AAPath Statements and Reports

AAPath filed an amicus brief in support of AMP and ACLA's lawsuits against FDA regulation of LDTs: On October 7, 2024, AAPath filed an amicus brief in support of the lawsuits filed by the Association for Molecular Pathology and the American Clinical Laboratory Association opposing the FDA’s regulation of laboratory developed tests (LDTs) like medical devices. Arguments that we put forward in the brief include: 

• FDA regulation impedes testing and creates unnecessary patient harm and deaths that affect everyone, but that disproportionately impacts vulnerable populations, such as people with cancer, rare diseases, and children, and exacerbate existing public health crises, with illustrative examples provided regarding the fentanyl epidemic, cancer diagnosis and treatment, and emerging pandemics, such as monkeypox and others; 
• Costs of seeking FDA approval will force academic medical centers to reduce or abandon LDT development, leaving Americans with diminished opportunities for treatment and recovery;
• LDTs are already appropriately regulated to protect patient safety via CLIA;
• Certain modifications or updates to CLIA may be necessary as the field of medicine progresses. 

Click here to read AAPath’s full amicus brief.

AAPath submitted a letter to Representative Virginia Foxx encouraging opposition to the Embracing Anti-Discrimination, Unbiased Curriculum and Advancing Truth in Education (EDUCATE) Act:  This act (House Resolution 7725), prevents medical schools from receiving Federal funds if they adopt policies and requirements relating to diversity, equity and inclusion (DEI). In our letter, we share that cultivating a diverse workforce to join our specialty is critical to addressing the current national shortage of pathologists and laboratory professionals, and can improve patient care, communication and financial performance in health systems. The bill has 43 co-sponsors, as of May 12, 2024, and amends the Higher Education Act of 1965. Click here to read AAPath’s full letter opposing this act.

APC Meetings with White House OMB on LDTs: During a 30-minute private meeting with the White House Office of Management and Budget (OMB), the APC shared our members’ concerns regarding the FDA’s proposed regulation of LDTs. These concerns were framed within the context of OMB’s oversight functions which include reducing administrative burden, budget development and execution, coordination and review of all significant Federal regulations from executive agencies, and management including oversight of agency performance, procurement, financial management, and information technology. Members of the FDA were also present at this meeting. A few questions were posed at the end of the presentation. We also shared our appreciation for the opportunity to directly share our perspectives. The OMB has had many meetings with other stakeholders, including the AAMC and other pathology organizations. Click here to view the PowerPoint used during APC’s presentation to the OMB.

APC Responds to LDT Request for Information: The APC submitted a letter to Senator Bill Cassidy, MD (R, Louisiana) on April 3, 2024, in response to his request for information regarding LDTs. Senator Cassidy is the first physician to serve as a Ranking Member of the Health, Education, Labor, & Pensions Committee (HELP) since 1933. The APC’s letter included responses to two dozen questions focusing on the regulatory framework for LDTs provided by the FDA and CLIA. Several APC members provided information and insights based on their own LDT experiences; their input was much appreciated since it helped ensure that the APC letter best reflected the opinions of our members. Click here to view this letter.

2024 APC Advocacy Priorities: In cooperation with APC’s Advocacy Committee, which consists of representatives from the Graduate Medical Education, Practice & Management, Research, and Undergraduate Medical Education Committees, APC Council issued their 2024 Advocacy Priorities.

The APC Responds to the FDA Proposed Rule: APC issues a formal response to the FDA regarding their proposed rule to regulate laboratory developed tests (LDTs) like medical devices (Docket No. FDA–2023–N–2177 for “Medical Devices; Laboratory Developed Tests.”). The FDA has sought to gain jurisdiction over LDTs for many years.  Their last effort was through the VALID Act which was not included in the 2023 Consolidation Appropriations Act as supporters had hoped.  This defeat prompted the FDA’s current approach via the proposed rule.

To facilitate evidence-based decisions regarding regulation, the FDA requests data as part of submitted responses to their proposed rule.  Currently, there is little existing data regarding laboratory practices and volume related to LDTs; however, anecdotal reports regarding significant adverse events from LDTs have appeared in the news raising concern by the FDA and the public.  To further illuminate practices regarding LDTs, the APC created and distributed a survey on November 18, 2023, to department chairs, department administrators, clinical laboratory leaders, and other key stakeholders.  This survey explores concerns regarding the FDA’s proposed rule which have been the topic of conversation among APC members and other laboratory organizations.  This survey provided a much needed window into laboratory practices and volume related to LDTs within academic clinical laboratories.   Questions included the number of LDTs within the respondent’s laboratory, anticipated ability to garner the necessary resources required to implement the FDA’s proposed rule, and the anticipated impact on turnaround time, patient care, access, and more.  The findings from the survey served as the foundation for the APC’s response to the FDA’s proposed rule.

Letter to Members to Submit Comments to FDA Proposed Rule Regulating LDTs: In October, the FDA proposed a controversial new rule (Docket #FDA-2023-N-2177) to regulate laboratory developed tests (LDTs) as medical devices within existing regulatory frameworks. The APC believes that this proposed regulation is unnecessary and onerous to academic clinical laboratories, and would lead to significant financial consequences that would negatively impact clinical services and training programs, and adversely affect patient care and the medical laboratory professional workforce. To ensure a unified voice that fully reflects the concerns of academic pathology, APC representatives have been meeting with representatives of the Association of American Medical Colleges and other professional organizations to help inform and shape the APC’s upcoming formal response. To fully demonstrate the depth of opposition by the academic pathology community to the proposed rule, member departments were encouraged to submit their own comments and to work closely with their medical schools, hospitals, and hospital systems to provide institutional responses that reflect the grave concerns of academic medical centers, and all of the clinical specialties they represent. To aid our members in submitting comments, APC issued an e-mail communication to its members on October 30th outlining specific points that could be useful in responses.

Open letter to the CDC regarding the recent report on COVID-19 response: On September 12, 2023, the APC sent a letter to CDC Director Mandy Cohen, MD, MPH to express APC’s considerable interest in participating in recommendations outlined in the recent report entitled “Review of the Shortcomings of CDC’s First COVID-19 Test and Recommendations for the Policies, Practices, and Systems to Mitigate Future Issues,” prepared by the United States’ Center for Disease Control and Prevention’s (CDC) Advisory Committee to the Director of the Laboratory. Many recommendations specifically mentioned the participation of academic laboratories, including developing better plans to rapidly develop, scale and deploy needed new tests for public health emergencies, and standardizing health data collection, and creating a new ‘Centers of Excellence’ program that includes academic laboratories. The APC letter applauded the CDC for embracing a quality-improvement approach in its recent exploration of these issues and for identifying the root causes that led to the initial failure in the SARS-CoV-2 test development and roll-out process.

APC Press Release - First Deputy Director Appointed: The Association of Pathology Chairs (APC) issues a statement announcing the appointment of Lydia Pleotis Howell, MD as its first Deputy Director. The APC welcomed Lydia Pleotis Howell, MD as its first Deputy Director at their annual meeting in Chicago on July 17-20, 2023. Dr. Howell is a Past President of the APC, Past President of the American Society of Cytopathology, Professor emerita and Chair emerita at the University of California Davis School of Medicine and former Medical Director of the UC Davis Health clinical laboratories. In addition to advocacy for research, education, and clinical care, Dr. Howell’s responsibilities will include brand strategy and advancing the APC’s strategic goals for leadership development and diversity initiatives.

APC Press Release - Academy of Distinguished Educators: The Association of Pathology Chairs (APC) issues a statement announcing the founding members of the New Academy of Distinguished Pathology Educators. The Association of Pathology Chairs has elected twenty of the most accomplished educators in the specialty of pathology and laboratory medicine as founders of the newly established Academy of Distinguished Pathology Educators. Click here for the full list of new founding members.

APC Joins Other Major Health Care Organizations in Support of SALSA: APC joined over 30 professional societies and organizations, including the American Hospital Association, the American Medical Association, and the Association of American Medical Colleges in signing on to a letter supporting the Saving Access to Laboratory Services Act (SALSA). The letter urges Congress to take action to pass this bicameral, bipartisan legislation that would update Medicare’s payment system for laboratory services to make it predictable and sustainable, ensuring our nation’s laboratory infrastructure is equipped to support the full range of testing that patients need for day-to-day care as well as during times of public health crisis, while fostering innovation in new diagnostics.

APC Council Signs on to the Medical & Public Health Laboratory Workforce Coalition Letter to Congress: APC joined 24 other professional societies and organizations representing approximately 350,000 essential laboratory professionals and pathologists responsible for patient care and public health in signing on to a letter asking Congress to recognize our urgent workforce issues and include laboratory professionals in policy and legislative solutions that address other healthcare workforce shortages. The letter urges Congress to include laboratory professionals in all Federal workforce programs and to focus on visa issues impacting the ability to hire qualified foreign candidates. APC remains dedicated to advancing academic pathology departments and participating in efforts that support our priorities.

2023 APC Advocacy Priorities: In cooperation with APC’s Advocacy Committee, which consists of representatives from the Graduate Medical Education, Practice & Management, Research, and Undergraduate Medical Education Committees, APC Council issued their 2023 Advocacy Priorities.

APC Comments Proposed Changes to Testing Personnel Requirements: APC submitted comments on the Centers for Medicare & Medicaid Services’ (CMS) proposed rule on CLIA Fees, Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories. In particular, APC expressed serious concerns about the proposed changes to the testing personnel requirements. The proposed rule would equate nursing degrees to clinical laboratory science, biology, and chemistry degrees, which means that individuals with a nursing degree would not be required to meet the coursework or clinical training requirements needed to qualify as high-complexity testing personnel. APC strongly and respectfully requests that CMS reconsider the proposed changes on testing personnel requirements for the reasons outlined in this letter. APC also signed onto a community letter led by the American Society for Clinical Pathology. 

APC Endorses the Uniform Timeline for Fellowship Recruitment: The Association of Pathology Chairs (APC) strongly endorses the national movement to a uniform timeline for fellowship recruitment as described in the recent article by Herrmann et al in Academic Pathology.   In a recent announcement by APC President, Lydia Pleotis Howell, MD, several key points were made on the importance and responsibility of APC membership supporting a uniform recruitment process to protect pathology residents. The APC Council endorses plans brought forward by the APC Graduate Medical Education (GME) Committee to establish guidelines to assist with this new uniform timeline that will take effect in a phased manner beginning July 2023. More information and updates can be found on APC’s NEW Fellowship Application Resources webpage: https://www.apcprods.org/fellowship-application-resources.

APC Supports Virtual Interviewing for 2022-2023 Residency Cycle: APC Council endorses and supports PRODS Council’s support for the recently released AAMC interview guidance for the 2022-2023 residency cycle. The AAMC recognizes the reported benefits to virtual interviewing for both students and programs, and emphasizes a shared sense of increased equity for students. Also acknowledging the benefits of in person interviewing, the AAMC encourages an evidence-based approach for establishing best practices taking into consideration the needs of students and programs alike. The recommendations are intended only as a guide for medical schools, institutions, and program directors during the 2022-2023 interview season and are not intended to interfere with individual institutional decisions on recruitment. PRODS Council firmly supports incorporating these recommendations for the recruitment season in as much as each institution and program will allow.

VALID Updates: The HELP Committee recently released the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act, which (as feared) includes the VALID Act of 2022. The VALID Act creates a new regulatory framework at the FDA for both IVD test kits and laboratory developed testing procedures (LDTs). This is a major overhaul to the current system of oversight with significant implications for patient care, clinical labs, and innovation. Stakeholders have been actively engaged in the policy development for years providing constructive feedback and specific language requests. Yet, the VALID Act of 2022 fails to reflect these requests and comments. 

The potential negative impact of the VALID Act on patient access and medical practice are deeply concerning to the academic pathology community. AMP, ACMG, AACC, and APC initiated an organizational and institutional sign-on letter, linked here. We are grateful to APC members who supported the letter by signing on behalf of their departments and by sharing the letter with their government relations offices for institutional sign-on. We are also grateful to the organizations that joined in support, including AAMC, ACLPS, API, ASCP, ASH, and ASHI. We remain committed to communicating our grave concerns to Congress, while they consider the VALID Act as part of the required FDA medical device user fee reauthorization bill in the coming months.   

APC Supports Pathology GME Program Coordinators: On behalf of the Association of Pathology Chairs (APC) Program Directors Section (PRODS) Chair and the Graduate Medical Education (GME) Committee Chair, Dr. Diane Kowalski and Dr. Douglas C. Miller, respectively, have written a letter of concern to the ACGME for considering a change in the minimum support range (between 20% and 50% FTE) to a minimum of at least 50%FTE support for Program Coordinators in pathology. Details and the rationale are included in this letter.

APC Supports FY22 National Institutes of Health Funding: APC joined over 300 organizations in signing onto the Ad Hoc Group for Medical Research’s fiscal year 2023 recommendations. To promote the sustained, robust growth necessary to make consequential progress against pressing health challenges, in fiscal year (FY) 2023, the Ad Hoc Group recommended a program level of at least $49.048 billion for the NIH base budget, which would represent an increase of $4.1 billion over the comparable FY2022 funding level (an increase of $3.5 billion or 7.9% in the NIH appropriation, plus funding from the 21st Century Cures Act for specific initiatives). Importantly, the Ad Hoc Group strongly urged lawmakers to ensure that any funding for the new Advanced Research Projects Agency for Health (ARPA-H) be over and above their $49 billion recommendation for NIH’s base budget, rather than take away from the foundational investment in the NIH. In addition, the coalition supported the President’s proposal to supplement NIH’s budget with additional mandatory funding to speed the pace of pandemic response and readiness.

APC Continues to Advocate for Solutions to LDT Oversight: APC recognizes there are an array of positions and perspectives about the FDA’s role in regulating various forms of testing – from patient groups, fellow physicians, manufacturers, and even among pathology groups. One thing almost every stakeholder can agree upon is that the current version of the VALID Act needs work. APC is grateful to the member institutions that signed on to the letter to show their support.

APC Joins ACE in Supporting Free and Open Academic Discourse: As a member of the Societies Consortium on Sexual Harassment in STEMM, APC was invited by the American Council on Education (ACE) to join nearly 100 organizations in higher learning to address growing concerns that states prohibiting content in schools undermines basic academic principles and civil society. As stated in a joint, open letter, free and open inquiry and debate on campuses is essential to our democracy and national wellbeing. The letter urges government to maintain support for the exchange of ideas and respectful discourse, which are core academic and democratic values.

APC Continues to Advocate for Solutions to LDT Oversight:
In partnership, AACC, ACMG, AMP, and APC drafted a letter asking Congress to consider the FDA-led regulatory process over LDTs (VALID Act) separately from the FDA and industry-negotiated agreement on medical device user fees (MDUFA) to allow more time for stakeholders to come to consensus on the complex and potentially detrimental effects of FDA regulation of LDTs as set forth in the current version of VALID.

APC Coordinates Senate Meetings with AACC on LDTs: APC is pleased to further our cooperation with the American Association for Clinical Chemistry (AACC) and other major stakeholders to ensure that legislation regulating laboratory developed tests (LDTs) is uncoupled from an unrelated reauthorization bill that must pass in the next several months. AACC invited APC members from select states to meet with Senate HELP Committee members to explain the importance of separating the complex and unresolved issues of the VALID Act (the FDA-led regulatory process over LDTs) from the FDA and industry-negotiated agreement on medical device user fees, known as MDUFA. APC continues to advocate for solutions to LDT oversight that respect these tests as the practice of laboratory medicine in academic health systems.

2022 APC Advocacy Priorities: In cooperation with APC’s Advocacy Committee, which consists of representatives from the Graduate Medical Education, Practice & Management, Research, and Undergraduate Medical Education Committees, APC Council recently issued their 2022 Advocacy Priorities. Click the link to learn more about APC’s advocacy efforts and collaborations to address the most pressing needs of academic pathology!

APC Supports FY22 National Institutes of Health Funding: APC signed on to a letter of support organized by the Association of American Medical Colleges’ Ad Hoc Group for Medical Research. The letter recommends for FY22 a program level of at least $46.111 billion, which represents a $3.177 billion increase over the comparable FY21 funding level, which would allow for the NIH’s base budget to keep pace with the biomedical research and development price index (BRDPI) and allow meaningful growth of 5%. The letter also advocates for emergency supplemental funding to support COVID-19-related expenses associated with both pandemic- and non-pandemic research and the research workforce pipeline.

Statement on the Value of Academic Labs and Their Supply Chain Issues During the 2020 COVID-19 Outbreak in the United States: The goal of this APC statement is to articulate the unequivocal value that academic labs can have in the nation’s recovery from the COVID-19 pandemic, but whose participation in that recovery has been handicapped by the prevalence and persistence of an unstable supply chain for reagents.