Advocacy Update

• Federal Court Judge Throws Out LDT Rule
• Unlock your Leadership Potential!
• New Nominee Tapped to Lead CDC
• Illinois Pathologists, CAP Oppose Burdens in Privacy Bill
• Back the PAC!

A US District Court judge on March 31 nullified the Food and Drug Administration (FDA) regulation on the oversight of laboratory-developed tests (LDT), agreeing with plaintiffs' and the College of American Pathologists' (CAP) arguments that the rule should be vacated. 

"The FDA's LDT rulemaking was burdensome, and the court rightly struck it down," said CAP President Donald Karcher MD, FCAP. "The regulation failed to target FDA oversight and threatened patient access to countless numbers of safe LDTs by saddling laboratories with unnecessary requirements. The CAP and its members are relieved that the court agreed with our arguments."

The CAP detailed its reasons to vacate the rule in an amicus brief filed in October 2024. 

Ready to elevate your leadership with strategy and vision? A new workshop to help pathologists grow their influence through strategic leadership is on the agenda when members of the College of American Pathologists meet in Washington, DC, this month.

The CAP is partnering with the American College of Healthcare Executives to produce an exciting and informative workshop, Increase Your Influence Through Strategic Leadership. This new workshop offers six CME hours to attendees at the House of Delegates and Pathologists Leadership Summit. The workshop is scheduled for the first day of the summit on April 26.

Jim Austin, faculty consultant for the Wharton School at the University of Pennsylvania and adjunct assistant professor at Brown University, will facilitate the new workshop to help pathologists grow their influence through strategic leadership.

Listen to a new podcast episode to learn more about the course and how to add it to your HODPLS schedule today!

Susan Monarez, PhD, has been named the new nominee to lead the Centers for Disease Control and Prevention (CDC). Dr. Monarez has been leading in an interim capacity at the agency.
Dr. Monarez holds degrees in microbiology and immunology from the University of Wisconsin-Madison. Her nomination comes in place of David Weldon, MD, a former Florida congressman whose nomination was withdrawn by the White House in March. 

Other key hearings and confirmations are also taking place. Last week, the Senate confirmed Martin A. Makary, MD, MPH, to lead the Food and Drug Administration (FDA). Dr. Makary is a surgical oncologist and Chair in Gastrointestinal Surgery at Johns Hopkins School of Medicine. The Senate also confirmed Jay Bhattacharya, MD, PhD, as Director of the National Institutes of Health. Dr. Bhattacharya is a physician-scientist and health economist who was previously a professor of medicine, economics, and health research policy at Stanford University.

The Senate Finance Committee approved the nomination of television personality Mehmet Oz, MD, MBA, to lead the Centers for Medicare and Medicaid Services (CMS). The Senate is expected to vote on his confirmation in the near future.

Pathologists in Illinois and the CAP called for amendments to a health care privacy bill that would overburden pathologists and laboratories with new requirements that should already be covered by federal statute.

The Illinois Society of Pathologists (ISP), with the support of the CAP and the Illinois State Medical Society (ISMS), is opposing House Bill 3041, which would establish the Illinois Data Privacy and Protection Act. The legislation is an outlier compared to other state privacy laws and public policy precedents which explicitly exempt information collected in the health care setting by health care providers impeding medical care.

In written testimony, the ISP said they strongly oppose the bill unless it’s amended. The Illinois Data Privacy and Protection Act would prohibit "covered entities" from collecting, processing, or transferring covered data beyond certain parameters and require certain policies, practices, and procedures as it pertains to such data. The current definition of "covered entities" implicitly includes pathologists and clinical laboratories.

The ISP further noted, "the purview of this bill should not include the practice of medicine, laboratory testing or medical genetic testing and other health care activities as these areas are already subject to rigorous regulation, including prohibitions on disclosure and robust privacy protections under the federal Health Insurance Portability and Accountability Act [HIPAA] of 1996."

The CAP will continue working with the ISP and ISMS to ensure that any current and forthcoming legislation includes a robust HIPAA exemption.

The fourth annual Back the PAC competition is underway!

Back the PAC is a fun and friendly effort to strengthen House of Delegates (HOD) support for PathPAC while educating delegates on its critical role in advancing the CAP's advocacy agenda and representing pathologists at the federal level.

During the friendly competition, the HOD will be divided into five regional teams with equal numbers of members based on the HOD roster as of March 1. The winning team(s) will be determined by: 

• Highest overall team participation rate
• Most PathPAC funds raised 

The competition ends at 2 PM ET on Sunday, April 27. Winners will be announced before the House of Delegates meeting adjourns that day.

Everyone who donates to PathPAC, regardless of being on an HOD team, will receive an invitation to a recognition reception on Monday, April 28. 

Learn more about PathPAC