Seventy-five healthcare systems will benefit from NETEC’s gift, applications open.
Infectious disease management is getting a significant lift, on October 15, 2025 the National Emerging Special Pathogens Training and Education Center (NETEC) announced their $37.5m grant aimed at High-Consequence Infectious Diseases (HCID), a NETEC press release announced. Labs working with High-Consequence Pathogen and Pathology will find this increased area of focus relevant and may look to encourage their employers apply to become one of the 75 facilities that will receive the grant in the US.
The grant, funded by the Administration for Strategic Preparedness and Response (ASPR) is slated to provide or upgrade the chosen 75 healthcare facilities within the US with a Level 2 Special Pathogen Systems (NSPS) status, NETEC added.
Selected hospitals will “receive up to $500,000 each to improve critical infrastructure, conduct staff training, and obtain specialized equipment aligned with NSPS Level 2 requirements,” according to the American Hospital Association (AHA).
“Level 2 centered are the backbone of a resilient, skilled response to special pathogen threats,” Shelly Schwedhelm, MSN, RN, NEA-BC, Executive Director of NSPS told NETEC. (Photo credit: UNMC)
“This initiative accelerates our mission to develop top tier care closer to communities nationwide while strengthening protective measures for our healthcare workers,” Shelly Schwedhelm, executive director of NSPS, told NETEC. The grant comes by way of the NSPS Level 2 Special Pathogen Treatment and Network Development (STAND) Award.
Positive Focus & Raising the Bar
The union of emergency providers and public health partners is crucial for disease maintenance, and NETEC’s vision paired with the grant aims to “provide safe, high-quality care during HCID outbreaks,” the press release noted.
Facilities moving into Level 2 status set the tone for more specialized care. These facilities are “specialized treatment centers that care for patients throughout the duration of illness,” the NETEC noted. To help facilities achieve this status is significant, John Lowe, PhD, NETEC co-principal investigator at University of Nebraska Medical Center, told NETEC. “This grant provides indispensable support for facilities striving to meet NSPS standards—from infrastructure upgrades to advanced training—making readiness both realistic and sustainable,” he commented.
The Importance of HDICs
HDICs, defined by the NETEC as having “high death rates and intense illnesses with limited remedies available,” are important to tackle for reasons beyond the obvious, NETEC noted.
“HDICs pose a significant threat to domestic and global security…some can be used as bioterrorism agents,” the Centers for Disease Control (CDC) noted on their site. They added that many HDICs spread from animals to humans and are contagious.
Looking Ahead
“We have a vision of a future with fewer infections and less suffering caused by high-consequence pathogens and disabling illnesses of unexplained causes,” CDC stated.
How to Apply
Labs interested in applying for the grant must have their employer submit proposals by 12/2/2025. Eligible hospitals must be in the US and offer inpatient services, emergency departments and critical care ability, as well as have airborne infection isolation capability. Both federal facilities and those already at Level 1 are not eligible.
Trifecta of forces at work that will affect the clinical laboratory and pathology industries have been described as a ‘perfect storm’ requiring lab and practice managers to be well informed
Digital pathology, artificial intelligence (AI) in healthcare, and the perfect storm of changing federal regulations, took centerstage at the 29th Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management in New Orleans this week, where more than 1,000 clinical laboratory and pathology leaders convened over three days.
This was the largest number of people ever onsite for what has become the world’s largest event focused exclusively on lab management topics and solutions. Perhaps the highlight of the week was the federal Food and Drug Administration’s (FDA’s) announcement of its final rule on Laboratory Developed Tests (LDTs). Overall, the conference featured more than 120 speakers, many of them national thought leaders on the topic of clinical lab and pathology management. More than 65% of the audience onsite were executive level lab managers.
“The level of interest in the annual Executive War College is testimony to the ongoing need for dynamic, engaging, and highly relevant conference events,” said Robert Michel (above), Editor-in-Chief of Dark Daily and its sister publication The Dark Report, and founder of the Executive War College. “These in-person gatherings present great opportunities for clinical laboratory and pathology managers and leaders to network and speak with people they otherwise might not meet.” (Photo copyright: Dark Intelligence Group.)
Demonstrating Clinical Value
For those who missed the action onsite, the following is a synopsis of the highlights this week.
Lâle White, Executive Chair and CEO of XiFin, spoke about the future of clinical laboratory testing and the factors reshaping the industry. There are multiple dynamics impacting healthcare economics and outcomes—namely rising costs, decreasing reimbursements, and the move to a more consumer-focused healthcare. But it is up to labs, she said, to ensure their services are not simply viewed as a commodity.
“Laboratory diagnostics have the potential to change the economics of healthcare by really gaining efficiencies,” she noted. “And it’s up to labs to demonstrate clinical value by helping physicians manage two key diagnostic decision points—what tests to order, and what to do with the results.”
But even as labs find ways to increase the value offered to clinicians, there are other disruptive factors in play. Consumer-oriented tech companies such as Google, Apple, and Amazon are democratizing access to patient data in unforeseen ways, and Medicare Advantage plans are changing the way claims are processed and paid.
Clinical labs are fundamental components of the public health infrastructure. So, the CDC plans on focusing on delivering high-quality laboratory science, supported by reliable diagnostics and informatics for disease outbreaks and exposures, and engaging with public and private sector partners.
The history of MolDX and Z-Codes were the topics discussed by Gabriel Bien-Willner, MD, PhD, Chief Medical Officer for healthcare claims and transaction processing company Palmetto GBA. Molecular testing is highly complex, and the lack of well-defined billing codes and standardization makes it difficult to know if a given test is reasonable and necessary.
Z-Codes were established to clarify what molecular testing was performed—and why—prompting payers to require both Z-Codes and Current Procedural Terminology (CPT) codes when processing molecular test claims. Medicare’s MolDX program further streamlines the claims process by utilizing expertise in the molecular diagnostics space to help payers develop coverage policies and reimbursement for these tests.
FDA Final Rule on LDT Regulation
Timothy Stenzel, MD, PhD, CEO of Grey Haven Consulting and former director of the FDA’s Office of In Vitro Diagnostics reviewed the latest updates from the FDA’s Final Rule on LDT (laboratory developed test) regulation. Prior to the FDA releasing its final rule, some experts suggested that the new regulations could result in up to 90% of labs discontinuing their LDT programs, impacting innovation, and patient care.
However, the final rule on LDTs is very different from the original proposed rule which created controversy. The final rule actually lowers the regulatory burden to the point that some labs may not have to submit their LDTs at all. The FDA is reviewing dozens of multi-cancer detection assays, some of which have launched clinically as LDTs. The agency is likely to approve those that accurately detect cancers for which there is no formal screening program.
Stenzel explained the FDA’s plan to down-classify most in vitro diagnostic tests, changing them from Class III to Class II, and exempting more than 1,000 assays from FDA review. He also discussed the highlights of the Quality Management System Regulation (QMSR). Launched in January, the QMSR bought FDA requirements in line with ISO 13485, making compliance easier for medical device manufacturers and test developers working internationally.
Looming Perfect Storm of Regulatory Changes
To close out Day 1, Michel took to the stage again with a warning to clinical laboratories about the looming “Perfect Storm” trifecta—the final FDA ruling on LDTs, Z-Code requirements for genetic testing, and updates to CLIA ’92 that could result in patient data being considered a specimen.
Laboratory leaders must think strategically if their labs are to survive the fallout, because the financial stress felt by labs in recent years will only be exacerbated by macroeconomic trends such as:
Staff shortages,
Rising costs,
Decreasing and delayed reimbursements, and
Tightening supply chains.
Lab administrators looking for ways to remain profitable and prosperous should look beyond the transactional Clinical Lab 1.0 fee-for-service model and adopt Clinical Lab 2.0, which embraces HEDIS (Healthcare Effectiveness Data and Information Set) scores and STAR ratings to offer more value to Medicare Advantage and other payers.
Wednesday’s General Session agenda was packed with information about the rise of artificial intelligence, big data, and precision medicine in healthcare. Taking centerstage on the program’s final day was Michael Simpson, President and CEO of Clinisys. Simpson gave a global perspective on healthcare data as the new driver of innovation in diagnostics and patient care.
As chronic disease and aging populations strain the UK’s medical systems, staffing shortages at pathology laboratories contribute to lengthening delays of critical diagnostic services
In the United Kingdom (UK), pathologists and other physicians are going public with their concerns that a growing shortage of pathologists and medical laboratory scientists will soon contribute to delays in performing the lab tests needed to diagnose patients—particularly those with cancer—and identify which therapies will work best for them.
Thanks to vast improvements to both medical laboratory capabilities and treatment options, the cancer survival rate in the UK doubled over the past four decades. However, early diagnosis is a critical component to a successful outcome. As further strain is placed on medical laboratories and diagnostic providers, wait times continue to increase beyond the thresholds created by the UK’s National Health Service (NHS).
Latest calls for easier public access to information on physician performance and quality is a reminder to clinical laboratories and pathology groups of the trend to greater transparency on provider outcomes
If any clinical laboratory executive or pathologist still doubts that more transparency of provider outcomes is a topic of interest to patients, they have only to look at Consumer Reports, well-respected for its advocacy on behalf of consumers. Consumer Reports is using multiple ways to educate their readers about medical errors and how the medical community makes it difficult for consumers to learn about physicians who have been involved in state medical board investigations.
