When lives were in jeopardy due to a global crisis, some people seemingly saw opportunity while others saw despair. Through pandemic profiteering, whereby laboratories capitalized on sorrow for their own benefit, potentially billing for the spirits of the afflicted and nonexistent people, my research uncovers a potentially unsettling reality." The coronavirus disease 2019 (COVID-19) was named by the World Health Organization (WHO) by February 11, 2020, for the illness caused by SARS-CoV-2 infection. Compared to other countries in the world, the United States reported the most COVID-19 cases and fatalities in 2020 (WHO, 2021). In the course of the year, there were three pandemic waves: (1) a spring outbreak in a small number of primarily urban areas following the introduction of the virus; (2) a summer wave that primarily affected the southern half of the country; and (3) an autumn-winter wave that persisted until the spring of 2021 (El-Shabasy et al., 2022).On January 20, the same day as the first case reported in South Korea, the State of Washington reported its first COVID-19 case (confirmed by a serological test) in the US (Holshue et al., 2020). Twelve weeks later, on April 11, the US surpassed Italy as the country with the most reported COVID-19 deaths (approximately 24,000, while South Korea had 10,450 deaths at that date (Bergquist et al., 2020). On April 11, twelve weeks later, the US surpassed Italy as the nation with the most COVID-19 deaths documented (about 24,000, compared to South Korea's 10,450 at that time).
In the wake of increasing covid – 19 cases and death tolls, the Center for Medicare and Medicaid Services (CMS) released many waivers and allowed for flexibilities in rules during the Public Health Emergency. Some of these waivers and flexibility include telehealth expansion services to include not just rural areas but also urban areas. Some flexibilities with respect to Covid-19 testing included surveillance testing in schools and workplace, over the counter self-tests, drive-thru testing, community-based testing, and weekly testing in nursing homes. Medicaid and Medicare mostly paid for these covid tests. This gave room for fraud, waste, and abuse in not just covid testing but it gave room for unscrupulous providers to be providing medically unnecessary tests as well as fake covid results just to increase the monetary gains (USDOJ 2023; FTC, 2022). Some of the medically unnecessary tests included testing for respiratory pathogen tests, genetic tests in addition to covid tests (USDOJ, 2022) These tests usually have little or no influence or outcome on the confirmation of the presence of COVID – 19 antibodies. To bill Medicare and Medicaid as well as private insurance for covid – 19 testing, treatment, and vaccination, you need to use current ICD-10 Current Procedural Terminology (CPT) codes and diagnostic codes such as U0003, U0004, U0005, G2023, 87426, K1034, 87798, 0202U, 87581, 87486, 87426, 87811, 87634, 87636, 87637, etc. G2023 is a code used to bill for specimen collection, while U0005 is used to bill where under the guidance of Center of Medicaid Services (C.M.S), the test was performed with a high throughput technology and the test were produced within 2 business days.
Background on Covid-19 Testing in the USA
The Centre for Disease Control and Prevention (CDC) issued guidelines for COVID-19 testing eligibility from the beginning of the outbreak to March 2020. The criteria for testing were: recent travel to certain countries, severe respiratory illness who require hospitalization, and contact with a confirmed corona virus-infected person.The results of the COVID-19 test are used to determine disease prevalence, recommend preventative measures (such as when to begin and end isolation and quarantine), and offer information about exposure and transmission risks. (Mercer & Salit, 2021).
The graphical representation of cumulative death counts reveals a consistent upward trend from March 2020 to March 2021, with a notable and steep increase observed between December 2020 and March 2021.
IMPACTS OF FRAUD, WASTE AND ABUSE ON COVID-19 TESTING
Lab tests have always been essential in delivering vital diagnostic data so that patients and clinicians can choose the best course of action (Mrazek et al., 2020). As to a CMS publication dated December 15, 2021, health expenditures experienced the greatest growth rate since 2002 in 2020, owing to the COVID-19 pandemic's impact. According to the same publication, federal spending on public health ($114.9 billion)—which included funding for COVID testing, vaccine development, and health facility preparedness—and financial assistance to providers to make up for lost revenue through the Provider Relief Fund ($122 billion in 2020) and the Paycheck Protection Program ($53 billion in 2020) were the main drivers of the rapid increase in health care spending in response to the pandemic. Consequently, in 2020, the federal government's growth in health care spending grew by 36.0% (CMS, 2021).
Federal and state officials such as the Federal Bureau of Investigations (FBI), issued public alerts about coronavirus testing frauds that preyed on the country's overburdened testing infrastructure and left Americans with false test results, erroneous medical bills, and expensive at-home tests (FBI, 2020; HHS-OIG, 2023; USDOJ, 2023 ).The virus had been the subject of fraud ever since the pandemic began, but the Omicron variant's quick spread provided possibilities for con artists to take advantage of the increased demand for tests (CBS News, 2022).
According to the CDC, Black, Indigenous, and People of Color (BIPOC) have shown an exceptionally rapid increase in COVID-19-related morbidity and mortality. As of January 2021, the CDC reports that there have been 20,558,489 cases of COVID-19 and 350,664 deaths in the US as a result of the illness (Muhrer, 2021).
FRAUD SCHEMES IN COVID-19 TESTING
An official search on United States Government website found a number of fraud schemes in Covid-19 testing and treatment. This deep search included federal agencies websites such as the Department of Healthcare and Human Services – Office of Inspector General ( HHS-OIG), the Federal Bureau of Investigations (FBI), the United States Department of Justice (USDOJ), the Food and Drugs Authority (FDA) and the Center for Disease Control (CDC).
42 U.S.C. § 1320a-7b(b) contains the Anti-Kickback Statute (AKS), a criminal statute that forbids the exchange of "remuneration" to influence patient referrals or business development under Federal healthcare programs. This encompasses a variety of non-cash types of compensation as well as Medicare and Medicaid services. Both parties are subject to the AKS when giving or receiving kickbacks, and a key factor in assessing responsibility is intent. Rewarding people who recommend you for business is appropriate in certain sectors. However, it is illegal to pay for referrals under the Federal health care programs (HHS-OIG, 2024). Kickback and Collusion schemes in Covid-19 testing and treatment might involve two or more labs or providers having large numbers of shared members or see the same members on the same date of service for the same procedure codes. Collusion schemes are common among labs who share the same or a close geographic location. If 50% of Lab A’s members are also seen by Lab B, there could be a possibility of kickback or collusion between these two labs that might warrant further investigation like requesting and reviewing medical records. Kickbacks or Collusions might also violate the physician self-referral often known as the stark law (Social Security Act 42 U.S.C 1395nn). Kickbacks in covid-19 testing can also arise between healthcare professionals and individuals. United States attorney, Philip R. Sellinger stated in an enforcement action against a Mercer county man and his conspirators that "clinical laboratories and health care professionals are on notice: paying kickbacks to steer tests to a lab may break the law" (USDOJ, 2023). The conspirators demanded payments in return for supplying Metpath Laboratories, a clinical laboratory in Parsippany, New Jersey, with COVID-19 test samples. Metpath Laboratories tested samples taken from specific patients to see whether COVID-19 was present. For the referrals of COVID-19 test samples, Metpath paid bribes. After that, the tests were billed to Medicare and other health care benefit programs.
Billing for services not rendered including stealing social security and phantom billing of state insurance programs is another fraud scheme. Providers sometimes use social media platform, fake websites, and click baits to entice members to sign up for services they end up not receiving. The providers then use these social security numbers to bill Medicare, Medicaid, and private insurance for services they did not render. A public alert on potential identity theft to charge Medicare and Medicaid for services not rendered was issued by HHS-OIG throughput the pandemic. These con artists put beneficiaries at risk of harm by using COVID-19-related needs and services for their own financial gain. Medical identity theft and fraudulent billing of federal health care programs are two possible uses for the gathered personal information (HHS-OIG, 2023). Billing for services not rendered can also be evident in scenarios where two labs or providers bill for the same members on the same date of services, for the same procedure code. It is likely that one provider actually performed the service, and the other provider did not render the service but both of them bill Medicare and Medicaid separately. Billing for services not rendered can also be extended to scenarios where a lab or provider performs a Covid tests, but the member or recipient never receives the results. Unusual spikes in claims billed by a lab or provider over a short period of time might also represent billing for services not rendered. Billing high number of improbable numbers of covid tests performed in a single day might also be indicative that these tests were not actually performed.
Upcoding is one of the most common fraud schemes. Upcoding in Covid-19 testing and treatment involves billing for a higher CPT code than the code actually performed. Examples of upcoding in covid testing schemes include billing for a high throughput technology codes whiles performing the test with a simple technology. On October 15, 2020, CMS announced that effective January 1, 2021, Medicare will be paying $100 for labs that performed covid tests using high throughput technology and also provided the covid test results within two calendar days (CMS, 2021). For providers who continue to perform covid tests using simple laboratory technology and providers who produce covid results in more than two calendar days, Medicare will be paying only $75. The rationale for this policy modification was to increase the accuracy of covid results and also to expedite covid test results. The add on covid test code when performed via high throughput within two calendar days was U0005. If a lab performs a covid test with a simple technology or produces the results in more than two calendar days, and bills Medicare using the U0005 add on, the provider or lab has upcoded her services. The correct procedure billing code is U0003 for 75$. Adding the U0005 code means that the lab or provider has charged an extra 25$ for using high throughput technology withing 2 calendar days for a service that he used simple technology for. Labs or Providers also billing in-lab codes for covid self-tests or over-the-counter tests also represents upcoding. Between April 4, 2022, and May 11, 2023, Medicare part b paid for over-the-counter tests.
Excessive covid testing are usually linked with overutilization of covid tests like billing a member more than 10 covid tests in a week. Unusual spikes and increases in covid tests billing also can represent services not rendered in some circumstances. Detection of excessive covid testing can be an outlier detection in relation to peers. Repetitive testing of the same members can also represent excessive covid testing. If a lab performs an antigen test and then a PCR test on the same member on multiple occasions, this could also represent excessive covid testing mainly targeted at state insurance programs for more money. Excessive testing is usually observed during mass testing’s in community-based program testing, testing in nursing homes, schools, and workplace testing. The frequency of carrying these testing is what usually makes it excessive. Inappropriate number of services to recipients is one of the ways to detect excessive covid – tests. For example, if a provider bill 50 covid tests for 2 members in a week, this means that the service to recipient ratio will be 25 (50/2). 25 tests in a week for a member might indicate excessive testing.
Duplicate billing can be evidenced when a visit is billed more than once. For example, billing an office visit and a telehealth visit for the same member on the same date of service. Duplicate billing in covid testing can be when a lab bill two separate covid testing codes for the same tests and for the same member and date of service. When a lab or provider collects a single specimen and bills Medicare or Medicaid more than once using the specimen collection code G2023, this could be seen as duplicate billing. When a lab performs an antigen test and charges more than once for the test, it could be indicative of susceptive duplicate billing. Duplicate billing is also evident when two providers bill the same members on the same date of service for the same procedure code or covid test. Shared members between two providers billing on the same date of service can also represent susceptive double billing.
The Division of Clinical Laboratory Improvement and Quality within the Center for Medicate and Medicaid Services regulates laboratory through the provision of a Clinical Laboratory Improvement Amendment (CLIA). The CLIA ensures that laboratories are operating in accordance with quality acceptable standards (CMS, 2005). If a lab whose is registered with CMS as a certificate of waiver lab bills for a procedure code like U0005, that could be considered as a violation against policy and a fraud, waste, and abuse scheme in covid testing because U0005 code is a high throughput code and not a simple technology code. Another FWA in covid testing related to CLIA is labs or providers with an expired CLIA certification billing Medicare and Medicaid. A CLIA certification is good for 2 years and subject to renewal. CMS maintains a website to check the type and validity of a CLIA certificate just by entering the name of the lab or their CLIA number.
Billing different brands of covid vaccine brands for the same member on the same date of service. One rare scheme in the covid testing is when providers bill the same member on the same date of service for administering different variants of covid vaccines. Some of the covid brands approved by FDA include Pfizer – BioNTech, Moderna, and Novavax. CMS also gave additional guidance and payments for administering covid vaccine in patients’ homes. This leaves room for fraud waste and abuse where a lab bills for covid vaccine administration in patients home even though it was done in the lab or during an office visit. When administering vaccine is in a Medicare patient home, the HCPCS level II code to use is M0201. Medicare paid $36 for this additional payment when the covid vaccine was administered in the Medicare patients’ home.
Post – Mortem billing basically involves billing covid tests on recipients who are dead. According to Rozen (2023), some unscrupulous fraudsters billed Medicare and Medicaid for sending covid test kits to dead people and this has led the USDOJ trying to figure out the breadth of this scheme. A way to catch this fraud scheme using data analytics might be to run the date of service when the covid test was performed against the date of death database. Any covid test performed after the date of death of a recipient might represent suspect billing. The Center for Disease Control’s Coronavirus Disease Death data and reporting as well as National Death Index might be useful databases.