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Clinical Laboratories and Pathology Groups

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Wastewater Analysis Continues to be an Effective Tool for Tracking Deadly Infectious Diseases in Human Communities

In addition to viruses, wastewater analysis can also be used to detect the presence of chemical substances such as opioids

Wastewater surveillance and analysis continues to be a useful tool for detecting the prevalence of viruses such as SARS-CoV-2, influenza, and respiratory syncytial virus (RSV) in a community. Perhaps more importantly, wastewater surveillance can fill in gaps where clinical laboratory testing data may be days or weeks behind the true spread of viral infections.

One sign of the value of testing wastewater for infectious diseases is the fact that government officials are financing a continuing program of wastewater testing. In September, the federal Centers for Disease Control and Prevention (CDC) awarded a contract to conduct wastewater surveillance/analysis worth millions of dollars to Verily Life Sciences, a Google company, rather than renewing its contract with Biobot Analytics, which had been doing the work since 2020. One interesting twist in the award of this contract is how an ensuing dispute pulled the plug on a significant portion of the wastewater analysis in this country.

In their September Morbidity and Mortality Weekly Report (MMWR), the CDC highlighted a CDC study during which wastewater samples were taken from 40 wastewater treatment plants located in Wisconsin’s three largest cities. The samples were collected weekly and tested for influenza and RSV. The findings were then compared with data regarding emergency department (ED) visits for those diseases.

The CDC found that higher detections of flu and RSV were associated with higher rates of ED visits for both illnesses. The study also suggests that wastewater might detect the spread of these viruses earlier than ED visit data alone.

Peter DeJonge, PhD

“During the COVID-19 pandemic, wastewater surveillance for SARS-CoV-2 provided valuable insight into community incidence of COVID-19,” said Peter DeJonge, PhD (above), a CDC Career Epidemiology Field Officer, in an interview with Infectious Disease Special Edition. “[The CDC’s] report supports the idea that wastewater surveillance also has the potential to serve as a useful method with which to track community spread of influenza and RSV.” Local clinical laboratories are also involved in the CDC’s wastewater surveillance programs. (Photo copyright: CDC.)

Keeping Communities Informed about Spread of Viral Infections

The CDC’s study was conducted from August 2022 to March 2023. The wastewater samples from all three cities tested positive for the viruses in advance of increases in ED visits. After the ED visits for those viruses had subsided, the viral material remained in sewersheds for up to three months. 

“Both influenza and RSV can cause substantial amounts of illness, hospitalization, and even death during annual epidemics, which often occur during winter months in the US,” Peter DeJonge, PhD, a CDC Career Epidemiology Field Officer assigned to the Chicago Department of Public Health, told Infectious Disease Special Edition (IDSE). “Clinical providers and public health officials benefit from surveillance data to understand when and where these diseases are spreading in a community each year. This type of data can help prepare clinics [and clinical laboratories] for anticipated cases, tailor public health messaging, and encourage timely vaccination.”

“The collective burden from these respiratory viruses is staggering. With these viruses circulating simultaneously and potentially shifting in seasonality and severity, communities must be able to understand the full impact of each of these illnesses to inform awareness and public health responses that can prevent infections, hospitalizations, and even deaths,” said Mariana Matus, PhD, CEO and cofounder of Biobot Analytics, in an August press release announcing the launch of a “Respiratory Illnesses Panel” that will monitor wastewater for Influenzas A and B (seasonal flu), Respiratory Syncytial Virus (RSV), and SARS-CoV-2 (COVID-19).

“Traditional testing methods for these illnesses do not provide a comprehensive picture of the number of people infected due to inaccurate reporting, as well as asymptomatic or misdiagnosed cases,” Matus continued. “By monitoring wastewater concurrently for influenza, RSV, and SARS-CoV-2, we can fill in these gaps and provide important information to communities.”

CDC Moves to Change Wastewater Surveillance Contractor Mid-stream

As new variants of SARS-CoV-2 emerge, a recent contract dispute may be the cause of a time delay in efforts to perform wastewater surveillance for the disease, as well as for other viral infections, according to Politico.

The CDC’s move to replace Biobot Analytics with Verily Life Sciences to do wastewater surveillance has led to Biobot filing a protest with the Government Accountability Office (GAO).

According to World Socialist Web Site (WSWS), “The scope of the [Biobot] contract [to provide extended data for the public health agency’s National Wastewater Surveillance System (NWSS)] included data from more than 400 locations from over 250 counties across the entire United States, covering 60 million people. On top of this, Biobot also conducted genomic sequencing to identify the latest variants in circulation.” 

About one quarter of the wastewater testing sites in the country have been shut down due to Biobot’s contract being suspended in September. The remaining 1,200 sites that are not covered under the original contract will continue wastewater testing, Politico reported. 

The GAO hopes to have a decision on the contract dispute in January. Verily says it is ready to proceed with testing in all locations and already has its infrastructure in place. 

“We are committed to working with the CDC to advance the goals of the … testing program, initiate testing on the samples already delivered when allowed to resume work, and make wastewater data available as quickly as possible,” Bradley White, PhD, Principal Scientist/Director at Verily, told Politico.

Under the terms of Verily’s contract, the company will collect samples from wastewater treatment centers cross the county and analyze the samples for COVID-19 and the mpox (monkey pox) virus.

This contract marks the first agreement between the CDC and Verily.

The CDC has not disclosed why it decided to change contractors, but it is probable that cost may have been played a role in the decision. Verily’s contract is for $38 million over the course of five years and Biobot’s most recent contract was for around $31 million for a period of less than 18 months, Politico reported. 

In a LinkedIn post, Matus reported that Biobot had already laid off 35% of its staff due to the contract decision by the CDC. 

Competition in Wastewater Surveillance Market

When seeking viruses in wastewater, scientists use gene-based detection methods to locate and amplify genetic signs of pathogens. But public health officials are just beginning to tap into the potential opportunities that may exist in the analysis of data present in wastewater.

Wastewater surveillance is also being looked at as a way to combat America’s opioid epidemic.

“Wastewater surveillance is becoming more mature and more mainstream month after month, year over year,” Matus told Time

Thus, regardless of which companies end up working with the CDC, it appears that wastewater surveillance and analysis, which requires a great deal of clinical laboratory testing, will continue to help fight the spread of deadly viral infections, as well as possibly the nation’s drug epidemic.

—JP Schlingman

Related Information:

Wastewater Shows COVID Levels Dipping as Hospitalizations Tick Up

How Wastewater Testing Can Help Tackle America’s Opioid Crisis

Wastewater Surveillance May Help Detect Flu, RSV Outbreaks

The Respiratory Illnesses Panel Will Include Monitoring for Influenza A and B, RSV, and SARS-CoV-2

Wastewater Surveillance Data as a Complement to Emergency Department Visit Data for Tracking Incidence of Influenza A and Respiratory Syncytial Virus—Wisconsin, August 2022–March 2023

Biobot Analytics Files Protest against CDC Issuing Wastewater Surveillance Contract to Verily

Biobot Analytics Awarded NIDA Funding for Nationwide Wastewater-based Monitoring Program for High Risk Substance and Others Associated with Health Risks

Wastewater Signals Upswing in Flu, RSV

Biobot Analytics Launches Respiratory Illness Panel

Detecting COVID Surges is Getting Harder, Thanks to a Contract Dispute

Verily Lands $38 Million Deal with CDC for Wastewater Surveillance

Genetic Testing of Wastewater Now Common in Detecting New Strains of COVID-19 and Other Infectious Diseases

San Francisco International Airport First in the Nation to Test Wastewater for SARS-CoV-2 Coronavirus

Opioid Epidemic is Latest Healthcare Fraud ‘Hot Spot’ as Some Unethical Clinical Laboratories, Physicians, and Service Providers Attempt to Cash-in

It’s critical that medical laboratory leaders prepare for increased scrutiny and pressure from DOJ fraud investigations

Recent efforts by federal investigators to ferret out and prosecute healthcare fraud have shown that certain clinical laboratory companies are guilty of fraud and abuse. And as Dark Daily covered in “Preparing Clinical Laboratories for Invasive Federal Enforcement of Fraud and Abuse Laws, Increased Scrutiny by Private Payers, New Education Audits, and More,” November 13, 2019, the US Department of Justice (DOJ) and other federal and state regulators are becoming more aggressive in their hunt for bad actors.

Thus, clinical laboratory leaders must constantly be on guard against being drawn into potentially fraudulent activities. For example, schemes involving substance-use disorder (SUD), which are the latest healthcare-related scams to draw the attention of the DOJ.

Lack of Oversight in Substance-Use Disorder (SUD) Leads to Fraud

According to four experts who co-authored a blog post in Health Affairs, America’s opioid epidemic has affected more than 20 million lives and become a “hot spot” for healthcare fraud.

“Substance-use disorder (SUD) treatment was a $9 billion per year industry in 1986 and is now a $35 billion industry that is expected to reach $42 billion in 2020,” they wrote. Thus, it has given rise to escalating opioid-related scams by unethical clinical laboratories, healthcare providers, and recovery-house operators.

Anuradha Rao-Patel, Lead Medical Director Government Programs at Blue Cross and Blue Shield of North Carolina; Michael Adelberg, Principal and Healthcare Strategy Lead at Faegre Baker Daniels Consulting; Samantha Arsenault, Vice President of National Treatment Quality Initiatives at Shatterproof; and Andrew Kessler, JD, Founder and Principal of Slingshot Solutions, explained in Health Affairs how lack of oversight led to the increase in fraud.

“While current regulations around SUD treatment aim to protect patient safety instead of criminalize addiction treatment, they vary by state—and in some states, patient protections are limited,” they explained. “This lack of oversight invites deceptive business practices, insurance fraud, patient neglect, and ultimately, treatment malpractice that can damage lives and tear families apart.”

In December 2019, the US Department of Health and Human Services (HHS) Office of the Inspector General (OIG) released its Semiannual Report to Congress. The report details the $5.9 billion HHS recovered from healthcare fraud investigations during fiscal year 2019, more than double the amount of the prior year.

Included in that amount was a $17 million settlement with Acadia Healthcare (NASDAQ:ACHC), and its subsidiary, CRC Health, LLC, which allegedly defrauded Medicaid out of $8.5 million from 2012 to 2018. According to a DOJ press release, the clinical laboratory testing reimbursement scheme ended in the largest healthcare fraud settlement in West Virginia history.

“Medicaid fraud is not a victimless crime,” US Attorney Michael Stuart (above) said in the DOJ press release. “In [the Acadia Healthcare] case, every dime in false billings was doubled for a total settlement that represents twice the harm caused. This is a strong message and a massive penalty. The message is clear—if you are cheating the system and we find you, you’ll not only pay for the damage done, but far more.” (Photo copyright: Wikipedia.)

The Health Affairs authors focused on the major players in addiction treatment-related fraud that were highlighted in a 2018 Government Accountability Office (GAO) report. They are:

  • SUD treatment providers who take advantage of “gaps in regulations and quality assurance to offer substandard and fraudulent care that endangers patients and wastes money.”
  • Unlicensed patient brokers who SUD providers pay to transport addicts to them, often from hundreds of miles away.
  • Disreputable recovery house or “sober home” operators who are subsidized financially by fraudulent SUD providers.

One example the GAO report outlined involved SUD providers in Florida who funded their illegal operations by billing patients’ insurance hundreds of thousands of dollars in unnecessary drug testing over the course of several months.

“At the very moment that ethical healthcare providers are working harder than ever to address the opioid crisis, unethical actors—such as providers engaged in fraud—pose a growing problem,” the Health Affairs authors stated.

Opioid Crisis Turns Urine Screening into ‘Liquid Gold’

Kaiser Health News (KHN) reported that many doctors who prescribe opioids began making drug screenings routine in their practices after being persuaded that doing so would keep them in good standing with licensing boards and law enforcement, while also reducing their liability and preventing patient abuse of prescription pills.

In some instances, doctors opened their own clinical laboratories, KHN stated.

KHN described the nation’s painkiller addiction as turning urine screening into “liquid gold,” particularly for doctors who operate their own clinical laboratories. In 2014 and 2015, Medicare paid $1 million or more for drug-related tests billed by healthcare workers at more than 50 pain management practices in the US, KHN reported.

“It was almost a license to steal. You had such a lucrative possibility, it was tempting to sell as many [tests] as you can,” Charles Root, PhD, Senior Consultant at consulting firm CodeMap, told KHN. CodeMap provides publications, tools, and services that help healthcare professionals navigate the federal Medicare program and has tracked the increase in medical testing laboratories in doctors’ offices, KHN noted.

The graphic above is built on data from CodeMap. It illustrates the “explosive” growth in certain urine tests to “detect and quantify a variety of drugs,” according to KHN. This has led some providers to open clinical laboratories in their offices to capture the increasing revenue generated by this testing. (Image copyright: Kaiser Health News.)

Federal officials have taken notice of physicians whose priority is testing patients, not treating them. Jason Mehta, JD, who at that time was Assistant US Attorney in Jacksonville, Fla., told KHN, “We’re focused on the fact that many physicians are making more money on testing than treating patients. It is troubling to see providers test everyone for every class of drugs every time they come in.”

Clinical laboratories have an important role to play in identifying fraud and solving the opioid epidemic. Not only are lab leaders ideally positioned to help providers better understand drug test ordering and interpretation, but also to help develop value-based interventions within the continuum of care for this national health crisis.

—Andrea Downing Peck

Related Information:

Fraud’s Newest Hot Spot: The Opioid Epidemic and the Corresponding Rise of Unethical Addiction Treatment Providers

U.S. Department of Health and Human Services Office of Inspector General: Semiannual Report to Congress: April 1, 2019-Sept. 30, 2019

United States Attorney Announces $17 Million Healthcare Fraud Settlement

Substance Use Disorder: Information on Recovery Housing Prevalence, Selected States’ Oversight, and Funding

Liquid Gold: Pain Doctors Soak Up Profits by Screening Urine for Drugs

National Health Care Fraud Takedown Results in Charges Against Over 412 Individuals Responsible for $1.3 Billion in Fraud Losses

10 Popular Health Care Provider Fraud Schemes

Preparing Clinical Laboratories for Invasive Federal Enforcement of Fraud and Abuse Laws, Increased Scrutiny by Private Payers, New Education Audits, and More