Clinical laboratory genetic testing labs and telemedicine groups among those charged
In the largest healthcare fraud bust in US history, the US Department of Justice (DOJ) announced it had levied criminal charges against 324 defendants for allegedly participating in various fraudulent healthcare schemes—including clinical laboratory genetic testing and telemedicine fraud—totaling over $14.6 billion in losses.
A DOJ press release states the agency’s 2025 National Health Care Fraud Takedown represents an unprecedented effort to alleviate fraud in healthcare that exploits patients and taxpayers.
The defendants include 96 doctors, nurse practitioners, pharmacists, and other licensed medical professionals. The cases are being prosecuted by Health Care Fraud Strike Force teams from the Criminal Division’s Fraud Section, 50 US Attorneys’ Offices, and 12 State Attorneys’ General Offices.
“This record-setting Health Care Fraud Takedown delivers justice to criminal actors who prey upon our most vulnerable citizens and steal from hardworking American taxpayers,” said Attorney General Pam Bondi in the press release. (Photo copyright: US Department of Justice.)
49 Clinical Lab Defendants Charged
The takedown relied on coordinated investigations from several agencies, including the:
Health Care Fraud Unit of the DOJ Criminal Division’s Fraud Section,
Department of Health and Human Services Office of Inspector General,
Federal Bureau of Investigation,
Drug Enforcement Administration, and,
Multiple US Attorneys’ Offices.
Clinical laboratory testing fraud was addressed in the takedown. Forty-nine defendants were charged with telemedicine and genetic testing fraud schemes where deceptive telemarketing campaigns targeted Medicare beneficiaries, resulting in $46 million in fraudulent claims being submitted to Medicare for durable medical equipment (DME), genetic tests, and COVID-19 tests.
“Make no mistake—this administration will not tolerate criminals who line their pockets with taxpayer dollars while endangering the health and safety of our communities,” said Attorney General Pam Bondi in the press release.
Other High-Profile Cases
The most prominent cases include a $10 billion urinary catheter scheme where foreign straw owners secretly purchased medical supply companies and then used stolen identities and personal health data of more than one million Americans to file erroneous Medicare claims. Known as Operation Gold Rush, the hoax resulted in the arrests of nineteen defendants, including four in Estonia and seven individuals attempting to avoid capture at US airports and at the Mexican border.
In another case involving foreign influence, owners and executives in Pakistan were charged in connection with a $703 million scheme where artificial intelligence (AI) was allegedly used to create fake recordings of Medicare recipients consenting to receive various products. The data was then sold to clinical laboratories and DME companies to fraudulently submit false claims to Medicare. In addition, some of these defendants allegedly conspired to conceal and launder proceeds from US bank accounts to overseas bank accounts.
Also, a defendant who owned a billing company allegedly planned a sham in which Arizona Medicaid was fraudulently billed $650 million for addiction treatment programs where services were never rendered or patients received substandard care. The defendant, who is based in Pakistan and the United Arab Emirates, supposedly received at least $25 million from the scheme and is also charged with a money laundering offense.
“It’s not done by small time operators,” said Mehmet Oz, MD, who leads the Centers for Medicare and Medicaid Services (CMS). “These are organized syndicates who are designing to hurt America.”
Other notable cases include a scam involving $1.1 billion in fraudulent claims for unnecessary amniotic wound allografts for elderly patients resulting in defendants receiving millions in illegal kickbacks. In another scheme, 74 defendants were charged with the illegal distribution of prescription opioids and other controlled substances.
DOJ Property Seizures
As a result of the fraud bust, the US government seized over $245 million in cash, luxury vehicles, cryptocurrency, and other assets and prevented an additional $4 billion from being paid out by CMS due to false and fraudulent claims.
“These criminals didn’t just steal someone else’s money. They stole from you,” Matthew Galeotti, JD, who leads the DOJ Criminal Division, told the Associated Press. “Every fraudulent claim, every fake billing, every kickback scheme represents money taken directly from the pockets of American taxpayers who fund these essential programs through their hard work and sacrifice.”
This latest bust demonstrates the DOJ’s increased resolve to pursue healthcare fraud, including cases involving clinical laboratory testing. Look for further coverage of this aspect in the 7-14-2025 issue of The Dark Report.
Device provides physicians with quick insights into infant’s immune system capabilities without requiring clinical laboratory testing
International researchers have developed a revolutionary tool that rapidly assesses an infant’s immune system using a single drop of blood. The novel device provides healthcare professionals with real-time insights about a newborn’s immune response in less than 15 minutes.
Scientists from the Singapore-MIT Alliance for Research and Technology (SMART) in collaboration with colleagues from KK Women’s and Children’s Hospital (KKH) in Singapore created the Biophysical Immune Profiling for Infants (BLIPI) portable device to help alleviate potentially life-threatening illnesses in newborns. The device only uses 0.05 ml of blood.
The work was led by researchers from the Critical Analytics for Manufacturing Personalized Medicine (CAMP) and Antimicrobial Resistance (AMR) interdisciplinary research groups within SMART. SMART is a major research collaboration between the Massachusetts Institute of Technology (MIT) and the National Research Foundation of Singapore.
“BLIPI represents a major step forward by providing clinicians with fast, actionable immune health data using a noninvasive method, where it can make a real difference for newborns in critical care,” said Kerwin Kwek Zeming, PhD, research scientist at SMART CAMP and SMART AMR, and co-lead author of the study, in an MIT news release.
“Our goal was to create a diagnostic tool that works within the unique constraints of neonatal care—minimal blood volume, rapid turnaround, and high sensitivity,” said Kerwin Kwek Zeming, PhD, research scientist at SMART CAMP and SMART AMR, and co-lead author of the MIT study, in the news release. (Photo copyright: MIT.)
Bridging Gap between Science and Healthcare
To perform their study, the team used BLIPI to screen 19 infants—eight full-term and 11 preterm—and compared the differences in immune cells between the infants. The device uses microfluidic technology to measure immune cell characteristics, such as size and flexibility, to expose how the immune system is responding to changes within the cells. Traditional tests look only for the presence of germs, but BLIPI also looks at results such as C-reactive protein levels, white blood cell counts, and immature-to-total neutrophil ratios, to determine if an infant is fighting an infection.
“BLIPI exemplifies our vision to bridge the gap between scientific innovation and clinical need. By leveraging microfluidic technologies to extract real-time immune insights from whole blood, we are not only accelerating diagnostics but also redefining how we monitor immune health in fragile populations,” said Jongyoon Han, PhD, professor of electrical engineering and biological engineering at MIT and coauthor of the paper, in the news release. “Our work reflects a new paradigm in point-of-care diagnostics: rapid, precise, and patient-centric.”
Saving Infant Lives
BLIPI only needs one tiny drop of blood, which equals 1/20 of the blood volume typical lab tests require. The onsite tool removes the need for sending blood samples to clinical labs, which may enable clinicians to make earlier decisions regarding treatment options for critical situations like sepsis or necrotizing enterocolitis.
“KKH cares for about two-thirds of all babies born weighing less than 1,500 grams (52.91 ounces or 3.31 pounds) in Singapore. These premature babies often struggle to fight infections with their immature immune systems. With BLIPI, a single prick to the baby’s finger or heel can give us rapid insights into the infant’s immune response within minutes. This allows us to tailor treatments more precisely and respond faster to give these fragile babies the best chance at a healthy start not just in their early days, but throughout their lives,” said Yeo Kee Thai, MD, senior consultant in the department of neonatology at KKH, and senior author of the study, in the news release.
BLIPI also could be extremely beneficial to healthcare settings in remote areas or with limited resources.
Further research and clinical trials are needed to validate the diagnostic accuracy of BLIPI. In addition, the researchers plan to improve the design to render it usable for widespread distribution. They also hope BLIPI will someday be used by pharmaceutical companies and medical researchers to evaluate immune responses to neonatal therapies in real time.
New AI tool doubled efficiency in busy university radiology department
Creative artificial intelligence (AI) solutions are being developed to address critical staffing shortages in radiology that could help with similar shortages in overworked pathology and clinical laboratories as well.
In a recent clinical study at 11-hospital Northwestern Medicine, researchers developed a new generative AI radiology tool to assist radiologists that demonstrates high accuracy and efficiency rates when working with multiple types of imaging scans.
For the study, approximately 24,000 radiology reports were analyzed and then compared for clinical accuracy with and without the AI tool. The tool evaluates an entire scan and generates a report that is 95% complete and personalized to each patient. A template based on that report is then provided to radiologists for review, according to a Northwestern Medicine Feinberg School of Medicine news release.
The study reported an average 15.5% increase in radiograph efficiency without compromising accuracy. Some radiologists even produced gains as high as 40%. The radiology reports were scrutinized during a five-month period last year and enabled radiologists to improve the time it took to return a diagnosis.
“This is, to my knowledge, the first use of AI that demonstrably improves productivity, especially in healthcare. Even in other fields, I haven’t seen anything close to a 40% boost,” said the study’s senior author Mozziyar Etemadi, MD, PhD, assistant professor of anesthesiology and biomedical engineering at Northwestern University McCormick School of Engineering, in the news release. (Photo copyright: Northwestern University.)
Doubled Efficiency for One Radiology Team
“For me and my colleagues, it’s not an exaggeration to say that it doubled our efficiency. It’s such a tremendous advantage and force multiplier,” said study co-author Samir Abboud, MD, emergency radiology in the department of radiology at Northwestern Medicine, in the news release.
“Having a draft report available, even before it is viewed by the radiologist, offers a simple, actionable datapoint that can be quickly and efficiently acted upon” added study senior author Mozziyar Etemadi, MD, PhD, assistant professor of anesthesiology and biomedical engineering at Northwestern University McCormick School of Engineering, in the news release. “This is completely different than traditional triage systems, which need to meticulously be trained one by one on each and every diagnosis.”
The AI tool can also alert radiologists to life-threatening conditions.
“On any given day in the ER, we might have 100 images to review, and we don’t know which one holds a diagnosis that could save a life,” Abboud said. “This technology helps us triage faster—so we catch the most urgent cases sooner and get patients to treatment quicker.”
Relying on In-house Data
Engineers at Northwestern developed the AI model using clinical data within the university’s own network, emphasizing that such tools can be created without assistance from other organizations.
“Our study shows that building custom AI models is well within reach of a typical health system, without reliance on expensive and opaque third-party tools like ChatGPT,” Etemadi noted.
The Journal of the American College of Radiology states the supply of radiologists is expected to increase by approximately 26% over the next 30 years. However, the need for radiologists is expected to grow between 17% and 27% over the same period. Becker’s Hospital Review reports there will be a shortage of up to 42,000 radiologists in the US by 2033.
Some health organizations are using a mixed model of permanent employees and contracted radiologists to meet the increasing demand for services. Others are also looking at options such as internal training programs, better benefits for workers, teleradiology, and remote radiologists to fulfill radiology needs.
“You still need a radiologist as the gold standard,” Abboud said. “Medicine changes constantly—new drugs, new devices, new diagnoses—and we have to make sure the AI keeps up. Our role becomes ensuring every interpretation is right for the patient.”
Can pathology practices and clinical laboratories learn from radiology’s situation? Development of AI solutions for those fields would likely have similar effects on workloads and overworked personnel.
Exploring the benefits of AI may be one way of helping meet clinical laboratory and pathology practice staff shortages.
Some of the former employees worked for public health labs involved in tracking HIV, hepatitis, and STDs
More than 450 federal employees who were laid off from the Centers for Disease Control and Prevention (CDC) during the April cutbacks are being reinstated by the Department of Health and Human Services (HHS).
Nearly half (214) worked for the National Center for HIV, Viral Hepatitis, STD, and Tuberculosis Prevention (NCHHSTP), which includes specialized public health laboratories. Another 158 worked at the National Center for Environmental Health (NCEH). Others were employed by the Immediate Office of the Director and Global Health Center.
“I think people are very tacitly hopeful that this means they can get their jobs back and continue serving in ways that they love,” NCEH health scientist Kathryn Sisler, MPH, told NPR. “But there has been so much instability and chaos that I think a lot of people would hesitate to say it is good news.”
Sisler, who works in NCEH’s Division of Environmental Health Science and Practice, received an email notification of her reinstatement on June 11, NPR reported.
She described the rehiring as “a step in the right direction,” but noted that she was among some employees in her division who had moved away from Atlanta, where the CDC is based. “Other employees had taken other jobs or had been offered them,” NPR reported.
In an interview with NPR, Scott Becker, CEO of the Association of Public Health Laboratories, admitted to being “happily flabbergasted” to hear about HHS’ offer to rehire the former federal workers. (Photo copyright: Association of Public Health Laboratories.)
Impact at Critical Labs
As part of the cutbacks, the CDC shut down two laboratories at NCHHSTP that were involved in tracking viral hepatitis and sexually transmitted diseases, even as “some of those scientists performed disease surveillance work unlike any other labs in the world,” NPR noted.
NCHHSTP staffers told NPR that some of the division’s labs were damaged due to the “lapse in activity” during April and May, and that “some disease outbreaks had not been properly tracked.” One employee said that, due to the cutbacks, the division’s hepatitis lab was unable to assist health workers tracking a hepatitis C outbreak in Florida. The CDC employees requested anonymity.
“It’s great to see that there is some recognition of the importance of these workers and that being in those positions is critical for the public health of America and that they are being reinstated in order to continue their important work,” Carmen J. Marsit, PhD, of Emory University’s Rollins School of Public Health, told NPR. He added, however, that “there’s still a lot of people that are not being reinstated.”
HIV Not Being Tracked
KFF Health News reported that the reinstatements included “dozens of HIV experts” who were laid off in April. At the time, they were working on a national survey conducted among 30,000 individuals at risk of acquiring the infection. They haven’t been told if the project will resume.
Public health departments use data from the survey as part of their efforts to reduce spread of the disease, KFF Health News stated, noting that “preventing HIV is far cheaper than treating people once they’re infected.”
Since the cutbacks, many HIV researchers at CDC have obtained new jobs or moved. Some employees “called the reinstatements perplexing because the notices don’t say what they’ll be doing when they return and for how long,” KFF Health News reported.
“I am concerned about how many of the people have already moved on or might move on and the trauma that they really must be going through with the uncertainty,” Scott Becker, CEO of the Association of Public Health Laboratories, told NPR about the reinstatements at CDC. “But all in all, it’s good news and I’ll take it.”
Programs Cut by Mistake
The reinstatements amount to approximately 20% of the 2,400 CDC employees laid off following the March 27 announcement of a massive restructuring at HHS.
HHS secretary Robert F. Kennedy, Jr. told ABC News in early April that some programs had been cut by mistake. “Personnel that should not have been cut were cut—we’re reinstating them, and that was always the plan,” he said.
In May, Kennedy said that 328 employees of the CDC’s National Institute for Occupational Safety and Health (NIOSH) would be reinstated, NPR reported, following “considerable pushback from labor organizations and congressional lawmakers.”
NPR and other outlets had earlier reported that HHS planned to cut at least 900 NIOSH employees, amounting to 90% of the institute’s workforce.
Industry commenters point to a void since the federal government shuttered the Clinical Laboratory Improvement Advisory Committee
For readers wondering what has happened to the Clinical Laboratory Improvement Advisory Committee (CLIAC), the bottom line is the panel has been terminated, causing a significant void for the lab industry at the federal level.
Dark Daily’s sibling brands, including The Dark Report, G2 Intelligence, and Today’s Clinical Lab, have been exploring various aspects about the demise of CLIAC.
The Centers for Disease Control and Prevention (CDC) confirmed to G2 Intelligence that CLIAC was terminated as of March 31, citing an executive order from President Donald Trump intended to reduce federal advisory committees. The decision blindsided even those closest to CLIAC. Incoming committee chairman Jordan Laser, MD, revealed in an email to colleagues that he did not have more insight into CLIAC’s demise beyond media reports, G2 reported.
Since its founding in 1992, CLIAC has played an influential—though non-regulatory—role in shaping updates to the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The committee brought together pathologists, lab directors, public health leaders, and representatives from federal agencies such as the CDC, Centers for Medicare and Medicaid Services, and Food and Drug Administration.
The federal government’s decision to eliminate CLIAC “risks stalling progress in laboratory medicine, which could ultimately hinder efforts to improve patient care,” CAP President Donald Karcher, MD, FCAP, told The Dark Report. (Photo copyright: College of American Pathologists.)
‘Critical Venue’ for Labs Has Been Eliminated
Industry groups are sounding alarms about what comes next. In an interview with Today’s Clinical Lab, Anthony Killeen, MD, PhD, president of the Association for Diagnostics and Laboratory Medicine (ADLM), said CLIAC was an important forum for medical lab scientists to discuss CLIA.
“[CLIAC] served as a critical venue for working through current problems with the rule and also for expert input on how new technologies—such as next-generation sequencing, digital pathology, and artificial intelligence-assisted diagnostics—should be assessed and integrated under CLIA,” Killeen said.
ADLM has formally urged Department of Health and Human Services Secretary Robert F. Kennedy, Jr. to reverse the CLIAC decision. In a May letter, the association emphasized that CLIAC’s work was funded entirely through user fees paid by clinical laboratories rather than taxpayer dollars—a point many in the lab industry say underscores CLIAC’s value.
CAP President Wonders about Future Communication Gaps
The Dark Report noted that the disbanding of CLIAC may cost labs time in certain cases, a commodity that few diagnostic settings have in abundance.
“The absence of this advisory body may lead to gaps in communication and slower response times in addressing [industry] challenges,” Donald Karcher, MD, FCAP, president of the College of American Pathologists (CAP), told The Dark Report.
The absence of CLIAC raises uncertainty for clinical labs because federal agencies have lost a prime source to gather specialized input on complex scientific and operational issues facing the lab industry. Dark Daily’s partner brands will continue to track this matter closely. If you’re not a subscriber, you can check out The Dark Report’s insider coverage with a 14-day free trial.
Pharmaceutical and biotech researchers convened last week to discuss their latest work on targeting neurodegenerative diseases
With all the news this year alone on progress being made with diagnostic testing for Alzheimer’s disease, clinical laboratory professionals will be interested to know that drug discovery efforts to combat neurogenerative diseases are also at a heightened pitch.
Last week at the one-day Neuroimmunology in Drug Discovery forum in Boston, scientists learned about the latest advances in therapeutic research to better treat Alzheimer’s disease, multiple sclerosis, and Parkinson’s disease. As the treatments advance, demand for them will increase, which goes hand-in-hand with medical lab testing to detect signs of these illnesses.
The concern is urgent. The US Food and Drug Administration (FDA) noted that 10% of people age 65 and older have Alzheimer’s disease, and that number could double by 2050. The FDA recently cleared the first in vitro diagnostics device that tests blood to diagnose Alzheimer’s, and other IVD manufacturers and clinical labs are working on other Alzheimer’s tests, Dark Daily reported.
“It’s looking quite promising for NLRP3 inhibitors,” said Cheryl Leyns, PhD, associate principal scientist in discovery neuroscience at Merck Research Laboratories, in discussing how mutations of the NLRP3 protein can lead to neurodegenerative diseases. (Photo copyright: ELRIG.)
Much of the discussion at the Neuroimmunology in Drug Discovery forum centered on the idea that neuroinflammation—in other words, inflammation of the brain or spinal cord—starts well before neurodegenerative diseases arise. Neuroinflammation can accelerate Parkinson’s disease and other neurodegenerative disorders, said Cheryl Leyns, PhD, associate principal scientist, neuroimmunology, at Merck Research Laboratories in Boston, who spoke at the event.
From that perspective, drug discovery researchers are on the prowl for these early signs of future problems.
Leyns discussed NLRP3, a protein that aids the body’s inflammation process. A mutation of NLRP3 can lead to inflammatory problems, making the protein a prime target for researchers. “We have been interested, in the biopharma space, in the potential of NLRP3 inhibitors,” she noted.
Older Immune Systems Are Susceptible
While many in the public correctly associate Alzheimer’s with a person being outwardly older, a lesser-known aspect is that the body’s immune system also ages, becoming more susceptible over time to chronic inflammation.
Wailings’ assertion was not rhetorical. She pointed to numbers which showed scholarly research that involved the terms “inflammation,” “neurodegeneration,” and “aging” was only about 17% of the total amount of journal articles that addressed the first two terms, but which did not include “aging.”
As the pharmaceutical, biotech, and medical fields move aggressively forward to defend people against neurodegenerative diseases like Alzheimer’s, clinical laboratory scientists should take comfort that diagnostic testing trends are solidly in the mix.
Therapeutic advances, along with increased options for testing, show promising signs that patients and their caregivers will have more tools to use in the battle against these illnesses.
