U.S. Department of Health and Human Services Office of Inspector General Data Brief December 2021, OEI-09-21-00240 COVID-19 Tests Drove an Increase in Total Medicare Part B Spending on Lab Tests in 2020, While Use of Non-COVID-19 Tests Decreased Significantly Medicare Part B spending on clinical diagnostic laboratory (lab) tests Key Takeaway in 2020 was affected by significant new spending on COVID-19 tests, Medicare Part B spent $1.5 billion a type of test that did not exist before the pandemic. Overall on COVID-19 tests in 2020, while spending increased from $7.7 billion in 2019 to $8.0 billion in 2020. at the same time, spending on This increase in spending non-COVID-19 tests declined by was driven by $1.5 billion in $1.2 billion. The result was a net new spending on spending increase of 4 percent, COVID-19 tests, including but the decrease in utilization of $1.0 billion on a rapid non-COVID-19 tests raises COVID-19 test procedure questions about the potential code, which was the number impacts on beneficiary health. 1 test by spending. Aside from COVID-19 tests, spending for all other tests, as a group, decreased by about $1.2 billion in 2020. The decline in spending was driven by a sharp decline in non-COVID-19 tests during the early months of the pandemic, as well as further reductions in payment rates for some of these tests, as required by the Protecting Access to Medicare Act of 2014 (PAMA). Why OIG Did This Review PAMA changed the way the Medicare program sets payment rates for lab tests by aligning Medicare payment rates with private payment rates. The Centers for Medicare & Medicaid Services (CMS) calculated new rates that took effect in 2018. 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 conduct analyses that OIG determines appropriate. This data brief provides an analysis of Medicare payments for lab tests in 2020. How OIG Did This Review We analyzed claims data for lab tests performed in 2020 that CMS paid for under the Clinical Laboratory Fee Schedule (CLFS). These tests are covered under Medicare Part B and do not include COVID-19 tests provided by community testing programs or 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 2020. We also identified key statistics and emerging trends, including Medicare spending by procedure code and test category. RESULTS Medicare Part B spent $8.0 billion on laboratory tests in 2020, a 4.2 percent increase from 2019 Medicare Part B spending on laboratory (lab) tests increased 4.2 percent in 2020, reflecting significant new spending on COVID-19 testing and a decline in utilization of other lab tests due to the pandemic. As shown in Exhibit 1, total spending has increased each year for the last 5 years. The average annual increase in payments since 2016 has been about 4.3 percent per year; no year had a decrease in total lab test spending. However, spending on non-COVID-19 tests in 2020 was the lowest it has been over this 5-year period. COVID-19 tests, a new type of test that did not exist before the COVID-19 pandemic emerged in 2020, accounted for the increase in spending for lab tests in 2020. COVID-19 tests accounted for about 19 percent of total Medicare Part B spending on lab tests. Aside from COVID-19 tests, spending for all other tests as a group decreased by 15.9 percent from 2019, to $6.5 billion. The decline in spending was driven by a decline in overall healthcare utilization during the pandemic, as well as a further reduction in payment rates for some tests, as required by PAMA. Exhibit 1: Medicare Part B spending on lab tests increased for the fifth year in a row, an increase largely driven by spending on new tests for COVID-19. Source: OIG analysis of 2016–2020 spending on lab tests in Medicare Part B, 2021. Data Brief: COVID-19 Tests Drove an Increase in Total Medicare Part B Spending on Lab Tests in 2020, While Use of Non-COVID-19 Tests Decreased Significantly, OEI-09-21-00240 Results | 2 Medicare Part B spent $1.5 billion on COVID-19 tests in 2020, which accounted for 19 percent of total Medicare Part B spending on lab tests In 2020, Medicare Part B spent $1.5 billion on 25 unique procedure codes related to COVID-19 testing. This set of tests included antibody tests, high-throughput tests with shorter test turnaround times, and panel tests that tested for COVID-19 along with other respiratory diseases. Medicare Part B payment rates for COVID-19 tests ranged from $18.09 per test to $100 per test for high-throughput tests. See Appendix B for more information about COVID-19 tests covered by Medicare Part B in 2020. Exhibit 2: Medicare Part B spending on COVID-19 tests increased throughout 2020. Source: OIG analysis of spending on lab tests in Medicare Part B, 2021. More than 8.4 million unique Medicare Part B beneficiaries received at least 1 COVID- 19 test paid under the CLFS in 2020. On average, each unique beneficiary received two COVID-19 tests paid for by Medicare Part B. Medicare Part B beneficiaries may have also received COVID-19 tests that were paid through other means, such as community testing programs. Overall Medicare Part B utilization of non-COVID-19 tests decreased significantly in 2020, compared to 2019 Medicare Part B paid for fewer tests in total in 2020 than in 2019, driven by a sharp decline in testing in the spring of 2020. For example, the number of non-COVID-19 tests administered in April 2020 was 53 percent lower than in April 2019. During this period, large segments of the U.S. economy, including parts of the healthcare sector, shut down to limit the community spread of COVID-19. Non-COVID-19 diagnostic test volume declined dramatically in spring 2020, before returning to more typical utilization patterns in the summer. Data Brief: COVID-19 Tests Drove an Increase in Total Medicare Part B Spending on Lab Tests in 2020, While Use of Non-COVID-19 Tests Decreased Significantly, OEI-09-21-00240 Results | 3 Exhibit 3: The number of non-COVID-19 tests administered was 53 percent lower in April 2020 than in 2019. Source: OIG analysis of 2019–2020 spending on lab tests in Medicare Part B, 2021. The decline in test volume is consistent with CMS guidance on how facilities could respond to the evolving pandemic. As the pandemic began, CMS issued guidance on April 7, 2020, that it developed in collaboration with medical societies and associations. This guidance presented a tiered framework to prioritize services for urgent, life-saving situations where lack of in-person care could result in patient harm. For the lowest acuity tier, the guidance recommended that providers consider postponing non-emergent care and preventative screening procedures in order to limit exposure to COVID-19 for patients and providers. 1 Two months later, on June 8, 2020, CMS issued additional guidance on how facilities could safely resume non-emergent care that had been postponed. 2 As shown in Exhibit 3, the number of non-COVID-19 tests that Medicare Part B beneficiaries received in June 2020 was 7 percent higher than the number of tests administered in June 2019. However, the monthly volume of non-COVID-19 tests did not continue to increase during the second half of 2020, suggesting that many Medicare beneficiaries did not make up the tests they may have missed in the spring during the rest of 2020. Research suggests that delays in diagnostic testing, such as cancer screening, could have long-term effects on beneficiary health and well-being. 3 1 CMS, "Non-Emergent, Elective Medical Services, and Treatment Recommendations." Issued April 7, 2020. Available at https://www.cms.gov/files/document/cms-non-emergent-elective- medical-recommendations.pdf. 2 CMS, "Re-opening Facilities to Provide Non-emergent Non-COVID-19 Healthcare." Issued June 8, 2020. Available at https://www.cms.gov/files/document/covid-recommendations- reopening-facilities-provide-non-emergent-care.pdf. 3 For an example, see Alkatout, I., Biebl, M., Momenimovahed, Z., Giovannucci, E., Hadavandsiri, F., Salehiniya, H., & Allahqoli, L. (2021), "Has COVID-19 Affected Cancer Screening Programs? A Systematic Review," Frontiers in Oncology, 11, 675038, available at https://doi.org/10.3389/fonc.2021.675038. Data Brief: COVID-19 Tests Drove an Increase in Total Medicare Part B Spending on Lab Tests in 2020, While Use of Non-COVID-19 Tests Decreased Significantly, OEI-09-21-00240 Results | 4 Although testing rebounded in the second half of 2020, the number of non-COVID-19 tests paid for by Medicare Part B during the full year declined by 12 percent. For example, chemistry tests-the largest category by both volume and spending- experienced a 12 percent decline in volume, from 174 million in 2019 to 153 million in 2020. Chemistry tests measure the level of a chemical-such as a protein, electrolyte, or hormone-in a specimen and providers use these tests to monitor a person's organ function and general health status. See Appendix C for spending and volume for selected test categories. Medicare Part B spent $4.99 billion on the top 25 tests, which accounted for 62 percent of total spending in 2020 Medicare Part B spending on the top 25 tests increased by 8 percent in 2020. As with spending overall, COVID-19 tests had a significant impact on spending and volume among the top 25 tests. Four COVID-19 tests were in the top 25 in 2020, as displayed on lines 1, 6, 24, and 25 in Exhibit 4 on page 6. The number 1 test by payments was a rapid COVID-19 test (procedure code U0003). Medicare Part B paid $1.02 billion for more than 10 million of these tests. This marks the first time a new test entered the top 25 as the number 1 test since OIG began monitoring spending on the top 25 tests in 2014. The number 2 test in 2020, the comprehensive group of blood chemicals test (procedure code 80053), had been the top test since new payment rates took effect in 2018. Utilization of this blood chemicals test declined by 10 percent, from 42.2 million in 2019 to 37.8 million in 2020, and payments declined by 18 percent. 4 Spending on 20 of the 21 non-COVID-19 tests in the top 25 tests decreased from 2019 to 2020. This set of tests includes routine screening tests that allow providers to identify potential issues in patients who would benefit from early intervention but may not have symptoms that require an urgent diagnosis. Similarly, volume for each of the cancer screening tests in the top 25 decreased in 2020, as displayed in lines 9, 18, 21, 22, and 23 of Exhibit 4 on page 6. Only one non-COVID-19 test in the top 25 increased from 2019 to 2020: a microbiology test that uses nucleic acid to detect an infectious agent (line 11). Volume increased by 92 percent and spending increased by 78 percent. This test was likely used in conjunction with COVID-19 tests. 5 4 The payment rate for this test declined by 10 percent, from $11.74 in 2019 to $10.56 in 2020, which accounts for the disproportionate change in payments, relative to volume. 5 CPT Assistant Special Edition: October Update, Volume 30, 2020. Available at https://www.ama-assn.org/system/files/2020-10/cpt-assistant-guide-coronavirus-october- 2020.pdf. Data Brief: COVID-19 Tests Drove an Increase in Total Medicare Part B Spending on Lab Tests in 2020, While Use of Non-COVID-19 Tests Decreased Significantly, OEI-09-21-00240 Results | 5 Exhibit 4: Medicare Part B spent $4.99 billion on the top 25 lab tests in 2020, including 4 new COVID-19 tests. 2020 2020 Volume 2020 Test Description (Procedure Code) payment volume change spending rate (millions) from 2019 (millions) 1 COVID-19 test: Infectious agent detection by nucleic acid for $100 10.2 New $1,017.0 COVID-19, high-throughput (U0003) 2 Blood test, comprehensive group of blood chemicals (80053) $10.56 37.8  -10% $402.7 3 Blood test, lipids (80061) $13.39 25.2  -12% $336.2 4 Blood test, thyroid stimulating hormone (84443) $16.80 18.9  -12% $315.4 5 Complete blood cell count, automated test (85025) $7.77 36.7  -11% $288.5 6 COVID-19 test: Any technique, high-throughput technologies $100 2.4 New $243.4 (U0004) 7 Vitamin D-3 level (82306) $29.60 8.1  -9% $237.6 8 Drug test(s), definitive, 22 or more drug class(es) (G0483) $246.92 0.9  -29% $221.9 9 Gene analysis (colorectal cancer) (81528) $508.87 0.4  -14% $208.1 10 Molecular pathology procedure level 9 (81408) $2,000 0.1  -31% $205.4 11 Detection test for organism (87798) $35.09 5.2  92% $183.5 12 Hemoglobin A1C level (83036) $9.71 17.6  -12% $170.9 13 Testing for presence of drug (80307) $62.14 2.6  -24% $161.0 14 Drug test(s), definitive, 15-21 drug class(es) (G0482) $198.74 0.7  -20% $127.7 15 Parathormone (parathyroid hormone) level (83970) $41.28 2.3  -8% $92.8 16 Blood test, basic group of blood chemicals (80048) $8.46 10.3  -18% $89.6 17 Drug test(s), definitive, 1-7 drug class(es) (G0480) $114.43 0.8  -26% $87.8 18 Gene analysis (breast cancer 1 and 2) (81162) $1,824.88 0.05  -21% $86.7 19 Drug test(s), definitive, 8-14 drug class(es) (G0481) $156.59 0.5  -17% $80.5 20 Cyanocobalamin (vitamin B-12) level (82607) $15.08 5.2  -11% $78.4 21 DNA gene analysis of 324 genes in solid organ tumor tissue $3,500 0.02  -3% $76.8 (0037U) 22 Test for detecting genes associated with breast cancer (81519) $3,873 0.02  -9% $76.6 23 PSA (prostate specific antigen) measurement (84153) $18.39 4.0  -8% $73.8 24 COVID-19 test: Amplified probe technique (87635) - 1.4 New $70.8 25 COVID-19 test: Any technique (U0002) - 1.2 New $60.7 Total 2020 spending on the top 25 tests: $4.99 billion Sources: OIG analysis of 2019–2020 spending on lab tests in Medicare Part B, 2021. Payment rates are from the 2020 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: COVID-19 Tests Drove an Increase in Total Medicare Part B Spending on Lab Tests in 2020, While Use of Non-COVID-19 Tests Decreased Significantly, OEI-09-21-00240 Results | 6 CONCLUSION Lab tests have always played a critical role in providing important diagnostic information so that providers and beneficiaries can make appropriate treatment decisions. This importance became even clearer in 2020, as the COVID-19 pandemic impacted all aspects of healthcare in the United States, including diagnostic testing. These trends affected both the increase in overall payments for lab tests in 2020 and the decline in volume for non-COVID-19 tests. The decline in volume for non-COVID-19 tests raises questions about the potential impacts on beneficiary health. The decline in testing coincided with the height of COVID-19-related economic shutdowns, which affected many parts of the healthcare sector. If Medicare beneficiaries delayed or avoided preventative healthcare services, they may not have received important tests, such as cancer screenings, that are medically necessary but not urgent. Research suggests that delays of such lab tests could have a long-lasting impact on the health of some Medicare Part B beneficiaries. The COVID-19 pandemic will continue to have an impact on Medicare Part B spending on lab tests as the pandemic continues. Testing strategy will continue to evolve as test technology and availability adjust to emerging variants. OIG has a body of oversight work focused on the impact of the COVID-19 pandemic on Medicare beneficiaries. Planned work includes an audit looking more closely at which lab tests had declines in volume in 2020. We will also continue to monitor annual payments for lab tests, including COVID-19 tests. Data Brief: COVID-19 Tests Drove an Increase in Total Medicare Part B Spending on Lab Tests in 2020, While Use of Non-COVID-19 Tests Decreased Significantly, OEI-09-21-00240 Conclusion | 7 METHODOLOGY Data Analysis: We based this report on our analysis of Medicare claims data for lab tests performed in 2020 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 2020 and compared that to the results from 2016 to 2019. • COVID-19 tests. We used Current Procedural Terminology (CPT) test codes and HCPCS codes to identify 25 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. Tests that Medicare Part B beneficiaries received through other programs, such as community testing efforts, were not included, unless they were paid for by Medicare Part B. For analysis by beneficiary, we identified beneficiaries 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. • Analysis by month. We identified the number of tests paid for during each month in 2019 and 2020. We calculated the number of COVID-19 tests paid for each month in 2020. We used the dates of service to identify the month in which the test was performed. • Top 25 lab tests. We identified the top 25 lab tests (on the basis of total spending for each procedure code) in 2020 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 2019 to 2020. 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 Data Brief: COVID-19 Tests Drove an Increase in Total Medicare Part B Spending on Lab Tests in 2020, While Use of Non-COVID-19 Tests Decreased Significantly, OEI-09-21-00240 Methodology | 8 systems other than the CLFS. We did not include claims for physician interpretation of tests. Limitations: Analysis for this report used the 16-month file, as it did in 2018 and 2019. In 2016 and 2017, we analyzed the 17-month file and, as a result, used a set of claims that was marginally more complete than sets used for other reports. Thus, the totals for 2016 and 2017 are marginally higher than those reported for other years. 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: COVID-19 Tests Drove an Increase in Total Medicare Part B Spending on Lab Tests in 2020, While Use of Non-COVID-19 Tests Decreased Significantly, OEI-09-21-00240 Methodology | 9 APPENDIX A Prior Office of Inspector General Reports on Medicare Part B Spending and Payment Rates for Lab Tests 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: COVID-19 Tests Drove an Increase in Total Medicare Part B Spending on Lab Tests in 2020, While Use of Non-COVID-19 Tests Decreased Significantly, OEI-09-21-00240 Appendix A | 10 APPENDIX B COVID-19 Tests Covered by Medicare Part B in 2020 HHS OIG identified the following COVID-19 tests on the CLFS in 2020 that were used to identify current or past COVID-19 infections. These COVID-19 tests include viral tests, which identify a current infection; antibody tests, which measure immune response; and respiratory panel tests, which use a single sample to test for multiple respiratory infections, including COVID-19. This list also includes COVID-19 tests that use high-throughput technology, which enables labs to process more tests and thus return results to the beneficiary more quickly. All but one of the 25 tests were added to the CLFS in 2020. One test (procedure code 86318) was on the CLFS prior to 2020 and was classified by AMA as a COVID-19 test on April 10, 2020. 6 Most of the new tests were contractor priced and some rates were adjusted throughout the year. CMS established payment rates at its annual meeting in June 2020; new rates took effect in 2021. Test Name HCPCS Date added to the code CLFS CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR U0001 February 4, 2020 Diagnostic Panel COVID-19, any technique, multiple types or subtypes (includes all U0002 February 4, 2020 targets), non-CDC Specimen collection for COVID-19, any specimen source. Payment rate G2023 March 1, 2020 set at $23.46. Specimen collection for COVID-19, from an individual in a skilled G2024 March 1, 2020 nursing facility or by a laboratory on behalf of a home health agency, any specimen source. Payment rate set at $25.46. Infectious agent detection by nucleic acid (DNA or RNA); COVID-19, 87635 March 13, 2020 amplified probe technique Immunoassay infectious agent. Existing test reclassified as a COVID-19 86318 Reclassified on test. Payment rate set at $18.09. April 10, 2020 Immunoassay for infectious agent antibody, qualitative or 86328 April 10, 2020 semiquantitative, single step method (e.g., reagent strip); COVID-19 Antibody; COVID-19 86769 April 10, 2020 6 CPT Assistant Special Edition: April Update, Volume 30, 2020. Available at https://www.ama- assn.org/system/files/2020-04/cpt-assistant-guide-coronavirus-april-2020.pdf. Data Brief: COVID-19 Tests Drove an Increase in Total Medicare Part B Spending on Lab Tests in 2020, While Use of Non-COVID-19 Tests Decreased Significantly, OEI-09-21-00240 Appendix B | 11 Test Name HCPCS Date added to the code CLFS Infectious agent detection by nucleic acid (DNA or RNA); COVID-19, U0003 April 14, 2020 amplified probe technique, making use of high-throughput technologies as described by CMS-2020-01-R. Payment rate set at $100 per test by CMS-2020-01-R. COVID-19, any technique, multiple types or subtypes (includes all U0004 April 14, 2020 targets), non-CDC, making use of high-throughput technologies as described by CMS-2020-01-R. Payment rate set at $100 per test by CMS-2020-01-R. Infectious disease (bacterial or viral respiratory tract infection), 0202U May 20, 2020 pathogen-specific nucleic acid (DNA or RNA), 22 targets including COVID-19, qualitative RT-PCR, nasopharyngeal swab, each pathogen reported as detected or not detected Infectious disease (bacterial or viral respiratory tract infection), 0223U June 25, 2020 pathogen-specific nucleic acid (DNA or RNA), 22 targets including COVID-19, qualitative RT-PCR, nasopharyngeal swab, each pathogen reported as detected or not detected Antibody, COVID-19, includes titer(s), when performed 0224U June 25, 2020 Infectious agent antigen detection by immunoassay technique, (e.g., 87426 June 25, 2020 enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; COVID-19 Infectious disease (bacterial or viral respiratory tract infection) 0225U August 10, 2020 pathogen-specific DNA and RNA, 21 targets, including COVID-19, amplified probe technique, including multiplex reverse transcription for RNA targets, each analyte reported as detected or not detected Surrogate viral neutralization test (sVNT), severe acute respiratory 0226U August 10, 2020 syndrome COVID-19, ELISA, plasma, serum Neutralizing antibody, COVID-19; screen 86408 August 10, 2020 Neutralizing antibody, COVID-19; titer 86409 August 10, 2020 COVID-19: antibody, quantitative 86413 September 8, 2020 Infectious disease (viral respiratory tract infection), pathogen-specific 0240U October 6, 2020 RNA, 3 targets (COVID-19, influenza A, influenza B), upper respiratory specimen, each pathogen reported as detected or not detected Data Brief: COVID-19 Tests Drove an Increase in Total Medicare Part B Spending on Lab Tests in 2020, While Use of Non-COVID-19 Tests Decreased Significantly, OEI-09-21-00240 Appendix B | 12 Test Name HCPCS Date added to the code CLFS Infectious disease (viral respiratory tract infection), pathogen-specific 0241U October 6, 2020 RNA, 4 targets (COVID-19, influenza A, influenza B, respiratory syncytial virus [RSV]), upper respiratory specimen, each pathogen reported as detected or not detected Infectious agent detection by nucleic acid (DNA or RNA); Bartonella 87636 October 6, 2020 henselae and Bartonella quintana, amplified probe technique COVID-19 and influenza virus types A and B, multiplex amplified probe technique Infectious agent detection by nucleic acid (DNA or RNA); Bartonella 87637 October 6, 2020 henselae and Bartonella quintana, amplified probe technique COVID-19, influenza virus types A and B, and respiratory syncytial virus, multiplex amplified probe technique Infectious agent antigen detection by immunoassay with direct optical 87811 October 6, 2020 (ie, visual) observation; Streptococcus, group B COVID-19 Infectious agent antigen detection by immunoassay technique, (e.g., 87428 November 10, 2020 enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; COVID-19 and influenza virus types A and B Data Brief: COVID-19 Tests Drove an Increase in Total Medicare Part B Spending on Lab Tests in 2020, While Use of Non-COVID-19 Tests Decreased Significantly, OEI-09-21-00240 Appendix B | 13 APPENDIX C Medicare Part B Spending and Utilization Details for Selected Test Categories Category Name Volume Spending 2019 2020 Change 2019 2020 Change Chemistry 174.1M 152.9M –12% $2.4B $1.9B –18% COVID-19 – 18.8M – – $1.5B – Microbiology 36.5M 37.1M 2% $762.3M $891.0M 17% Organ or disease-oriented 88.7M 77.7M –12% $1.09B $871.8M –20% panels Drug tests 11.2M 8.7M –22% $951.2M $723.3M –24% Molecular pathology 1.6M 1.1M –29% $848.9M $540.3M –36% Multianalyte algorithmic 591,919 533,110 –10% $462.9M $451.2M –3% assays Hematology and coagulation 69.0M 59.4M –14% $500.2M $404.4M –19% Immunology* 23.0M 19.2M –16% $347.2M $278.0M –20% Proprietary laboratory 54,394 91,663 69% $117.0M $132.2M 13% analyses Genomic sequencing 69,993 101,305 45% $47.2M $78.7M 66% procedures and other molecular multianalyte assays *In 2019, Medicare Part B spent $390,336.97 on the Immunology test that was reclassified in 2020 as a COVID-19 test. Data Brief: COVID-19 Tests Drove an Increase in Total Medicare Part B Spending on Lab Tests in 2020, While Use of Non-COVID-19 Tests Decreased Significantly, OEI-09-21-00240 Appendix C | 14 ACKNOWLEDGMENTS AND CONTACT Acknowledgments Chelsea Samuel served as the team leader for this study. Office of Evaluation and Inspections staff who provided support include 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: COVID-19 Tests Drove an Increase in Total Medicare Part B Spending on Lab Tests in 2020, While Use of Non-COVID-19 Tests Decreased Significantly, OEI-09-21-00240 Acknowledgments and Contact | 15