Advocacy News

• FDA doesn't challenge LDT decision
• Tariffs tug-of-war continues
• CDC cuts lab advisory group
• CDC shifts COVID-19 vaccine guidance
• Oklahoma blocks out-of-network bill
• Texas mandates EHR delays for release of sensitive test results
• Will you be in Orlando for CAP 25?

The deadline has passed to appeal the court decision that nullified the FDA's oversight regulations over laboratory-developed tests (LDTs). 

Why it matters: The FDA will no longer defend the LDT rules, which pathologists and labs said threatened patient access to testing.

• The CAP applauded the March 31 decision, saying that the regulation failed to target FDA oversight and would impede patient access to safe LDTs.
• The FDA had until May 30 to appeal, but no appeal was filed.

Go deeper: Read the CAP's amicus brief in the case.

A federal appeals court temporarily reinstated President Donald Trump's tariffs, after a US Court of International Trade initially overturned his authority to impose extensive tariffs on most countries.

Why it matters: The impacts of tariffs on the costs of medical supplies, the health care supply chain, and laboratory budgets has been a concern for pathologists.

What's next: As the tariff legal battle unfolds in court, the CAP continues to collaborate with other organizations to highlight the consequences on medical supplies, and will update members as information becomes available.

According to several reports, the CDC is eliminating the Clinical Laboratory Improvement Advisory Committee (CLIAC).

Why it matters: CLIAC has been providing nonbinding advice and guidance on clinical lab quality policy and other issues related to CLIA standards since 1992.

The big picture: The elimination of CLIAC is part of broader cuts across the CDC and the Department of Health and Human Services (HHS) for fiscal year 2026.

• HHS' discretionary budget would be $95.4 billion, a 25% decrease from 2025.
• CDC's budget would be $4.3 billion, a 22% decrease from 2025.

Other agencies like the National Institutes of Health are facing steeper cuts of more than 40%.

The CDC has revised its COVID-19 vaccine recommendations for healthy children and pregnant women. 

Why it matters: This change increases the possibility of COVID-19 infection for school-aged children, as well as immunocompromised members of their household.

• Parents are advised to consult with their doctors before deciding on vaccinations for their children aged 6 months to 17 years. 

What's new: The change comes after HHS Secretary Robert F. Kennedy Jr. announced that COVID-19 vaccines will no longer be universally recommended for healthy children and pregnant women. 

Go deeper: Read the CDC's official guidance.

Oklahoma pathologists and the CAP successfully blocked legislation that would have set an unfavorable benchmark for out-of-network reimbursements. 

Why it matters: Senate Bill 1047 would undermine the federal No Surprises Act, adversely impacting physicians and patients. 

• The No Surprises Act, signed into law by President Trump in 2020, protects patients from medical bills for out-of-network services.
• Senate Bill 1047 favored health insurance payers by tying out-of-network payment to the in-network pay rates of health plans—an approach rejected in federal law. 

Driving the news: The CAP, alongside the Oklahoma State Association of Pathologists, led a coalition of state chapters of anesthesiologists, radiologists, and emergency physicians to oppose the bill. 

• Despite the bill passing unanimously out of committee, the coalition deterred it from going forward. 

What's next: The CAP will continue to oppose tying out-of-network reimbursement to rates controlled by the health insurance industry, which is detrimental to physicians and patients.

Texas has mandated a delay in releasing specific test results via electronic health records (EHRs).

Gov. Greg Abbott signed Senate Bill 922, assigning responsibility to EHR administrators for the delayed release of certain test results under provisions advocated by pathologists. 

Why it matters: The provisions advocated by pathology ensure pathologists and clinical labs can comply with federal law expressly prohibiting "information blocking." They cannot be held liable under state regulations that allow ordering and treating physicians to review EHR results and speak with patients. 

• Introduced with amendments from the CAP, the Texas Society of Pathologists, and the Texas Medical Association, the legislation ensures that the responsibility for the delay in reporting test results is on those managing EHRs.
• The three organizations worked together to amend similar legislation in 2023. 

State trend: Texas joins Montana, Tennessee, and Kentucky in enacting similar legislation. 

What's next: The new law takes effect on September 1.

Join us at CAP 25: Pathologists worldwide are warmly invited to The Pathologists' Meeting, a prestigious annual event designed to foster networking, enhance professional connections, and provide the latest updates in the specialty. This meeting represents a unique opportunity to engage with peers, share insights, and discuss the future of pathology.

• When: September 13–16
• Where: Orlando, Florida
• Details: Register today to secure your spot and gain valuable insights, expand your knowledge, and contribute to the advancement of pathology through collaborative learning and the exchange of ideas.

Register today!