APC Statements and Reports
2022
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. Continue reading to learn more about APC’s advocacy efforts and collaborations to address the most pressing needs of academic pathology!
| Date |
Title |
| 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.
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| 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.
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| 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.
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| 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.
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| 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.
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| 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.
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| 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.
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| 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!
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2021
| 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.
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| 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. |
2020
| 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.
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| February 26 |
FY2021 CDC Funding Support Letter |
| February 26 |
FY2021 HRSA Funding Support Letter |
2019
Previous Statements and Reports from past years will be posted here!
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.
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