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.
From MD Anderson’s workforce pillars to NYU Langone’s digital pathology overhaul, the 2026 Executive War College speaker spotlight highlights the “boots-on-the-ground” experts set to reveal how labs can navigate reimbursement pressure and regulatory shifts this April in New Orleans.
As clinical laboratories face a “perfect storm” of reimbursement pressure, workforce shortages, and shifting regulatory mandates, the upcoming Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management (April 28-29, 2026) has released its first wave of speaker spotlights. The 2026 agenda will focus on “early-adopter” case studies that demonstrate how labs can stop merely keeping pace to instead set new standards in innovation.
Speaker Highlights: Driving Financial and Operational Resilience
Among the key thought leaders taking the podium are experts focused on the high-stakes intersection of clinical quality, workforce stability, and bottom-line profitability.
Walter McAndrew, MB(ASCP), SSGB, molecular diagnostics laboratory manager at MD Anderson Cancer Center
McAndrew will detail a high-impact case study on workforce stability. In an era of rampant burnout and reliance on expensive traveler staff, McAndrew will demonstrate how MD Anderson re-engineered its molecular operations to better drive measurable quality while simultaneously reducing costs.
Jonathan Burgart, director of US marketing at Abbott Core Diagnostics
Burgart is set to challenge the “cost-center mindset” that plagues many hospital-based laboratories. His session will provide a strategic framework for hospital executives to use excess capacity and operational data to improve operating margins and net income.
Christina Olesnycky and Syed T. Hoda, MD, NYU Langone Health
Leading the shift toward high-volume automation, the two speakers will share the roadmap NYU Langone used to achieve a full digital pathology workflow in just one year. Their presentation will highlight how pathology at scale accelerates diagnosis and provides a necessary foundation for AI-enabled innovation.
Stefanie Davidson, laboratory director at Foundation Health
Davidson will share proven workforce strategies that help laboratories break their dependency on temporary staffing and achieve long-term operational stability.
Executive War College 2025. Photo credit: EWC
Why It Matters for Lab Leaders
The 2026 program arrives at a critical strategic tipping point as laboratories move from a period of regulatory uncertainty into a year of mandatory execution. With the expiration of legislative moratoriums on PAMA reporting and the shift toward a post-LDT ruling reality, the margin for operational error has effectively disappeared. This year’s sessions move beyond high-level theory to address the hurdles of 2026: navigating the “regulatory cliff,” defending shrinking margins against a surge in federal audit activity, and transitioning AI and digital pathology from expensive pilot projects into essential, everyday workflows.
“The laboratory has the potential to reframe its role in the healthcare system,” noted Burgart, emphasizing that this year’s sessions will provide the specific financial and operational blueprints required to turn regulatory challenges into a sustainable competitive advantage.
About the Event
The 31st Annual Executive War College will be held at the Hyatt Regency New Orleans. It remains the largest gathering of lab and pathology leaders focused exclusively on the business and management of diagnostic medicine.
This article was created with the assistance of Generative AI and has undergone editorial review before publishing.
Experts share strategies to help clinical laboratories prepare for disruptions, protect samples, and maintain testing operations during unexpected crises.
Laboratory crises rarely announce themselves in advance. They may begin with an after-hours phone call, a freezer alarm that fails to trigger, or a system outage that forces leaders to act before all the facts are known. In clinical laboratories, a crisis is not limited to catastrophic accidents. It can include any event that disrupts regulated operations or threatens staff safety—from equipment failures and power outages to cyber incidents, water damage, or supply chain breakdowns. For laboratory leaders, the central question is not whether disruptions will occur, but whether the lab is prepared when routine safeguards fail.
Effective preparation begins by identifying where failures could cascade across laboratory operations. Many labs track hazards, but fewer examine how a single breakdown could ripple through staffing, equipment, utilities, vendors, and data systems.
Jason Nagy, PhD, MLS (ASCP), lab safety support coordinator for Sentara Health, recommended starting with the earliest point of failure and working backward to identify mitigation steps. In practice, this type of analysis often reveals a common issue: staff uncertainty during emergencies. Written procedures alone rarely prepare laboratorians to respond under pressure, making drills and scenario-based training essential. (Photo credit: Sentra Health)
Cross-training is another critical safeguard. When only a few individuals know how to manage spill responses, downtime procedures, or emergency shutdowns, those employees quickly become overwhelmed while others hesitate to act.
Systems, Communication, and Leadership
Infrastructure reliability is another major factor in crisis resilience. Critical systems—including alarm monitoring, backup power, and environmental controls—must be tested regularly to ensure they function when staff are offsite. Durnan noted that many laboratories discover alarm failures only after equipment losses occur, such as freezer systems that fail over a weekend without notifying staff.
Supply redundancy can also determine whether labs preserve irreplaceable materials. During a building flood that disrupted liquid nitrogen deliveries, Durnan’s lab avoided sample loss because a backup supply tank was already in place.
When disruptions occur, leadership coordination becomes essential. Nagy described how Sentara Health activates an incident command center during emergencies, bringing together couriers, receiving labs, and leadership to quickly coordinate decisions such as specimen rerouting and operational adjustments.
Even with preparation, uncertainty remains inevitable. Nagy emphasized the importance of contingency planning, noting that laboratories should always have multiple fallback strategies when normal workflows break down.
For clinical laboratory leaders, the broader takeaway is that resilience must be built into everyday operations. Training, infrastructure testing, cross-training, and well-defined communication structures help ensure laboratories can protect staff, preserve samples, and maintain testing services when unexpected disruptions occur.
This article was created with the assistance of Generative AI and has undergone editorial review before publishing.
New funding will help Vitestro expand clinical validation, scale manufacturing, and prepare its autonomous blood-draw technology for broader hospital and laboratory adoption.
Vitestro has secured $70 million in oversubscribed Series B financing to accelerate development and commercialization of its Aletta Autonomous Robotic Phlebotomy Device (ARPD), a platform designed to automate routine blood collection in clinical settings.
In March 2025, The Dark Reportreported on Vitestro’s development of the ARPD—one of the last manual steps in the laboratory testing workflow. The company had recently received CE mark approval in Europe and reported clinical trial results showing a 95% first-stick success rate and strong patient acceptance, positioning the technology as a potential solution to phlebotomy staffing shortages and pre-analytical variability in clinical laboratories.
For clinical laboratory leaders facing persistent staffing shortages and rising specimen volumes, the investment highlights growing industry interest in automating one of healthcare’s most common clinical procedures.
“Closing our Series B financing reflects strong conviction in our mission to establish a new standard in autonomous robotic venous access and diagnostic blood collection,” said Toon Overbeeke, chief executive officer and co-founder of Vitestro. “Diagnostic blood collection remains the highest-volume invasive medical procedure globally, with billions of procedures performed annually.” (Photo credit: Vitestro)
Vitestro plans to use the capital to advance the next generation of its Aletta platform, conduct additional clinical studies, and scale manufacturing as the company prepares for broader commercial rollout in Europe and eventual entry into the United States through the FDA’s de novo regulatory pathway.
The Aletta system combines multimodal imaging, robotics, and artificial intelligence to autonomously identify veins, guide needle insertion, and collect blood samples with high precision. The platform is designed to perform routine diagnostic blood draws, potentially helping laboratories standardize collection quality while reducing human-dependent variability.
For laboratory executives, the technology could offer a new strategy to stabilize phlebotomy operations as workforce shortages persist. By automating routine blood draws, robotic platforms like Aletta may allow organizations to improve workflow predictability, support existing staff, and maintain patient throughput in high-volume outpatient settings.
A forthcoming issue of The Dark Report will feature interviews with Vitestro executives and provide deeper analysis of what autonomous robotic phlebotomy could mean for clinical laboratories, including its potential impact on staffing, workflow efficiency, and specimen quality.
New LinkedIn data highlights workflow optimization, compliance, and clinical laboratory testing as fast-growing skills shaping the future of lab careers.
LinkedIn’s latest “Skills on the Rise” report offers fresh insight into how the healthcare workforce is evolving—and clinical laboratory professionals are directly impacted. The ranking, based on year-over-year growth in skill acquisition and hiring success, reflects real-time labor market demand between December 2024 and November 2025.
For laboratories facing staffing shortages, reimbursement pressure, and expanding test volumes, the findings reinforce a clear message: Technical expertise alone is no longer enough.
Operational Excellence and Compliance Take Center Stage
The No. 1 fastest-growing skill, Workflow Optimization, underscores mounting pressure on labs to improve efficiency across specimen processing, documentation, scheduling, and result reporting. As automation expands and margins tighten, laboratory managers are expected to streamline operations while maintaining quality and turnaround times.
Standards Compliance (No. 4) further highlights the regulatory realities labs operate within. With ongoing scrutiny around billing practices, data privacy, and quality systems, laboratorians must be fluent in compliance frameworks and documentation standards. Strong governance is no longer confined to the quality department; it is becoming a core competency across the laboratory workforce.
Photo credit: LinkedIn
Clinical Laboratory Testing itself ranked No. 7, which signals sustained demand for professionals skilled in analyzing blood, urine, and tissue samples for disease detection and monitoring. Growth in this skill aligns with rising diagnostic utilization driven by chronic disease prevalence, aging populations, and precision medicine initiatives.
Soft skills are gaining equal weight. Cross-Functional Communication (No. 2) reflects the increasing integration of laboratories within broader health systems. Lab professionals must collaborate effectively with physicians, nurses, IT teams, and administrators to ensure accurate test utilization, minimize errors, and support value-based care goals.
The appearance of Report Preparation (No. 10) points to another expanding expectation: turning complex clinical and operational data into actionable insights. As health systems rely more heavily on laboratory metrics to guide strategic decisions, professionals who can organize and present compliant, high-quality data will hold a competitive advantage.
Taken together, the report signals a shift in how laboratory expertise is defined. Tomorrow’s most competitive lab professionals will pair strong technical knowledge with operational savvy, regulatory fluency, data literacy, and communication skills—positioning the laboratory as a strategic driver of clinical and financial performance.
High negative predictive value and real-time insights make donor-derived cell-free DNA testing a strategic addition to molecular diagnostic menus.
A new blood test that measures donor-derived cell-free DNA (dd-cfDNA) is reshaping post-transplant surveillance by offering clinical laboratories a powerful, noninvasive tool to detect organ injury earlier than traditional methods.
The assay enables physicians to monitor graft health through a blood draw—potentially reducing reliance on invasive tissue biopsies and allowing for more timely intervention. The research was outlined in a recent article published by the College of American Pathologists, “Utilizing Cell-Free DNA Technologies for Clinically Significant Biomarkers in Solid Organ Transplantation,” about the clinical application of cell-free DNA technologies in solid organ transplantation.
“This new test functions as an early warning system, providing real-time insight into transplant health using a simple blood draw,” shares co-author Julianne Szczepanski, MD, FCAP, clinical instructor, Pathology, University of Michigan Health. (Photo credit: University of Michigan Health)
For lab professionals, dd-cfDNA represents a meaningful advance in transplant diagnostics. When cells from a transplanted organ are injured—whether due to rejection, infection, or ischemia—they release fragments of donor DNA into the recipient’s bloodstream. Quantifying these fragments provides a dynamic biomarker of graft injury. In stable patients, donor-derived DNA levels remain low. Rising levels, however, may indicate early organ damage, often before clinical symptoms or traditional markers become apparent. This creates an opportunity for laboratories to deliver actionable, real-time data that directly informs patient management decisions.
The clinical utility of dd-cfDNA testing is now supported by professional guidelines for kidney and heart transplant recipients. Studies demonstrate that the assay has a strong negative predictive value, meaning low dd-cfDNA levels can reliably rule out rejection. For laboratory directors and pathologists, this is significant because the findings show that high-confidence, rule-out testing can help reduce unnecessary biopsies, lower procedural risk, and decrease healthcare costs. At the same time, elevated results can identify patients who require closer surveillance, immunosuppression adjustments, or further diagnostic workup.
Broader Use Increases Demand for Lab Expertise
Importantly, while dd-cfDNA testing is highly sensitive to graft injury, it does not always specify the underlying cause. Elevated levels may reflect rejection, infection, or other forms of tissue damage, requiring correlation with clinical findings and additional testing. This reinforces the laboratory’s role not just in generating results, but in guiding interpretation and supporting multidisciplinary transplant teams.
Ongoing research aims to expand dd-cfDNA applications beyond kidney and heart transplantation to include liver and lung recipients. Investigators are also exploring refinements that could differentiate types of organ injury, further enhancing diagnostic specificity.
For clinical laboratories, dd-cfDNA testing underscores the expanding role of molecular diagnostics in precision transplant medicine—offering a scalable, patient-centered approach to graft monitoring that aligns with broader trends toward minimally invasive, data-driven care.
