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.
“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.
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.
“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.
“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.
Vermont-based clinical laboratory company integrates social determinants of health (SDH) with lab data to help doctors at University of Vermont Health Network better manage their opioid patients
“We are thrilled to be recognized for our work serving the unique
needs of substance use healthcare. And, most importantly, across our
organization for our unyielding commitment to employing innovations to solve
this [opioid] crisis,” Aspenti Health CEO
Chris Powell stated in the news release.
The projects were judged on Clinical Lab 2.0 attributes,
such as:
Risk stratification by population;
Closure of care gaps;
Lab results as early detection; and
Lab intervention for improved clinical outcomes.
“This project, as well as all of the other cases that were
presented, were quite strong and all were aligned with the mission of the
Clinical Lab 2.0 Movement,” said Khosrow
R. Shotorbani, President, Executive Director, Project Santa Fe Foundation,
in a news
release. “This movement transforms the analytic results from a laboratory
into actionable intelligence at the patient visit in partnership with
front-liners and clinicians—allowing for identification of patient risks—and
arming providers with insights to guide therapeutic interventions.
“Further, it reduces the administrative burden on providers
by collecting SDH [social determinants
of health] predictors in advance and tying them to outcomes of interest,”
continued Shotorbani. “By bringing SDH predictors to the office visit, it
enables providers to engage in SDH without relying on their own data collection—a
current care gap in many practices. The lab becomes a catalyst helping to
manage the population we serve.”
Co-Use of Opioids Tied to Social Factors
Aspenti Health’s “Shark Tank” entry—“Integration of the
Clinical Laboratory and Social Determinants of Health in the Management of
Substance Use”—focused on the social factors tied to the co-use of opioids and benzodiazepines, a
combination that puts patients at higher risk of drug-related overdose or death.
The project revealed the top two predictors of co-use were the:
Prescribing provider practice, and the
Patient’s age.
“This was a unique project because it integrated social determinants, which are a key part of our overall health and wellness, with laboratory data, which is well-defined, quantitative, and very accurate,” said Jill Warrington, MD, PhD (above), Chief Medical Officer at Aspenti Health and Assistant Professor in the Department of Pathology and Laboratory Medicine University of Vermont Medical Center, in an exclusive interview with Dark Daily. “So, combining something that is really meaningful clinically with something that is very predictive and accurate has a nice blend of strengths.” (Photo copyright: Aspenti Health.)
Myra L.
Wilkerson, MD, who served on a three-judge panel tasked with selecting the
winning project, said the Vermont toxicology laboratory’s entry stood out in
two key areas.
“We felt their project had an application to a broader
population, but also moved beyond traditional [laboratory] functions or even
medicine,” explains Wilkerson, who is Chair of the Diagnostic
Medicine Institute for the Geisinger
Health System. “Patient advocacy groups, payers, and providers all have
come to realize you can identify a disease, you can provide a treatment, but so
many other things impact it, especially in this community. When it is an
addiction, there are so many other factors that play into whether or not they
are going to be successful in their treatment plan. And a lot of them are
social things.”
Educating Care Givers and Public on Dangers of Co-Use
Drug Addictions
Working in collaboration with Staple Health and the University of Vermont Health
Network, Aspenti selected “co-use” for this initial lab outcome study because
of the significant patient safety implications and relative simplicity of its
definition—the co-presence of positive laboratory results for both opioids and
benzodiazepines.
According to the National
Institute on Drug Abuse, more than 30% of overdoses involving opioids also
involve benzodiazepines. Aspenti’s “Shark Tank” presentation highlighted the
fact that co-use of the drugs accounts for nearly 2.5% of opioid-related
emergency department visits, costing the healthcare system an estimated $47.5
million per year.
Based on the study results, Aspenti Health plans to develop
educational programs that warn about the dangers of co-using opioids and
benzodiazepines.
“We identified geographically hotspots where co-use was more
prevalent, so we can target our educational initiatives centered on those
geographical locations—not just to providers, but also to families and patients—to
raise awareness about co-use so the risks are mitigated collectively,” Warrington
said.
Advancing the Value-based Healthcare Agenda
The Executive War College Clinical Lab 2.0 “Shark Tank”
advances a conversation about the lab industry’s future that began at the
inaugural 2016
Project Santa Fe meeting. Lab industry stakeholders brainstormed about the
transition from volume-based to value-based healthcare, and the role
laboratory-driven innovations could play in reducing total cost of care.
As healthcare shifts to a value-based reimbursement model,
Wilkerson believes laboratory leaders must re-engineer their role in the
continuum of care by creating meaningful clinical diagnostic insights for population health
initiatives.
“What’s your executive leadership concerned about? What are
your payers concerned about? What are your accrediting or regulatory bodies
concerned about? What are their top priorities and how can you do something
that improves patient care but helps them address their problems as well?” she asks.
“That’s where you create value.”
As the Clinical Lab 2.0 Innovation Award winner, Aspenti Health
will receive:
An invitation to speak at national lab
conferences this fall;
A consultation with a Project Santa Fe member lab
to discuss successful Clinical Lab 2.0 innovations and identify new ways to
deliver more value in patient care; and
Publication of a case study of their Clinical
Lab 2.0 project by Dark Daily or its sister publication The Dark
Report.
With labs in Vermont and Massachusetts, Aspenti continues to
identify opportunities for directly contributing to improvements in the care of
substance abuse and pain management patients. Warrington says that with its SDH
project, Aspenti plans to focus on other key laboratory outcome measures—such
as treatment adherence and relapse. Next steps include integrating this work
into the practices of partner doctors within the University of Vermont Health
Network.
Wilkerson’s advice to other clinical laboratories is to
follow Aspenti Health’s lead.
“When you look at the national trends, the percentage of
traditional fee-for-service or volume-based healthcare is going to go down to
25% of the total healthcare spend by 2021,” she points out. “The other 75% will
be based on value-added services around quality metrics, efficiency, cost
reduction, utilization, etc. Labs that aren’t starting to think this way now
are going to be behind and at risk in the future.”
A legal, supervised injection site (SIS) affiliated with Vancouver Coastal Health found 86% of drugs tested with strips contained fentanyl when tested with these medical lab test kits
Here’s an unexpected application of point-of-care testing (POCT) that may surprise pathologists and medical laboratory leaders. In a sort of “guerilla-warfare” street experiment that applies diagnostic technologies to a problem, the manager of a needle-exchange program in the Bronx has been helping heroin and other opioid users discover if a product they are about to ingest is contaminated by handing out test strips designed for testing urine.
The addicts participating in these special programs use the POCT urine test strips to test their drugs for the presence of fentanyl, a powerful synthetic opioid analgesic similar to morphine that can increase the potency of opioids to lethal levels. Rehab program directors adopted this approach to help prevent overdoses and deaths among drug users.
Reducing Overdoses with Test Strip Handouts
Opioids such as morphine are often prescribed to cancer or surgery patients to treat severe pain. However, according to a National Institute on Drug Abuse (NIDA) fact sheet, fentanyl is “50 to 100 times more potent than morphine.” When fentanyl is mixed with heroin or cocaine and sold on the streets, the potent mix can be deadly, NIDA explained.
Test strips ordered from Canada designed to check patients’ urine for fentanyl are being used by St. Ann’s Corner of Harm Reduction (St. Ann’s) in the Bronx, New York. The strips are being used to check drug users’ syringes for fentanyl, according to a National Public Radio Shots article. The idea is to inform drug users of what they have in hand and possibly encourage them to choose not to take the drug, use less, or slow things down, Shots reported.
“If you’re doing dope, we’ll give you a test strip so you can test and see if there’s fentanyl,” stated Van Asher, Data Manager at St. Ann’s, in the Shots article.
Whether an unlicensed individual distributing test strips to drug users violates state or federal regulations was not broached in the Shots article.
St. Ann’s gives out about 15 strips a day each costing $1, Shots noted. St. Ann’s staff is sharing data collected on the encounters with the Centers for Disease Control and Prevention (CDC) and with New York health departments.
Finding Fentanyl with Test Strips in Canada
St. Ann’s isn’t the first to use urine test strips for drug checking. Vancouver Coastal Health (VCH) in British Columbia, Canada, launched a pilot program for drug-checking in 2016 at its Insite facility.
At Insite’s “supervised injection site” facility (above) in Vancouver, British Columbia, drug users can “legally” inject illegal drugs. Directors of this program have adapted point-of-care urine test kits typically used in medical laboratory testing to allow drug users to test their heroin and opiate drugs for the presence of fentanyl. The goal is to reduce overdoses and deaths from users unknowingly ingesting fentanyl. (Photo copyright: CBCNews.)
Insite began to test drugs for the presence of fentanyl in the fall of 2016. Data from 173 tests performed in July and August found that 86% of drugs tested contained fentanyl, noted a VCH news release.
“These initial results confirm our suspicion that the local drug supply is overwhelmingly contaminated with fentanyl. We’re hoping this information can help people who use drugs,” stated Mark Lysyshyn, MD, MPH, VCH Medical Health Officer and Professor of Medicine at University of British Columbia.
The test works when the client dilutes the substance with a few drops of water. A positive or negative result for fentanyl is revealed within seconds.
The test strip used by Insite was designed to check for fentanyl in urine, not for checking drugs, noted the VCH statement. Insite intends to review the pilot program test data and decide whether to continue testing services after the pilot program concludes.
Alexander Walley, MD, Director of the Addiction Medicine Fellowship Program and Assistant Professor of Medicine at Boston Medical Center, stated the test may aid users’ decision-making.
“Even when they know they’re going to be positive for fentanyl, the experience of somebody testing their drugs and seeing that it’s fentanyl has an impact. It really encourages them to use more safely,” he stated in the Shots article.
Overdose Deaths Due to Fentanyl in America
A CBC News, Manitoba, article called the death rate due to fentanyl ingestion a “Canada-wide disaster.” However, the problem is significant in the US as well.
Death rates from synthetic opioids, including fentanyl, rose more than 72% from 2014 to 2015 in the US, according to the CDC.
In New York City, fentanyl is increasingly being linked to overdoses. In 2016, nearly half (44%) of drug deaths involved drugs mixed with fentanyl. That’s a 16% increase over 2015, according to a NYC Health press release.
A report from the Tennessee Department of Health noted that 1,451 people died from drug overdose in 2015. That’s a state record. Deaths associated with fentanyl rose significantly from 69 in 2014 to 174 in 2015, the report noted.
How Fentanyl Works and Why It Is Dangerous
Here are some fentanyl facts from the NIDA:
Fentanyl works by binding to opioid receptors located in areas of the brain that control pain and emotions;
People may experience side effects such as euphoria, drowsiness, nausea, confusion, addiction, respiratory arrest, unconsciousness, coma, and death;
Increased risk of overdose exists when drug users are unaware a drug they are ingesting contains fentanyl.
Clinical laboratory directors and pathology groups nationwide might want to follow the progress of test strip services at St. Ann’s Corner and Insite’s SIS. This twist on traditional POCT—using urine test strips to look for the presence of fentanyl in substances—could aid their own communities achieve public awareness, change behaviors, and save lives.
