The CAP President’s Involvement in Advocacy

As CAP President, I am truly excited to represent pathologists and to use my role to advance the profession. This involves identifying what pathologists need and how we as an organization can do whatever is possible to address those needs. Much of this work is in the form of advocacy, where CAP leaders, members, and staff directly or indirectly engage with local, state, and federal representatives, private payers, and others to influence public policy and payment arrangements that benefit pathologists and our patients. Our advocacy work deals with a wide range of issues. Three stand out as particularly timely and important.

Payment for Pathology and Clinical Laboratory Services

The first major issue is payment for pathology and clinical laboratory services. Over the years, payment for these services, by both government and private payers, has been under siege and I don’t use that phrase lightly. With government payers shifting their funding from specialists to primary care providers; and private payers continuing to threaten payment for pathology and clinical laboratory services across the board, these challenges are the worst they’ve been in recent memory. Not only does this devalue our services, but it also jeopardizes our ability to provide these vital services to our patients whenever and wherever they need it.

Regulatory Oversight of Clinical Laboratories

The second issue is regulatory oversight of clinical laboratories. Currently, the “big” issue in this space is the FDA’s proposed oversight of laboratory developed tests (LDTs). This issue has been around for more than a decade, starting with a draft regulatory framework from the FDA several years ago and multiple legislative proposals since then. The Verifying Accurate, Leading-edge IVCT Development (VALID) Act was the most recent legislative package to appear, but like its predecessors it didn’t become law. Without further guidance from Congress, the FDA decided to proceed with oversight under its current statutory authority and released a proposed regulatory rule in October of 2023. The CAP has just submitted detailed comments to the FDA on the proposed rule, including many recommendations to make it more acceptable to clinical labs, while still protecting quality and patient safety. Another substantial regulatory challenge is government oversight of new and evolving technologies used in pathology and laboratory practice, such as artificial intelligence and machine learning. We’re continuing to work with the FDA and CMS on this evolving oversight.

Strengthen the Pathway to Pathology

Finally, there’s the increasing shortage of pathologists. For a variety of reasons, medical students for several years weren’t choosing to pursue a career in pathology in the same numbers as previously. Pair that with the ongoing retirement of pathologists and increasing demand for pathology services and one can readily see how the shortage of pathologists we see today developed. A few years ago, the CAP started its Pathologist Pipeline Initiative, and I’m happy to report that our initiative seems to be making a difference. More students now know about pathology as a great career path and are beginning to apply in larger numbers for pathology residency training. That’s why it’s imperative that Congress expand the number of residency slots, another legislative proposal we’re actively supporting.

The CAP has advocated for the advancement of pathology and pathologists since its founding. As CAP President, I’m honored to lead the premiere pathologist organization and to have the opportunity to work with CAP members and staff who are just as passionate as I am in supporting the needs of our profession and the patients we serve.

Donald S. Karcher, 38th president of the College of American Pathologists (CAP), is professor and immediate past chair of the Department of Pathology at the George Washington (GW) University Medical Center in Washington, DC. He has been a member of the GW pathology faculty since 1984, rising through the ranks to become chair of pathology in 1999, a role in which he served for 20 years. Dr. Karcher is board-certified in anatomic and clinical pathology and hematopathology, and actively practices and teaches hematopathology, flow cytometry, and laboratory administration. In addition to his CAP presidency, Dr. Karcher has also served as president of the Association of Pathology Chairs from 2014 to 2016.