Advocacy Update

• CAP Advocacy Highlights at CAP24 in Las Vegas
• Dr. Myles Receives CAP Advocate of the Year Award
• FDA Explains LDT Regulation in Court Brief Filed Late October 25
• FDA Names Medical Device Director
• Webinar: What Will Be the Impact of the Final 2025 Fee Schedule on Your Practice?
• Register for LDT Webinar on Nov. 7! Ready Your Laboratory for the FDA’s Stage 1: Adverse Event Reporting Requirement
• Take Our News Quiz for October

Pathologists attending CAP24 received updates on legislative and regulatory achievements and how the CAP is tackling the challenges ahead through its advocacy programs. CAP leaders discussed the latest updates on Food and Drug Administration (FDA) regulation for laboratory-developed tests (LDTs), Medicare payment, and the release of a new CAP report on health insurer interference in patient care.

Council on Government and Professional Affairs Chair Joe Saad, MD, FCAP, first presented these advocacy topics during a meeting of the House of Delegates on October 19. State Affairs Subcommittee Chair Rebecca F. Yorke, MD, FCAP then discussed the CAP’s state advocacy priorities and wins in 2024.

These topics were later reviewed in greater detail during our annual advocacy town hall event on October 20. The town hall featured Dr. Saad; Council on Government and Professional Affairs Vice Chair Diana Cardona, MD, MBA, FCAP; newly elected Board of Governor, Matthew R. Foster, MD, MMM, FCAP; and Theresa S. Emory, MD, FCAP, chair of the Payment Policy Subcommittee.

Pathologist Workforce

The Advocacy Policy Roundtable session on October 22 discussing pathologist supply in the US was the best received advocacy topic. It featured W. Stephen Black-Schaffer MD, FCAP, Dr. Saad and David Gross PhD from the CAP. The course addressed the collaboration between the CAP and the American Academy of Medical Colleges (AAMC) that has radically revised the count of US pathologists. The panelists reviewed a new study “Re-evaluation of the Methodology for Estimating the U.S. Specialty Physician Workforce,” published by Health Affairs Scholar, that uncovered an undercount in the workforce of pathologists as a result of omitting subspecialized training over several years.

LDT Hot Topic

On October 22, Bobbi S. Pritt MD, MS, FCAP, CAP Council on Scientific Affairs Chair; Jonathan R. Genzen MD, PhD, FCAP; and Dr. Saad examined how the FDA will potentially enforce the regulation of LDTs, the pathways laboratories might use to comply, and the options possible to reduce regulatory burden going forward. The course reviewed significant aspects of the final rule and its impact on pathologists, laboratories, other care providers, and patients.

Editor-in-Chief Speaks

On October 19, Bob Cusack, Editor-in-Chief of The Hill provided insider knowledge of policy and politics evolving from his post at one of the most respected news organizations in congressional circles during his PathPAC luncheon keynote speech. Mr. Cusack discussed how the next Congress could affect them.

PathPAC Raises $18,000

PathPAC later hosted a reception on October 20 for contributors to the only political action committee to represent pathologists. PathPAC celebrated its supporters with a reception attended by a pro-pathology member of Congress, Rep. Ami Bera, MD (D-CA). CAP members thanked Rep. Bera for his work to improve patient access to care, expand the physician workforce, and advocate for legislative solutions that will add economic stability to the physician payment system.

PathPAC raised $18,000 during the CAP24 Annual Meeting.

The 2025 Advocate of the Year award was presented to Jonathan Myles, MD, FCAP.

The award recognizes outstanding accomplishments in advocacy on the CAP’s behalf in the legislative, regulatory, and/or political arenas. It is presented to a member who has made significant contributions to the CAP’s advocacy efforts and demonstrated dedication to helping achieve the CAP’s advocacy goals.

Dr. Myles is currently a member of the Board of Governors of the CAP where he previously served as Chair of the Council on Government and Professional Affairs, Vice-Chair of the Council on Scientific Affairs, Board Member of PathPAC, and member of the Information Technology Leadership, Compensation, Investment and Finance Committees. Dr. Myles previously served for 11 years as the Pathology Advisor to the AMA-RUC (Relative Value Update Committee) and 7 years as Chair of the Economic Affairs Committee at the CAP.

The Food and Drug Administration (FDA) filed a legal brief defending its regulation of laboratory-developed tests (LDTs) late on October 25. The CAP has urged the federal court to throw out the regulation because it is arbitrary and capricious.

The CAP’s position is found in our amicus brief filed on October 7.

With the FDA filing, the court granted the FDA’s request to deny motions to vacate the final LDT rule. The ACLA/AMP vs FDA case will proceed, and the CAP will provide additional updates as new information is released.

On October 22, the Food and Drug Administration (FDA) named Michelle Tarver, MD, PhD as the new Director of the Center for Devices and Radiological Health (CDRH). The CDRH oversees in vitro diagnostics and laboratory-developed tests.

Dr. Tarver has worked more than 15 years as a medical device regulator and has held various leadership positions while at the FDA. Over the course of her career, she has conducted laboratory-based and epidemiological studies, clinical trials, and surveys to capture patient preferences, as well as developed registries and patient-reported outcome measures, the FDA said.

Dr. Tarver received a BS in Biochemistry from Spelman College in Atlanta and completed the MD/PhD program at the Johns Hopkins University School of Medicine and Bloomberg School of Public Health.

The Centers for Medicare & Medicaid Services (CMS) soon will release the final 2025 Medicare payment regulations, including rules for the Medicare Physician Fee Schedule and the Quality Payment Program.

On December 4 at 2 PM ET/ 1 PM CT, the CAP will offer a complementary live webinar where CAP experts will review final regulations that will impact Medicare payment for services and pathologists’ participation in the quality initiatives. Presenting are the Council on Government and Professional Affairs Chair A. Joe Saad, MD, CPE, FCAP; Economic Affairs Committee Chair Ronald McLawhon, MD, PhD, FCAP; and Quality and Clinical Data Registry Affairs Committee Chair Gregary Bocsi DO, FCAP.

Register today!

Under the FDA’s planned regulation, laboratories with LDTs must have a process in place for adverse event reporting starting May 6, 2025. The CAP’s second webinar in our series will discuss existing accreditation requirements and ways laboratories can comply with the FDA rules on medical device-related adverse event reporting. Accreditation experts will review best practices associated with quality management and discuss real world scenarios. Join us on November 7, 2 PM ET/ 1 PM CT, to learn more!

Speakers

• Bobbi S. Pritt, MD, FCAP, chair, Council on Scientific Affairs
• Earle S. Collum, MD, FCAP, chair, Council on Accreditation

Register today!

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