AAPath Statements and Reports


In cooperation with AAPath’s Advocacy Committee, which consists of representatives from the Graduate Medical Education, Practice & Management, Research, and Undergraduate Medical Education Committees, AAPath Council issued their 2024 Advocacy PrioritiesContinue reading to learn more about AAPath’s advocacy efforts and collaborations to address the most pressing needs of academic pathology!

Date Title
April 4

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.

April 3

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.

January 26

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.



Date Title
December 1

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.

October 30

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.

September 12

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.

July 21

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.

July 12

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.

May 22

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.

April 25

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.

January 27

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.



Date Title
September 26

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. 

June 27

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.

May 23

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.

May 22

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.   

May 12

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.

May 10

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.

March 16

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.

March 03

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.

February 23

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.

January 31

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.

January 28

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!



Date Title
November 19 APC Joins the NKF on Implementation of New eGFR Equations
APC was recently invited by the National Kidney Foundation (NKF) to join their Laboratory Engagement Initiative to facilitate implementation of the new non-race-based equations for the estimation of glomerular filtration rate (eGFR). The new equations were developed by an NKF Task Force and will be formally published in January 2022. APC endorses the use of the new equations and will hold a virtual event in February 2022 to provide background on the changes and examples of implementation in academic health systems, with the hope of accelerating adoption.
November 2 APC Joins AACC, ACMG and AMP in Support of CLIA’s Oversight of LDTs: APC’s resolve against LDT regulation by the FDA, in favor of affirming CLIA’s oversight of LDTs, has strengthened during the COVID-19 pandemic. Academic labs, and the healthcare systems and patients they serve, waited anxiously for weeks to begin rapid PCR testing locally to contain the spread of the virus, while the FDA gave authority only for faulty CDC test kits. As evidenced by the AMA’s and AHA’s support of CLIA improvements hospital leaders and fellow clinicians learned what distinguishes pathologists and professionals practicing laboratory medicine (whose labs are overseen by CLIA and some state health departments), from kits and devices commercially produced or performed outside of CLIA-certified labs (which are regulated by the FDA).
May 28 APC Issues a Statement on Fellowship Recruitment Practices
Consistent with APC’s advocacy priority to “collect data on unexpected fellowship openings and resident concerns about the fellowship recruitment process to inform recommendations for systemic changes”, APC Council and PRODS Council have noted and discussed the increasing numbers of unexpected fellowship openings (defined as fellows withdrawing their commitments within 18 months of matriculation). The Councils jointly approved a statement concerning this urgent matter. Member feedback is welcomed at [email protected].
 May 25 APC Supports the ACLU’s Efforts Against Gene Patenting
APC signed onto the American Civil Liberties Union’s coalition letter to the Biden Administration against gene patenting and related issues. The letter expresses opposition to legislation and regulatory action that would overturn established Supreme Court precedent and expand patent-eligible subject matter to encompass abstract ideas, laws of nature, and natural phenomena. Click here to read the full letter.
May 18 APC Joins AMP in Supporting Reintroduction of the VITAL Act
APC previously endorsed the Verified Innovative Testing in American Laboratories (VITAL) Act, which would codify current federal regulations that place oversight of laboratory developed tests (LDTs) under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) administered by the Centers for Medicare and Medicaid Services (CMS). In cooperation with the Association for Molecular Pathology (AMP), APC submitted a letter of support for reintroduction of VITAL to the bill’s sponsor, Senator Rand Paul. On May 17th, Senator Paul reintroduced this legislation. APC and AMP released a joint statement of support on May 18th and urged Congress to pass this very important piece of legislation.
April 5 APC Supports the VITAL Act: APC endorses the Verified Innovative Testing in American Laboratories (VITAL) Act, which would codify current federal regulations that place oversight of laboratory-developed tests (LDTs) under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) administered by the Centers for Medicare and Medicaid Services (CMS). In cooperation with the Association for Molecular Pathology, APC submitted a letter of support for reintroduction of VITAL to the bill’s sponsor, Senator Rand Paul.
March 15 APC Supports Comments to the Federal Registrar: APC joined ADASP, ASCP, and CAP in endorsing comments submitted by the Association for Pathology Informatics (API) to the Food & Drug Administration (FDA) on making permanent regulatory flexibilities provided during the COVID-19 public health emergency by exempting certain medical devices from premarket notification requirements, including several devices used in remote and digital pathology.
March 11 NIH Capitol Hill Day Report: Representing APC and the Research Committee, Dr. Daniel Remick attended an annual Capitol Hill Day hosted by the Federation of American Societies for Experimental Biology (FASEB) on March 11, 2021. This year’s participants met virtually with Congressional staff to advocate for additional funding for the National Institutes of Health (NIH) and the National Science Foundation (NSF). Click here to read Dr. Remick’s report.
March 8 APC Supports Additional HRSA Funding: Again, in 2021, APC joined fellow Friends of HRSA and the Health Professions and Nursing Education Coalition in support of funding for the Health Resources and Services Administration (HRSA), including $1.51 billion for the Title VII health professions and Title VIII nursing workforce development programs and $9.2 billion for HRSA to sustain their important work in medical workforce pipeline research and development.
February 9 APC Supports Tracking COVID-19 Variants Act: APC signed on to a letter of support for the Tracking COVID-19 Variants Act. The bill aims to provide supplemental funding to the Centers for Disease Control and Prevention (CDC) to expand sequencing. The bill is supported by the American Society for Microbiology, Association for Molecular Pathology and University of California Health. Funding is intended to be broad-based, including academic labs, especially those already engaged in CDC’s SPHERES program.
January 29

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.

January 18 2021 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 APC’s 2021 Advocacy Priorities.



Date Title
December 4 The Ad Hoc Group for Medical Research Letter on NIH to President-Elect Biden
November 24 FY2021 CDC Funding Coalition Letter
October 30 Novel Testing White Paper
October 19 Comments on Proposed Visa Changes Impacting Trainees: APC submitted comments in opposition to the U.S. Immigration and Customs Enforcement’s proposed rule of establishing a fixed time period for certain classes of non-immigrant visas, including J-1 visas. The response emphasizes, “Due to the uncertainty of outcomes in applications for extension, APC anticipates crippling disruptions to resident and fellow training in pathology, with devastating impact on the pipeline of pathologists in the U.S."
October 5 E&M Coalition Letter to CMS: APC joined nearly 50 professional medical organizations as part of the Evaluation and Management (E&M) Coalition, led by the American College of Radiology, in signing a letter requesting CMS to take the necessary steps to prevent steep cuts associated with the finalized E/M code policies slated for implementation on January 1, 2021.
September 9 Testimony in the ACGME External Stakeholders Congress: Leaders of the APC GME Committee, PRODS Council, and GMEAS Council are preparing to give testimony in the ACGME External Stakeholders Congress on November 10, 2020. Their testimony will be based on APC’s comments to ACGME on Common and specialty-specific Program Requirements relating to duties, functions, dedicated time, and support for program directors, assistant/associate program directors, program coordinators, and core faculty members.
July 30

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.

February 26 FY2021 CDC Funding Support Letter
February 26 FY2021 HRSA Funding Support Letter



Date Title
November 27                Letter to CMS on NCD for NGS
October 24                FY2020 NIH Funding
July 17                 PAMA Stakeholder Statement
October 22                 PCORI-Reauthorization Act Letter
May 20                 Stakeholder Letter Requesting a Comment Extension on NGS NCD Reconsideration
March 4                 FY2020 CDC Funding Coalition Letter
February 22                 APC support for an increased NIH budget with the Ad Hoc Group for Medical Research
February 14 APC Comments on the VALID Act draft legislation
February 5 APC Position Paper on Assessing Autopsy Competency in Pathology Residency Training
February 5 APC Position Paper on Surgical Pathology Residency Training
January 31 Stakeholder Letter to CMS on NCD for NGS for Medicare beneficiaries with early-stage cancer
January 29 APC and CAP Letter to the Editor of JAMA refuting a recent AMA News article that misrepresented pathology


Previous Statements and Reports from past years will be posted here!