A top public hospital CEO says AI could soon take over radiology functions to cut costs—raising similar automation questions for clinical labs—though critics warn the technology is not ready to replace physicians.
The CEO of NYC Health + Hospitals says his system is prepared to begin replacing radiologists with artificial intelligence (AI) in certain use cases, once regulatory barriers are addressed. From a clinical lab professional perspective, health systems are actively evaluating where AI can reduce reliance on highly trained specialists while maintaining diagnostic throughput.
“We could replace a great deal of radiologists with AI at this moment, if we are ready to do the regulatory challenge,” Katz said.
AI as a Cost and Workflow Strategy
Katz noted that AI could expand access to screening—particularly in breast cancer—while lowering operational costs. One proposed model would shift radiologists into a secondary review role, validating only abnormal findings flagged by AI.
For clinical laboratories, this mirrors ongoing discussions around digital pathology, AI-assisted test interpretation, and automated workflows in areas such as hematology, microbiology, and molecular diagnostics. If imaging adopts a “AI-first, specialist-second” model, similar expectations could follow in the lab.
This approach could deliver what Katz described as “major savings,” particularly for large systems facing staffing shortages and increasing test volumes.
“For women who aren’t considered high risk, if the test comes back negative, it’s wrong only about 3 times out of 10,000,” Lubarsky said, adding that the technology is “actually better than human beings.” (Photo credit: Westchester Medical Center Health Network)
Katz also questioned whether regulations should evolve to allow AI to interpret imaging independently—potentially establishing a precedent that could influence how regulators approach AI in laboratory medicine.
Why Clinical Labs Should Pay Attention
While the discussion centers on radiology, the underlying drivers—cost containment, workforce shortages, and demand for faster turnaround times—are identical pressures facing clinical laboratories.
If regulators permit AI to operate with reduced physician oversight in imaging, labs could see accelerated adoption of AI-driven decision support, automated result interpretation, and even reduced hands-on review in certain testing workflows.
At the same time, the debate highlights a key risk of balancing efficiency gains with diagnostic accuracy and patient safety.
Pushback Raises Safety Concerns
Not all healthcare professionals agree with the direction. Some radiologists warn that current AI tools are not ready for independent clinical use.
“Undeniable proof that confidently uninformed hospital administrators are a danger to patients: easily duped by AI companies that are nowhere near capable of providing patient care,” said Mohammed Suhail, MD, of North Coast Imaging.
“Any attempt to implement AI-only reads would immediately result in patient harm and death, and only someone with zero understanding of radiology would say something so naive.”
The debate signals what may be ahead for the broader diagnostics industry. As health systems test AI-driven models in radiology, clinical laboratories may soon face similar expectations to leverage automation for cost savings—while defending the continued role of expert oversight in ensuring quality and patient safety.
This article was created with the assistance of Generative AI and has undergone editorial review before publishing.
Walk-in lab testing in West Virginia is giving patients faster, more affordable access to diagnostics—while pushing clinical labs to adapt to a more consumer-driven care model.
Across the clinical laboratory industry, the shift toward consumer-directed healthcare continues to gain momentum. A recent report by the Charleston Gazette-Mail highlights a growing trend in West Virginia of walk-in laboratory services that allow patients to bypass traditional physician referrals for routine diagnostic testing.
For pathologists and clinical lab professionals, this shift represents a significant evolution in the traditional diagnostic workflow. Facilities like Any Lab Test Now and local hospital-affiliated outreach centers are increasingly offering direct-to-consumer (DTC) options, allowing individuals to purchase tests such as lipid panels, glucose levels, DNA, and toxicology screens.
Key Drivers of Walk-In Testing
The article identifies several factors pushing patients toward walk-in labs:
Cost transparency: Many patients with high-deductible health plans are choosing walk-in labs that offer transparent, upfront pricing, often avoiding the “sticker shock” of traditional hospital billing.
Convenience and speed: The ability to walk in without an appointment and receive results via secure online portals—often within 24 to 48 hours—appeals to the modern healthcare consumer.
Proactive health management: There is a growing demographic of proactive patients who wish to monitor chronic conditions or wellness markers more frequently than their annual, insurance-covered physical allows.
“This gives [patients] an opportunity to manage their own health,” said Matt Brooks, director of clinical laboratory services at Marshall Health Network based in Huntington, W.V. “And it gives patients the opportunity to pay for the test without having to go through their insurance.” (Photo credit: Marshall Health Network).
The Changing Role of the Provider
While the convenience is clear, the trend raises questions regarding the interpretation of results. Patients have access to more data, yet they still require professional guidance to put that data into clinical context.
Most walk-in models encourage patients to share their results with their primary care physicians, but the “patient-as-the-customer” model places the initial responsibility for action squarely on the individual.
Implications for Clinical Labs
For traditional clinical laboratories, the growth of walk-in testing in regions like West Virginia serves as a signal to adapt. As patients become more accustomed to retail-style healthcare experiences, laboratories may need to invest more heavily in user-friendly digital interfaces and transparent pricing structures to remain competitive.
This trend also underscores a broader national movement. As more states relax regulations regarding DTC testing, the laboratory’s role is shifting from a behind-the-scenes diagnostic provider to a front-facing participant in the patient’s healthcare.
The research was published in Cell Metabolism and reported by The Scientist, a sibling brand of Dark Daily.
For clinical laboratory professionals, the approach highlights a possible shift away from time-intensive stool-based sequencing toward faster, more scalable testing workflows. “One of the key barriers to integrating our knowledge of the microbiome into clinical care is the time it takes to analyze the data on the microbiome,” said Ariel Hernandez-Leyva, an MD/PhD student working for gut microbiome researcher Andrew Kau’s group at Washington University School of Medicine. (Photo credit: Kau Lab)
Breath-Based Testing Could Streamline Microbiome Workflows
The research team found that volatile organic compounds (VOCs) in breath samples closely correlate with gut microbiome activity, suggesting a streamlined alternative that could reduce turnaround times and expand access to microbiome-informed diagnostics. In both human and mouse studies, breath “volatilome” profiles mirrored microbial metabolites in the gut.
In a proof-of-concept analysis, VOC patterns distinguished children with asthma from healthy controls and predicted levels of a gut bacterial species associated with the condition. Such capabilities could support earlier clinical decision-making and reduce reliance on complex sequencing workflows.
If validated in larger studies, breath-based diagnostics could offer clinical labs a practical pathway to integrate microbiome insights into routine testing, with potential applications in pediatric care, infectious disease risk assessment, and chronic disease management.
This article was created with the assistance of Generative AI and has undergone editorial review before publishing.
Set for April 28–29 in New Orleans, the 31st Annual Executive War College will bring lab leaders together for practical, execution-focused strategies across reimbursement, staffing, compliance, and emerging technologies, with new emphasis on digital pathology and AI-driven operations.
The 31st Annual Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management, April 28–29 in New Orleans, will bring together clinical laboratory leaders to address the most pressing challenges shaping the industry in 2026. This year’s event emphasizes practical, execution-focused strategies across financial performance, workforce development, compliance, and emerging technologies.
A key addition to the 2026 program is the inaugural Executive Forum on Digital Pathology Management, a dedicated session exploring digital workflows, artificial intelligence (AI), and data integration. Designed as an interactive and collaborative experience, the forum will highlight real-world implementation strategies and provide attendees with actionable insights into adopting new technologies.
Recently, the Dark Report highlighted what’s to come at the event. Further, Dark Daily reported on key sessions that attendees won’t want to miss.
Six Major Themes Shaping the Industry
The conference agenda is structured around six strategic themes reflecting the evolving laboratory landscape.
Financial strategy sessions will focus on improving reimbursement, strengthening payer relationships, and using analytics to drive revenue growth.
Workforce discussions will address staffing shortages, automation, and leadership development.
Compliance sessions will offer frameworks for managing regulatory risk and embedding compliance into daily operations.
Innovation and technology will play a central role, with case studies demonstrating how laboratories can leverage molecular diagnostics, automation, and informatics to enhance clinical value and operational efficiency.
AI will receive particular attention, with sessions examining both its opportunities and challenges, including governance, validation, and return on investment.
Additionally, experts will explore trends in mergers and acquisitions and strategic partnerships, providing guidance on growth, valuation, and long-term positioning.
Healthcare attorney Elizabeth Sullivan of McDonald Hopkins leads a panel discussion at last year’s Executive War College. Sullivan will return for two sessions at the upcoming 2026 conference. (Photo credit: EWC)
2025 Executive War College Highlights
Workforce challenges persist in 2026 and will again be a key theme at the event. The 2025 Executive War College highlighted several innovative approaches to staffing.
For example, the Dark Report reported on a 2025 Executive War College presentation by Jennifer Fralick, vice president anatomic pathology and clinical laboratories at Stanford Health Care. Fralick noted that clinical labs are addressing severe staffing shortages by focusing on internal talent development through career ladders, training programs, and smarter staffing models that shift routine tasks away from licensed professionals. These strategies improve efficiency, reduce burnout, and help labs build sustainable, long-term workforce pipelines instead of relying solely on external hiring. (Fralick is returning to this year’s event to discuss an AI playbook for labs.)
Operational solutions will also be highlighted in the 2026 agenda. Last year, as the Dark Report noted in an article, Shashirekha Shetty, PhD, professor in the Department of Pathology at Case Western University, presented on how up to 70% of laboratory errors occur in the pre-analytical phase, often due to incorrect test orders, improper sample handling, and poor communication, making it a major risk to patient care and lab efficiency. Shetty emphasized that labs must take full ownership of this phase by implementing standardized workflows, strengthening training and collaboration with clinicians, and embedding pre-analytic quality into their overall quality management systems.
Attendees can expect updated solutions for these challenges and more presented by experts at this year’s Executive War College, which is just a short month away. With nearly 80 sessions and around 150 speakers, the program is designed to equip attendees with practical tools, real-world case studies, and operational playbooks. Laboratory executives will leave with clear, actionable roadmaps to navigate financial pressures, regulatory scrutiny, and rapid technological change.
Keith J. Gray’s conviction underscores rising enforcement and audit risk as Medicare spending shifts toward high-cost genetic testing.
A federal jury in Dallas has convicted Texas laboratory owner and former NFL player Keith J. Gray for orchestrating a $328 million Medicare fraud scheme tied to unnecessary cardiovascular genetic testing. Gray, age 39, owned and operated Axis Professional Labs LLC and Kingdom Health Laboratory LLC, which billed Medicare for tests that were not medically necessary, according to the US Department of Justice (DOJ).
The jury convicted Gray on multiple counts, including conspiracy to defraud the United States, violations of the Anti-Kickback Statute, and money laundering. He now faces up to 10 years in prison for each count, with sentencing to be determined by a federal judge.
Gray briefly pursued a professional football career after playing at the University of Connecticut, signing as an undrafted free agent with the Carolina Panthers in 2009 and later spending time on the Indianapolis Colts practice squad, though he never appeared in a regular-season NFL game, according to Fox Sports.
Kickbacks and Sham Contracts Drove Genetic Testing Fraud
According to evidence presented at trial, Gray paid illegal kickbacks to marketers in exchange for Medicare beneficiaries’ DNA samples, personal information, and signed physician orders, the DOJ said. These marketers relied on aggressive telemarketing tactics and a practice known as “doctor chasing,” in which they identified patients’ primary care physicians and pressured them to approve genetic testing orders, prosecutors noted. In many cases, these approvals were based on pre-screening conducted by non-medical personnel rather than legitimate clinical evaluations.
To conceal the scheme, Gray used sham contracts and falsified invoices that were labeled as payments for marketing services, software, or loans. In reality, these payments were structured to match per-sample kickbacks. “Evidence at trial included text messages between Gray and his co-conspirator becoming giddy over the amount of money they were making from Medicare,” the DOJ noted.
Photo credit: NFL Photos
The two laboratories billed Medicare approximately $328 million in fraudulent claims, resulting in about $54 million in payments. Gray used some of these proceeds to purchase luxury vehicles, including high-end trucks and SUVs, as part of efforts to launder the illicit funds.
The case was investigated by multiple federal and state agencies, including the FBI, HHS Office of Inspector General, Texas Medicaid Fraud Control Unit, and the VA Office of Inspector General, underscoring ongoing enforcement efforts targeting fraud in clinical laboratory testing.
The Gray case underscores exactly the risk highlighted in a recent article from The Dark Report on a report from the Department of Health and Human Services’ Office of Inspector General that found genetic tests make up just 5% of volume but now drive 43% of Medicare Part B lab spending. As Medicare spending becomes increasingly concentrated in high-cost genetic testing, enforcement agencies are intensifying scrutiny around medical necessity and billing practices.
Gray’s $328 million fraud scheme—built on kickbacks, questionable ordering practices, and medically unnecessary tests—reflects the same misbehaviors regulators are now targeting. Because of fraud cases such as this, honest laboratories must make greater effort to strengthen compliance, validate ordering patterns, and prepare for heightened audits in the molecular diagnostics space.
Strategies to mitigate diagnostic testing fraud will be a key focus at the 31st Annual Executive War College taking place in New Orleans April 28-29.
With genetic test spending under the microscope, CMS is asking labs to help shape future anti-fraud rules—before formal proposals are drafted.
Clinical laboratory leaders have a narrowing window to influence a major new federal anti-fraud initiative, as the Centers for Medicare and Medicaid Services (CMS) closes its March 30 comment period on its “CRUSH” request for information (RFI).
Published Feb. 27, the CRUSH (Comprehensive Regulations to Uncover Suspicious Healthcare) initiative signals CMS’s intent to pursue broader regulatory changes aimed at strengthening program integrity across Medicare, Medicaid, and Medicare Advantage. For laboratories, the RFI offers an early opportunity to weigh in before formal rulemaking begins.
CMS Targets Genetic Testing Spend, MolDX Oversight, and Advanced Analytics in Fraud Crackdown
A central focus is fraud tied to clinical diagnostic testing, particularly genetic and molecular assays. CMS cited recent federal data showing that while genetic tests accounted for just 5% of Medicare Part B test volume in 2024, they represented 43% of total lab spending—approximately $3.6 billion. The agency also pointed to ongoing enforcement actions and fraud alerts tied to laboratory testing as justification for heightened scrutiny.
Photo credit: Wikimedia Commons
CMS is asking laboratories and other stakeholders to identify what new regulatory authorities, analytics tools, and data-driven approaches could improve detection and prevention of fraudulent billing. The agency’s questions suggest interest in expanding pre- and post-payment review, strengthening data analytics, and accelerating fraud detection earlier in the reimbursement claims lifecycle.
Another key issue for labs is CMS’s examination of the Molecular Diagnostic Services (MolDX) program. The agency is seeking feedback on whether MolDX registration reduces fraud risk and why some payers require participation even outside MolDX jurisdictions—raising the possibility of broader adoption or new requirements tied to molecular test oversight.
For laboratory executives, compliance leaders, and revenue cycle teams, the implications are significant. The RFI signals where CMS may tighten oversight next, particularly for high-cost, high-complexity testing. Policies affecting enrollment, documentation, payment review, and test validation could follow.
With the March 30 deadline approaching, laboratories still have time to submit operational insights and data to help shape future regulations.
