News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Shutdown Puts RESULTS Act and Lab Relief on Hold Until Congress Reopens

The bipartisan RESULTS Act, designed to overhaul Medicare’s payment system for clinical laboratory testing, is on hold amid the ongoing government shutdown. With cuts of up to 15% set to hit 800 common lab tests in 2026, laboratory leaders warn that the delay threatens patient access and lab stability nationwide.

Efforts to reform how Medicare pays for clinical laboratory testing have hit a standstill as the ongoing federal government shutdown freezes legislative progress on Capitol Hill, delaying long-awaited relief for labs facing steep payment cuts in 2026.

The bipartisan Reforming and Enhancing Sustainable Updates to Laboratory Testing Services (RESULTS) Act—introduced in September by Senators Raphael Warnock (D-GA) and Thom Tillis (R-NC)—was gaining momentum as a fix to long-standing problems in the Medicare Clinical Laboratory Fee Schedule (CLFS). But with Congress largely at a standstill, the bill and several other healthcare measures are now in limbo, leaving labs anxious about their financial outlook heading into next year.

At stake are payment reductions of up to 15% for more than 800 commonly ordered laboratory tests, scheduled to take effect on January 1, 2026. Laboratory organizations warn that without swift action, the cuts could destabilize the nation’s diagnostic infrastructure, threaten patient access, and further weaken community and hospital outreach laboratories already strained by workforce shortages and inflation.

Organizations Pen Letter

In a letter sent to congressional leaders on October 30, more than two dozen healthcare and laboratory organizations, including the American Clinical Laboratory Association (ACLA), the College of American Pathologists (CAP), the American Hospital Association (AHA), and the American Medical Association (AMA), urged Congress to pass the RESULTS Act to “protect patient access to clinical laboratory services.”

“Timely access to innovative clinical laboratory tests is critical to the prevention, early detection, therapy selection, and effective management of chronic and life-threatening diseases,” the coalition wrote. “Without action, around 800 laboratory tests will be subject to payment cuts of up to 15% on January 1, 2026, threatening patient access to routine and life-saving diagnostics.”

The letter highlights a decade-long problem stemming from the Protecting Access to Medicare Act (PAMA) of 2014. That law aimed to align Medicare reimbursement with private market rates but relied on limited data reporting—less than 1% of lab data nationwide—resulting in artificially low payment rates. In its first three years alone, PAMA implementation cut nearly $4 billion from the CLFS. Congress has since delayed those cuts five times, but advocates say temporary fixes are no longer sustainable.

“The time for permanent reform is now,” the coalition urged.

Shutdown Leaves Critical Medicare Lab Payment Fix Hanging in the Balance

The RESULTS Act seeks to overhaul the payment process to ensure rates reflect the full diversity of the laboratory market, including independent, hospital outreach, and physician office laboratories. It would reduce administrative burdens on both labs and the Centers for Medicare & Medicaid Services (CMS), cap annual payment reductions at 5% instead of 15%, and extend data reporting cycles to every four years. The bill would also empower CMS to work with an independent third party to collect more representative market data and make rates subject to administrative or judicial review.

Supporters say these reforms would promote innovation and stabilize Medicare reimbursement. Industry groups agree that without reform, continued cuts could push smaller community and regional labs, particularly those serving rural or underserved populations, to close their doors.

ACLA president Susan Van Meter underscored the importance of laboratories in guiding medical decisions. “Clinical laboratories deliver essential information that individuals need to better understand their own health status, while also serving as the backbone of our healthcare system, providing the results that inform 70% of medical decisions,” she said.

ACLA president Susan Van Meter noted, “As our industry continues to innovate and tailor healthcare solutions through personalized medicine, the RESULTS Act is a critical step to safeguard access to these life-saving tools, reinforce our healthcare infrastructure, and support continued innovation in laboratory medicine.” (Photo credit: ACLA)

However, with the government shutdown halting normal committee business and delaying budget negotiations, the RESULTS Act—along with various other bipartisan healthcare bills—remains stuck in legislative limbo. For laboratory leaders, that means more uncertainty and a narrowing window for action before the 2026 cuts take effect.

The coalition letter concluded, “We stand ready to help advance the RESULTS Act to achieve fundamental reform of the flawed Medicare clinical laboratory payment system.”

—Janette Wider

Public Trust in CDC Falls to Record Low, Opening Door for Labs to Lead Local Health Response

A new KFF poll shows Americans’ trust in the CDC has dropped to its lowest point since COVID-19, creating an opportunity for clinical laboratories to become trusted local voices in public health.

An article from CIDRAP recently reported that public trust in the Centers for Disease Control and Prevention (CDC) has fallen to its lowest level since the start of the COVID-19 pandemic, according to a KFF poll. The decline comes amid renewed misinformation about vaccines and autism and reflects growing skepticism toward the agency from both sides of the political spectrum.

The survey, conducted September 23–29 among more than 1,300 adults, found that only 18% of respondents have “a great deal” of trust in the CDC to provide reliable vaccine information, and 32% have “a fair amount.” That means just half of Americans have at least some trust in the CDC—down from 63% in 2023 and 57% as recently as mid-2025.

The findings followed remarks by President Donald Trump linking acetaminophen use in pregnancy to autism and calling for the measles, mumps, and rubella (MMR) vaccine to be split into three separate shots, claims that lack scientific evidence.

The erosion of trust, however, extends beyond political statements. While conservatives have long viewed the CDC with suspicion over perceived government overreach during COVID-19, many liberals now express frustration with what they see as inconsistency and political influence within the agency.

Higher Trust in Professional Medical Organizations

Interestingly, trust remains higher in professional medical organizations. Sixty-nine percent of parents polled said they trust the American Academy of Pediatrics, and 64% said they trust the American Medical Association.

“It’s encouraging, if far from ideal, that as trust in our nation’s scientific agencies crumbles, the public does trust the professional associations who have stepped forward,” said KFF president and CEO Drew Altman, PhD, in the organization’s press release. (Photo credit: KFF)

Support for Health and Human Services Secretary Robert F. Kennedy Jr. and his “Make America Health Again” (MAHA) movement was also low, with 62% disapproving of his handling of vaccine policy and 59% disapproving of his overall job performance.

What Labs Can Do

Amid this erosion of trust in federal health leadership, local clinical and public health laboratories may be poised to fill an emerging gap. Because labs are often the first to detect spikes in testing volume or positive results, they have a front-line view of disease trends—sometimes days or weeks before such patterns are visible nationally. If skepticism toward the CDC continues to grow, local labs could play an increasingly vital role in identifying and communicating outbreaks, especially during flu season or in the event of a new respiratory virus surge.

Beyond surveillance, labs can also help rebuild confidence in science by engaging their communities directly. Educational outreach, transparent data sharing, and collaboration with local healthcare providers can position laboratories as trusted sources of public health information, at a time when trust in national institutions is faltering.

As the CDC works to rebuild its credibility, laboratories across the country have a unique opportunity to step into the information void by translating data into understanding, and helping restore the link between diagnostics, public awareness, and trust in science.

This article was created with the assistance of Generative AI and has undergone editorial review before publishing.

—Janette Wider

Global AMR Crisis Deepens, WHO Calls on Labs to Strengthen Data and Diagnostics

Drug-resistant infections are outpacing treatments, and WHO says laboratory leaders are vital to protecting antibiotic effectiveness.

For laboratory leaders, the latest WHO report on antimicrobial resistance (AMR) underscores just how critical diagnostic testing, data accuracy, and surveillance capacity have become in the global fight against drug-resistant infections. With one in six bacterial infections now resistant to antibiotics, labs stand on the front lines. They are responsible not only for detecting resistant strains but also for generating the data that informs national and international response strategies.

According to a press release, the “Global antibiotic resistance surveillance report 2025”warns that between 2018 and 2023, “antibiotic resistance rose in over 40% of the pathogen-antibiotic combinations monitored,” with “an average annual increase of 5–15%.”

Data from over 100 countries reported to the WHO Global Antimicrobial Resistance and Use Surveillance System (GLASS) show that growing resistance to essential antibiotics “poses a growing threat to global health.” For the first time, the report presents “resistance prevalence estimates across 22 antibiotics used to treat infections of the urinary and gastrointestinal tracts, the bloodstream and those used to treat gonorrhea.” It examines eight common bacterial pathogens—Acinetobacter spp., Escherichia coli, Klebsiella pneumoniae, Neisseria gonorrhoeae, non-typhoidal Salmonella spp., Shigella spp., Staphylococcus aureus, and Streptococcus pneumoniae—each linked to these major infections.

Resistance Highest in South-East Asia and Eastern Mediterranean

WHO found that the “risk of antibiotic resistance varies across the world.” The highest resistance levels are in the WHO South-East Asian and Eastern Mediterranean Regions, “where 1 in 3 reported infections were resistant.” In the African Region, “1 in 5 infections was resistant.”

According to the report, resistance “is also more common and worsening in places where health systems lack capacity to diagnose or treat bacterial pathogens.”

“Antimicrobial resistance is outpacing advances in modern medicine, threatening the health of families worldwide,” said Tedros Adhanom Ghebreyesus, PhD, WHO director-general.

Tedros Adhanom Ghebreyesus, PhD, WHO director-general noted, “As countries strengthen their AMR surveillance systems, we must use antibiotics responsibly, and make sure everyone has access to the right medicines, quality-assured diagnostics, and vaccines. Our future also depends on strengthening systems to prevent, diagnose and treat infections and on innovating with next-generation antibiotics and rapid point-of-care molecular tests.” (Photo credit: WHO)

Gram-Negative Bacteria Present the Greatest Threat

The WHO report highlights that drug-resistant Gram-negative bacteria are becoming increasingly dangerous worldwide, with the heaviest impact seen in countries least equipped to manage the threat. Among these pathogens, E. coli and K. pneumoniae remain the most common causes of drug-resistant bloodstream infections—serious conditions that can lead to sepsis, organ failure, and death.

Globally, resistance to third-generation cephalosporins—the standard treatment for these infections—has climbed above 40% for E. coli and 55% for K. pneumoniae, and in parts of Africa, it exceeds 70%. Other essential antibiotics, including carbapenems and fluoroquinolones, are also losing effectiveness against E. coli, K. pneumoniae, Salmonella, and Acinetobacter. Once rare, carbapenem resistance is now emerging more frequently, reducing available treatment options and forcing reliance on last-resort antibiotics that are expensive, difficult to obtain, and often unavailable in low- and middle-income countries.

Progress in Surveillance but Major Gaps Remain

Despite these concerning trends, the report noted progress in global surveillance.

“Country participation in GLASS has increased over four-fold, from 25 countries in 2016 to 104 countries in 2023.” However, challenges persist: “48% of countries did not report data to GLASS in 2023,” and “about half of the reporting countries still lacked the systems to generate reliable data.” Many nations facing the highest burden of resistance “lacked the surveillance capacity to assess their antimicrobial resistance (AMR) situation.”

The report links its findings to the “political declaration on AMR adopted at the United Nations General Assembly in 2024,” which set global targets for combating antimicrobial resistance.

The declaration emphasizes strengthening health systems and working with a ‘One Health’ approach coordinating across human health, animal health, and environmental sectors.

WHO is calling on countries to strengthen laboratory systems and build reliable surveillance networks, particularly in underserved regions, to better guide treatment decisions and public health policies. The organization has set a goal for all nations to submit high-quality data on antimicrobial resistance and antibiotic use to the GLASS platform by 2030. Achieving this target will require coordinated efforts to improve data quality, expand geographic coverage, and enhance information sharing. WHO also encourages countries to implement comprehensive strategies to address antimicrobial resistance across all levels of healthcare and to ensure that treatment guidelines and essential medicines lists reflect local resistance trends.

The report is accompanied by expanded digital content available in the WHO’s GLASS dashboard, offering global and regional summaries, country profiles based on unadjusted surveillance coverage and AMR data, and detailed information on antimicrobial use.

With resistance trends worsening across regions, laboratory leaders are pivotal to turning the tide on AMR. Expanding diagnostic capabilities, improving data quality, and sharing timely resistance information will be key to shaping effective treatment guidelines and national policies. By advancing surveillance and stewardship from within the lab, clinical professionals can help preserve the power of antibiotics for future generations.

This article was created with the assistance of Generative AI and has undergone editorial review before publishing.

—Janette Wider

Medical Laboratory Personnel Shortage Relief Act Reintroduced to Combat Workforce Crisis

Lawmakers are renewing efforts to tackle the national clinical lab staffing crisis with the reintroduction of the Medical Laboratory Personnel Shortage Relief Act of 2025, a bipartisan bill that would expand training grants and loan forgiveness programs to strengthen the medical laboratory workforce.

Efforts to address the nation’s clinical laboratory staffing crisis have regained momentum with the reintroduction of the Medical Laboratory Personnel Shortage Relief Act of 2025. The bipartisan legislation, introduced by Rep. Jen Kiggans (R-VA-02) and Rep. Deborah Ross (D-NC-02), seeks to bolster recruitment and retention across a profession facing severe shortages.

According to a September press release from Kiggans and Ross, the bill is designed to “address the nationwide shortage of clinical laboratory professionals” by expanding eligibility for the National Health Service Corps (NHSC) to include medical laboratory personnel and establishing new federal grants for accredited colleges and universities to train future lab workers.

“Across the country, clinical laboratories face vacancy rates as high as 25%,” the release stated. “These shortages strain healthcare delivery, lead to longer wait times for patients, and contribute to burnout among existing lab staff.” The lawmakers noted that laboratory professionals are essential to healthcare operations, as “doctors depend on the diagnostic work done by laboratory professionals for nearly 70% of their medical decisions.”

“As a nurse practitioner, I know that access to quality healthcare depends on having the right professionals in place at every level,” said Congresswoman Kiggans in the press release. “That’s why I’m proud to join Congresswoman Deborah Ross on the Medical Laboratory Personnel Shortage Relief Act. This important legislation will add medical laboratory professionals to the National Health Service Corps and provide grants to accredited institutions to train more laboratory scientists and technicians.

Rep. Jen Kiggans (R-VA-02) said, “Our nation faces a severe shortage of clinical laboratory professionals—a problem that will only worsen as our population ages. Without enough trained experts, our clinical labs cannot keep pace with the growing demand and complexity of medical testing, which is essential for diagnosing and treating patients. Investing in our medical laboratory workforce strengthens our health system, supports patients, and ensures we are prepared to meet future challenges.” (Photo credit: https://kiggans.house.gov/)

Medical Laboratory Personnel Shortage Relief Act of 2024

The proposal is built upon the Medical Laboratory Personnel Shortage Relief Act of 2024, introduced the previous year before the November elections, as reported by G2 Intelligence. The updated version continues provisions that would amend the Public Health Service Act (42 U.S.C. 254e) to direct the Health and Human Services Secretary to identify areas suffering from shortages of qualified laboratory professionals and deploy NHSC members to those locations.

The act would also establish a Medical Laboratory Personnel Education Program, operated through grants and contracts awarded to accredited nonprofits, allied health schools, and hospitals. These funds would expand training capacity, support internships required for certification, and help recruit qualified faculty which have been longstanding barriers to increasing the pipeline of lab professionals.

In an interview with G2 Intelligence, Jim Flanigan, CAE, executive vice president of the American Society for Clinical Laboratory Science (ASCLS), said the act offers two major advantages: “the establishment of a federal grant program that would allow educational programs to expand the number of students they can train at a given time” and the inclusion of laboratory professionals in the NHSC, which would make them eligible for student loan forgiveness. “Both efforts will help in attracting individuals to the lab career path,” he said.

Rodney Rohde, PhD, MS, SM(ASCP)CM, SVCM, MBCM, FACSC, chair and professor of clinical laboratory science at Texas State University, told G2 Intelligence that he “cannot overemphasize the impact that establishing a program for lab personnel loan repayment will have for building our pipeline in recruiting and retention of students interested in the medical laboratory major and career path.” He added, “Laboratory testing follows patients throughout their lives, from cradle to grave, and it drives about two-thirds of all medical decisions made by doctors and other healthcare professionals.”

Despite the strong backing from organizations such as ASCLS, the Association for Diagnostics and Laboratory Medicine, and the American Clinical Laboratory Association, the bill’s path forward remains uncertain amid fiscal restraint on Capitol Hill. “All programs that incur significant costs are going to face challenges in getting passed,” Flanigan noted.

Still, as G2 Intelligence reported, supporters see the act as a vital “investment in our public health and our invaluable laboratory workforce.”

—Janette Wider

Infectious Disease Management Gets Big Boost With $37.5m Grant

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.

—Kristin Althea O’Connor

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