October 23, 2026
CAP Raises Concerns About Proposed 2027 Lab Payment Rates
CAP Urges Risk-Based Approach to GenAI Medical Devices
Transcript
Nancy Johnson
The CAP opposed a billion-dollar annual cut to the Medicare clinical laboratory fee schedule and urged a physician-led approach to AI medical devices. And a member of the CAP board on the work it does. These stories and more coming up next.
Nancy Johnson
Welcome to CAP News. I'm Nancy Johnson with the College of American Pathologists. It's Friday, October 23rd. Here's what's making news in pathology and laboratory medicine.
Nancy Johnson
The CAP this week urged the Trump administration to abandon a flawed approach to setting clinical laboratory fees for next year. In a letter to the Centers for Medicare and Medicaid Services, the CAP said the preliminary 2027 Medicare Clinical Laboratory fee schedule would significantly reduce payment for more than three-quarters of laboratory tests for which the agency calculated new rates. CMS itself estimates the new rates are about 16% lower on average and would reduce spending by $1 billion annually. The CAP questioned the data CMS used to come up with the new rates, arguing that it does not accurately represent the laboratory market and may not align with what Congress has instructed CMS to measure. The CAP is also supporting a legislative solution that would create a more accurate and sustainable method of setting Medicare laboratory payment rates.
Nancy Johnson
Separately, the CAP weighed in on the FDA's proposed approach to regulating medical devices that use generative AI. The CAP urged the FDA to emphasize patient safety and appropriate physician oversight. The CAP said each device should be evaluated based on its intended use, role in clinical workflow, potential effect on patient care, and the ability of qualified users to identify and correct errors. For pathology-specific devices, the CAP said pathologist oversight and manufacturer accountability are essential. And Gen AI tools should assist pathologists' diagnostic interpretation, not independently diagnose disease or make patient care decisions.
Nancy Johnson
November 2nd is the application deadline for the CAP Foundation's Career Development Award in HER2 research. The foundation is offering up to $120,000 in funding to support quantitative research on HER2 assay use for solid tumors beyond breast and gastric cancers.
Nancy Johnson
And finally, Dr. Diana Cardona was just re-elected to a second term on the CAP Board of Governors. Last week, we told you about her views on the state of pathology and some of its advocacy challenges. We also asked her a question many members may have about the board. What does it do?
Dr. Diana Cardona
I had the same question before joining the board too. What we want to avoid is basically ticking off all the boxes of all the possible types of lab tests that could present in a patient with slightly abnormal bleeding factors and or a suspected bleeding history. So I guess what I would like the members to know is that the board is constantly focused on the long-term health of our profession, the long-term health of our CAP organization, and then also those things in combination, ensuring that we can continue to serve the patients that we serve, right? A great deal of the work that we do happens behind the scenes. What we want to avoid is basically ticking off all the boxes of all the possible types of lab tests that could present in a patient with slightly abnormal bleeding factors and or a suspected bleeding history. So it may not always be visible, but you know, we're focused on advocating for payment stability, responding to regulatory proposals, ensuring pathology has a voice in discussions. But then there's also the other side of the organization that's ensuring that we have a way to deliver high-quality laboratory medicine through our accreditation and proficiency testing programs, our educational programs. What we want to avoid is basically ticking off all the boxes of all the possible types of lab tests that could present in a patient with slightly abnormal bleeding factors and or a suspected bleeding history. So it's really always focusing on that broader strategy around our profession.
Nancy Johnson
But the board can't do it alone.
Dr. Diana Cardona
The board works really closely with all of the CAP councils, the committees, and the staff to help identify emerging threats as well as those emerging opportunities, whether it's in innovation and the like. What we want to avoid is basically ticking off all the boxes of all the possible types of lab tests that could present in a patient with slightly abnormal bleeding factors and or a suspected bleeding history. So I guess basically the board really helps set direction, but the strength of the CAP comes from the thousands of volunteer pathology members.
Nancy Johnson
That's all for today. See the show notes for more information on today's stories and spread the word about this podcast by sharing a link on social media. We'll be back Monday, October 26th with another edition of CAP News. I'm Nancy Johnson. Have a great weekend.