In this issue:
- Let’s finish the August Recess Rally strong
- Your advocacy can go beyond action alerts
- Recharge, connect, and learn at the PAC Lounge
- FDA seeks feedback on generative AI medical devices
- FDA authorizes robotic blood draw technology
- NIH seeks feedback on proposed grant review changes
- Heidi Overton nominated to lead FDA
Let’s finish the August Recess Rally Strong
Our August Recess Rally is entering its final week, and CAP advocates have already made a major impact on Capitol Hill.
So far:
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8,000 action alerts have been sent to Congress in 2026, surpassing our goal and ahead of where we were at this time last year.
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More than 400 pathologists from across the country have participated in the rally.
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In one week, 500 alerts were sent on the physician workforce shortage.
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Seven congressional districts that had not yet heard from a pathologist this year received action alerts this month.
This week’s focus: Local coverage determinations (LCDs). The current process lacks the transparency, consistency, and meaningful stakeholder input needed to ensure Medicare coverage decisions reflect sound medical evidence and the realities of patient care.
The Timely Access to Coverage Decisions Act (HR 8500) would:
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Ensure input from qualified health care stakeholders.
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Require timely action on new and revised LCDs.
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Increase oversight of reconsideration decisions.
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Improve transparency throughout the LCD process.
The CAP has advocated for this legislation since the bill was introduced in April and continues to work with Senate offices to build support for a companion bill.
Help us finish strong: Send an action alert today and urge Congress to support H.R. 8500.
Your advocacy can go beyond action alerts
Advocacy doesn’t end when the August Recess Rally concludes. Our Grassroots Program offers opportunities to stay engaged in advocacy year-round and build relationships with policymakers on issues that matter to pathology.
Get involved:
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Meet with lawmakers. We can help arrange virtual or in-person meetings with members of Congress and their staff.
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Host a lab tour. Use our step-by-step planning toolkit to showcase the people, work, and patients behind the issues we advocate for.
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Become a Grasstops Leader. Build meaningful relationships with elected officials and serve as a trusted pathology resource in your community. Want to know more about Grasstops? View our one pager.
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Stay informed. We can provide political briefings, legislative updates, and insights to help you understand your state’s political landscape and what the midterms may mean for healthcare.
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Share your story. Help raise awareness through interviews, op-eds, social media, and other advocacy opportunities.
Take the next step: Whether you’re new to advocacy or looking to deepen your involvement, the CAP Grassroots Program can help turn your expertise into action.
Recharge, connect, and learn at the PAC Lounge
CAP PathPAC contributors attending CAP26 will have access to the PAC Lounge, a dedicated space for attendees to relax, take calls, charge devices, and connect with colleagues.
The lounge will also feature informal advocacy programming, including an Advocacy 101 session for residents and an election update.
Hours: Open daily during CAP26.
Who can attend: The PAC Lounge is open to all CAP PathPAC members who have a PAC ribbon.
See you there: Stop by the PAC Lounge during CAP26 to recharge, network, and learn more about advocacy.
FDA seeks feedback on generative AI medical devices
The FDA is seeking public comment on a discussion paper outlining potential approaches to regulating generative AI–enabled medical devices, including technologies that rely on laboratory-generated data and may increasingly be used in laboratory settings.
The FDA specifically defines generative AI as “a class of AI models that emulate the structure and characteristics of input data in order to generate derived synthetic content. This can include images, videos, audio, text, and other digital content.” The FDA notes that generative AI–enabled in vitro diagnostic (IVD) functions may require special consideration, because users may not be able to independently evaluate whether an output is correct. Diagnostic laboratory tests are among the technologies under discussion.
The discussion paper explores a potential framework based on risk classification, premarket evaluation, and postmarket monitoring of AI-enabled devices. The FDA is also seeking feedback on broader topics, including foundation models and agentic AI systems.
What’s next: Comments are due October 19. The CAP is reviewing the discussion paper and gathering input to help inform comments on the FDA’s proposed framework.
FDA authorizes robotic blood draw technology
The FDA has authorized the first standalone robotic device that can draw blood from a patient’s arm without hands-on operator intervention. The device is authorized for use in adults in outpatient settings and must operate under the supervision of a professional trained in phlebotomy.
The FDA notes that one phlebotomist can oversee up to three devices simultaneously, a capability the agency says could help address workforce shortages and improve access to blood collection services.
This authorization highlights continued advances in automation and medical device technology, including tools that may influence future laboratory workflows.
NIH seeks feedback on proposed grant review changes
The National Institutes of Health (NIH) is seeking public comment on a proposal that would significantly change how grant review outcomes are reported. Rather than releasing numerical impact scores or percentiles, NIH would categorize applications as “most competitive,” “competitive,” or “not discussed.”
The impact: While applicants would continue to receive reviewer critiques and other feedback, final impact scores and percentiles would no longer be released. Critics say the change could reduce transparency and make it more difficult to assess grant review outcomes over time.
What’s next: NIH is accepting comments through October 13. The CAP is reviewing the proposed changes.
Heidi Overton nominated to lead FDA
President Trump has nominated Heidi Overton, MD, PhD, a White House domestic policy advisor, to serve as FDA commissioner. If confirmed, Overton would lead the agency that oversees medical device review, including in vitro diagnostics, artificial intelligence, and other regulatory priorities. Overton is board certified in public health and general preventive medicine.
What’s next: The Senate would need to confirm Overton before she could assume leadership of the FDA.