APC Statements and Reports

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.