Advocacy Update

• Video Statement: Dr. Karcher Discusses Amicus Brief to Vacate LDT Regulation
• Take Action to Stop 2025 Medicare Cuts!
• 9 Advocacy Sessions You Need Add to Your CAP24 Agenda
• Advocacy Win! Remote Waiver Bill Becomes Law in California
• New Podcast! LDT Advocacy: What You Should Know
• Register Today for Upcoming LDT Webinar! Ready Your Laboratory for the FDA’s Stage 1: Adverse Event Reporting Requirement
• Take Our News Quiz for October

On October 7, the CAP filed an amicus brief in a US District Court against the Food and Drug Administration (FDA) and its regulation of laboratory-developed tests (LDTs). The CAP joined the American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP) in challenging the LDT rulemaking by the FDA, which acted arbitrarily and capriciously in violation of the Administrative Procedure Act.

In the amicus brief, the CAP urged the court to vacate the FDA regulation for several reasons, including the ultimate impact on patient access to diagnostic tests and the agency failing to adequately justify the rule’s unsustainable costs that will hinder the development of LDTs.

When the court issues its ruling, the CAP further urges the court to avoid suggestions that LDTs constitute the practice of medicine. The CAP has emphasized that the states, not the federal government, are primarily responsible for regulating medical practice.

Read the CAP’s amicus brief to the court case ACLA and HealthTrackRX, Inc. v. FDA, US District Court Eastern District of Texas and watch the video statement released by CAP President Donald Karcher, MD, FCAP here.

Pathologists are projected to receive a 2.4% cut in pathology payments in 2025. In response to ongoing yearly cuts, Reps. Miller-Meeks (R-IA), Panetta (D-CA), Murphy (R-NC), Ruiz (D-CA), Bucshon (R-IN), Schrier (D-WA), Joyce (R-PA), and Bera (D-CA) released a letter to House congressional leadership urging them to pass legislation to replace the impending Medicare payment cuts with an inflationary payment update, make targeted adjustments to the Medicare Physician Fee Schedule’s budget neutrality requirements, and limit yearly changes to the conversion factor.

CAP members must act! Contact your representative by October 11 and urge them to sign on to this letter to House leadership.

It is imperative that pathologists ask their representatives to sign the letter to House leadership. With the proposed cut for 2025, over the last six years, payments to pathologists have decreased by approximately 7% while physician practice costs (medical supplies, lab personnel, professional liability insurance) have increased over 17%. With inflation, in 2025 alone, pathologists are anticipated to experience a net 6% reduction in revenues as Medicare reimbursement is expected to fall by close to 2.4% while expenses are expected to increase by 3.6%.

Whether you join in person for all four days or just one, or you choose to participate afterwards on demand, there’s no greater opportunity to learn, grow, and explore than at CAP24! Here are nine sessions guaranteed to get you excited about how advocacy impacts the practice of pathology.

Hot Topic: Pathways for Pathologists and Laboratories Under FDA Oversight of LDTs: Practical Aspects
Examine how the Food and Drug Administration (FDA) can potentially enforce regulation of laboratory-developed tests (LDTs), propose pathways laboratories might use to comply, and provide an evaluation of the options possible to reduce regulatory burden going forward. This course will review significant aspects of the final rule and its impact on pathologists, laboratories, other care providers, and patients. Don’t miss this must-see course to gain the knowledge you need to be prepared for the future!

Date and time: Tuesday, October 22, 10:30 AM-12:00 PM

Panelists
Bobbi S. Pritt MD, FCAP
Jonathan R. Genzen MD, PhD, FCAP
A. Joe Saad MD, CPE, FCAP

Advocacy Town Hall
Get your questions answered on FDA LDT oversight regulation Advocacy Town Hall. The CAP works to expand the public policy impact of pathology at the federal and state levels of government by engaging with our members. This is your chance to discuss the impacts of the LDT regulation with the CAP’s advocacy leaders and ask questions. This session provides CAP members with a better understanding of the scope of our advocacy agenda and how it impacts the practice of pathology.

Date and time: Sunday, October 20, 9:30 AM-10:30 AM

Moderator:
A. Joe Saad MD, CPE, FCAP

Panelists:
Diana M. Cardona MD, MBA, FCAP
Matthew R. Foster, MD, MMM, FCAP
Theresa S. Emory, MD, FCAP

Advocacy Isn’t for Me … Or Is It?
Pathology's influence extends well beyond the laboratory and into policy making. Discover how to get involved in advocacy—from getting started and understanding the issues to first-time Hill visits and state-level leadership—with panelists who will share insights and discuss the transformative impact of advocacy on our profession.

Date and time: Saturday, October 19, 9:00 AM-10:00 AM

Moderator:
Swati Bhardwaj, MD, MBBS

Panelists:
Kathryn T. Knight, MD, FCAP
William H. Yong, MD FCAP
Elizabeth V. McLeod, MD, MS

Advocacy Policy Roundtable: Pathologist Supply in the US—Too Many or Too Few?
Too many pathologists in the US, or too few? Collaboration between the CAP and the American Academy of Medical Colleges (AAMC) has radically revised the count of US pathologists and shed light on where current trends are going. Whether you're just entering practice or you’re the senior member responsible for recruitment, the demographics of our specialty matter to you. Our new understanding of current and trending US pathology numbers is essential to planning, for individuals and for the specialty, and this is what our work with the AAMC and this course is about.

Date and time: Tuesday, October 22, 8:30 AM-9:30 AM

Panelists:
W. Stephen Black-Schaffer MD, FCAP
A. Joe Saad MD, CPE, FCAP
David Gross PhD, College of American Pathologists

Strategies to Address the Use of Race in Laboratory Medicine—A Work in Progress
This course will review and distinguish between the concepts of race, ethnicity, and genetic ancestry, and will address laboratory medicine practices that misguidedly use race and ethnicity. It will also highlight areas that require more significant inclusion of racialized minorities. This course will distinguish race and ethnicity from genetic ancestry, identify areas of laboratory medicine where race and/or ethnicity are used inappropriately and identify areas of laboratory medicine where inclusion of ancestrally diverse populations can improve care.

Date and time: Monday, October 21, 2:30 PM-3:30 PM

Presenter
Cristina C. Pierre, PhD, DABCC

Current Payment Policy Challenges in Pathology Practice
Pathologists are often challenged by payment policy-related issues regarding the services they provide. It is important that pathologists better understand how Advocacy seeks to influence payment policies, why changes in reimbursement occur, and how to adapt within their practices. Workshop participants will gain knowledge and insight into the engagement opportunities available. The faculty will present payment policy information associated with Physician Fee Schedule valuation (that can influence payment policy development), Clinical Laboratory Fee Schedule Payment Reform (PAMA), emerging payment models, and other payment challenges and possible solutions.

Date and time: Sunday, October 20, 2:30 PM-3:30 PM

Presenter
A. Joe Saad MD, CPE, FCAP

Advocacy Update at the House of Delegates Meeting
Year after year, pathologists’ Medicare payments are under threat, cuts to clinical laboratory payments hang in the balance and the new FDA LDT rule could have negative impacts on pathologists and laboratories across the country. Learn about the most current Advocacy policies affecting the practice of pathology and how you can make an impact on Capitol Hill and protect the future of our specialty.

Date and time: Saturday, October 19, 2:15 PM-3:10 PM

Presenters
A. Joe Saad MD, CPE, FCAP
Rebecca F. Yorke, MD, FCAP

How Is My Payment Determined for Pathology Services?
Learn about concepts of current procedural terminology (CPT) coding and payment for services on the Medicare Physician Fee Schedule (PFS). In this highly-interactive course, faculty will provide an introduction to and overview of the development of current coding, Relative Value Scale Update Committee (RUC ) valuations, and billing practices-Details on how the Centers for Medicare & Medicaid Services (CMS) values codes on the PFS-Particulars on how CPT codes are modified and the steps involved-Information regarding aspects of payment policy such as the National Correct Coding Initiative (NCCI) Additionally, faculty will share information about the changing payment and regulatory environment, anticipate future developments, and enable the participants to better adapt their practices to current reimbursement trends.

Date and Time: Sunday, October 19, 9:30 AM – 10:30 AM

Presenters:
Mark S. Synovec, MD, FCAP
Jonathan L. Myles, MD, FCAP

CPT Coding…You Can’t Practice Without It! Why Pathologists Need to Understand CPT Coding
Is understanding current procedural terminology (CPT) coding and its impact on your practice making your head spin? Get an insider expert’s insights and examples of current CPT coding practices and relevant payment policies for pathology and laboratory medicine.

Date and Time: Sunday, October 19, 7:30 AM – 8:30 AM

Presenter:
Mark S. Synovec, MD, FCAP

Gov. Gavin Newsom signed into law on September 27 Assembly Bill 2107 permitting pathologists’ remote review of digital materials after a departmental determination has been made with the Centers for Medicare & Medicaid Services (CMS) that remote review conforms to CLIA’s requirements. The CAP encouraged Gov. Newsom to sign the bill into law as California was the only state that didn’t recognize CMS’s remote sign-out guidance.

The CAP and the California Society of Pathologists (CSP) previously amended the bill to ensure only pathologists practicing in California licensed laboratories could conduct remote review and recently, amended the bill to lessen concerns from the California Department of Public Health over federal compliance. The CSP and CAP worked closely to argue that the CMS’s enforcement discretion recognizing pathologists’ remote review does not violate CLIA and noted it is recognized in 49 other states.

California must consult CMS by June 30, 2025, and must issue their determination by January 1, 2026. The CAP will continue to partner with CSP on this initiative in the coming months.

The FDA LDT final rule outlines new regulations for tests developed and used within a single laboratory. In this podcast episode, we discussed the FDA regulation and the CAP’s ongoing advocacy efforts in opposition to the rulemaking.

In this podcast, Joe Saad, MD, FCAP, the chair of the Council on Government and Professional Affairs, discussed proposed legislation and the CAP’s advocacy efforts that will best maintain patient safety.

Listen to the podcast here.

Under the Food and Drug Administration (FDA) regulation, laboratories with laboratory-developed tests (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 that relate to quality management and review real world scenarios. Join us on Nov. 7, Noon-1 PM CT to learn more!

Speakers

• Bobbi S. Pritt, MD, FCAP, chair, Council on Scientific Affairs
• Earle S. Collum, MD, FCAP, vice chair, Council on Accreditation
• Timothy Stenzel, MD, PhD, former Director of the FDA’s Office of In Vitro Diagnostics, current CEO of Grey Haven LLC

Register today!

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