It did not take long for fraudsters to pursue hundreds of billions of federal dollars designated to support SARS-CoV-2 testing and it is rare when federal prosecutors bring cases only a few months after illegal lab testing schemes are identified
As if the COVID-19 pandemic weren’t bad enough, unscrupulous clinical laboratory operators quickly sought to take advantage of the critical demand for SARS-CoV-2 testing and defraud the federal government.
Unfortunately for the many defendants in these cases, federal investigations into alleged cases of fraud were launched with noteworthy speed. As a result of these investigations into alleged healthcare fraud by clinical laboratories and other organizations during fiscal year (FY) 2020, the US Department of Justice (DOJ) announced the US government has recovered $1.8 billion.
The federal prosecutions involved dozens of medical laboratory owners and operators who paid back “hundreds of millions in alleged federal healthcare program losses,” Goodwin Life Sciences Perspectives explained.
When combined with similar efforts starting in prior years, the program has returned to the federal government and private individuals a total of $3.1 billion, the DOJ noted.
“In its 24th year of operation, the program’s continued success confirms the soundness of a collaborative approach to identify and prosecute the most egregious instances of healthcare fraud, to prevent future fraud and abuse, and to protect program beneficiaries,” the report states.
According to the graphic above, which is based on analysis by B2B research company MarketsandMarkets, “North America will dominate the healthcare fraud analytics market from 2020–2025.” As clinical laboratory testing represents a significant portion of the fraud, medical lab managers will want to remain vigilant. (Graphic copyright: MarketsandMarkets.)
COVID-19 Pandemic an Opportunity for Fraud
The HHS report notes that the COVID-19 pandemic required CMS to develop a “robust fraud risk assessment process” to identify clinical laboratory fraud schemes, such as offering COVID-19 tests in exchange for personal details and Medicare information.
“In one fraud scheme, some labs are targeting retirement communities claiming to offer COVID-19 tests but are drawing blood and billing federal healthcare programs for medically unnecessary services,” the HHS report notes.
Still other alleged schemes involved billing for expensive tests and services in addition to COVID-19 testing. “For example, providers are billing a COVID-19 test with other far more expensive tests such as the Respiratory Pathogen Panel (RPP) and antibiotic resistance tests,” the report says.
“Other potentially unnecessary tests being billed along with a COVID-19 test include genetic testing and cardiac panels CPT (current procedural terminology) codes. Providers are also billing respiratory, gastrointestinal, genitourinary, and dermatologic pathogen code sets with the not otherwise specified code CPT 87798,” the report states.
Different Types of Healthcare Organizations Investigated in 2020
Beyond clinical laboratories, the HHS’ 124-page report also shares criminal and civil investigations of other healthcare organizations and areas including:
clinics,
drug companies,
durable medical equipment,
electronic health records,
home health providers,
hospice care,
hospitals and healthcare systems,
medical devices,
nursing home and facilities,
pharmacies, and
physicians/other practitioners.
According to the DOJ, “enforcement actions” in 2020 included:
1,148 new criminal healthcare fraud investigations opened,
440 defendants convicted of healthcare fraud and related crimes,
1,079 civil healthcare fraud investigations opened, and
1,498 pending civil health fraud matters at year-end.
“Federal Bureau of Investigation (FBI) investigative efforts resulted in over 407 operational disruptions of criminal fraud organizations and the dismantlement of the criminal hierarchy of more than 101 healthcare fraud criminal enterprises,” the DOJ reported.
Furthermore, the report said OIG investigations in 2020 led to:
578 criminal actions against people or organizations for Medicare-related crimes,
781 civil actions such as false claims, and
2,148 people and organizations eliminated from Medicare and Medicaid participation.
Implications for Clinical Laboratories
In 2020, OIG issued 178 reports, completed 44 evaluations, and made 689 recommendations to HHS divisions.
Clinical laboratory leaders may be most interested in those related to patient identification as a means to combating fraud and Medicare Part B lab testing reimbursement.
The HHS report says, “Medicare Advantage (MA) encounter data continue to lack National Provider Identifiers (NPIs) for providers who order and/or refer … clinical laboratory services,” adding that, “Almost half of MA organizations believe that using NPIs for ordering providers is critical for combating fraud.”
Additionally, the report states, “Medicare Part B spending for lab tests increased to $7.6 billion in 2018, despite lower payment rates for most lab tests. The $459 million spending increase was driven by:
“increased spending on genetic tests,
“ending the discount for certain chemistry tests, and the
“move to a single national fee schedule.”
Medical laboratory leaders may be surprised to learn that federal healthcare investigators were so vigorous in their investigations, even during the worst of the COVID-19 pandemic.
Vigilance is critical to ensure labs do not fall under the DOJ’s scrutiny. This HHS report, which describes the types and dollars involved in fraudulent schemes by clinical labs and other providers, could help inform revisions to federal compliance regulations and statutes.
Legal, regulatory, and payer experts outline steps that help medical laboratories better navigate federal and state regulatory guidelines, eliminate coding and billing missteps, and maximize reimbursements
Even as daily COVID-19 test numbers continue to decrease, many clinical laboratories have substantial numbers of COVID-19 test claims that remain unpaid. Despite federal and state law requiring that labs be paid for these tests, commercial health plans are using many strategies to avoid paying labs for COVID-19 test claims.
That means a large portion of the nation’s labs are owed tens of thousands, hundreds of thousands, even millions of dollars for unpaid SARS-CoV-2 test claims they submitted since the onset of the pandemic last year.
What Clinical Labs Can Do to Be Paid for Their COVID-19 Test Claims
These four subject-matter experts provided insider tips and insights on steps clinical laboratories can take to get paid for COVID-19 test claims. This advice can help labs, maximize collected dollars, reduce the chance of post-payment audits, and navigate emerging payer trends.
During the webinar, Caitlin Forsyth, an Associate Attorney at Davis Wright Tremaine LLP in Seattle who specializes in healthcare regulatory compliance, said the new guidance “impressed upon commercial health plans the requirement to cover COVID testing in a lot of different circumstances.” The guidance included information on how providers can be reimbursed for providing COVID-19 care to uninsured people.
However, labs should be aware of what may come after they receive payment.
“We applaud you if you’ve had success thus far in securing reimbursement,” Forsyth continued. “However, clinical laboratories are not necessarily home free if Medicare, Medicaid, or a health plan has paid all or most of the lab claims for COVID-19 tests. This is because the payer may at some point down the line require the laboratory to submit to a post-payment audit. As part of the audit, the government payer or health plan is likely to require a laboratory to provide supporting documentation underscoring the medical necessity of each test performed on each patient at issue.”
What Constitutes ‘Medical Necessity’ for a SARS-CoV-2 Test?
There are many tripwires that can derail COVID-19 test claims. Medical necessity standards related to testing is one example that has been a major area of concern for clinical laboratories.
Kathryn Edgerton, Esq., Counsel at Davis Wright Tremaine LLP in Los Angeles, notes that the guidance providers have received has been “somewhat inconsistent and has created confusion as to what test is covered.” This lack of clarity in Medicare’s guidance has caused many denials of payment.
This Special Report from Dark Daily is the companion to the recent Dark Daily webinar on “Getting Paid for COVID-19 Test Claims: Prepare for Audits, Maximize Reimbursement and Navigate Payer Trends.” Clinical laboratory professionals can download the report by clicking here. (Photo copyright: Dark Daily.)
The webinar panelists provided the following three tips for optimizing billing claims for COVID-19 tests (additional recommendations on decreasing the number of COVID-19 test claim denials, increasing payments, and avoiding post-payment audits are available in the webinar’s on-demand replay and its companion special report):
When seeking reimbursement for COVID-19 testing from non-traditional sources, such as employers, schools, or local governments, ensure valid orders support each test claim. “Even if the employer, school, or local government has agreed to pay for the tests, a medical laboratory still must comply with state laws in regard to persons authorized to order the tests, as well as comply with CLIA requirements for a valid order,” Forsyth said.
Serial testing is on the rise in workplaces to increase the chances of detecting asymptomatic infection. However, Forsyth says, laboratories should “push for direct reimbursement from the workplace” because coverage from Medicare, Medicaid, and health plans is uncertain. “We also expect health plans to start cracking down on tests performed as part of an employment or surveillance program, taking the position that even if there are physician orders supporting each test performed as part of the program, health plans are not required to cover tests,” she added.
COVID-19-only testing providers and independent laboratories should expect health plans to begin narrowing their provider networks. To avoid being pushed out, Steve Stonecypher, Managing Partner at Shipwright Healthcare Group, says laboratories should “think about what you do, how you do it, and how you can be a benefit [to the health plan]. Make the payers think of you not as a nice-to-have in their network, but as a need-to-have in their network.”
COVID-19 Testing Labs Advised to ‘Have All Your Ducks in a Row’
Stonecypher urges clinical laboratories to be vigilant in record keeping, noting that the US Department of Health and Human Services Office of Inspector General (OIG) indicated earlier this year that it will conduct audits that focus on aberrant billing for COVID-19 testing during the pandemic.
“There are flags out there already that the OIG is potentially going to look to do claim audits,” he said. “You can pretty much guarantee that the payers are going to follow. So, have all your ducks in a row. We’re talking about all the individual patient assessments, all that necessary documentation … make sure all of that is in order because payers are going to look at this as an opportunity to come back and recoup money.”
Billing and finance executives, clinical laboratory leadership, compliance officers, and billing and coding administrators are especially encouraged to listen to this webinar about increasing the number of COVID-19 test claims for which the lab is reimbursed. This webinar is available to stream on-demand.
This can be one of the best low-cost, high return investments your lab team can make, particularly if it helps the lab’s coding/billing/collections team interact with health insurance plans to settle SARS-CoV-2 test claims that then bring in tens of thousands or hundreds of thousands of dollars from outstanding claims that have yet to be paid.
Oddly, as upcoding severity levels have risen, reported higher-severity inpatient hospital stays have dropped, OIG reported
Medicare upcoding fraud is a growing problem for the federal Centers for Medicare and Medicaid Services (CMS). Now, a report from the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) suggests that the practice is increasingly occurring for high-severity inpatient hospital stays that account for the most expensive part of US healthcare.
“The [COVID-19] pandemic has placed unprecedented stress on the country’s healthcare system, making it more important than ever to ensure that Medicare dollars are spent appropriately,” the OIG report states.
The OIG website notes, “Medicare pays for many physician services using Evaluation and Management (commonly referred to as “E/M”) codes. New patient visits generally require more time than follow-up visits for established patients, and therefore E/M codes for new patients command higher reimbursement rates than E/M codes for established patients.”
The OIG describes one type of upcoding as “… an instance when [providers] provide a follow-up office visit or follow-up inpatient consultation, but bill using a higher-level E/M code as if [they] had provided a comprehensive new patient office visit or an initial inpatient consultation.
“Another example of upcoding related to E/M codes is misuse of Modifier 25,” the OIG continued. “Modifier 25 allows additional payment for a separate E/M service rendered on the same day as a procedure. Upcoding occurs if a provider uses Modifier 25 to claim payment for an E/M service when the patient care rendered was not significant, was not separately identifiable, and was not above and beyond the care usually associated with the procedure.”
How OIG Conducted the Study of Hospital Coding Practices
To perform its research, the OIG analyzed Medicare Part A claims for hospital stays for the six-year period from fiscal year (FY) 2014 through FY 2019. The OIG identified trends in billing and payments for inpatient hospital stays at the highest severity levels, as determined by the Medicare Severity Diagnosis Related Group (MS-DRG).
The OIG investigation revealed that the number of hospital stays billed at the highest severity level increased almost 20% between 2014 and 2019, while the number of stays billed at other severity levels decreased. These expenditures accounted for nearly half of all Medicare spending on inpatient hospital stays, the OIG reported.
According to the OIG report, “Medicare pays hospitals more for beneficiaries in MS-DRGs with higher severity levels because they are typically more costly to treat.” The graphic above taken from the OIG report illustrates “how the presence of complications can affect Medicare payment for three beneficiaries with the same principal diagnosis.” (Graphic copyright: Federal Office of Inspector General Department of Health and Human Services.)
As Severity Levels Went Up, Inpatient Length of Stays Went Down
Interestingly, the average length of inpatient stays at the highest severity level decreased, and the average length of hospital stays overall remained largely the same, decreasing by just 0.1 days. In addition, the total number of inpatient hospital stays decreased by 5%.
The OIG report noted that “the increase in the number of stays billed at the highest severity level implies that beneficiaries were sicker overall. However, the decrease in the average length of stays at the highest severity level potentially undermines that idea because it is not consistent with sicker beneficiaries. Length of stay generally has a positive relationship to severity of stay; sicker beneficiaries stay in the hospital longer.”
The OIG confirmed that in FY 2019, Medicare spent $109.8 billion for 8.7 million hospital stays. Approximately 3.5 million (or 40%) of those stays were billed at the highest severity level, as determined by the MS-DRG. In addition, nearly half of the $109.8 billion spent, or $54.6 billion, was for stays billed at the highest severity level and Medicare paid an average of $15,500 per stay at that level.
The OIG report states that “stays at the highest severity level are vulnerable to inappropriate billing practices, such as upcoding—the practice of billing at a level that is higher than warranted. Specifically, nearly a third of these stays lasted a particularly short amount of time and over half of the stays billed at the highest severity level had only one diagnosis qualifying them for payment at that level. Further, hospitals varied significantly in their billing of these stays, with some billing much differently than most.”
The OIG study also found that over half of the inpatient stays billed at the highest severity level achieved that level due to only one diagnosis. According to the OIG, the severity of an inpatient stay depends on a patient’s secondary diagnosis and it only takes one secondary diagnosis to propel a patient into the highest severity level. The OIG determined that if the diagnosis was inaccurate or inappropriate, higher payments would not be warranted.
OIG Recommends CMS Conduct Targeted Reviews
The report found that the most frequently billed MS-DRG in FY 2019 was septicemia or severe sepsis and that hospitals billed for 581,000 of these stays, for which Medicare paid $7.4 billion. In addition, kidney and urinary tract infections, pneumonia, and renal failure were among the most common conditions to have a complication that led to a high severity classification.
In its report, the OIG recommended more oversight from CMS to ensure that Medicare dollars are spent appropriately. The OIG also suggests that CMS conduct targeted reviews of MS-DRGs and hospital stays that are vulnerable to upcoding, as well as the hospitals that frequently bill them.
Clinical Laboratories Are Forewarned
Medicare audits continue to be more detailed and rigorous and all healthcare providers—including clinical laboratories and anatomic pathology groups—should be prepared to present all necessary documentation to support claims if and when they are audited.
Improvements in software, machine learning, and artificial intelligence (AI) give Medicare officials and the OIG powerful tools to spot questionable provider billing. This includes medical laboratories whose billing patterns could arouse suspicions and trigger audits.
Upcoding is a long-standing problem for the Medicare program. What is changing is that federal officials now have better tools and resources to use in identifying patterns of upcoding that fall outside accepted parameters.
Sophisticated cyberattacks have already hit hospitals and healthcare networks in Oregon, California, New York, Vermont, and other states
Attention medical laboratory managers and pathology group administrators: It’s time to ramp up your cyberdefenses. The FBI, the federal Department of Health and Human Services (HHS), and the federal Cybersecurity and Infrastructure Security Agency (CISA) issued a joint advisory (AA20-302A) warning US hospitals, clinical laboratories, and other healthcare providers to prepare for impending ransomware attacks, in which cybercriminals use malware, known as ransomware, to encrypt files on victims’ computers and demand payment to restore access.
The joint advisory, titled, “Ransomware Activity Targeting the Healthcare and Public Health Sector,” states, “CISA, FBI, and HHS have credible information of an increased and imminent cybercrime threat to US hospitals and healthcare providers.” It includes technical details about the threat—which uses a type of ransomware known as Ryuk—and suggests best practices for preventing and handling attacks.
In his KrebsOnSecurity blog post, titled, “FBI, DHS, HHS Warn of Imminent, Credible Ransomware Threat Against U.S. Hospitals,” former Washington Post reporter, Brian Krebs, wrote, “On Monday, Oct. 26, KrebsOnSecurity began following up on a tip from a reliable source that an aggressive Russian cybercriminal gang known for deploying ransomware was preparing to disrupt information technology systems at hundreds of hospitals, clinics, and medical care facilities across the United States. Today, officials from the FBI and the US Department of Homeland Security hastily assembled a conference call with healthcare industry executives warning about an ‘imminent cybercrime threat to US hospitals and healthcare providers.’”
Krebs went on to reported that the threat is linked to a notorious cybercriminal gang known as UNC1878, which planned to launch the attacks against 400 healthcare facilities.
Clinical Labs, Pathology Groups at Risk Because of the Patient Data They Keep
Hackers initially gain access to organizations’ computer systems through phishing campaigns, in which users receive emails “that contain either links to malicious websites that host the malware or attachments with the malware,” the advisory states. Krebs noted that the attacks are “often unique to each victim, including everything from the Microsoft Windows executable files that get dropped on the infected hosts to the so-called ‘command and control’ servers used to transmit data between and among compromised systems.”
Charles Carmakal, SVP and Chief Technology Officer of cybersecurity firm Mandiant told Reuters, “UNC1878 is one of the most brazen, heartless, and disruptive threat actors I’ve observed over my career,” adding, “Multiple hospitals have already been significantly impacted by Ryuk ransomware and their networks have been taken offline.”
John Riggi (above), senior cybersecurity adviser to the American Hospital Association (AHA), told the AP, “We are most concerned with ransomware attacks which have the potential to disrupt patient care operations and risk patient safety. We believe any cyberattack against any hospital or health system is a threat-to-life crime and should be responded to and pursued as such by the government.” Hospital-based medical laboratories and independent clinical laboratories that interface with hospital networks should be assess their vulnerability to cyberattacks and take appropriate steps to protect their patients’ data. (Photo copyright: American Hospital Association.)
Multiple Healthcare Provider Networks Under Attack
Hospitals in Oregon, California, and New York have already been hit by the attacks, Reuters reported. “We can still watch vitals and getting imaging done, but all results are being communicated via paper only,” a doctor at one facility told Reuters, which reported that “staff could see historic records but not update those files.”
Some of the hospitals that have reportedly experienced cyberattacks include:
In October, the Associated Press (AP) reported that a recent cyberattack disrupted computer systems at six hospitals in the University of Vermont (UVM) Health Network. The FBI would not comment on whether that attack involved ransomware, however, it forced the UVM Medical Center to shut down its computer system and reschedule elective procedures.
Threat intelligence analyst Allan Liska of US cybersecurity firm Recorded Future told Reuters, “This appears to have been a coordinated attack designed to disrupt hospitals specifically all around the country.”
He added, “While multiple ransomware attacks against healthcare providers each week have been commonplace, this is the first time we have seen six hospitals targeted in the same day by the same ransomware actor.”
An earlier ransomware attack in September targeted 250 healthcare facilities operated by Universal Health Services Inc. (UHS). A clinician at one facility reported “a high-anxiety scramble” where “medical staff could not easily see clinical laboratory results, imaging scans, medication lists, and other critical pieces of information doctors rely on to make decisions,” AP reported.
Outside of the US, a similar ransomware attack in October at a hospital in Düsseldorf, Germany, prompted a homicide investigation by German authorities after the death of a patient being transferred to another facility was linked to the attack, the BBC reported.
CISA, FBI, HHS, Advise Against Paying Ransoms
To deal with the ransomware attacks, CISA, FBI, and HHS advise against paying ransoms. “Payment does not guarantee files will be recovered,” the advisory states. “It may also embolden adversaries to target additional organizations, encourage other criminal actors to engage in the distribution of ransomware, and/or fund illicit activities.” The federal agencies advise organizations to take preventive measures and adopt plans for coping with attacks.
The advisory suggests:
Training programs for employees, including raising awareness about ransomware and phishing scams. Organizations should “ensure that employees know who to contact when they see suspicious activity or when they believe they have been a victim of a cyberattack.”
Regular backups of data and software. These should be “maintained offline or in separated networks as many ransomware variants attempt to find and delete any accessible backups.” Personnel should also test the backups.
Continuity plans in case information systems are not accessible. For example, organizations should maintain “hard copies of digital information that would be required for critical patient healthcare.”
“Without planning, provision, and implementation of continuity principles, organizations may be unable to continue operations,” the advisory states. “Evaluating continuity and capability will help identify continuity gaps. Through identifying and addressing these gaps, organizations can establish a viable continuity program that will help keep them functioning during cyberattacks or other emergencies.”
Dark Daily Publisher and Editor-in-Chief, Robert Michel, suggests that clinical laboratories and anatomic pathology groups should have their cyberdefenses assessed by security experts. “This is particularly true because the technologies and methods used by hackers change rapidly,” he said, “and if their laboratory information systems have not been assessed in the past year, then this proactive assessment could be the best insurance against an expensive ransomware attack a lab can purchase.”
Though not a replacement for clinical laboratory testing, the CDC says the surveillance system will help slow spread of COVID-19 in vulnerable communities
Clinical laboratory testing for COVID-19 is receiving an ally. In mid-August, the Centers for Disease Control and Prevention (CDC) and the US Department of Health and Human Services (HHS) announced they were initiating a National Wastewater Surveillance System (NWSS) in response to the COVID-19 pandemic.
In collaboration with other federal agencies, the NWSS will work with state, local, territorial, and tribal health departments to collect data on wastewater (aka, sewage) samples throughout the United States.
The goal of the NWSS is to detect SARS-CoV-2, the coronavirus that causes COVID-19, before it spreads by detecting traces of it in local sewer systems. The level of the virus detected in wastewater can be a leading indicator of a worsening outbreak in a community, according to a CDC statement.
“Quantitative SARS-CoV-2 measurements in untreated sewage can provide information on changes in total COVID-19 infection in the community contributing to that wastewater treatment plant,” noted the CDC.
People infected with the coronavirus discard traces of it—whether they are symptomatic or asymptomatic—and levels of the virus in untreated sewage can provide scientists with information about the degree of outbreak in specific areas.
The NWSS will not include or monitor homes that use septic tanks or entities with decentralized systems that treat their own waste, such as hospitals, universities, and prisons.
Not a Replacement for Clinical Laboratory Testing
The CDC stressed that sewage testing is not meant to replace clinical laboratory testing, but it can be a valuable tool in communities where COVID-19 tests are underutilized or unavailable. Wastewater testing, CDC noted in its statement, could have an enormous reach as 80% of households in the US are connected to a municipal sewage system.
The CDC is not actively taking samples from wastewater, but relying on local partners to take samples, test them, and enter data into the NWSS portal for the purpose of summarizing and interpreting for public health action.
The agency predicts that participation in a national database will ensure data comparability across separate jurisdictions.
Could Testing Raw Sewage Be More Effective than Contact Tracing for Tracking COVID-19 Outbreaks?
A Yale University study published in Nature Biotechnology, titled, “Measurement of SARS-CoV-2 RNA in Wastewater Tracks Community Infection Dynamics,” detected SARS-CoV-2 concentrations in sewage sludge in New Haven, Conn., over a 10-week period earlier this year. The results of the study “show the utility of viral RNA monitoring in municipal wastewater for SARS-CoV-2 infection surveillance at a population-wide level,” the study authors noted.
The published study states that “SARS-CoV-2 RNA was detected throughout the more than 10-week study and, when adjusted for time lags, tracked the rise and fall of cases seen in SARS-CoV-2 clinical test results and local COVID-19 hospital admissions. Relative to these indicators, SARS-CoV-2 RNA concentrations in sludge were 0–2 [days] ahead of SARS-CoV-2 positive test results by date of specimen collection, 0–2 [days] ahead of the percentage of positive tests by date of specimen collection, 1–4 [days] ahead of local hospital admissions and 6–8 [days] ahead of SARS-CoV-2 positive test results by reporting date.”
The Yale researchers concluded, “Our results demonstrate that measurement of SARS-CoV-2 RNA concentrations in primary sludge provides an approach to estimate changes in COVID-19 prevalence on a population level. Sludge results were not a leading indicator compared to positive test results or percentage of positive tests by date of specimen collection. However, they led hospitalizations by 1–4 [days] and test results by report date by ~1 week. Thus, in communities where test reporting is delayed, sludge results, if analyzed and reported on the same day as sampling, can provide substantial advance notice of infection dynamics.”
Jordan Peccia, Jr., PhD (above), Professor of Chemical and Environmental Engineering at the Yale School of Engineering and Applied Science, and study author, told NBC News, “There’s still a lot more to do. We’re one of the earlier groups to have developed a robust relationship between wastewater and coronavirus cases, but this is just a first step.” He added, “It doesn’t replace contact tracing. [But] if we know a little bit ahead of time, we can raise the alarm.” (Photo copyright: Yale University.)
Sewage Testing for COVID-19 Around the World
Sewage testing can provide data to complement other collected information about COVID-19 and steer public health decision-making. However, the CDC notes that “it is not possible to reliably and accurately predict the number of infected individuals in a community based on sewage testing” and that “more data on fecal shedding by infected individuals over the course of disease are needed to better understand the limits of detection.”
Nevertheless, some experts have leaned heavily on sewage sample testing for their conclusions about the origination of the coronavirus. In August, Dark Daily reported on a theory based on finding remnants of SARS-CoV-2 in sewage systems that suggested the virus may not have originated in Wuhan, China. Analysis of sewage samples in Italy, Spain, and Brazil indicated the virus was present in those countries before the disease was known to exist outside of China. The controversy over these findings has motivated virologists to expand wastewater testing.
The creation of the NWSS by the CDC validates growing interest in new methods of testing for infectious disease. Lower cost, faster response time, more automation of genetic sequencing, and improved analytical software has enabled this type of testing to become a useful tool. It would be wise for clinical laboratory managers to monitor the expanded use of new testing technologies for infectious diseases.
