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September 2, 2025
In this Issue:
CAP discusses improved device transparency with FDA
The CAP met with FDA Commissioner Martin Makary, MD, and other FDA officials on August 26 to discuss pathologists’ concerns and explore future opportunities for collaboration.
The impact: The CAP will follow up on several priority issues ranging from supply chain challenges to advancements in AI-enabled devices.
Representing the CAP were President Donald Karcher, MD, FCAP; President-Elect Qihui "Jim" Zhai, MD, FCAP; Council on Government and Professional Affairs Chair Joe Saad, MD, CPE, FCAP; and Value-based Programs and Healthcare Policy Committee Chair Gregary Bocsi, DO, FCAP.
FDA Meeting Readout
The meeting began with officials thanking the CAP for its contributions to improve laboratory data infrastructure through the FDA SHIELD project.
CAP leaders then spoke to a reliance on the FDA's timely, evidence-based reviews to ensure patient safety. We emphasized the need for clinicians to have access to the right test for patients.
AI-enabled devices: Transparency of information regarding AI development is also crucial for pathologists to verify device use in the laboratory setting.
- The data used to test and train the device should come from a pool of diverse laboratory settings to ensure applicability to the US population.
- The CAP and FDA agreed on the importance of education on the intended use and specifications involved in the FDA's clearance process.
One final item: Obtaining certain lab supplies and materials still remains a problem for pathologists and their laboratories.
- The FDA officials expressed an interest in collaborating with the CAP to obtain more dynamic information on these challenges.
Leadership change at CDC
The White House fired CDC Director Susan Monarez, PhD, on August 27 after she clashed with HHS Secretary Robert F. Kennedy Jr. over vaccine policy.
The impact: Dr. Monarez accused Kennedy of "weaponizing public health for political gain" and placing patient lives at risk after he pressured the CDC to limit access to vaccines.
- HHS Deputy Secretary Jim O’Neill was named interim CDC director. He was confirmed by the Senate in June.
- O'Neill previously served at the HHS during President George W. Bush’s administration.
What's next: Following news of Dr. Monarez' dismissal, Sen. Bill Cassidy, MD (R-LA), said such "high profile departures will require oversight"
- Sen. Cassidy is chair of the Senate HELP Committee and is a member of the Finance Committee, which has scheduled a hearing with Kennedy for Thursday.
Homeland Security places limits on student visas
The Department of Homeland Security proposed a four-year cap on foreign student visas, including those used by international medical graduates pursing residency and fellowship programs.
The impact: A four-year J-1 visa would be sufficient to complete a pathology residency program, but it may interfere with subsequent fellowship training.
- Many US pathologists typically complete at least one fellowship.
- The proposal would have an outsized impact on specialties with longer residencies, such as surgery.
We're analyzing the proposal and will discuss changes with our members before submitting comments. Send your thoughts on the proposal to stories@cap.org.
Our push for HIT improvement
The CAP is urging the administration to improve the nation's health care system through enhanced Health Information Technology (HIT).
HIT priorities: In a letter to the National Coordinator for HIT, the CAP expressed a desire to collaborate with the HHS on interoperability, information blocking, and AI.
What's next: The CAP has requested a meeting to address these challenges and explore opportunities for collaboration to improve health outcomes and patient care.
Make sure pathology is part of the policy conversation
As Congress returns to Capitol Hill, key decisions in the coming days will directly impact pathologists.
Stay engaged in advocacy to let Congress know where you stand on important issues.
- Use our Action Center to contact members of Congress.
- Become a member of PathNET, the CAP's grassroots advocacy network.
- Sign up for advocacy grassroots text alerts.
- Invite a lawmaker to tour your laboratory.
The bottom line: Let's keep pathology topics at the table where health care decisions are made.
Add advocacy to your CAP25 agenda
Through organized advocacy, pathologists can influence public policy and safeguard diagnostic services.
Add these courses and discussions about advocacy topics to your CAP25 itinerary.
Sunday, September 14
- Value-Based Programs and Payment Reform
- Policy, Pathology, and the Future of Health Care: Key Challenges and Opportunities for Pathologists
- How Is My Payment Determined for Pathology Services?
- Advocacy Town Hall
Monday, September 15
- Fireside Chat: Toward a Patient-Centered Pathology Report
- Fireside Chat: Value-Based Payment, Past and Future
- CPT Coding…You Can't Practice Without It! Why Pathologists Need to Understand CPT Coding
Tuesday, September 16
Already registered? Share with your colleagues on social media using the #CAP25 toolkit!
PathPAC Donor Lounge – enjoy a cup of coffee on us!
If you're a PAC donor attending CAP25, take a break in the PathPAC Lounge, a place to recharge your phone, tablet, or laptop, but most importantly, yourself. It’s exclusive to PAC donors.
Coffee service hours:
- Saturday, September 13: 1:30–3:00 PM
- Sunday, September 14: 1:00–2:30 PM
- Monday, September 15: 1:00–2:30 PM
- Tuesday, September 16: 8:00–10:00 AM
Brought to you by PathPAC. Your support keeps pathology’s voice strong.