Advocacy Update

• LDT Court Decision: Answers to 5 Questions
• Why Pathologists Need to Advocate
• Senate Confirms Dr. Oz to Lead CMS
• Sweeping Changes at HHS

Here are answers to five top questions you might have after a US District Court judge nullified the Food and Drug Administration (FDA) regulation on the oversight of laboratory-developed tests (LDT) on March 31.  

What effect did the judge’s decision have on the LDT rulemaking?

The judge's decision canceled the FDA LDT rulemaking and all the rulemaking’s associated requirements and guidance documents.

Do we need to still comply with any of the FDA's new LDT oversight requirements on May 6? 

No. Laboratories no longer need to comply with Stage 1 FDA regulatory changes that were set to take effect on May 6, 2025. Laboratories do not need to comply with the latter stages of the rulemaking, either.  

Will the Department of Health and Human Services (HHS) or FDA appeal the ruling? 

We have seen no indication that the government will appeal the court ruling. 

How does the court decision affect CLIA? 

The judge’s decision does not impact CLIA laboratory regulations. CLIA requirements for laboratories remain in effect as they did prior to the FDA LDT rulemaking.

What effect does the court decision have on CAP accreditation checklists? 

CAP laboratory accreditation checklists, including our most recent edition, have no changes related to the FDA LDT final rule. CAP accreditation checklists do include requirements for LDT method validation, adverse event reporting, and quality management to ensure CLIA compliance. Visit our Accreditation Resources within e-LAB Solutions Suite for an array of educational resources to help you and your laboratory maintain compliance.  

As a pathologist, you know how to advocate, but do you have plans to let Congress know where you stand? Now is your chance to make your voice heard on Medicare payment reform, workforce concerns, and other critical pay-related policies.

Listen to Diana M. Cardona, MD, MBA, FCAP, Vice Chair of the Council on Government and Professional Affairs and a member of the CAP's Board of Governors, explain why it’s important for pathologists to attend the House of Delegates and Pathologists Leadership Summit April 26–29 and join their colleagues on Capitol Hill. 

Mehmet Oz, MD, MBA, was confirmed by the Senate on April 3 to lead the Centers for Medicare and Medicaid Services (CMS). Dr. Oz is a cardiothoracic surgeon and former television personality. He will now lead the agency that manages Medicare, Medicaid, Children's Health Insurance Program, and various other national health programs.

Other pending nominations include Susan Monarez, PhD, who has been tapped to lead the Centers for Disease Control and Prevention (CDC). Marty Makary, MD, MPH, a surgical oncologist, was sworn in as the new commissioner of the Food and Drug Administration on April 1.

The CAP will continue to update members as the confirmation process continues.

The Department of Health and Human Services (HHS) has begun a significant reorganization plan, which will reduce the number of employees in the department by 10,000 staffers, or 25%. Reduction in force notices were given out on April 1. Here is a breakdown of the reductions in force at HHS effective June 30:

• The Food and Drug Administration is cutting 3,500 employees.
• The Centers for Disease Control and Prevention (CDC) is cutting 2,400 employees.
• The National Institutes of Health (NIH) is cutting 1,200 employees.
• The Centers for Medicare & Medicaid Services (CMS) is cutting 300 employees.

The CAP is committed to supporting members and laboratories as we navigate the evolving political and medical landscape. We will continue monitoring changes that may impact CAP policy and update members as information becomes available.