U.S. Department of Health and Human Services  
 Office of Inspector General  
 Data Brief  
 December  2022, OEI- 09 -22- 00400  
Medicare Part  B  Spending  on Lab  Tests  Increased  in 2021,  Driven By 
Higher Volume of  COVID-19  Tests, Genetic  Tests, and  Chemistry Tests  
Medicare Part B spending on laboratory (lab)  tests increased by 
Key Results  
$1.3 billion in 2021, from $8.0 billion in 2020 to  $9.3 billion in 
Medicare  Part  B  spent  $9.3  billion  on  
2021. The 17-percent increase was the biggest change in 
laboratory  tests  in  2021,  a 17- percent  
spending since OIG began monitoring payments in 2014.  
increase from  2020.   The spending 
increase resulted from  increased 
In 2021, Medicare Part B spent $2.0 billion on COVID-19 tests, a  
volume  for  three  types of  tests:  
29-percent increase from 2020.  Medicare  Part B paid for 
COVID -19  tests,  genetic  tests,  and  
26  different  procedure codes for COVID-19 tests, including code 
chemistry tests.   Genetic  tests  
U0005, a new code that  incentivized faster test turnaround 
exceeded pre -pandemic  spending  
times.  More than 10 million enrollees received at least 
levels,  while chemistry  test  spending 
increased  from  2020  but  did  not  fully   1  COVID-19  test paid  for  by Medicare Part B. 
return to  pre -pandemic  levels.  
Medicare Part B spending on non-COVID-19 tests also  
increased.  Total spending on four categories of  high-priced genetic tests increased by 56 percent, from 
$1.2  billion  in 2020 to $1.9 billion in 2021, exceeding pre-pandemic spending levels.  Spending on 
chemistry teststhe largest category of tests by both spending and volumeincreased  from  
$1.9  billion in  2020 to $2.1  billion  in 2021, but  remained  below  pre-pandemic levels.  
Medicare Part B spent $5.5 billion in 2021 on the top 25 tests, which  accounted for 59 percent of total  
test spending.  The factors that affected overall spending  also contributed to the increase in spending  
on the top 25 tests.  These factors were the  increased volume for COVID-19 tests, the continued growth 
of high-priced  genetic tests, and  the increased volume for panel and  chemistry tests.  
Why OIG  Did This Review  
The Protecting Access to Medicare Act of 2014 (PAMA) changed the way the Medicare program sets 
payment rates for lab tests by aligning Medicare payment rates with rates paid by private payers.  The 
Centers for Medicare &  Medicaid  Services (CMS) calculated new rates that took effect in 2018, lowering  
Medicare payment rates for many tests.  As part of PAMA,  Congress also mandated that the Office of  
Inspector General (OIG)  publicly release an annual analysis of the top 25 tests based on Medicare  
spending and  that it conduct  analyses that OIG determines appropriate.  OIG issued the first report in 
2015, analyzing Medicare Part B payments for lab tests in 2014.  This data brief provides an analysis of  
Medicare payments for lab tests in 2021.   
How OIG Did This Review  
We analyzed claims data for lab tests performed in 2021 that CMS paid for under the Clinical  
Laboratory Fee Schedule (CLFS).  These tests are covered under Medicare Part B and do not  include 
tests that Medicare paid for under other payment systems, such as the payment system for critical  
access hospitals or the Hospital  Outpatient Prospective Payment System.  We identified the top 25 lab 
tests based on Medicare spending for tests performed in 2021.  We also  identified key statistics and  
emerging trends, including Medicare spending by procedure  code and test category.    
RESULTS  
 
Medicare Part  B  spent  $9.3  billion on laboratory tests  in 2021,  
a  17-percent  increase from  2020  
Medicare Part B spending on laboratory (lab)  tests increased by $1.3 billion in 2021, 
from $8.0 billion in 2020 to $9.3 billion in 2021.  The 17-percent increase was the 
biggest change in spending since OIG began monitoring payments in 2014.  The 
increase in spending in 2021 resulted  from  higher spending  in three groups of tests: 
COVID-19 tests, genetic tests, and chemistry tests, as shown in Exhibit 1.  See the 
Appendix for a list  of prior OIG  reports on Medicare Part B spending and payment  
rates for lab tests.  
Exhibit 1: Overall Medicare Part B spending increased by 17 percent in 2021, 
driven by increased spending on  COVID-19  tests,  genetic tests,  and  
chemistry tests.  
 
Source: OIG analysis of Medicare Part  B  claims data,  2022.   Groups  may not add  up to total  because of  rounding.  
Legislation related to  the COVID-19 pandemic delayed the changes to payment rates 
for lab tests that were mandated by PAMA.1   Under the provisions of PAMA, payment  
rates for procedure codes that were on the CLFS  prior to PAMAs implementation in 
2018 are based on the volume-weighted median of  lab-reported data, which resulted  
in lower payment rates for many of these tests.  PAMA also  limited how  much 
payment rates for tests could fall  for the first 6 years of its implementation.  However, 
legislation related to  the  COVID-19 pandemic  delayed  the reductions to  payment  
rates in 2021 and 2022.  Thus, payment rates did not change in 2021.    
Data Brief:  Medicare  Part B Spending on Lab  Tests  Increased  in 2021, Driven By Higher  Volume of Tests  
OEI-09-22-00400   Results | 1   Medicare Part B spending on COVID-19 tests increased by 
29  percent in 2021, to $2.0 billion  
In 2021, Medicare Part B spent $2.0 billion on COVID-19 tests, a $440 million increase 
from $1.5 billion in 2020.   Medicare paid for COVID-19 tests across 26 procedure  
codes, including antibody tests, high-throughput tests, panel tests, and a new code 
used to incentivize faster test turnaround times (see 
About U0005.   CMS introduced a new  
sidebar).2   The volume of  COVID-19 tests that Medicare 
procedure code, U0005, in 2021 to 
Part B paid for also  increased in 2021, from 18.8 million 
incentivize faster test turnaround times.   
tests in 2020 to 25.8 million tests in 2021, a  37-percent  
Labs that returned results within 2 
increase.3  
calendar days could bill CMS for an  
additional $25 using procedure code   The increase in volume was driven by more tests  received  
U0005.  This code is an add-on code  and  by more people.  In 2021, more than 10.1 million people 
can only be included on  claims with  received at least one COVID-19 test  paid for by Medicare 
procedure codes U0003 and U0004.  
Part B, a 19-percent increase from 2020, when 8.5  million  
Medicare Part B paid for procedure code  
enrollees received a COVID-19 test paid for by Medicare  
U0005 12.3 million times in 2021 and 
Part B.  On average, Medicare Part B  paid for 2.6 COVID-
spent a total of $305 million for this code.  
19 tests per person, an increase from 2.2 tests per person 
Although these payments do not represent  in 2020.4  
additional tests, they indicate that labs  
returned at least 12.3 million COVID-19  Medicare spending on COVID-19 tests fluctuated  
test results within 2 calendar days.   throughout 2021, as shown in Exhibit 2.  Testing in the 
United States declined notably during the first half of the  
year and increased in August and December 2021, which coincided with two new  
variants: the Delta variant and the Omicron variant, respectively.5    
Exhibit 2: Medicare Part B spending on COVID-19 tests decreased early in  
2021 but  increased  in  response to the Delta and Omicron variants. 
Source:  OIG analysis  of Medicare Part B claims  data, 2022, and CDC timeline of the emergence of variants.  
Data Brief:  Medicare  Part B Spending on Lab  Tests  Increased  in 2021, Driven By Higher  Volume of Tests  
OEI-09-22-00400   Results | 2   Medicare Part B spending on genetic tests increased  by  
56  percent in 2021, to $1.9  billion, continuing a long-term trend  
Medicare Part B spending on genetic tests increased to $1.9 billion in 2021, a  
$677  million increase from $1.2 billion in 2020.  Genetic tests, as a group, comprise 
four categories of tests: molecular pathology tests, multianalyte algorithmic assays, 
genomic sequencing procedures, and proprietary lab analysis tests.  Total spending  
on these genetic tests accounted for 20 percent of  Medicare spending for lab tests in  
2021.  
Medicare Part B spending for genetic tests continued its upward trend, as shown in 
Exhibit 3.   Since OIG began monitoring Medicare Part B spending on lab tests in 2014, 
spending on genetic tests has more than tripled.  The increase in spending was driven  
by  both an increase in the volume of claims for genetic tests and an increase in the 
number of  procedure codes eligible for payment.  
Exhibit 3: Total spending on  genetic tests has increased significantly since 
PAMA was enacted in 2014.  
Source: OIG analysis of Medicare Part  B  claims data,  2022.  
The volume of genetic tests that Medicare Part B  paid  for increased by 55 percent,  
from 1.8  million in 2020 to 2.8 million in 2021.  Compared to  volume from  2019, the 
volume of genetic tests increased 24 percent from 2.3 million.  These are all high-
priced tests,  with an average payment of $666 per test in 2021.  In 2021, the number 
of procedure codes for genetic tests increased to 365, an additional 31 codes to the 
334  procedure codes that Medicare Part B paid  for in 2020.6    
Medicare Part B  spending on chemistry tests increased by 
10  percent in 2021,  but did not  return to  pre-pandemic levels  
Medicare Part B spending on chemistry tests increased in 2021, following  a decline in 
2020. This is the largest category on the CLFS, by both spending and volume.  In 
Data Brief:  Medicare  Part B Spending on Lab  Tests  Increased  in 2021, Driven By Higher  Volume of Tests  
OEI-09-22-00400   Results | 3   2021, Medicare Part B spent $2.1  billion on 165 million chemistry tests, compared to  
$1.9  billion spent on 153  million tests in 2020.  Chemistry testswhich averaged  
about $13 per test in 2021measure the level of a chemical  such as a protein, 
electrolyte, or hormone in a specimen.  These are among the most common types of  
tests,  and providers use the results to monitor a  persons organ function and general  
health status.  The increase in spending on these tests in 2021 was driven by an 
increase in volume, which could indicate that Medicare enrollees resumed at least  
some medical care they had postponed during the height of the pandemic in 2020.   
However, volume for chemistry tests  in 2021  was 6 percent lower than it  was in 2019, 
as shown in Exhibit 4.  Volume for chemistry tests remained  fairly  stable  until 2020,  
when volume declined by 12  percent.  Although volume increased from 2020, the 
decrease in volume from 2019 raises questions about the continuing impact of the 
COVID-19  pandemic on the healthcare system.  If fewer Medicare Part B enrollees 
received  these  tests, it could indicate that they may not have accessed healthcare at  
the same level  as  they did before the COVID-19 pandemic began.  
Exhibit 4: Volume of  chemistry tests  in 2021 was 6 percent lower than it was in  
2019, following  fairly  stable volume prior to the COVID-19 pandemic.  
 
Source: OIG analysis of Medicare Part  B  claims data,  2022.  
Medicare Part  B  spent  $5.5  billion on the top  25  tests,  which  
accounted  for 59  percent  of  total spending  in 2021   
Medicare Part B spent $5.5 billion on the top 25 tests, a  10-percent increase  from  
$4.99 billion in 2020.  Spending on the top 25 tests accounted for 59 percent of total  
spending in 2021.  Three factors  that  contributed to the increase in spending  included  
increased spending on COVID-19 tests;  continued growth of  genetic tests;  and  
increased volume for panel and  chemistry tests.   
Data Brief:  Medicare  Part B Spending on Lab  Tests  Increased  in 2021, Driven By Higher  Volume of Tests  
OEI-09-22-00400   Results | 4   COVID-19 tests  in the top 25.  Medicare Part B  spent a total of $1.7 billion on 
COVID-19  tests in the top 25.  For the second year in a row, the top procedure code 
paid for by Medicare Part B was a COVID-19 test that used high-throughput  
technology (procedure code U0003,  line 1 in Exhibit 5).  Despite a 22-percent increase 
in volume for this test in 2021, spending decreased due to a decrease in the payment  
rate that CMS set for the test.   When CMS  introduced U0005, it  reduced the payment  
rates for U0003 and U0004 from $100 to $75.7   In 2021, five procedure codes related  
to COVID-19  tests, including procedure code U0005, were in the top 25.  
Genetic tests in the top 25.   Medicare Part B spent $803 million on genetic tests in 
the top 25.  Five procedure codes for high-priced  genetic tests were in the top 25 in 
2021. As shown in Exhibit 5, these procedure codes had the highest payment rates 
ranging from $509  to $3,873but  accounted for the lowest volume (lines 7, 9, 19, 20, 
and 24 in Exhibit 5).  Medicare Part B paid for a total  of 809,671 tests across three 
molecular pathology procedure codes and two  multianalyte assays with algorithmic 
analyses procedure codes.  
Although these tests represented a notable portion of spending for the top 25 tests, 
they accounted for the lowest  volume.  For example, Medicare Part B spent  
$282.2  million on 141,146 units of a specific molecular pathology code (procedure 
code 81408, line 7 in Exhibit 5).  Volume for this test increased by 36  percent in 
2021  and had the highest change in volume and  spending for genetic tests.      
Organ- and disease-oriented panel tests and chemistry tests in the top 25.   
Medicare Part B spent  $1.8 billion on two categories of  tests: organ- and disease-
oriented panel tests and chemistry tests.  For example, the number 2 test by spending  
is an organ- or disease-oriented panel test.  Spending for this test, the comprehensive 
group of blood chemicals test (procedure code 80053, line 2 in Exhibit 5),  increased  
by 6 percent, from $402.7 million in 2020 to $425.3  million in 2021.  However, 
spending for this test was still 13 percent lower than the $491.6 million spent in 2019.  
Similarly, spending for the top chemistry test, the thyroid stimulating  hormone test  
(procedure code 84443, line 4 in Exhibit 5),  was 15  percent lower in 2021 than it was 
in 2019.  Historically, volume for these tests has been relatively steady, with changes 
in spending driven mostly by PAMA-related changes to payment rates.   Declines in 
spending  on these tests are  driven by declines in volume,  which  could  reflect  lower  
healthcare utilization for people enrolled in Medicare Part B.8   In 2021, there were  
5  chemistry tests and 3 organ- or disease-oriented panel tests in the top  25.  
   
Data Brief:  Medicare  Part B Spending on Lab  Tests  Increased  in 2021, Driven By Higher  Volume of Tests  
OEI-09-22-00400   Results | 5   Exhibit 5: Medicare Part B spent $5.48 billion on the top 25 lab tests in 2021.  
2021   2021   Volume   2021  
Test  Description (Procedure  Code)   payment   volume  change  spending  
rate   (millions)   from  2020   (millions)  
 
1   COVID-19  test: Infectious  agent  detection by  nucleic  acid for   $75.00   12.5   22.2%   $935.9  
COVID-19,  high-throughput  (U0003)  
2   Blood test,  comprehensive group of  blood chemicals (80053)   $10.56   39.5     4.7%   $425.3  
3   Blood test,  lipids (80061)   $13.39   26.5     4.9%   $355.2  
4   Blood test,  thyroid  stimulating  hormone  (84443)   $16.80   19.9     5.3%   $334.4  
5   COVID-19  test: Add-on payment  for  high  throughput  tests   $25.00   12.3   New  in  $305.4  
completed within 2  calendar  days  of  specimen  collection (U0005)   2021  
6   Complete blood cell  count,  automated  test  (85025)   $7.77   37.8     3.1%   $300.2  
7   Genetic  test:  Molecular  pathology  procedure  level  9  (81408)   $2,000.00   0.1     36.4%   $282.2  
8   Vitamin  D-3  level  (82306)   $29.60   9.1     11.8%   $267.2  
9   Genetic  test:  Gene  analysis  (colorectal  cancer)  (81528)   $508.87   0.5     20.6%   $252.6  
10   COVID-19  test: Any  technique,  high-throughput  technologies   $75.00   2.9     20.7%   $220.8  
(U0004)  
11   Detection  test  for  organism  (87798)   $35.09   6.1     16.2%   $213.7  
12   Drug  test(s),  definitive,  22  or  more drug  class(es)  (G0483)   $246.92   0.8     -9.2%   $203.0  
13   Hemoglobin A1C  level  (83036)   $9.71   18.6     5.9%   $182.3  
14   Testing for  presence  of  drug (80307)   $62.14   2.5     -3.6%   $156.4  
15   Drug  test(s),  definitive,  15-21  drug class(es)  (G0482)   $198.74   0.7     1.3%   $130.2  
16   COVID-19  test: Amplified probe technique (87635)   -  2.0     46.9%   $104.8  
17   COVID-19  test: ELISA  detection of  severe acute respiratory   -  2.6   New to    $101.5  
syndrome coronavirus  2  (COVID-19)  (87426)   top  25  
18   Parathormone  (parathyroid  hormone) level  (83970)   $41.28   2.5     8.6%   $101.4  
19   Genetic  test:  Gene  analysis (breast  cancer  1  and  2)  (81162)   $1,824.88   0.05     7.7%   $94.0  
20   Genetic  test:  Test  for  detecting genes  associated with breast   $3,873.00   0.02     20.1%   $92.7  
cancer (81519)  
21   Blood  test,  basic group  of  blood  chemicals  (80048)   $8.46   10.3      -0.1%   $90.3  
22   Cyanocobalamin  (vitamin  B-12) level  (82607)   $15.08   5.8     11.4%   $87.9  
23   Drug  test(s),  definitive,  1-7  drug class(es) (G0480)   $114.43   0.8     -2.6%   $86.6  
24   Genetic  test:  Molecular  pathology  procedure  level  8  (81407)   $846.27   0.1   New to    $81.6  
top  25  
25   Drug  test(s),  definitive,  8-14  drug  class(es)  (G0481)   $156.59   0.5     -2.5%   $79.1  
  Total  2021  spending on  the top 25  tests:  $5.48  billion  
Sources:  OIG analysis of  20202021 spending on lab tests in  Medicare Part  B, 2022.   Payment rates are from the 2021  CLFS.   Local Medicare 
Administrative Contractors are responsible for developing the  payment amount for claims  they receive for some newly  created  procedure  
codes until  Medicare establishes  national payment rates.  
Labs bill for each test on the CLFS using a Healthcare Common Procedure Coding System (HCPCS)  code, which  we refer to as a procedure  
code.  The HCPCS is  divided into two systems, referred to as Level  I and Level  II.  Level I  HCPCS codes are composed  of CPT  codes.   The five 
character codes and descriptions included in this study  are obtained from Current Procedural Terminology (CPT), copyright  2018 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 study should refer to  
the most current version of the Current Procedural Terminology available from AMA.   Applicable FARS/DFARS  apply.   Level II HCPCS  
codes are established by  CMS primarily for items,  supplies, and  non-physician  services not  covered by CPT codes.  
Data Brief:  Medicare  Part B Spending on Lab  Tests  Increased  in 2021, Driven By Higher  Volume of Tests  
OEI-09-22-00400   Results | 6    
CONCLUSION  
 
 
The COVID-19 pandemic continued to have an impact on Medicare Part B spending  
on lab tests.  In 2021, more people received more COVID-19 tests than in 2020, 
driving an overall increase on spending for COVID-19 tests.  However, looking to  
2022, it is likely  that the increased availability of  at-home COVID-19 tests could  affect  
overall  Medicare Part B spending for lab-performed tests.9  
Another category increasing in Medicare Part B spending is genetic tests, which have 
been continuing an upward trend since OIG began monitoring spending on lab tests  
in 2014.  The number of genetic test procedure codes on the CLFS continues to grow  
and total spending on genetic tests has more than tripled since OIG began 
monitoring  payments in 2014.  
However, the second year in a row  of low volume for chemistry tests raises questions 
about the pandemics long-term impact on Medicare enrollee health.  Although 
volume increased from 2020 to  2021, it did not  fully return to pre-pandemic levels, 
which could  indicate that people are not seeking the routine or preventive  care 
appointments where these tests are ordered.   Research suggests that delays of such 
tests could have a long-lasting impact on peoples health.  
The COVID-19 pandemic also affected CMSs long-term timeline for implementing  
PAMA.  In addition to the pause in payment rate reductions, pandemic-related  
legislation delayed the next set of payment rates, which are scheduled to take effect  
on January 1, 2024.  These new rates will be based on data  that labs collected in 2019,  
meaning that procedure codes added  to the CLFS in 2020 and afterincluding codes 
for COVID-19 tests and new genetic testswill  not be based on private payer data  
until the next set of payment rates, currently scheduled for 2027, takes  effect.10 
Data Brief:  Medicare  Part B Spending on Lab  Tests  Increased  in 2021, Driven By Higher  Volume of Tests  
OEI-09-22-00400   Conclusion | 7    
 METHODOLOGY  
 
 
Data Analysis:  We based this report on our analysis of  Medicare claims data for lab 
tests performed in 2021 and reimbursed under the CLFS.  Through our analysis, we 
identified key statistics and emerging trends for Medicare spending on lab tests.  We 
analyzed Medicare spending and test volume by procedure code and category.  Test  
volume is based on the number of units for which labs billed  Medicare.  We calculated  
total spending for 2021 and compared that to the results from 2014 to 2021.  
  COVID-19 tests.   We used Current  Procedural Terminology (CPT) test codes
and HCPCS  codes to identify 26  COVID-19 tests that were authorized for
payment in 2021.  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.  Tests that Medicare Part B 
enrollees received through other programs, such as community testing efforts, 
were not included, unless they were paid for by Medicare Part B.  For analysis
by Medicare enrollee, we  identified enrollees by using the Health Insurance
Claim Numbers on the claims.  
  Analysis by test category.   We used CPT categories for all tests on the CLFS,
except tests used to diagnose COVID-19, which were analyzed as a group.  For
HCPCS  Level II codes that are unique to the CLFS, we used categories
previously assigned by CMS. 
  Top 25  lab tests.   We identified the top 25 lab tests (based on  total spending 
for each procedure code) in 2021 and calculated  total spending for these tests.  
For this group of tests, we calculated the change in the volume of test units
paid for from 2020  to 2021. 
Data Source:  The claims data were from the National  Claims History 
Physician/Supplier Part B claim files and National  Claims History Outpatient files.  The 
Physician/Supplier Part B files primarily include claims from independent labs and  
physician office labs.  The Outpatient files primarily include claims from hospital  labs.   
We did not  include tests paid for under other payment systems, such as the payment  
system for critical  access hospitals or the Hospital Outpatient  Prospective Payment  
System.  Many of the lab tests performed in outpatient settings (such as hospitals, 
skilled nursing facilities,  and dialysis facilities)  are paid for under Medicare payment  
systems other than the CLFS.   We did not include claims for physician interpretation 
of tests.  
Limitations:  Analysis for this report was conducted on claims that Medicare Part B  
had processed by June 2022.  Data from past reports used the 16-month or 17-month 
files and, thus, may be marginally different from the set of claims used in 2022.  
However, this set of claims is comparable to the 16-month and 17-month files.  
Data Brief:  Medicare  Part B Spending on Lab  Tests  Increased  in 2021, Driven By Higher  Volume of Tests  
OEI-09-22-00400   Methodology | 8   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.   
 
Data Brief:  Medicare  Part B Spending on Lab  Tests  Increased  in 2021, Driven By Higher  Volume of Tests  
OEI-09-22-00400   Methodology | 9    
APPENDIX  
 
Prior Office of  Inspector General Reports  on Medicare Part  B  
Spending  and  Payment  Rates  for Lab  Tests  
COVID-19 Tests  Drove an Increase in Total  Medicare  OEI-09-21-00240   December 2021  
Part B Spending  on  Lab Tests in 2020, While Use of 
Non-COVID-19 Tests  Decreased Significantly  
Federal COVID-19 Testing Report: Data Insights from   PRAC Health Care   January 2021  
Six Federal  Health Care Programs*   Subgroup  
Despite Savings on Many Lab Tests in 2019, Total   OEI-09-20-00450   December 2020  
Medicare Spending Increased Slightly Because  of 
Increased Utilization for Certain High-Priced Tests  
Medicare Laboratory Test Expenditures Increased in   OEI-09-19-00100   August 2020  
2018, Despite New Rate  Reductions  
Medicare Payments for Clinical Diagnostic Laboratory   OEI-09-18-00410   September 2018  
Tests in 2017: Year  4  of Baseline Data  
Setting  Medicare Payment Rates for  Clinical   OEI-09-17-00050   July 2018  
Diagnostic Laboratory Tests: Strategies To Ensure Data  
Quality  
Medicare Payments for Clinical Diagnostic Laboratory   OEI-09-17-00140   September 2017  
Tests in 2016: Year 3  of Baseline Data  
Changing How Medicare Pays for Clinical Diagnostic   OEI-09-16-00100   September 2016  
Laboratory  Tests: An Update on CMS's Progress  
 
Medicare Payments for Clinical Diagnostic Laboratory   OEI-09-16-00040   September 2016  
Tests in 2015:  Year 2 of  Baseline Data   
Medicare Payments for Clinical Laboratory Tests in   OEI-09-15-00210   September 2015  
2014: Baseline Data  
Comparing  Lab Test  Payment Rates: Medicare Could   OEI-07-11-00010   June 2013  
Achieve Substantial Savings  
Variation in  the Clinical Laboratory  Fee Schedule   OEI-05-08-00400   July 2009  
*This report was  released by the Pandemic Response Accountability Committee Health Care Subgroup and included  
analysis of Medicare Part B  claims for COVID-19 tests performed between February 1, 2020, and August 31, 2020.  
  
Data Brief:  Medicare  Part B Spending on Lab  Tests  Increased  in 2021, Driven By Higher  Volume of Tests  
OEI-09-22-00400   Appendix | 10    
ACKNOWLEDGMENTS AND CONTACT  
 
Acknowledgments  
Chelsea Samuel  served as the team leader for this study, and  Eunji Kim  served as the  
lead analyst.  Office of Evaluation and Inspections staff  who  provided support include  
Althea Hosein, Christine Moritz, Michael Novello, and Sara Swisher.  
We would also like  to acknowledge the contributions of other Office of Inspector 
General staff, including Mandy Brooks, Karen Lowe, 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 and Michael  Henry, Deputy Regional Inspectors 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  
Data Brief:  Medicare  Part B Spending on Lab  Tests  Increased  in 2021, Driven By Higher  Volume of Tests  
OEI-09-22-00400   Acknowledgments and Contact | 11    
ENDNOTES  
 
 
1  On December  10, 2021, the Protecting Medicare and American Farmers  from Sequester Cuts Act, 117 Pub. L. No. 71,  was  
passed and  delayed the reporting requirement under Section 1834A of the Protecting Access to Medicare  Act of 2014 (the Act)  
and delayed the application of the 15% phase-in reduction.  
2  To bill using procedure code  U0005, the lab had to meet two requirements.  First, the lab  had to complete the test within 2 
calendar days of the specimen being collected.  Additionally, the lab must have completed the majority of its COVID-19 tests  
that use high-throughput technology within 2 calendar days for all patients, not just its  Medicare  patients, during the prior  
calendar month.   CMS  Ruling 2020-1-R2.  
3  We excluded code U0005 from this analysis, as it does not represent actual tests.  Rather, it represents additional payments  
for tests included in volume for other procedure codes.  
4  We excluded code U0005 from this analysis, as  it does not represent actual tests.  Rather, it represents additional payments  
for tests included in volume for other procedure codes.  
5  The Centers for Disease Control and Prevention (CDC) designated Delta as  a Variant of Concern (VOC) on June 15, 2021,  and 
Omicron as a  VOC on Nov. 30, 2021.   SARS-CoV-2 Variant Classifications and Definitions (cdc.gov).  
6  Additional  genetic test procedure codes may be on the CLFS but may not have been included on any Medicare Part B claims  
for payment.  
7  CMS Ruling 2020-1-R2.   See also CMS Press  Release,  CMS Changes Medicare Payment to Support Faster COVID-19 Diagnostic  
Testing, CMS Changes Medicare Payment to Support Faster  COVID-19 Diagnostic Testing | CMS.   Accessed on September 10,  
2022.  
8  Because payment rates did not change from 2020 to 2021,  all declines in spending  were  driven by declines in volume.  
9  Medicare Part  B began  covering over-the-counter tests in April 2022, in addition to tests available  by mail.   Medicare Covers  
Over-the-Counter COVID-19 Tests | CMS.  
10  On December  10, 2021, the Protecting Medicare and American Farmers  from Sequester Cuts Act, 117 Pub. L. No.  71, was  
passed and  delayed the reporting requirement under Section 1834A of the Act.  
Data Brief:  Medicare  Part B Spending on Lab  Tests  Increased  in 2021, Driven By Higher  Volume of Tests  
OEI-09-22-00400   Endnotes | 12