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July 16, 2025
The ASCP 2025 Annual Meeting is only four months away, Nov. 17-20 in Atlanta, GA. Renowned for its distinguished faculty, whose knowledge and expertise help prepare pathologists and clinical laboratory professionals to make a significant impact on patient care, the ASCP 2025 Annual Meeting is your chance to elevate your knowledge for better patient care.
Here is a preview of some key presentations and their faculty.
Laboratory-Developed Tests (LDTs)—Future Directions and Lessons Learned
With the recent federal court ruling vacating the Food and Drug Administration’s (FDA) LDT Final Rule, many in the laboratory community wonder what is next.
Presenters Jonathan R. Genzen, MD, PhD, MBA, and Michelle Campbell, MS, MLS(ASCP)CMMBCMSCCM, will reflect on recent events and what the laboratory community has learned from its experiences in preparing for the now-vacated FDA LDT Final Rule. What are the lessons learned and best practices as the laboratory community prepares to move forward? How can laboratories better prepare for future regulatory oversight frameworks?
Dr. Genzen is the chief medical officer and senior director of government affairs at ARUP Laboratories, and professor of pathology at the University of Utah, and Ms. Campbell is the senior developer for the Translational Research, Innovation and Test Development Office at Mayo Clinic, and adjunct assistant professor at the University of North Carolina at Chapel Hill.
Emerging and Reemerging Pathogens: An Update
Rodney Rohde, PhD, MS, SM(ASCP)CMSVCMMBCM, will focus on current and evolving threats in infectious diseases, including pathogens, such as SARS-CoV-2, mpox, pertussis, and antimicrobial-resistant organisms. He will also highlight global trends, diagnostic innovations, and the implications of public health challenges such as vaccine hesitancy and misinformation.
This session is intended for medical laboratory scientists, pathologists, infectious disease specialists, and public health professionals, essentially anyone working at the intersection of diagnostics and disease prevention. His goal is to equip attendees with practical knowledge and a broader understanding of how these pathogens are reshaping our workflows, biosafety protocols, and the role of the laboratory in early detection and response.
“It’s a timely topic, and I aim to both inform and empower laboratory professionals as frontline defenders in global and community health,” says Dr. Rohde, associate director for the Translational Health Research Initiative at Texas State University, in San Marcos, TX, where he is also the College of Health Professions chair and Distinguished Regents' Professor of Clinical Laboratory Science.
Cancer Biomarker Testing Navigation: Bridging Gaps to Achieve Optimal Patient Outcomes
This session focuses on a novel new Biomarker Testing Navigation (BTN) role and ASCP's online certificate program for cancer biomarker navigation. The expert panel, which includes Lynnette Pineault, MBA, SCT(ASCP), manager of Laboratory Operations and Genetic Counseling Services HealthPartners – Regions Hospital in St. Paul, MN, will highlight how biomarker navigation can enhance laboratory workflows to ensure patients get timely access to life-saving targeted therapies. The session is intended for individuals who currently work in this space—laboratory professionals, pathologists, leaders and support staff—who are eager to optimize cancer biomarker testing.
“This topic is incredibly relevant today, as we navigate the rapid acceleration of precision medicine in cancer diagnosis and treatment,” Ms. Pineault says. “As the complexity of cancer biomarker testing increases, critical workflow gaps often emerge that can delay patient care. Biomarker navigation directly addresses these challenges, improving test turnaround, reducing errors, and ensuring patients receive personalized treatments quickly. It's a proactive solution to a pressing need in modern pathology.”
The panel comprises members of the current BTN Project Advisory Committee, which Ms. Pineault chairs. “We'll unveil the rationale and innovative design of the BTN role, share compelling real-world success stories from our own experiences, and provide practical insights into how BTNs improve coordination and diagnostic stewardship.” Ms. Pineault says.
The group will also introduce ASCP’s new virtual certificate program, Mastering Cancer Biomarker Testing Navigation.
Why ASCP 2025 is the premier annual meeting
The ASCP Annual Meeting stands out because of its unique integration of laboratory medicine, pathology, and public health, creating a truly interdisciplinary environment. It brings together not just scientists and clinicians, but also educators, policymakers, and innovators who are shaping the future of diagnostics and laboratory science.
“What I find especially compelling is ASCP’s deep commitment to both cutting-edge science and professional advocacy,” Dr. Rohde says. “The meeting doesn’t just focus on technical advances—it also highlights workforce development, health equity, global health, and the critical role of medical laboratory professionals in patient care.”
Unlike many other meetings, ASCP creates space for strategic conversations that bridge clinical practice with real-world implementation. Whether it’s antimicrobial resistance, diagnostic stewardship, or mentoring the next generation of laboratory professionals, ASCP is future-facing in a very actionable way.
Additionally, the energy and engagement of the attendees—particularly students and early-career professionals—is exceptional. It’s a community that values both legacy and innovation.
“Every year, I leave the meeting reenergized and proud to be part of this profession.” Dr. Rohde says. “It feels like a family reunion each and every time I’m working with ASCP and the outstanding experts and passionate laboratory professionals that compose the organization!”
Learn more and register here.
July 16, 2025
On July 14, the Centers for Medicare and Medicaid Services (CMS) released its Physician Fee Schedule (PFS) Proposed Rule for CY 2026. The proposed PFS, the first released under new U.S. Health and Human Services Secretary Robert F. Kennedy, Jr., outlines major changes in the methodology used by CMS to reimburse physicians for their services. In addition, CMS is proposing the creation of a new MIPS Value Pathway for pathology. The proposal includes a modest increase in payment rates.
CMS proposes to make several significant changes to its payment methodology for physician services, including:
Reducing the PFS work relative value units via a new efficiency adjustment based on the cost of the Medicare Economic Index
Declining to update PFS practice expense (PE) data as outlined in AMA’s Physician Practice Information survey
Increasing indirect practice expense costs for practitioners in office-based settings
Utilizing the Medicare Outpatient Prospective Payment System to set relative rates and inform cost assumptions for some technical services.
These changes will likely reduce the Medicare Relative Value Units used to calculate some physician payment rates.
As required by the Medicare Access and CHIP Reauthorization Act (MACRA), CMS is proposing two conversion factors, the multiplier used to adjust payment rates each year. Physicians who are qualifying participants (QPs) in advanced alternative payment models will receive a slightly higher conversion factor update of 0.75 percent, and hence a bigger increase in payment rates. Physicians who are not QPs will receive an update of 0.25 percent. The CY 2026 conversion factor also includes the 2.5 percent update just approved by Congress (see July ePolicy article, “President Signs Massive Tax and Budget Bill”) and an estimated +0.55 percent adjustment necessary to account for proposed changes in work RVUs for certain services. As a result, the total conversion factor increases 3.83 percent for QPs and 3.62 percent for non-QPs.
The proposed rule’s impact table, which provides a specialty-specific breakdown of the impacts on each specialty’s overall payments, projects that overall payments for pathologists will decline approximately 2 percent; however, CMS has made site of service data available indicating that overall payments will decline by 3 percent in facilities such as hospitals, and 2 percent in non-facilities, such as physician’s offices. Independent laboratories fared similarly, with a 3 percent reduction in overall payments, almost all of which CMS indicates is provided in non-facility settings. Depending on the services performed, pathologists may see a slight increase in overall payments of approximately 1percent.
Efficiency Adjustment: CMS is proposing to adopt a newly proposed “efficiency adjustment” as part of the PFS update process. CMS states in the rule that it has frequently relied on AMA Relative Value Scale Update Committee (AMA RUC) survey data to estimate practitioner time, work intensity, and practice expense, which are often reflected in the valuation of codes paid under the PFS. CMS maintains that AMA’s surveys have low response rates and that providers may have inherent conflicts of interest in responding (since their responses are used in setting their payment rates). As a result, the agency is proposing to reduce work relative value units equal to the sum of the past five years of the Medicare Economic Index (MEI) productivity adjustment. For CY 2026, this number would be 2.5 percent. In addition, CMS is proposing to make corresponding changes to the intraservice physician time for codes describing non-time-based services. According to the proposed rule, CMS is proposing to apply this to pathology, radiology, and surgical specialties; overall the impact on these specialties will be about -1 percent. The efficiency update would be applied every three years under CMS’s proposal.
Practice Expenses: In addition, CMS is proposing, for the same reason as the efficiency adjustment, a series of changes to how it calculates PFS Practice Expense costs. The Agency is proposing to reject the practice expense data or cost shares from the AMA’s most recent PPI and Clinician Practice Information (CPI) Survey data. Instead, CMS has “modeled estimated payment impacts of the data’s implementation,” which it has included in the proposed rule for public comment and consideration for future rulemaking.
In addition, CMS is proposing significant updates to its PE methodology. It is proposing to recognize greater indirect costs for practitioners in office-based settings compared to facility settings. CMS is also proposing to utilize data from “auditable, routinely updated hospital data (i.e., from the Medicare Outpatient Prospective Payment System to set relative rates and inform [its] costs assumptions for some technical services paid under PFS.” For CY 2026, CMS is proposing to start by using this data in setting rates for radiation treatment services, and for some remote monitoring services.
MIPS Value Pathways: CMS is proposing to adopt a new Merit-based Incentive Payment System (MIPS) Value Pathways (MVP) for pathology. The new pathway includes measures for quality, performance improvement and cost.
Quality: The Quality category utilizes existing MIPS Quality and Qualified Clinical Data Registry measures to create this part of the pathology MVP pathway.
The quality measures are as follows:
Q249: Barretts Esophagus
Q250: Radical Prostatectomy Pathology Reporting
Q395: Lung Cancer Reporting (Biopsy/Cytology Specimens)
Q396: Lung Cancer Reporting (Resection Specimens)
Q397: Melanoma Reporting
Q440: Skin Cancer: Biopsy Reporting Time – Pathologist to Clinician
Q491: Mismatch Repair (MMR) or Microsatellite Instability (MSI) Biomarker Testing Status
CAP30: Urinary Bladder Cancer: Complete Analysis and Timely Reporting
CAP34: Molecular Assessment: Biomarkers in Non-Small Cell Lung Cancer
CAP40: Squamous Cell Skin Cancer: Complete Reporting
QMM21: Incorporating results of concurrent studies into Final Reports for Bone Marrow Aspirate of patients with Leukemia, Myelodysplastic syndrome, or Chronic Anemia
QMM25: Use of Structured Reporting for Urine Cytology Specimens
QMM29: Use of Appropriate Classification System for Lymphoma Specimen
QMM30: Appropriate Use of Bethesda System for Reporting Thyroid Cytopathology on Fine Needle Aspirations (FNA) of Thyroid Nodule(s).
Performance Improvement: For this category, CMS is proposing including 13 improvement activities that reflect actions and processes undertaken by clinicians who specialize in pathology, as well as activities that promote advancing health and wellness, patient engagement and patient-centeredness, shared decision making, and care coordination. These measures are as follows:
IA_BE_6: Regularly Assess Patient Experience of Care and Follow Up on Findings
IA_BE_15: Engagement of Patients, Family, and Caregivers in Developing a Plan of Care
IA_BE_X: Promote Use of Patient-Reported Outcome Tools
IA_BMH_12: Promoting Clinician Well-Being
IA_CC_9: Implementation of practices/processes for developing regular individual care plans
IA_CC_12: Care coordination agreements that promote improvements in patient tracking across settings
IA_CC_19: Tracking of clinician’s relationship to and responsibility for a patient by reporting MACRA patient relationship codes
IA_MVP: Practice-Wide Quality Improvement in MIPS Value Pathways
IA_PSPA_1: Participation in an AHRQ-listed patient safety organization
IA_PSPA_2: Participation in MOC Part IV
IA_PSPA_12: Participation in private payer CPIA
IA_PSPA_13: Participation in Joint Commission Evaluation Initiative
IA_ PSPA_X: Adopt Certified Health Information Technology for Security Tags for Electronic Health Record Data
Cost Measures: CMS has proposed to include one MIPS cost measure within the cost performance category of this MVP:
MSPB_1: Medicare Spending Per Beneficiary (MSPB) Clinician (This MIPS cost measure applies to clinicians providing pathology care in inpatient hospitals).
In addition, CMS proposed to maintain the threshold to avoid a MIPS penalty of up to 9 percent at 75 points for the CY 2026 performance year/2028 MIPS payment year and through the CY 2028 performance year/2030 MIPS payment year.
ASCP is still in the process of reviewing the nearly 2,000-page regulation and will soon begin the process of developing a formal response to the agency’s proposals. ASCP will be reaching out to its advocacy partners on the rule, such as the American Medical Association and various pathology and clinical laboratory organizations with the hope of developing a coordinated, more impactful response to the Agency.
To access the Medicare Payment Advisory Commission’s “basics” on the three Medicare fee schedules mentioned in this article, see below:
Physician Fee Schedule (click here)
Clinical Laboratory Fee Schedule (click here)
Outpatient Prospective Payment System (click here)
July 14, 2025
Supreme Court Decision on USPSTF Produces Uncertainty
The Supreme Court upheld the constitutionality of the Affordable Care Act’s preventive services mandate and the U.S. Preventive Services Task Force (USPSTF) appointments, securing continued access to preventive care for patients. However, the ruling also gave the HHS Secretary the authority to remove USPSTF members and reject their recommendations, raising concerns about political interference and the Task Force’s scientific independence. ASCP and partner organizations are now evaluating the ruling’s implications for future preventive service recommendations and access. Read more.
President Signs Massive Tax and Budget Bill
President Trump’s One, Big Beautiful Bill Act (OBBB) has been signed into law, bringing sweeping changes to healthcare, student financial aid, and artificial intelligence policy. While the bill includes positive provisions like a Medicare Physician Fee Schedule increase and expanded 529 fund usage for credentialing programs, it also introduces concerning cuts to Medicaid, CHIP, and federal student loan programs, potentially impacting healthcare workforce development. ASCP and other medical societies have raised alarms about the bill’s potential to worsen healthcare access, student debt burdens, and physician shortages. Read more.
State of Science Address Calls for Radical Reform of STEM in the U.S.
In her State of Science address, National Academy of Sciences President Marcia McNutt warned that the U.S. is losing ground in global scientific leadership due to declining STEM investment, outdated policies, and regulatory burdens. She and fellow panelists called for major reforms, including streamlined regulations, modernized funding, and education initiatives to restore American competitiveness. ASCP supports these efforts through advocacy, workforce outreach, and its Institute for Science, Technology and Policy, promoting evidence-based policy and advancing laboratory medicine as a pillar of U.S. scientific leadership. Read more.
ASCP’s Leading Laboratories Recognition Program is Now Open to More Laboratories!
ASCP’s Leading Laboratories recognition program has expanded to include all hospital-based accredited laboratories in the U.S., beyond just those accredited by The Joint Commission. The program celebrates laboratories for leadership, mentorship, innovation, and their essential role in improving patient care, while also supporting recruitment and investment through public recognition of excellence. ASCP aims to raise awareness of the laboratory community and promote diagnostic excellence by offering more labs the opportunity to showcase their achievements and commitment to quality. Read more.
ASCP Voices Concern Over Disbanding of ACIP
On June 9, 2025, HHS Secretary Robert F. Kennedy Jr. dismissed all 17 members of the Advisory Committee on Immunization Practices (ACIP), raising serious concerns among health organizations, including ASCP, about the spread of misinformation and damage to public trust in vaccine science. The decision comes amid rising cases of preventable diseases and the appointment of some new committee members who lack relevant expertise or hold vaccine-skeptical views, risking a loss of scientific rigor and institutional memory. In response, ASCP joined a coalition of medical organizations in supporting an emergency AMA resolution demanding the reversal of the dismissals and a Senate investigation, underscoring its leadership in advocating for evidence-based vaccine policy. Read more.
Launching the Future of Laboratory Science: ASCP Campaign Targets Next-Gen Talent
ASCP and the Medical and Public Health Laboratory Workforce Coalition launched a national campaign to promote medical laboratory careers to students, educators, and counselors through email, social media, and educator publications. Centered around the message “Save Lives with Science,” the campaign aims to address critical lab staffing shortages by raising awareness of career pathways in laboratory medicine. Read more.
Ring Scholarship Expands Access Through Varied Outreach
ASCP recently closed the second year of applications for the Dr. Alvin Ring Empowerment Scholarship, which supports students from medically underserved or rural areas pursuing education in medical laboratory sciences. This year ASCP implemented targeted outreach strategies—such as engaging with science teachers, school counselors, and promoting the scholarship on public websites—which led to a 55% increase in eligible applications and 10 submissions from high school students. Read more.
Addressing Workforce Challenges: ASCP at the 2025 CMSS Workforce Summit
ASCP joined more than 20 medical societies at the 2025 CMSS workforce summit to address physician workforce challenges, including rural shortages, healthcare consolidation, and reliance on international medical graduates. ASCP reaffirmed its commitment to strengthening the pathology workforce through data-driven advocacy and career pathway development, led by the Institute for Science, Technology, and Policy. Read more.
Empowering New Lab Staff with Foundational Skills
ASCP has launched a free eLearning series, “Basic Medical Laboratory Skills,” offering beginner-friendly, CMLE-accredited courses on foundational laboratory topics such as safety, terminology, math, equipment, procedures, and quality control. Designed by ASCP experts to support lab directors and new team members, the series helps ease the burden of on-the-job training and provides practical, case-based learning for those entering or refreshing their knowledge in medical laboratory work. Read more.
July 14, 2025
On June 3, National Academy of Sciences President Marcia McNutt, PhD, delivered the second annual State of Science address, calling attention to the urgent need for reform in U.S. science and technology policy. Amid historic declines in federal STEM investment, international talent inflow and researcher support, Dr. McNutt emphasized that the U.S. is falling behind in global scientific leadership. Key challenges included excessive regulatory compliance standards, outdated funding processes, and the lack of a cohesive national research strategy. Panelists echoed the need for change, calling for pro-innovation policy, education reform and cultural shifts to restore American competitiveness and inspire the next generation of U.S. scientists.
ASCP remains a strong advocate for evidence-based policy that supports laboratory professionals and patients. From defending quality patient care from excessive regulatory costs and burdens to championing educational workforce outreach, ASCP is leading efforts to support the pathology and laboratory medicine community and promote diagnostic excellence (click here to see ASCP’s 2025-2026 Public Policy Priorities). Through its Institute for Science, Technology and Policy (ISTP), ASCP will continue driving research-informed policy that ensures U.S. laboratory medicine remains a cornerstone of global scientific leadership.
View the full State of the Science address here and explore ASCP's current policy and advocacy efforts here.
July 14, 2025
ASCP is proud to launch “Basic Medical Laboratory Skills,” a new eLearning series designed to empower new lab team members with essential knowledge. With 1.0 CMLE credit offered per course and free access in the ASCP Store, this CMLE-bearing series dives into the core building blocks of medical laboratory work: Laboratory Safety, Laboratory Terminology, Laboratory Math, Basic Operations of Laboratory Equipment, Routine Procedures, and Quality Control. Each beginner-friendly course blends foundational learning with practical, case-based examples—perfect for team members new to the medical laboratory or wanting to brush up on some skills.
This training package was intended to offset the burden of on-the-job training required of medical laboratory directors as they level-set new and uncertified members of their laboratory teams. The scope of the education was designed by the ASCP Workforce Steering Committee, and the educational materials were developed by a wide range ASCP member subject matter experts serving active medical laboratory roles.
Help us spread the word about this high-quality and free educational training package! Share this resource with your laboratory network, trainees, and new lab team members who could benefit from an introduction to core medical laboratory skills.
July 14, 2025
On June 11, ASCP joined more than 20 medical specialty societies at the 2025 Council for Medical Specialty Societies workforce summit to address pressing challenges facing the U.S. physician workforce issues. The summit featured in-depth discussions on the supply and distribution of physicians, rural workforce shortages, evolving practice environments and workforce modeling innovations. Key discussion points for the summit included the rising impact of healthcare consolidation on patient access and care delivery; the need for more robust, standardized workforce data; and the U.S. healthcare system’s reliance on international medical graduates to fill critical care gaps.
ASCP is committed to advancing pathology workforce resilience through data-driven policy advocacy and research. ASCP’s Institute for Science, Technology, and Policy is currently expanding its efforts to strengthen pathology career pathways and increase pathologist visibility. ASCP’s participation in the CMSS summit reflects its dedication to supporting and advocating for the pathology and laboratory medicine workforce. Learn more about ASCP’s workforce initiative efforts here.
July 14, 2025
At the end of May, ASCP closed the application window for its second year of the Dr. Alvin Ring Empowerment Scholarship for Laboratory Professionals, established to provide financial aid to students from medically underserved and/or rural areas who are pursuing higher education in the medical laboratory sciences. This scholarship is unique in that it provides scholarship support to a wide range of applicants—from high school seniors interested in starting their education in medical laboratory science to in-service laboratory professionals looking for career advancement through higher education.
In the first year of the scholarship’s administration, 14 scholarships were awarded to students across the U.S. in NAACLS-accredited HTL (2), MLT (4), and MLS (8) programs. Despite outreach efforts, no high school student applications were received in this initial cohort of 73 eligible applicants. As a part of process improvement strategies to recruit this new target audience, ASCP, in its second year of scholarship engagement, deployed a number of additional outreach strategies to reach high school students interested in this financial aid opportunity.
Some of these strategies included: 1) in-person and virtual engagement with high school science teachers (e.g., ASCP staff engagement at the National Science Teaching Association Conference 2025) and school counselors (advertisements through the American School Counselors Association’s website and e-Newsletter channels); 2) promotion on free, public-facing scholarship websites (i.e., Fastweb, Scholarships.com, Peterson’s); and 3) development of bilingual (English and Spanish) flyers distributed electronically via the ASCP Online Community pages and at ASCP KnowledgeLab 2025. Using this improved outreach strategy, 116 eligible applications were received—a 55 percent increase over 2024.
Although active MLS students (not yet in the laboratory workforce) represented the largest group of applicants (41 percent), applications from 10 eligible high school students were received, representing 9 percent of the eligible applicant pool. This is a significant improvement in recruitment strategies for this specific target audience; ASCP intends to continue to learn and adapt outreach strategies to expand this applicant cohort in future years.
July 14, 2025
ASCP and the Medical and Public Health Laboratory Workforce Coalition launched a nationwide campaign to raise awareness of medical laboratory careers among students, educators and counselors. In partnership with Spyre, this multichannel campaign reached out through email, social media, and national educator publications to promote meaningful, high-demand opportunities in laboratory medicine. The effort centers on informing high school and early college students as well as teachers and school counselors about career pathways into medical and public health laboratories.
The core message of the campaign is “Save Lives with Science,” as it is part of ASCP’s broader mission to address nationwide laboratory staffing shortages and open new doors for future professionals. View educator resources and student tools here and learn more about ASCP’s workforce advocacy and outreach here.
July 14, 2025
On June 9, 2025, U.S. Department of Health and Human Services Secretary, Robert F Kennedy Jr. terminated all 17 members of the Advisory Committee on Immunization Practices (ACIP), an advisory panel that provides crucial guidance on vaccine safety, including schedules and dosing. While Secretary Kennedy stated that the move was aimed to “rebuild public trust and eliminate perceived conflicts of interest,” it has sparked significant concern among leading U.S. health organizations— including ASCP—over the spread of misinformation about evidence-based medicine and the further erosion of public confidence in vaccine science.
The move by the HHS Secretary is particularly concerning in light of rising cases of preventable diseases in the U.S., such as measles, mumps, rubella, and pertussis (whooping cough). Additionally, by replacing the entire committee with new members, some of whom have expressed vaccine skepticism or lack relevant expertise, there is potential for significant loss of crucial institutional memory and the committee's ability to maintain scientific rigor.
In response to the Secretary’s actions, the American Medical Association (AMA) passed an emergency resolution during the 2025 AMA House of Delegates meeting, of which ASCP delegates were a part. The emergency resolution called for the “immediate reversal” of the changes to ACIP and urged the Senate Health, Labor, and Pensions (HELP) Committee to investigate the removals. ASCP Delegates supported the resolution as part of the Pathology Section Council (PSC), which is comprised of delegates from the American Society of Cytopathology, ASCP, the College of American Pathologists, and the National Association of Medical Examiners. The emergency resolution yielded a joint letter, signed on June 18, to the HHS Secretary expressing these strong concerns, calling for transparency and accountability in the vaccine oversight process. Numerous organizations have issued similar responses.
ASCP’s AMA delegation actively engages in pertinent policy discussions with partner organizations and exemplifies leadership in representing the field to colleagues at the AMA. The members of ASCP’s AMA delegation include Ed Donoghue, MD, MASCP; Jennifer Stall, MD, FASCP; ASCP Past Presidents Steve Kroft, MD, MASCP, and William Finn, MD, MASCP; as well as H. Clifford Sullivan, MD, FASCP; Nirali M. Patel, MD, FASCP; and Peter DeRosa, MD, FASCP. Additionally, Ebruphiyo Okpako, MD, FASCP, and Katerina Kearns, MD, FASCP, represent ASCP on the Resident and Fellow Section. AMA will host the Interim Annual Meeting in November, and ASCP will report on any issues that arise.
July 14, 2025
ASCP’s Leading Laboratories recognition program is expanding to include additional eligible laboratories. The Leading Laboratories designation recognizes laboratory teams for exemplary leadership, mentorship, and innovative best practices. The designation supports a positive patient- and community-centric mission, which increases visibility for laboratories and their vital role in a patient’s healthcare journey.
Ali Brown, MD, FASCP, ASCP Chief Medical Officer, says, “We are expanding the program to give more laboratories the opportunity to showcase the great work they are doing to raise awareness of the laboratory community; this is a celebration of laboratories and their positive impact on patients.”
When it first launched in 2021, the Leading Laboratories program was a collaborative initiative with The Joint Commission and was only open to Joint Commission-accredited laboratories. With program expansion, much of the content in the program remains the same; however, laboratories accredited by other providers will now also be eligible to apply for the designation, according to Dr. Brown.
Leading Laboratories, developed and refined by laboratory leaders, provides a set of criteria that is designed to quantify and exhibit excellence in the areas of elevating quality outcomes, supporting professional development, cultivating trusted leadership, and promoting laboratory visibility.
This designation sets the gold standard for laboratory excellence, providing:
Public recognition of a laboratory’s meaningful achievements in improving patient outcomes
Evidence of a laboratory’s commitment to the ongoing professional development of its team
Proof of laboratory leadership’s dedication to their team and to their patients.
According to past designees, the designation can make an impact in recruitment, especially for hard-to-fill roles like medical laboratory scientists. It gives the laboratory a competitive edge in attracting top talent and strengthens the laboratory’s case for investments from the C-suite. Additionally, the process encourages comprehensive self-assessment that highlights areas of excellence, as well as areas ripe for improvement within the laboratory. The Leading Laboratories designation underscores the laboratory’s crucial role in the healthcare continuum.
By expanding the eligibility criteria to include all hospital-based accredited laboratories in the U.S., ASCP hopes to elevate and promote more laboratories with this prestigious designation. To learn more about eligibility requirements and the application process, please visit leadinglaboratories.org.
July 14, 2025
President Donald Trump’s One Big Beautiful Bill Act (OBBB), which has dominated Congress’s attention for the last few months, has been signed into law by the president. The budget and tax legislation includes scores of policy changes impacting healthcare, some good, and some bad. During Congressional consideration of the measure, ASCP and advocacy partners, including the American Medical Association, expressed concern about several provisions in the bill. In addition, the legislation includes numerous changes to federal student loan programs that may exacerbate healthcare workforce shortages.
Medicare/Medicaid: Congress included a positive update of 2.5 percent to the Medicare Physician Fee Schedule (PFS) in OBBB for 2026. Unfortunately, the final bill did not include the House-passed—and ASCP endorsed—provisions that would have provided a permanent annual update tied to the Medicare Economic Index (a measure of inflation for medical practice costs).
Moreover, there is a concern that the bill, which increases the U.S. debt an estimated $2.3 trillion over the next 10 years, could result in significant cuts to Medicare, Medicaid, and many other federal programs. These cuts would be required by an existing law, known as the Statutory Pay-As-You-Go Act, which imposes automatic across-the-board cuts in federal spending when deficits increase. However, it is unclear whether these cuts would actually occur as Congress has in the past blocked some of these cuts. ASCP will be working to prevent such cuts from impacting Medicare and other public insurance programs.
In addition, the Congressional Budget Office, an independent advisory agency to Congress, estimates that the legislation would cut Medicaid and CHIP about $1 trillion over 10 years and could result in more than 10.5 million individuals losing their insurance coverage. ASCP, along with 75 other medical societies, urged Congress not to cut benefits or access to these programs for eligible individuals.
Education and Student Financial Aid Changes: On the positive side, the new law includes the provisions of the Tomorrow’s Workforce Act, for which ASCP has been lobbying. The measure allows individuals to use their 529 funds to pay for qualified credentialing programs and related costs. The change means that 529 funds may soon be used to pay for certification examinations, study guides, and possibly even the cost of certain laboratory training programs.
Trump’s signature bill also includes a number of cuts—estimated at $300 billion—to Federal Student Financial Aid programs. The bill eliminates the GradPLUS program, used by 40 percent of medical students, effective July 1, 2026. It includes “legacy provisions” to maintain access to loans for current borrowers. OBBB also sets caps on the amount of financial aid a student can borrow. It consolidates the number of student loan repayment options from a dozen to just two and lengthens the loan forgiveness term for these programs from 20 years to 30 years.
In addition, the legislation imposes a cap on the ParentPLUS program of $65,000. These loans will no longer be eligible for forgiveness like other student loans. Pell Grant program eligibility would also change—part-time students would no longer be eligible, but eligible students will soon be able to use this program to pay for short-term professional programs, like certificate programs.
The loan caps are expected to be particularly onerous for medical students. The legislation imposes a cap of $100,000 for students seeking master’s degrees and $200,000 for doctoral, medical, and professional degrees. According to the Education Data Initiative, medical school graduates owe approximately $240,000 on average on student loans. The new caps will be particularly challenging for individuals attending private medical schools. The American Association of Medical Colleges reports that the average cost of attending a private medical school is $390,848 compared to $286,454 for in-state public medical school.
In several letters to congressional leaders (see here and here), ASCP and a coalition of medical societies opposed the proposed student loan cuts and their impact on training the next generation of physicians in particular.
The reduced ability to secure federal financing for college degrees may force students to seek loans from commercial lenders, which provide fewer borrower protections and are not eligible for loan forgiveness. Education experts believe that the changes contained in the OBBB will likely reduce the number of students seeking college degrees. ASCP is concerned that these changes may result in a worsening of healthcare and laboratory workforce shortages, particularly for pathologists and other physicians. We will be working with our advocacy partners to address the impacts of these policies on the pathology and laboratory medicine workforce.
Artificial Intelligence: The OBBB also includes several provisions related to artificial intelligence (AI). Notably, the bill did not include provisions contained in the House version of the budget and tax bill preempting state laws governing the use of AI. This change is especially relevant to the medical and laboratory community as AI is increasingly being integrated in reimbursement decisions as well as diagnostic device development and clinical care.
California, for example, restricts the use of healthcare-related AI, algorithms and similar technologies by private payers to help ensure that treatment decisions are made by healthcare providers. Given that Congress passed on including a moratorium on state AI regulation, diagnostic device manufacturers and clinical laboratories offering laboratory developed tests will need to ensure that their products and services are compliant with applicable state laws.
ASCP is still in the process of reviewing this legislation and will be working with our advocacy partners to address outstanding concerns with the legislation.
July 14, 2025
The Supreme Court recently issued a ruling on a case regarding the constitutionality of the Affordable Care Act’s (ACA’s) preventive services mandate and the U.S. Preventive Services Task Force (USPSTF) appointments. The decision in Kennedy v. Braidwood Management, Inc. yielded mostly positive results: the ruling upheld both the constitutionality of the USPSTF’s current appointments and its preventive services mandate. But it also holds that the Secretary of Health and Human Services (HHS) has the authority to remove USPSTF members at will and reject their recommendations. This latter point is potentially concerning as it could affect the Task Force’s independence. In fact, on July 9 Secretary Kennedy cancelled without explanation the USPSTF’s meeting scheduled for that day.
ASCP is speaking with partner organizations to discuss several issues with the ruling, including the potential for political influence over the USPSTF recommendation process and interference with the Task Force’s scientific process. Additionally, there is uncertainty regarding the long-term impacts of the ruling on access to preventive services and the recommendations themselves. It should be highlighted, however, that the ruling is a major victory for patient care, as it ensures patient’s continued access to recommended preventive services and affirms USPSTF’s constitutional authority to recommend preventive services that insurers must cover.
July 11, 2025
The Board of Directors of the American Society for Clinical Pathology (ASCP) announces that E. Blair Holladay, PhD, MASCP, SCT(ASCP)CM, is retiring as Chief Executive Officer, concluding a remarkable 20-year career with the organization.
Throughout his tenure, Dr. Holladay has partnered with ASCP volunteer leaders in a period of exceptional growth and impact. During his time, the organization has expanded access to diagnostics worldwide, built influential partnerships with healthcare and policy leaders, and strengthened its role as a global authority in pathology and laboratory medicine. His efforts have placed pathologists and laboratory professionals at the forefront of patient care and health system transformation.
Prior to serving as CEO for 15 years, Dr. Holladay held the role of Executive Director of the ASCP Board of Certification for 5 years, where he was instrumental in advancing certification processes and expanding global outreach. Across all of his roles, he has championed innovation, equity in healthcare, and the advancement of the laboratory workforce.
The ASCP Board of Directors has appointed Alexandra Brown, MD, FASCP, ASCP Chief Medical Officer, as Interim CEO beginning August 1, 2025. Dr. Brown’s longstanding involvement with ASCP began well before she joined the staff, having served as a dedicated volunteer in several leadership roles—including Chair of the Resident Council and Chair of the Pathologist (Fellow) Council. In 2016, she joined ASCP as Chief Officer, Medical Quality, and in 2023 was appointed Chief Medical Officer, playing a key role in shaping and supporting many of ASCP’s strategic initiatives.
Dr. Brown’s deep clinical expertise and unwavering commitment to ASCP’s patient-centered mission position her well to guide the organization through this important period of transition. A formal search committee is being convened by the Board of Directors to lead the process of selecting a permanent Chief Executive Officer.
ASCP remains steadfast in its mission to provide excellence in education, certification, and advocacy on behalf of patients, pathologists, and laboratory professionals in the United States and around the world. We extend our sincere gratitude to Dr. Holladay for his visionary leadership and years of dedicated service, and we look forward to the continued strength and stability of ASCP under Dr. Brown’s interim leadership.
June 11, 2025
Celiac disease is often underdiagnosed because patients exhibit minimal symptoms or are misdiagnosed because of confusion with other conditions.
A chronic digestive and immune disorder that damages the small intestine, it is also one of the few autoimmune conditions that can be detected with a single laboratory test that is more than 95 percent sensitive and specific, according to Jane Dickerson, PhD, clinical associate professor in the Department of Laboratory Medicine and Pathology at the University of Washington as well as Division Head of Laboratory Medicine, director of the Core Lab Reference Laboratory Services, and medical director of the North Clinic Laboratory at Seattle Children’s Hospital. She is also co-founder of the Patient-Centered Laboratory Utilization Guidance Services (PLUGS).
Celiac disease affects the abdomen and may cause a feeling of bloating or nausea, and unexplained weight loss. It is caused by a diet that includes gluten, which is found in bread or pasta. Currently, there are many antibody tests available to diagnose the disease.
ASCP is collaborating with experts from the PLUGS network to develop an education module that highlights when and which laboratory tests are best used in the diagnosis and management of celiac disease. The education offers a case-based activity designed to help medical laboratory professionals, laboratory directors, and pathologists to improve their knowledge, skills, and competence in recognizing which diagnostic tests are most appropriate to use in the diagnosis of celiac disease and to focus on evidence-based guidelines.
“The testing algorithm for the diagnosis of celiac disease is very complex, and there are many providers who don’t know the appropriate testing strategy,” explains Sachin Gupta, PhD, MBA, MT(ASCPi)MB, Lean SSBB, scientific director of ASCP’s Center for Quality and Patient Safety.
Dr. Dickerson specializes in celiac disease and has published several research articles on the topic. Along with colleagues Maria Christina Pacheco, MD, and Rebecca Wilson, PhD, she is a primary author of the education developed in collaboration with ASCP. Dr. Gupta and Elise Occhipinti, MD, FASCP, reviewed and contributed to the education. Dr. Occhipinti, chair of ASCP’s Quality and Patient Safety Steering Committee and an advising member in PLUGS, was the catalyst for the collaboration.
The goal of the new education is to educate laboratory professionals and pathologists on testing algorithms to select the right test. “We explain if a patient comes with certain symptoms, what testing should be ordered by provider,” Dr. Gupta says.
In the education module, participants are asked a series of questions, each followed by a choice of responses. The user would select a specific answer and then receive an explanation of why their answer is correct or incorrect. If it is incorrect, the program asks the user to revisit information on that particular topic in order to enhance their knowledge.
This is the first education product with PLUGS.
“We are very excited about our collaboration with ASCP,” Dr. Dickerson says. “The collaboration represents a strategic alignment between two organizations deeply committed to improving the quality and value of laboratory medicine. PLUGS brings expertise in laboratory stewardship, utilization management, and navigating the complexities of insurance reimbursement, with a strong emphasis on reducing inappropriate testing and financial toxicity for patients. ASCP, as a leading professional organization for pathologists and laboratory professionals, contributes its vast network, influence in clinical practice guidelines, and commitment to advancing diagnostic excellence and professional development. Together, they create a powerful platform for systemic improvement in laboratory test ordering, interpretation, and coverage.”
PLUGS is based at Seattle Children’s Hospital and is a consortium whose members are able to access its test utilization consultation services.
“Many laboratories lack this kind of education,” says Dr. Gupta. “I hope laboratories and pathologists will leverage this education and implement the evidence-based testing algorithm at their labs.”
June 11, 2025
When ASCP announced plans to host a Day of Service in conjunction with the 2025 Lab Week, Jeannie Guglielmo, MS, MAT, MLS(ASCP)CM, jumped into action and started planning.
As chair and clinical associate professor in the Department of Clinical Laboratory Sciences in the School of Health Professions at Stony Brook University in New York, Ms. Guglielmo is committed to raising the visibility of the clinical laboratory.
She set up a table in the corridor of the health system where she works and displayed four petri dishes each taped with different images of microbiology plates with organisms. Then she told passersby about the “patients” – named Daphne, Velma, Scooby-Doo, and Fred, in keeping with ASCP’s Medical Mysteries theme for Lab Week. Each patient had different symptoms. She told of the laboratory diagnostic test results and offered several possible conditions the patients might have. The passersby tried to determine the correct diagnosis for each patient.
“I have a passion to let people know about this amazing career path,” she says. “We have a shortage of people going into the field. I like to present our field as a hidden gem because not everyone knows about it.”
A longtime ASCP Career Ambassador, Ms. Guglielmo is well versed at giving career presentations to young people and knowing how to pique their interests in the various laboratory careers.
“I have had the privilege of having people tell me they would not have gone into the profession had they not met me. ASCP has provided a vehicle for me to do that.”
Another ASCP Career Ambassador, LaTerra Slate, PBT(ASCP)CM, MLT(ASCP)CM, of Columbus, Ohio, is equally dedicated to reaching out to cultivate the next generation of laboratory professions. For ASCP’s Day of Service, she hosted a Career Information and Discussion Day designed for early-career healthcare professionals, including individuals from nursing, radiology, clinical research, esthetics, and allied health. Many were unfamiliar with the range of laboratory careers available.
Her goal was to promote awareness of laboratory medicine as a viable and meaningful career path. “We explored roles such as phlebotomy, MLT/MLS, blood banking, diagnostic science, and research-based lab work,” says Ms. Slate, who is an instructor at Intelvio, as a DBA phlebotomy training specialist and founder of E4RTH Allied Health & Wellness LLC, which provides integrative, laboratory-based wellness services.
Highlights of her outreach included:
A hands-on hematology activity where participants identified normal and abnormal RBC morphology, created custom cells using a hematology drawer kit, and observed a demonstration of blood bank cross-matching; and,
A group discussion on the role of phlebotomists as frontline professionals in lab quality, the hidden but essential contributions of laboratory professionals, and she shared her personal journey and outreach as an ASCP Career Ambassador.
Several attendees showed interest in pursuing formal training in phlebotomy and MLT programs, and all participants certainly gained a greater appreciation for laboratory diagnostics and the professionals who make it possible.
“I believe visibility begins with storytelling,” Ms. Slate says. “Laboratory professionals are not just running tests—we’re driving decisions that save lives. ASCP’s Day of Service gave us the platform to invite others into this meaningful field.”
June 11, 2025
Cancer biomarker testing is an essential part of oncology precision medicine. It helps guide treatment plans and enhance patient outcomes. However, the process is complex and can present challenges, which can lead to inefficiencies that can ultimately undermine the quality of patient care.
To address this, ASCP has launched a new Cancer Biomarker Testing Navigation (BTN) Certificate Program. The first six education modules were unveiled in early June and five more modules will be released in August. The certificate program is geared toward laboratory professionals and is designed to help cancer care facilities improve cancer biomarker testing processes in the laboratory.
“In the last decade, we have seen the rapid growth of cancer precision medicine,” says Joe Kim, MD, MBA, MPH, FACHE, a member of the ASCP Biomarker Testing Navigation Project Team. “The idea is, if a patient has a certain biomarker, whether genes or proteins, you can target it. You need to conduct diagnostic testing to identify the problem. The challenge is that biomarker testing is sometimes not done on a patient or is not being done completely on some patients. And that is a missed opportunity when someone actually could be tested. Patients often need more than one test. The idea of a navigator can help a patient find the right test. We are using the concept of a navigator in testing primarily with tissue and blood samples.”
The new certificate program requires participants to successfully complete six essential modules and two of the five electives that are offered.
The core “essential” modules are:
Foundations of Precision Medicine and Personalized Cancer Care Delivery
Overview and Types of Cancer Biomarkers
Following Standard Biomarker Testing Protocols
Biomarker Test Order Management and Sample
Specimen Workflow Optimization for Biomarker Testing
Multi-Disciplinary Team Communication and Collaboration
The elective modules are:
In-Depth Review of Biomarker Testing in Solid Tumors
Hematologic Malignancies and Biomarkers
Managing Send-Out Biomarker Tests
Quality Management in Cancer Biomarker Testing
Biomarker Testing and Laboratory Financial Management
Successful completion of the program offers one continuing education credit per module for laboratory professionals.
ASCP began studying the feasibility of a BTN role on laboratory operations and workflows in 2023. The three-phase project, supported by a sponsorship from AstraZeneca, has included a quantitative needs assessment, qualitative focus group discussions, and a short-term feasibility pilot conducted at two cancer centers. The needs assessment findings, outlined in a June 2025 article in AJCP, ASCP explores the cancer biomarker testing navigator as a novel role to improve laboratory operations and workflows: A special report from the ASCP Biomarker Testing Navigator Project Team, found that without a dedicated staff member to oversee biomarker testing, the processes were often fragmented and inefficient.
Lynnette Pineault, MBA, SCT(ASCP), chair of the project, commented, "Our pilot study highlighted substantial gaps and bottlenecks in the consistent application of recommended biomarker testing guidelines for all cancer patients. Our team designed this program to bridge these gaps, streamline testing pathways, and enhance collaboration between the laboratory and the broader multidisciplinary care team. Our goal is to ensure every patient receives the accurate, timely biomarker testing they deserve, paving the way for more personalized treatment strategies and improved clinical outcomes. This initiative reflects our shared commitment to advancing precision oncology and reshaping the future of patient care."
The pilot studies show that the role of BTNs could include coordination of multigene next generation sequencing panels and expediting critical steps to ensure optimal preanalytical processes, reducing delays in testing, and ensuring smooth operations, according to the article.
In July, ASCP will release additional tools and establish an online community to support participants in the certificate program.
“The ultimate goal of this program is to ensure that more patients will be tested with the right cancer biomarker tests and achieve better outcomes,” Dr. Kim says.
To learn more about the BTN certificate program, click here.
June 11, 2025
ASCP is thrilled to announce that two of the most groundbreaking scientific figures of our time, Dr. Francis Collins and Dr. Craig Venter, will serve as keynote speakers at ASCP’s Annual Meeting in Atlanta, November 17-20.
These visionary scientists have not only redefined scientific discovery, they have also fundamentally transformed the way we understand, diagnose, and treat disease, ushering in a new era of patient-centered care.
Special General Session Scientific Keynote Speaker
Best known for his leadership in the Human Genome Project, Dr. Collins guided one of the most ambitious scientific efforts in history to successful completion—decoding the human genetic blueprint and making it available to researchers worldwide.
During his 12-year tenure as director of the National Institutes of Health, Dr. Collins oversaw the country’s biomedical response to public health crises, championed precision medicine, and led transformative initiatives in cancer, neuroscience, rare diseases, and COVID-19.
Dr. Collins’ legacy extends beyond science. He has become a trusted voice exploring the harmony between science and spirituality. His pioneering research and his passion for public service and ethical dialogue continue to shape the future of healthcare, and of science itself.
Don’t miss these keynote events that will energize and inspire your role in the future of patient care.
Opening General Session Scientific Keynote Speaker
From decoding the first free-living organism’s genome to co-leading the race to sequence the human genome, Dr. Venter’s innovative approaches have revolutionized the pace and scale of genomic science. Dr. Venter has pushed the boundaries in biology, from synthetic life forms to predictive healthcare powered by deep genomic data.
His vision of harnessing the power of genomics to improve health and sustainability continues to inspire the next wave of scientific and clinical innovation.
Premier educational offerings
ASCP is recognized worldwide as the provider of premier educational offerings for pathologists and laboratory professionals to learn, share, and grow throughout the entirety of their careers. More than 1,200 education sessions developed by renowned experts will deliver the variety, convenience, and quality you need to earn credits and enhance your skills in your area of practice.
Network with your peers
ASCP 2025 packs a lot of learning into just a few days, yet there will be ample opportunities to relax and enjoy the company of your peers. Take this chance to meet other professionals from across the nation–and from around the world–to share ideas, collaborate, and validate or change your perspectives.
Register before August 11 and save 50 percent on registration! Learn more and register at www.ascp.org/2025 .
June 11, 2025
ASCP is relaunching its Leading Laboratories recognition program and opening the program to more laboratories. The Leading Laboratories designation recognizes laboratory teams for exemplary leadership, mentorship, and innovative best practices. The designation supports a positive, patient-centric mission, increasing visibility for laboratories and their vital role in a patient’s healthcare journey.
“We are expanding the program to give more laboratories the opportunity to showcase the great work they are doing to raise awareness of the laboratory community,” says Ali Brown, MD, FASCP, ASCP Chief Medical Officer. “This is a celebration of laboratories and their positive impact on patients.”
When it first launched in 2021, the Leading Laboratories program was a collaborative initiative with The Joint Commission and was only open to Joint Commission-accredited laboratories. With the relaunch, much of the content in the program remains the same, though now laboratories accredited by other providers will also be eligible to apply for the designation, according to Dr. Brown.
Leading Laboratories, developed and refined by laboratory leaders, provides a set of criteria that is designed to quantify and exhibit excellence in the areas of elevating quality outcomes, supporting professional development, cultivating trusted leadership, and promoting laboratory visibility.
This designation sets the gold standard for laboratory excellence, providing:
Public recognition of a laboratory’s meaningful achievements in improving patient outcomes
Evidence of a laboratory’s commitment to the ongoing professional development of its team
Proof of laboratory leadership’s dedication to their team and to their patients.
Torrance Memorial Medical Center, in Torrance, CA, was the first system to attain the Leading Laboratories designation. “This recognition validated the tremendous effort and dedication of our entire laboratory team — from bench techs to leads, supervisors, and managers — who work tirelessly every day to ensure quality, patient safety, and efficiency,” says Ihab Abumuhor, MS, MLS(ASCP), SBB, MSHCA, director of laboratories at Torrance Memorial Medical Center.
“It significantly elevated our laboratory’s visibility both within the organization and externally. It also brought greater awareness and appreciation from the C-suite and other key stakeholders, reinforcing the critical role the laboratory plays in patient care and operational excellence,” he adds.
Internally, Torrance Memorial Medical Center leveraged the Leading Laboratories designation to celebrate its laboratory team by hosting a recognition event to which key stakeholders across the organization were invited to share in the achievement.
“We displayed signage outside the main laboratory and at each of our phlebotomy draw stations, featured it in newsletters, and highlighted it during conference presentations, laboratory inspections, tours, and advisory board meetings,” says Mr. Abumuhor.
The designation also made a real difference in recruitment, especially for hard-to-fill roles like medical laboratory scientists. It gave the laboratory a competitive edge in attracting top talent and strengthened the laboratory’s case for operational and capital investments from the C-suite.
Likewise, when laboratory leaders at Dignity Health-Glendale Memoria Health and Hospital, in Glendale, CA, embarked on the application process to gain Leading Laboratories status, they found it provided a valuable exercise in team reflection and continuous improvement, according to Ramy Moawad, MBA, CLS, director of laboratory services.
“The process required a comprehensive self-assessment across various domains—from quality and safety to leadership and collaboration,” he says. “It prompted us to look critically at our operations and brought to light areas where we were excelling, as well as a few that needed strengthening.”
“The Leading Laboratories designation underscored our laboratory’s role as a cornerstone of patient safety and care quality,” Mr. Moawad adds. “It has helped foster deeper collaboration with nursing, providers, and executive leadership. By aligning our work with the values recognized in the designation, we've been able to champion patient-centered initiatives, reduce diagnostic errors, and improve turnaround times—all of which directly impact the patient experience and outcomes.”
What has been especially encouraging is that many of his peers have reached out, expressing interest in the process and enthusiasm about pursuing the designation for their own health systems.
“The Leading Laboratories designation has set a powerful example,” Mr. Moawad adds. “We now hold ourselves to the highest standards of patient care and safety, not just for recognition, but as part of our ongoing mission.”
He encourages other laboratories to embark on seeking Leading Laboratories status. “It is more than just a badge of honor; it serves as a strategic opportunity to reflect on your laboratory’s performance, culture, and alignment with patient care goals. The process itself drives improvement and team engagement. It helps laboratories create a roadmap to excellence and reinforces a laboratory’s value within the larger health system.”
Learn more about Leading Laboratories at www.leadinglaboratories.org.
June 03, 2025
The LDT Final Rule is Officially Dead: FDA Has No Jurisdiction
On May 30, the FDA chose not to appeal a court decision that vacated its attempt to regulate laboratory developed tests (LDTs), marking a major win for patient care and ending a decades-long dispute over regulatory authority. The court affirmed that oversight of LDTs belongs to CMS under the CLIA framework, not the FDA, aligning with the position of ASCP. ASCP now plans to support CMS in its regulatory role and continue opposing legislation like the VALID Act, which could impose burdensome requirements on clinical laboratories. Read more.
Federal Workforce Programs, Medicare Payment Impacted by Congressional Reconciliation Bill
Congressional Republicans passed a budget reconciliation bill which extends $4.5 trillion in tax cuts while cutting $1.7 trillion in federal spending, and a potential $500 billion in Medicare cuts. While the bill includes a modest inflationary update to Medicare’s physician fee schedule and provisions from the Tomorrow’s Workforce Act to support lab training programs, it also makes significant cuts to student loan and workforce development programs. ASCP is actively lobbying against Medicare and education funding reductions and urging the Senate to mitigate their impact on healthcare professionals. Read more.
ASCP Urges Trump Administration to Reinstate CLIAC
ASCP is urging the Trump Administration to reinstate the Clinical Laboratory Improvement Advisory Committee (CLIAC), which was terminated following Executive Order 14217 aimed at reducing federal bureaucracy. CLIAC, a key advisory body on laboratory testing and patient care, officially shut down on March 31. ASCP and allied organizations are calling for the restoration of CLIAC and its website, emphasizing the critical value of its guidance and resources. Read more.
ASCP Opposes Legislation to Allow Gene Patents
ASCP, alongside more than 20 medical and patient advocacy groups, is opposing the Patent Eligibility Restoration Act, which would allow companies to patent human genes and other natural phenomena. ASCP argues that such patents could hinder clinical care, research, and patient access to vital genetic information. ASCP was a key plaintiff in the 2013 landmark case where the Supreme Court ruled that genes like BRCA1 and BRCA2 are not patentable, and which upheld that naturally occurring genes are not eligible for patents under the Patent Act. Read more.
June 02, 2025
Patients and Pathology Win Latest Battle
May 30th marked an important date in FDA’s effort to claim oversight of laboratory developed tests (LDTs). This was the deadline for FDA to appeal U.S. District Court Judge Sean D. Jordan’s decision to vacate the agency’s Final Rule seeking to regulate LDTs (see the infographic below outlining some of the key dates related to LDT oversight). And by the end of that day, we learned that the federal government declined to appeal the judge’s decision. This victory for patient care marks the latest milestone in a 40-year saga regarding government responsibility to regulate LDTs.
FDA began asserting jurisdiction over LDTs in the early 1990s and started seriously considering taking regulatory action in the early 2000s. ASCP recognized that these were significant developments and began implementing patient-centric policy and advocacy initiatives to ensure that high-quality patient care considerations were at the forefront of the debate. These efforts have been a defining element of our advocacy agenda for well over a decade, and they were the reasons that ASCP, guided by the expertise of noted attorney Jane Pine Wood, joined with four other patient-focused medical specialty societies to file an amicus curiae brief in the lawsuit opposing FDA’s oversight scheme.
ASCP is extremely pleased that Judge Jordon’s ruling means that FDA lacks the statutory authority to regulate LDTs. ASCP President Gregory Sossaman, MD, MASCP, said after Jordon announced his decision, “This is an important victory for quality patient care.” Under FDA’s oversight plan, most laboratories would have faced significant barriers to providing these critical services, ultimately restricting patient access to vital testing and care.
Not surprisingly, the court victory raises a question about LDT oversight moving forward. ASCP and the vast majority of organizations representing the laboratory community believe that LDTs should be regulated by CMS under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) framework. The district court addressed this question, stating that “Congress considered the unique regulatory issues raised by clinical laboratories and the tests they develop and perform. It addressed those issues through the comprehensive but distinct statutory regime of CLIA, not through the FDCA [Food, Drug, and Cosmetics Act].” Meaning that the authority to regulate LDTs belongs to CMS, not FDA.
When CMS adopted new regulations for CLIA in early 2003, it set in place new performance requirements a laboratory must satisfy when it “introduces a test system not subject to FDA clearance or approval (including “methods developed in-house…[emphasis added]).” These requirements are still in place, and they serve as the foundation for CLIA’s analytical validity requirement, among others, and can encompass any other “performance characteristic required for test performance.”
That said, supporters of the onerous Verifying Accurate, Leading-edge IVCT Diagnostic Act (VALID), an FDA-centric proposal that is similar to the FDA Final Rule in terms of its cost and burden, are currently trying to line up support to reintroduce this legislation. This is the same bill that was nearly included in a must-pass omnibus spending bill in 2022, until ASCP and its members lobbied Congress mounting a highly successful grassroots campaign that flooded Congress with more than 10,000 messages opposing the bill.
With the court’s ruling about who has authority over LDTs settled, ASCP will be working with its advocacy partners to lend expertise to CMS in its oversight of LDTs. We will also continue our efforts to prevent any legislation similar to the VALID Act from stymieing clinical laboratories to meet the needs of their patients.
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