims for COVID-19 tests regardless of the patients symptoms.  See Lab Profile  #4 on  
the next page for an example of a lab that billed for a series of IRTs for over 
20  percent  of their claims for COVID-19 tests.   The  resulting average payment for the 
COVID-19 claim with add-on test was six  times more than the average payment for a  
COVID-19-only claim.  This combination of billing for add-on tests significantly 
increased the amount that Medicare Part B  paid the lab.    
Labs  With Questionably  High  Billing for  Additional Tests  Alongside COVID-19 Tests Warrant Further Scrutiny   
OEI-09-20-00510        
  Findings |  8     
 
Respiratory  Pathogen  Panels (RPPs)   
RPPs   were the second most common type of add-on tests that 
outlier labs billed with COVID-19 tests in 2020.  An  RPP can  use a  
$19M  
single sample to test for a panel of different bacteria or viruses that  
cause respiratory symptoms.   The average payment for an RPP   Medicare Part  B  
paid to outlier  
add-on test  was $237, which is significantly more expensive per 
labs  for  RPP  
test on average than IRTs.  Of the 378  outlier labs, 178 billed  
add -on tests  
Medicare for at least  1  RPP add-on  test on claims for COVID-19 
billed with  
tests, costing Medicare almost  $19  million in 2020.  Two labs 
COVID -19  tests  
accounted for 36  percent of  payments  for  RPP add-on  tests.   
in  2020  
While outlier labs billed for  5  different types of RPPs, by far the 
2  most common were a  panel test that targeted  3-5 respiratory viruses (HCPCS  code  
87631) and a panel test  that targeted 12-25 respiratory viruses (HCPCS  code  87633).  
The amount Medicare paid for each RPP add-on test depended on the number of  
tests conductedthe more tests conducted within a panel, the higher the Medicare 
payment.  See Exhibit  4  below  for the breakdown of  RPPs  most  commonly  billed by 
outlier labs.   
Exhibit  4:  Most common respiratory  pathogen panels  that  outlier labs  billed  with  COVID-19 tests  
HCPCS   Average  Total   Number of   Number of  
Test Description    
Code   Payment   Payment   Tests   Outlier Labs  
 
Detection test by nucleic acid for multiple types of  
87631   $141   $7,235,494   51,152   72  
respiratory virus, multiple types or subtypes, 3-5 targets  
Detection test by nucleic acid for multiple types of    
87633   $413   $11,018,560   26,687   138  
respiratory virus, multiple types or subtypes, 12-25 targets  
Source: OIG analysis of Medicare Part  B  claims data  from February through December 2020.  
Labs  With Questionably  High  Billing for  Additional Tests  Alongside COVID-19 Tests Warrant Further Scrutiny   
OEI-09-20-00510        
  Findings |  9     
See Lab Profile #5 below  for an example  of a lab  that billed  Medicare for almost 2,000 RPP add-on tests 
with COVID-19 tests  in 2020.     
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Labs  With Questionably  High  Billing for  Additional Tests  Alongside COVID-19 Tests Warrant Further Scrutiny   
OEI-09-20-00510        
  Findings |  10     
CONCLUSION    
 
Our  analysis suggests that further scrutiny of billing by the  378 outlier labs is needed  
and, therefore,  OIG has referred  these labs to CMS for further review.  Outlier  labs  
exceeded  the thresholds for one or both measures of questionable billing, raising  
concerns about potential waste or fraud.   Compared to their peers, these labs billed  
for a high proportion  of  add-on tests relative to COVID-19  tests or received a  
significant amount of payments for add-on tests or both.  
We  found that  outlier labs billed for a high proportion of add-on tests with COVID-19 
tests  or  received a high proportion of  Medicare  Part B payments from add-on tests 
billed with COVID-19 tests, or both.   On their claims for COVID-19 tests, some of  the 
378 labs billed for add-on tests in combinations that had little if any variation across 
patients.  The add-on tests significantly increased the per-claim amounts that  
Medicare Part B paid to these labs.  As a result, some reimbursements for  claims  for  
COVID-19 tests with add-on tests were six times more than reimbursements for 
COVID-19  tests  alone.  These billing  patterns raise concern about waste or potential  
fraud, suggesting a need for further scrutiny of billing by these labs.  
 
Labs  With Questionably  High  Billing for  Additional Tests  Alongside COVID-19 Tests  Warrant  Further Scrutiny   
OEI-09-20-00510      
    Conclusion  | 11    
APPENDIX  
Appendix A:  COVID-19  and  Add-On  Tests Included  in This  Analysis  
COVID-19 Tests:  To create a list of  COVID-19 tests, we used Current  Procedural Terminology16  test 
codes and HCPCS codes to identify 23 COVID-19 tests that were authorized for payment in 2020.  This 
set of codes includes viral tests, antibody tests, and respiratory panel tests that include COVID-19 in 
the panel.  We included only tests paid for by Medicare Part B in our analysis.   See below for the list  
for HCPCS codes that we reviewed.  Not all  of these codes were billed with an add-on test in 2020.  
COVID-19 HCPCS  codes: 23 tests    
87426, 87428,  87635, 87636,  87637, 87811,  0202U, 0223U,  0225U, 0240U,  0241U, U0001,  U0002, U0003, U0004, 86318, 
86328, 86769, 86408, 86409,  86413, 0224U, 0226U                
Add-On Tests:  We consulted with our OIG counterparts and CMS to identify the add-on tests to  
include in each of the add-on test categories that we used in our final analysis.  We also reviewed  
relevant sections of the AMA codebook, as suggested by CMS, as well as other reports that analyzed  
these types of tests to create the list  of tests included in each of the four add-on test categories.  
Note that there may be other tests that could be considered add-on tests (e.g., allergy  tests, genetic  
tests, IRTs, and RPPs  that were billed alongside COVID-19 tests) that were not included in our review.  
See below for the list  of HCPCS codes that we reviewed for each of the four add-on test categories.  
Not all  of the tests that we identified were actually billed with a COVID-19 test in 2020.  
Individual  Respiratory HCPCS  codes: 47 tests  
87265, 87275, 87276, 87278, 87279, 87280, 87281, 87299, 87300, 87305, 87385, 87400, 87420, 87430, 87449,  87483, 
87485, 87486, 87487, 87501, 87502, 87503, 87540, 87541, 87542, 87555, 87556, 87557, 87580, 87581,  87582, 87634, 
87650, 87651, 87652, 87653, 87797, 87798, 87799, 87800, 87801, 87802, 87804, 87807, 87880,  87899, 87999        
RPP  HCPCS  codes: 8 tests  
87631, 87632, 87633,  0098U, 0099U,0100U, 0115U, 0151U  
Allergy HCPCS  codes: 35  tests  
95004,  95012, 95017,  95018, 95024,  95027, 95028,  95044, 95052,  95056, 95060,  95065, 95070,  95076, 95079,  95115, 
95117, 95120, 95125, 95130, 95131, 95144, 95145, 95146, 95147, 95148, 95149, 95165, 95170, 95180, 95199, 86001, 
86003, 86005, 86008       
Genetic HCPCS  codes: 456  tests  
81105-81112, 81120, 81121, 81161-81168, 81170-81194, 81200-81279, 81283-81337, 81340-81348, 81350-81353,  
81355,  81357, 81360-81364, 81370-81383, 81400-81408, 81410-81417, 81420, 81422, 81425-81427, 81430-81440,  
81442-81443, 81445, 81448, 81450, 81455, 81460, 81465, 81470, 81471, 81479, 81490, 81493, 81500, 81503-81504,  
81506-81512, 81518-81522, 81525, 81528, 81529, 81535, 81536, 81538-81542, 81545, 81546, 81551, 81552, 81595, 
81596, 87153, 0001M, 0001U,  0002M, 0002U, 0003M, 0003U, 0004M, 0005U, 0006M, 0006U,   0007M, 0007U, 0008M, 
0008U, 0009M,  0009U, 0010U,  0011M, 0011U, 0012M, 0012U, 0013M, 0013U, 0014M, 0014U, 0015M, 0016M, 0016U, 
0017U, 0018U, 0019U, 0021U-0027U, 0029U-0056U, 0058U-0061U, 0067U, 0069U, 0080U, 0083U, 0084U, 0087U-
0092U, 0101U-0103U, 0110U, 0111U, 0113U, 0120U, 0129U-0138U, 0153U, 0156U-0162U, 0168U-0171U, 0175U, 
0177U, 0179U-0201U, 0203U-0205U, 0208U, 0209U,  0211U-0219U, G9143, S3800, S3840-S3842, S3844-S3846, S3849, 
S3850, S3852-S3854, S3861, S3865, S3866, S3870    
Labs  With Questionably  High  Billing for  Additional Tests  Alongside COVID-19 Tests  Warrant Further Scrutiny   
OEI-09-20-00510      
    Appendix  | 12    
ACKNOWLEDGMENTS  AND  CONTACT  
Acknowledgments  
Christina Lester  served as the team leader for this study.  Others in the Office of  
Evaluation and  Inspections who conducted the study include Eunji Kim and Ivy Ngo.  
Office of Inspector General staff who provided support include Berivan Demir 
Neubert, Althea Hosein, Christine Moritz, Mike Novello, Robin Sheehan, Jessica  
Swanstrom, Sara Swisher, and China  Tantameng.  
This report was prepared under the direction of  Blaine Collins, Regional Inspector 
General for Evaluation and  Inspections in the San Francisco regional  office, and Abby 
Amoroso, Deputy Regional Inspector General.  
Contact  
To obtain additional information concerning this report, contact the Office of Public 
Affairs at Public.Affairs@oig.hhs.gov.  OIG reports and other information can be found  
on the OIG website at  oig.hhs.gov.  
Office of Inspector General  
U.S. Department of Health and Human Services  
330 Independence Avenue, SW  
Washington, DC 20201  
 
 
 
 
 
 
 
 
 
   
 
Labs  With Questionably  High  Billing for  Additional Tests  Alongside COVID-19 Tests  Warrant  Further Scrutiny   
OEI-09-20-00510   Acknowledgments and Contact | 13     
ABOUT THE 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 the following  
operating components:  
The Office of  Audit Services (OAS)  provides 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.   
These audits help reduce waste, abuse, and mismanagement and promote economy 
and efficiency throughout HHS.  
The Office of Evaluation and Inspections  (OEI)  conducts national  
evaluations to provide HHS, Congress, and the public with timely, useful, and  reliable  
information on significant issues.  These evaluations focus on preventing fraud, waste, 
or abuse and promoting economy, efficiency, and effectiveness of departmental  
programs.  To promote impact, OEI reports also  present practical recommendations 
for improving program operations.  
The Office of Investigations  (OI)  conducts criminal, civil, and administrative 
investigations of fraud and misconduct related to HHS programs, operations, and  
beneficiaries.  With investigators working in all 50 States and  the District of Columbia, 
OI utilizes its resources by actively coordinating  with the Department of  Justice and  
other Federal, State, and local law enforcement authorities.  The investigative efforts 
of OI often lead to criminal convictions, administrative sanctions, and/or civil  
monetary penalties.  
The Office of Counsel to the Inspector General (OCIG)  provides 
general legal services to  OIG, rendering advice and opinions on HHS programs and  
operations and providing all  legal support for OIGs internal operations.  OCIG 
represents OIG in all civil and administrative fraud and abuse cases involving HHS  
programs, including False Claims Act, program exclusion, and civil monetary penalty 
cases.  In connection with these cases, OCIG also  negotiates and monitors corporate 
integrity agreements.  OCIG renders advisory opinions, issues compliance program 
guidance, publishes fraud alerts, and provides other guidance to the health care 
industry concerning the anti-kickback statute and other OIG enforcement authorities. 
Labs  With Questionably  High  Billing for  Additional Tests  Alongside COVID-19 Tests  Warrant  Further Scrutiny   
OEI-09-20-00510     
  About the Office of Inspector  General  | 14     
ENDNOTES  
 
1  DOJ,  Lab Owner Pleads Guilty to $6.9  Million  Genetic Testing &  COVID-19 Testing Fraud Scheme,  January 13, 2022.  Accessed  
at  https://www.justice.gov/opa/pr/lab-owner-pleads-guilty-69-million-genetic-testing-covid-19-testing-fraud-scheme  on 
October 18, 2022.  
2  DOJ,  Millennium Health Agrees to Pay $256  Million to Resolve Allegations of Unnecessary  Drug and Genetic Testing and Illegal  
Remuneration to Physicians,  October 19, 2015.   Accessed at  https://www.justice.gov/opa/pr/millennium-health-agrees-pay-
256-million-resolve-allegations-unnecessary-drug-and-genetic  on October  18, 2022.  
3  CMS, CMS Press Release,  CMS Develops Additional Code for Coronavirus Lab Tests, March 5, 2020.  Accessed at  
https://www.cms.gov/newsroom/press-releases/cms-develops-additional-code-coronavirus-lab-tests  on October 18, 2022.    
4  For example, in order to expand access to certain diagnostic respiratory tests, CMS removed the requirement for a  
practitioner order for those tests.  See 85 Fed. Reg. 27558,  27620 (May 8,  2020) (amending 42 CFR  410.32(a)).   For a list of  
the tests see CMS,  Commonly Ordered COVID-19, Influenza, and RSV Clinical Diagnostic  Laboratory Tests for which Medicare  
Allows One Test Without a Practitioner Order During the PHE, May  5, 2021.   Accessed at  
https://www.cms.gov/files/document/covid-ifc-2-flu-rsv-codes.pdf  on November  28,  2022.  
5  The CDC recommendations for COVID-19 testing have been developed on the basis of  what is currently known about  
COVID-19 and are subject to change as additional information becomes available.  CDC,  Updated Guidance on Evaluating and  
Testing Persons for Coronavirus Disease 2019  (COVID-19),  March 8, 2020.  Accessed at 
https://emergency.cdc.gov/han/2020/HAN00429.asp  on October 18, 2022.  
6  OIG,  Fraud Alert: COVID-19 Scams,  February 2, 2022.   Accessed at  https://oig.hhs.gov/fraud/consumer-alerts/fraud-alert-
covid-19-scams/?utm_source=web&utm_medium=web&utm_campaign=covid19-fraud-alert  on October 18, 2022.  
7  DOJ,  DOJ Announces Coordinated Law Enforcement Action to Combat  Health Care Fraud Related to COVID-19, May 26,  2021.   
Accessed at  https://www.justice.gov/opa/pr/doj-announces-coordinated-law-enforcement-action-combat-health-care-fraud-
related-covid-19  on October 18, 2022.   
8  DOJ,  Federal Law Enforcement Action Involving Fraudulent Genetic Testing Results in Charges Against 35 Individuals 
Responsible for Over $2.1 Billion in Losses in One of the Largest Health Care Fraud Schemes Ever Charged, September 27, 2019.   
Accessed at  https://www.justice.gov/opa/pr/federal-law-enforcement-action-involving-fraudulent-genetic-testing-results-
charges-against  on October 18, 2022.  
9  This report identifies tests by procedure code.   The  five  character codes  and  descriptions  included  in this  report  are  
obtained from Current  Procedural  Terminology (CPT), copyright  2021  by the  American Medical  Association (AMA).  
CPT is developed by the AMA as a listing of descriptive terms and five character identifying codes and modifiers for 
reporting medical services and  procedures.  Any use of CPT outside of this design should refer to the most current  
version of the Current Procedural Terminology available  from AMA.   Applicable FARS/DFARS apply.  
10  This is a standard exploratory method for identifying members of a population with unusually high values on a given  
statistic compared to the rest of the population when no benchmarks exist.  See J.W. Tukey,  Exploratory Data Analysis, 
Addison-Wesley, 1977.  
11  These 378 labs represent 2 percent of all labs that billed for  COVID-19 tests in 2020.   
12  These averages included claims both with and without add-on tests.  
13  See endnote 9 for AMA copyright notice.  
14  Because of  rounding, the sum of the individual tests listed in the payment column do not add  up to the total of $830 in the  
payment column.  
 
Labs  With Questionably  High  Billing for  Additional Tests  Alongside COVID-19 Tests  Warrant Further Scrutiny   
OEI-09-20-00510     
  Endnotes | 15     
 
15  Each of these  8 labs submitted at least 10 claims where both labs billed for the same  enrollee for the same tests on the  
same day.  
16  See endnote 9 for AMA copyright notice.  
Labs  With Questionably  High  Billing for  Additional Tests  Alongside COVID-19 Tests  Warrant Further Scrutiny   
OEI-09-20-00510     
  Endnotes | 16