ASCP has contacted the Trump transition team leaders to urge the incoming administration of President-elect Donald Trump to rescind the U.S. Food and Drug Administration’s (FDA) Final Rule claiming oversight authority over laboratory developed tests (LDTs).

In a letter to Linda McMahon and Howard Lutnick, co-chairs of the Trump transition team, ASCP President Greg Sossaman, MD, MASCP, noted that the previous Trump Administration ruled that the FDA should not regulate LDTs. In 2020, U.S. Health and Human Service Secretary Alex Azar blocked the FDA from exercising oversight over LDTs. Secretary Azar’s decision was based on a legal opinion drafted by the General Counsel of the U.S. Department of Health and Human Services, arguing that the FDA lacked sufficient statutory authority to provide oversight of LDTs. 

ASCP—which filed an amicus curiae brief in October in a lawsuit seeking to overturn the Final Rule and submitted congressional testimony earlier this year opposing both the Final Rule and the Verifying Accurate and Leading-edge IVCT Development Act, or VALID Act—believes that both the FDA Final Rule and the VALID Act fundamentally undermine patient access to quality care by imposing expensive and duplicative oversight burdens on clinical laboratories without improving patient outcomes.

By rescinding FDA’s Final Rule, ASCP President Sossaman expressed hope that President Trump’s leadership would send a clear message to both the FDA and Congress that LDTs are currently regulated appropriately in a manner that is nimble and free of excessive bureaucracy. This is provided by the Clinical Laboratory Improvement Amendments of 1988. To maintain the highest quality patient care, we must never discourage accredited clinical laboratories from developing and providing innovative, cost effective, quality laboratory services. 

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ASCP Urges Trump Transition Team to Rescind FDA LDT Rule

ASCP has contact the Trump transition team leaders to urge the incoming administration of President-elect Donald Trump to rescind the U.S. Food and Drug Administration’s (FDA) Final Rule claiming oversight authority over laboratory developed tests (LDTs). Read more.

CMS Finalizes Medicare PFS, CLFS Cuts for 2025

The physician fee schedule for calendar year 2025, recently released by the Centers for Medicare and Medicaid Services, includes an average payment rate decrease of 2.8 percent. ASCP is working with the American Medical Associations and other medical societies to lobby Congress to reverse this proposed cut. Read more.

ASCP Endorses Medicare Patient Access and Practice Stabilization Act

Legislation to reverse the looming cuts in the Medicare Physician Fee Schedule has been introduced in Congress. The bipartisan Medicare Patient Access and Practice Stabilization Act would provide a 4.73-percent update to the 2025 Medicare PFS, reversing cuts proposed by CMS and provide a 1.93 percent update. Read more.

Ambassador John Nkengasong’s Takeaways on Global Health Inequity

Strong political leadership, innovation, and establishing partnerships are key lessons learned from the worldwide response to the HIV/AIDS crisis over the past two decades, global health trailblazer Ambassador John Nkengasong said during his keynote address at the ASCP 2024 Annual Meeting. Ambassador Nkengasong, U.S. Global AIDS Coordinator and Senior Official of the Bureau of Global Health Security and Diplomacy, offered insights on how to develop effective responses to global health issues. Read more.

Congressional Support for Medicare Prior Authorization Reform Bill Building
In early October, legislation—which ASCP supports—to reform prior authorization policies within Medicare Advantage plans reached a significant achievement: a majority of members of the U.S. House of Representatives signed on as co-sponsors of the legislation. Discover how this affects pathology and laboratory medicine. Read more.

CDC Launches New Office of Laboratory Systems and Response

The CDC has approved a reorganization plan to create the new Office of Laboratory Systems and Response (OLSR), merging several key laboratory divisions. This move elevates the role of CDC, public health, and clinical laboratories, recognizing them as core public health infrastructure. Read more.

ASCP Patient Champions and DPA Launch a New Patient Educational Resource

ASCP Patient Champions is partnering with the Digital Pathology Association to create a patient guide to digital pathology. Read more.

ASCP Patient Champions Joins with Tribal Communities to Improve Health Literacy

As part of its ongoing partnership with the Arizona Advisory Council on Indian Health Care, ASCP Patient Champions recently collaborated on the 2024 Tribal Health Literacy Workshop.  ASCP’s presentation underscored the importance of understanding pathology reports and laboratory results, using storytelling to explain complex topics, and the value of peer-to-peer advocacy and support. Read more.

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ASCP Patient Champions recently collaborated on the 2024 Tribal Health Literacy Workshop as part of its ongoing partnership with the Arizona Advisory Council on Indian Health Care (AACIHC).

AACIHC serves as a resource for all Tribal governments and the State of Arizona by supporting prevention, training, education, workforce development, policy and legislation to meet the unique healthcare needs of the American Indian and Alaska Native (AI/AN) population in Arizona. It seeks to educate and advocate for improved health outcomes.

ASCP Patient Champions brings together individuals who have personally experienced the impact of laboratory medicine and diagnostics. These passionate patient advocates share their stories, raise awareness and collaborate with healthcare professionals to improve patient care and outcomes.

At the Tribal Health Literacy Workshop, Patient Champions Project Manager Sophia Lewin Adams partnered with Patient Champion Deedee O’Brien to present to members of Arizona’s 22 tribal communities. Their presentation covered the importance of understanding pathology reports and laboratory results, strategies for using storytelling to explain complex topics, and the value of peer-to-peer advocacy and support.

In addition to their educational presentation, Ms. O’Brien shared her personal story to explain how understanding pathology reports and laboratory results helped her as both a patient and a caregiver.

Learn more about AACHIC.

Hear Deedee tell part of her story.

Learn more about Patient Champions on the Patient Champions website. If you are interested in learning more about ASCP Patient Champions initiatives to educate and empower patients, please contact Patient Champion Staff at champions@ascp.org.

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ASCP Patient Champions has partnered with the Digital Pathology Association to create an a patient guide to digital pathology. The flyer explains the process and value of digital pathology as well as lays out ways patients can engage with their own pathology.

ASCP Patient Champions brings together individuals who have personally experienced the impact of laboratory medicine and diagnostics. These passionate patient advocates share their stories, raise awareness, and collaborate with healthcare professionals to improve patient care and outcomes.

The Digital Pathology Association (DPA) is a professional organization that facilitates awareness, education, and adoption of digital pathology and AI applications in healthcare and life sciences.

ASCP Patient Champions maintains a library of educational flyers to help patients understand their diagnoses and laboratory results. By teaching them about the laboratory, ASCP Patient Champions empowers patients and caregivers to navigate their care and choose the treatments that work best for them.

“A Patient’s Guide to Digital Pathology” is their newest addition to the flyer library and answers frequently asked questions like “How does AI in pathology impact patient care?” and “Can digital pathology improve my care?”

The flyer is available in via the Educational Resource library on the Patient Champions website.

To learn more about ASCP Patient Champions, please visit the Patient Champions website or contact ASCP Patient Champions staff at champions@ascp.org.

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The Centers for Disease Control and Prevention (CDC) recently approved a reorganization plan creating the new Office of Laboratory Systems and Response (OLSR), merging several key laboratory divisions. This move elevates the role of CDC, public health, and clinical laboratories, recognizing them as core public health infrastructure. The OLSR, led by Dr. Ren Salerno, will support laboratory quality, safety, informatics, workforce and response readiness, with a goal to foster greater cross-agency collaboration.

For laboratory professionals, this reorganization will mean more streamlined operations and consistent communication with CDC leadership, which will further integrate public health laboratories and clinical partners into a cohesive national network. The OLSR’s unified structure is expected to improve coordination during health crises, ensuring laboratories are well-prepared for threats ranging from infectious disease outbreaks to hazardous exposures.

Laboratory professionals are encouraged to stay engaged with the CDC as the OLSR strengthens its partnerships across federal, public, and clinical sectors to ensure public health protection.

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Legislation to reverse the looming cuts in the Medicare Physician Fee Schedule (PFS) was introduced in Congress on October 30, 2024. The bipartisan Medicare Patient Access and Practice Stabilization Act (HR 10073)—endorsed by ASCP, the American Medical Association, and more than 100 other medical associations—would provide a 4.73 percent update to the 2025 Medicare PFS, reversing the 2.8 percent cut proposed by the Centers for Medicare and Medicaid Services and providing a 1.93-percent update. The 1.93 percent update is equal to one half of the Medicare Economic Index (MEI) and is in line with a recommendation from the Medicare Payment Advisory Commission.

The benefit of this legislation, however, is temporary. While the legislation is important, it does not address one of the fundamental problems with the PFS, specifically the lack of a permanent annual update to offset the impact of inflation. That is why ASCP supports H.R. 2474, the Strengthening Medicare for Patients and Providers Act, enacted. This measure provides a permanent, annual inflationary update equivalent to the full MEI while also reversing the 2.8 percent cut in the PFS.

Given the corrosive impact that inflation has had on Medicare payment rates, it is critical that Congress reverse the 2.8 percent cut scheduled for 2025. ASCP will be working with the AMA and other medical associations to both reverse the 2025 cut and secure a permanent, full annual update for the Medicare PFS. To help us achieve that goal, ASCP urges members to act on a recent ASCP Advocacy Alert empowering our members to contact their congressional representatives and urge them to Fix Medicare Payment Rates. Please click here to help.

On Oct. 9, legislation supported by ASCP to reform prior authorization policies within Medicare Advantage (MA) plans reached a significant achievement: a majority of members of the U.S. House of Representatives has signed on as co-sponsors of the legislation. Currently, 221 members of the House (155 Democrats, 86 Republicans) have co-sponsored HR 8702, the Improving Seniors’ Timely Access to Care Act. The Senate version of the bill, S. 4532, similarly enjoys support from the majority of U.S. Senators.

In addition, the measure recently received excellent news from the Congressional Budget Office (CBO). The measure received a $0 “score”, meaning that the measure is not expected to increase federal spending. CBO scores are an important factor that weighs heavily on the chances a bill might be enacted.

Prior authorization has been identified as the #1 administrative burden by healthcare providers, and three out of four MA enrollees are subject to these burdens. Moreover, a recent audit by the U.S. Department of Health and Human Services (HHS) found that MA plans ultimately approved 75 percent of requests that were originally denied. Additionally, HHS  found that MA plans were incorrectly denying Medicare beneficiaries’ access to services even though they met coverage requirements. 

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At the ASCP 2024 Annual Meeting, Ambassador John Nkengasong, a trailblazer in global health, delivered the prestigious Dr. Paul Farmer Keynote Address. Ambassador Nkengasong currently serves as the U.S. Global AIDS Coordinator and Senior Official of the Bureau of Global Health Security and Diplomacy. He is well-known for his influential leadership with the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) and the Africa CDC, where he advanced efforts to combat infectious diseases and strengthen health systems across the African continent. 

Reflecting on his career, Ambassador Nkengasong emphasized three key lessons from the global HIV/AIDS response: the need for strong political leadership, the transformative power of innovation, and the importance of partnerships. These lessons align closely with the work ASCP has been doing for over 15 years in global health. As we look ahead, these pillars offer a path to sustained progress and equitable healthcare worldwide. To read more about these three key lessons in reducing global health inequity and ASCP’s work to further these efforts, check out this new article on Critical Values online here. 

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The Centers for Medicare and Medicaid Services (CMS) released its CY 2025 Physician Fee Schedule (PFS) on November 1. As expected, average payment rates under the PFS fell by 2.8 percent in CY 2025. This cut is attributable to the expiration of several temporary payment updates Congress had enacted to offset cuts in the PFS for 2023 and 2024. ASCP is actively working with the American Medical Association and other medical societies to lobby Congress to reverse this projected cut.

One of the factors that has helped mitigate cuts in pathology services over the last few years (including this year) are the increases CMS made to the clinical labor rates for certain anatomic pathology services. CMS adopted data from ASCP’s biennial Wage Survey to increase certain technical component rates to reflect increased labor costs of certain laboratory professionals—specifically histotechnologists and cytotechnologists. CMS increased the per minute labor rate for histotechnologists by 15 percent and increased the clinical labor rate for cytotechnologists by 12 percent.

In addition, CMS finalized plans to impose cuts of up to 15 percent on approximately 800 laboratory tests reimbursed by the Medicare Clinical Laboratory Fee Schedule (CLFS). These cuts stem from the Protecting Access to Medicare Act (PAMA). ASCP has been lobbying Congress to enact the Saving Access to Laboratory Medicine Act, or SALSA to fix the flaws in the way CMS crafted the current CLFS payment rate system. 

While the prospects for SALSA are uncertain, ASCP is working with the American Clinical Laboratory Association to block the CLFS cuts for 2025 and to find a sustainable alternative moving forward.

To help ensure that Congress reverses the cuts in the PFS and blocks the cuts to the CLFS, ASCP is urging EVERYONE concerned about quality patient care and the future of pathology and laboratory medicine to contact their legislators and urge them to reverse the PFS and CLFS cuts. Please use ASCP’s eAdvocacy Center to send your congressional representatives this important message, click here.

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The ASCP 2024 Annual Meeting had an atmosphere full of wonder, excitement, and purpose for the laboratory. Attendees were eager to take part in collaborative sessions, mingle with fellow colleagues, and be part of ASCP’s mission to elevate pathology and laboratory medicine to meet the challenges of tomorrow.

ASCP was honored to host Martin Luther King III as the keynote speaker at the Grand Opening Session and Ambassador Dr. John Nkengasong as the keynote for the Scientific General Session. Mr. King has been a leading voice for peace, justice, and equity in the U.S. and globally. His work has had a transformative impact, and his keynote address will celebrate unity, equity, and inclusion that will inspire conversations and actions that will bring us a better tomorrow and help shape a more just society for all. Listen to his presentation here.

Longtime friend and member of ASCP, Ambassador Dr. John Nkengasong serves as the U.S. Global AIDS Coordinator and Senior Bureau Official for Global Health Security and Diplomacy. His leadership in overseeing the Presidents Emergency Plan for AIDS Relief (PEPFAR), which has made historic strides in addressing HIV/AIDS, highlights the power of strategic intervention in global public health, and his tenure as the first director of the Africa Centres for Disease Control and Prevention further underscores his ability to drive transformative change. His presentation can be accessed here. 

Meanwhile, if attendees missed any sessions at the Annual Meeting, they can purchase the On Demand package and still add it to their registration. For more about the On Demand package, click here.

Mark your calendars for the ASCP 2025 Annual Meeting, which will be held on November 17-20, 2025, at the Hyatt Regency Atlanta. Register early for the best available rates, up to 58% off. Click here to register. 

Staying current with advancements in pathology, increasing visibility of the profession among medical students, and bolstering appreciation of the value of pathologists in patient care are among the top 10 topics that weigh heavily on the minds of laboratory professionals, according to the results of an ASCP survey conducted this past summer.

Every summer, ASCP conducts a member survey to find out the topics that weigh on members’ thoughts. The chairs of ASCP’s four member councils—Council of Laboratory Professionals, Resident Council, Pathologist Council, and Council of Laboratory Management and Administrators.

“The Pathologist Council has opportunities to address these hot topics through ASCP’s roundtables and also by creating an online library that is open to all members when they want to learn more about certain areas,” says Pathologist Council Chair Deniz Peker Barclift, MD, FASCP.

“A number of our members are in academic medical centers where we have access to medical students. We need to promote pathology more among medical students,” she adds. “According to data, the number of American Medical School Graduates who choose pathology as a profession has been decreasing.”

She suggested that one way to encourage awareness of the profession among medical students is for pathologists to serve as mentors to help them learn about the profession and the various professional opportunities it offers. Another way could be to explore providing seed funds to start pathology interest groups in medical schools so students can learn about the profession.

“As for boosting awareness of our profession among patients, there is a new trend nationwide which might benefit pathologists: every time you finalize a patient report, it becomes available to the patient (via MyChart or other electronic platforms) at that moment,” Dr. Peker says. “So, we can create a culture among pathologists to write reports that are tailored to the patients, as if you are talking to them. The report would also display pathologists’ names and contact information, so patients can reach pathologists to discuss their reports.”  

Other topics of concern to pathologists were leadership training and managing workload. Dr. Peker pointed out that ASCP offers courses on leadership training and said the Pathologist Council will help to promote them.

“The workload concern is quite a big topic, especially in the current era where all have shortages of staff,” she adds. “This is an area that ASCP needs to focus on. The first step is to collect the data, analyze it, and come up with a response. Since we have members from all subspecialties in pathology, maybe ASCP, with our council’s help, can come up with some workload guidelines for the pathologists.”

Another facet of addressing the workforce and heightening awareness of the profession is to work at fostering relationships and nurturing leadership skills. “It is crucial to create a balanced atmosphere in every pathology practice,” says Dr. Peker. “One way to address this is to provide enough resources for pathologists to develop better interpersonal and communication skills. We need to help our pathologists find common ground with colleagues in other departments and help them to understand and appreciate each other’s work.  

“Pathologists often work behind the scenes, but their expertise is essential for diagnosis and patient care. Improving communication can enhance collaboration with other healthcare professionals. Since many interactions occur digitally, offering pathologists training on how to write clear, considerate, and professional emails or reports is important. This might include being mindful of phrasing, avoiding abrupt language, and considering how messages may be perceived by colleagues, other healthcare professionals, and patients” Dr. Peker adds.

Lastly, the survey results indicated that advocating for their patients is an important topic. The work of ASCP’s Effective Test Utilization Committee is one way in which to advocate on behalf of patients’ needs.

Members can expect to see the Pathologist Council roll some of these initiatives out in the coming year. Meantime, Dr. Peker encourages members to check into the ASCP Online Communities to help keep the conversation going about issues of concern that need to be addressed going forward.

“We want our members to know that we have heard their concerns, and we are doing our best to develop thoughtful programming or initiatives to respond to their needs,” she says.

Advocating for work conditions and commensurate compensation in the medical laboratory, demonstrating the value of laboratory professionals in health care are among the top 10 topics that weigh heavily on the minds of laboratory professionals, according to the results of an ASCP survey conducted this past summer.

Every summer, ASCP conducts a member survey to find out what are the topics that weigh on members’ thoughts. The chairs of ASCP’s four member councils—Council of Laboratory Professionals, Resident Council, Pathologist Council, and Council of Laboratory Management and Administrators.

CLP Council Chair Laura Severs, MHA, MLS(ASCP)^CM addressed the compensation issue, saying, “In general, laboratory medicine professionals feel undercompensated for the complexity of our work. A contributing factor to the compensation issue is the perception we are not patient-facing professionals. However, our higher purpose as laboratory professionals is to care for our patients. Together, we are working to change and challenge these misconceptions.”

Compensation is also tied into another top concern—demonstrating the value of laboratory professionals as part of the healthcare team.

“Based on these and other concerns, the CLP is formulating content for our member roundtables as well as opening some key roundtables to non-members,” Ms. Severs says.

Four other key topics that are all related are the workforce shortage, staff recruitment and retention, and improving workplace culture.

“A lot of these hot topics tie in together,” Ms. Severs says. “We try to address them at a broad level. On staff retention and dealing with staff shortages, our council is really committed to providing support for our members to speak about their careers in the medical laboratory. Our Career Ambassadors program is a significant grassroots effort that equips our members with the tools, resources, and support to go into their communities and engage with people so they can learn about the wonderful and impactful careers in laboratory medicine.”

Building awareness of the key role that laboratory professionals play in patient care also ties in with another topic—conveying the importance of the laboratory to leaders of other departments in a healthcare system.

Another resource that the CLP is tapping into is the Negotiation and Advocacy Toolkit, which has a wide array of assets to equip laboratory professionals and leaders with the confidence to advocate for the laboratory when speaking with other department leaders and colleagues. As an example, many CLP members participated an interactive session, The Amazing Lab Race, during the ASCP 2024 Annual Meeting in September. Participants were divided into several teams comprising many different members of the laboratory as they worked together to solve problems and face challenges many of us experience. In January, the CLP will host a session on how to be an effective and engaged trainer in the laboratory. This will address making sure that the individuals who may work with laboratory students and new in practice professionals during a rotation are equipped to properly teach and train.

Meanwhile, the CLP continues to brainstorm ideas for member roundtables that are focusing on a mix of scientific content that pertains to emerging technologies in the laboratory field, such as artificial intelligence (AI) and machine learning and what kind of implications that has on laboratory professionals’ work. Other potential topics the CLP wants to address include advanced techniques in genomics, data science in the laboratory, and maximizing impact in resource constrained laboratories.

Members can expect to see the CLP roll some of these initiatives out in the coming year. Meantime, Ms. Severs encourages members to check into the ASCP Online Communities to help keep the conversation going about issues of concern that need to be addressed going forward. The diverse perspectives in our membership is displayed by the unique problem solving and open communication you will find in the ASCP Online Communities.

“We want our members to know that we have heard their concerns, and we are doing our best to develop thoughtful programming and initiatives to respond to their needs,” she says.

ASCP Files Amicus Brief Urging Court to Overturn FDA Final Rule on LDTs

ASCP has filed an amicus curiae brief in a lawsuit urging the court to overturn the U.S. Food and Drug Administration Final Rule claiming authority to regulate laboratory developed tests. ASCP and four other medical specialty societies have joined together to bolster the lawsuits filed by the American Clinical Laboratory Association and the Association of Molecular Pathology. Read more.

Biden Signs Bill Blocking Laboratory Payment Rate Cuts

President Biden has signed a key temporary funding bill, which would block a series of massive cuts in the Medicare Clinical Laboratory Fee Schedule for 2025. Blocking cuts in laboratory payment rates for 2025 is a significant legislative victory for the laboratory community. Read more.

President’s Cancer Panel Invites ASCP to Workforce Meeting

ASCP Chief Medical Officer, Ali Brown, MD, FASCP was invited to a Sept. 12^th meeting of President Biden’s National Cancer Panel, on Developing and Retaining a Robust and Diverse Cancer Workforce. The panel, housed at the National Institutes of Health, is responsible for overseeing implementation of the National Cancer Plan. Read more.

ASCP 2024 Effective Test Utilizations Best Practice Recommendations Now Available

ASCP has released its 2024 Effective Test Utilization (ETU) Best Practice recommendations. The six recommendations were curated by member experts of the ETU subgroup, part of the ASCP Quality and Patient Safety Steering Committee. By implementing these and other ETU best practices in the laboratory, ASCP is striving to see higher quality care, lower costs, and a more effective use of laboratory resources and personnel. Read more.

New Forensic Pathology Scholarship Open to Medical Students and Residents. Apply by October 11

ASCP is looking for medical students and pathology residents interested in gaining experience in forensic pathology through the transformative ASCP Forensic Pathology Rotation Scholarship Award, funded through a grant supported by the National Institute of Justice and George Mason University. Applications are due by Friday, October 11, 2024. Read more.

Help ASCP Better Understand the Financial Realities of Laboratory Education

ASCP and ASCP BOC are conducting a survey related to the costs associated with laboratory education and training for professionals in medical and public health laboratories, including students and program directors. The goal is to identify deficiencies in existing student debt-reduction programs at federal and state levels and advocate for better support for laboratory professionals and propose solutions to address the educational and training needs of the laboratory workforce. The survey closes October 21. Read more.

Calling All Pathology Residents Interested in Global Health!

Are you an ASCP member resident or fellow, currently training in pathology in the US or Canada, who is interested in expanding your experience, knowledge, and exposure to pathology in a low- to middle-income country setting? If so, we encourage you to apply for the prestigious ASCP Resident Global Health Fellowship. The application deadline for this opportunity is November 1, 2024. Read more.

ASCP has filed an amicus curiae brief in a lawsuit seeking to overturn the U.S. Food and Drug Administration (FDA) Final Rule claiming authority to regulate laboratory developed tests (LDTs). ASCP and four other medical specialty societies (hereafter referred to as "the Amici Group," or "the Group")--representing the largest collection of pathology and laboratory organizations submitting an amicus brief urging the court to overturn FA's misguided LDT oversight scheme--have joined together to bolster the lawsuits filed by both the American Clinical Laboratory Association (ACLA) and the Association of Molecular Pathology (AMP). Besides ASCP, the American Association of Bioanalysts, the American Society for Microbiology, the Assocation for Diagnostics & Laboratory Medicine, and the Infectious Disease Society of America are united in their opposition to the FDA rule.  

In joining with other key stakeholders on the amicus, ASCP President Gregory N. Sossaman, MD, MASCP, said, “ASCP has heard loud and clear from our members that they are very concerned that FDA’s Final Rule will undermine their ability to provide appropriate care for their patients. FDA’s approach to oversight is too slow, cumbersome, and expensive to allow clinical laboratories to continue providing these critical diagnostic services. This flawed rule will massively scale back what LDTs services patients will be able to access, including when no commercial diagnostic is available. Given ASCP’s focus on ensuring quality care, submitting this amicus brief is essential to our mission of caring for patients.”

In submitting the amicus brief, ASCP and its partners concur with plaintiffs ACLA and AMP that the FDA does not have the authority to regulate laboratory developed tests. The Amici Group argues that the Final Rule has already had “serious detrimental effects on the clinical laboratories that perform these tests, and, ultimately, on the provision of medical care to patients who rely on these testing services for prompt diagnosis and treatment.”

In the brief, the Amici Group rejects FDA’s position that clinical laboratories offering LDT services are violating federal law, citing the Clinical Laboratory Improvement Amendments (CLIA), which specifically outlines federal legal requirement clinical laboratories must satisfy to provide testing services not approved by the FDA. The Group argues that FDA’s enforcement discretion policy allowing certain CLIA-certified laboratories to continue offering a limited subset of LDT services is so narrow that it fails to achieve its stated purpose of ensuring patient access to critical testing services. Additionally, FDA’s Final Rule infringes upon the practice of medicine by experienced, educated, and dedicated medical professionals.

Representing ASCP in developing the amicus brief is Jane Pine Wood, of McDonald Hopkins, an attorney well known for her work with the pathology and laboratory medicine community.

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Are you an ASCP member resident or fellow, currently training in pathology in the US or Canada, who is interested in expanding your experience, knowledge, and exposure to pathology in a low- to middle-income country setting? If so, we encourage you to apply for the prestigious ASCP Resident Global Health Fellowship here. The application deadline for this opportunity is November 1, 2024 and the selected awardee will be notified by Friday, December 6, 2024.

The fellowship offers $5,000 in travel and stipend support to participate in an ongoing research project on prostate cancer awareness, barriers to screening, and correlations with PSA levels among men in Northern Tanzania. This fellowship includes a 1-month visit to the Kilimanjaro Christian Medical Center (KCMC) in Moshi, Tanzania, as well as virtual support to the site, carried out between January – June 2025. Scheduling of the in-person visit is flexible to the resident’s availability (with on-site mentor’s approval).

Don’t miss this unique opportunity to gain invaluable global health experience and contribute to global pathology efforts!

To access the full application, eligibility criteria, expectations for the resident, and more information about the project, click here.

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ASCP and ASCP BOC are conducting a study related to the costs associated with laboratory education and training for professionals in medical and public health laboratories, including students and program directors. This study aims to (1) identify deficiencies in existing student debt-reduction programs at federal and state levels and advocate for better support for laboratory professionals, and (2) propose solutions to address the educational and training needs of the laboratory workforce. By recognizing financial obstacles, the study will highlight the necessity of affordable education and provide insights into issues impacting career progression and job satisfaction.

We invite you to take part in this important survey between September 23, 2024, and October 21,2024 by clicking here.  For more information on our workforce resources, please visit our workforce webpage.

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ASCP is looking for medical students and pathology residents interested in gaining experience in forensic pathology through the transformative ASCP Forensic Pathology Rotation Scholarship Award, funded through a grant supported by the National Institute of Justice and George Mason University.

ASCP has previously awarded 19 scholarships to pathology residents through this unique opportunity and, in its final round of this scholarship program, ASCP is expanding eligibility to include medical students alongside pathology residents. Applications are due by Friday, October 11, 2024, and rotations must occur by June 30, 2026. Interested applicants can apply here.

Through this unique opportunity, medical students and pathology residents are matched with a participating partner Medical Examiner-Coroner Office (10 sites available) across the country, for a 1-month on-site rotation. Awardees are provided with a $6,000 stipend to support travel and lodging during the rotation.

Past awardees have overwhelmingly reported rotations to be well-mentored, transformative experiences that have opened their eyes to the vital and fascinating role forensic pathology plays in modern society. Following her award rotation as a pathology resident, Anna Garcia MD said, “My ASCP/NIJ forensic pathology scholarship rotation was one of the best experiences in medicine thus far. I worked with forensic pathologists who were supportive, committed to my learning, and down-to-earth, fun people. The advice they have given me is invaluable. I would recommend this scholarship to anyone who wants the opportunity to be immersed in the field of forensic pathology while learning about underserved/underrepresented communities and their unique needs.”

To apply for this rotation experience, visit the full application here.

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ASCP is pleased to announce that its 2024 Effective Test Utilization (ETU) Best Practice Recommendations are now available. The list of six recommendations was curated by member experts of the ETU subgroup, part of the ASCP Quality and Patient Safety Steering Committee, from the many submissions we received -- including some from our colleagues at the American Society for Microbiology (ASM). The recommendations were reviewed and vetted by ASCP member experts and where appropriate, colleagues from sister societies such as the American College of Obstetricians and Gynecologists (ACOG).

As in years past, the tests selected for this list were those that:

• Are frequently performed
• There is evidence that the test either offers no benefit or is harmful (either entirely or in specific clinical situations)
• The test is costly, and it does not provide higher quality patient care
• Eliminating the test or changing to another test is within the control of the clinician

By implementing these and other ETU best practices in the laboratory, we strive to see higher quality care, lower costs, and a more effective use of laboratory resources and personnel. Please share this list widely to raise awareness about effective test utilization best practices in the laboratory that impact the entire spectrum of patient care. ASCP continues to champion efforts to bring the right test to the right patient, at the right time. For more information and resources, please visit the ASCP Effective Test Utilization webpage.

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ASCP Chief Medical Officer, Ali Brown, MD, FASCP was invited to a meeting of President Biden’s National Cancer Panel. The meeting on Developing and Retaining a Robust and Diverse Cancer Workforce was held on September 12th. The Panel, which is housed at the National Institutes of Health (NIH), is responsible for overseeing implementation of the National Cancer Plan. The National Cancer Plan - Everyone Has a Role provides a framework for collaboration to guide the nation’s efforts against cancer. It establishes eight goals that we must achieve to prevent cancer, reduce the cancer mortality rate, and maximize the quality of life for people living with cancer.

ASCP was proud to represent the field of pathology and laboratory medicine at this meeting, and to highlight our efforts to help end cancer. These efforts all center around initiatives that support our members in providing high-quality, equitable diagnostic laboratory services to our patients. At the meeting, Dr. Brown emphasized the importance of the pathology and laboratory medicine workforce and highlighted many of the efforts and challenges we face to retain a robust and diverse laboratory medicine workforce that serves our nation’s patients.

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 ASCP is pleased to announce that President Biden has signed a key temporary funding bill. Importantly, the measure blocks a series of massive cuts in the Medicare Clinical Laboratory Fee Schedule (CLFS) for 2025. Under the Protecting Access to Medicare Act (PAMA) of 2016, Congress tasked the Centers for Medicare and Medicaid Services (CMS) with revising the CLFS.  When CMS did so, it created a new fee schedule that massively undervalued payment rates.  Under that scheme, CMS was planning to cut payment rates in 2025 by up to 15 percent for approximately 800 laboratory tests—approximately one-third of the laboratory services reimbursed under the Medicare CLFS. 

Blocking cuts in laboratory payment rates for 2025 is a significant legislative victory for the laboratory community as the cuts would have wreaked havoc with laboratories wrestling with the dire shortage of laboratory professionals, the upcoming implementation of the flawed U.S. Food and Drug Administration’s Final Rule on Laboratory Developed Tests, among other challenges.

ASCP has been actively lobbying Congress to fix the flaws with PAMA by enacting the Saving Access to Laboratory Services Act and blocking cuts to the CLFS. As part of our goal of attaining a sustainable CLFS, ASCP will be working with our partners in the pathology and laboratory community to secure long-term PAMA reform as part of an end-of-year legislative package that Congress is expected to consider after the election. 

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