Advocacy Update

• LDT Lawsuits Against FDA Consolidated in US District Court
• CAP, ACR and over 120 Medical Organizations Ask Congress to Stop Physician Medicare Cuts Before 2025
• CMS and WPS Notify Medicare Patients of Data Breach
• Pathologists Amended Remote Waiver Bill Sent to California Governor
• Register for Tomorrow’s Webinar! Understanding the Impact of the FDA’s LDT Risk Classification on Your Laboratory Featuring Former FDA Director
• Take Our News Quiz for September

Lawsuits over the federal oversight of laboratory-developed tests (LDTs) filed by the American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP) will be consolidated by the courts, according to a motion filed in the US District Court Eastern District of Texas on September 9. As the two entities challenge and seek to stop the Food and Drug Administration’s (FDA’s) regulation on the oversight of LDTs, the FDA proposed combining the cases, and ACLA and AMP agreed to consolidate.

The groups similarly argue the FDA’s LDT oversight final rule exceeded the agency’s authority and violated the Administrative Procedure Act, which establishes the federal rulemaking process for federal agencies to follow.

The CAP has also opposed the FDA regulation and is drafting an amicus brief that urges the court to also vacate the FDA regulation. The CAP believes the FDA acted arbitrarily and capriciously in violation of the Administrative Procedure Act. The CAP will provide additional updates on this issue as new information emerges.

Under a timeline in the September 9 motion, amicus briefs in support of the plaintiffs will be due by October 7. ACLA’s and AMP’s closing briefs would be due by November 25 and the FDA’s closing brief would be due by December 23. A final decision may not be made until Summer 2025.

Learn more about the CAP’s laboratory-developed test oversight advocacy.

The CAP, American College of Radiology (ACR), and more than 120 medical organizations and societies are lobbying Congress to pass legislation to stop the 2.8% Medicare physician payment cuts that are set to take effect on January 1, 2025. The groups sent a letter to both the House and Senate on September 10, calling on Congress to eliminate the cuts by increasing the Medicare Physician Fee Schedule conversion factor and ensuring that Medicare payments to physicians in 2025 and beyond are adjusted each year with an inflationary update.

Bipartisan legislation has been introduced in the House to add a permanent MEI-based inflationary update to the Medicare physician fee schedule - the Strengthening Medicare for Patients and Providers Act. Additionally, two bills currently pending before Congress – the Providers Reimbursement Stability Act and the Physician Fee Stabilizations Act – have been introduced to provide changes to the budget neutrality requirements and help ensure payment stability in the future.

CAP members can urge their representatives and senators to pass legislation that ensures financial security for pathologists and preserves patients' access to care by using the CAP’s Action Center.

On September 6, the Centers for Medicare & Medicaid Services (CMS) and the Medicare Administrative Contractor Wisconsin Physicians Service Insurance Corp. (WPS) began notifying close to 1 million Medicare patients that their protected health information or other personally identifiable information may have been compromised in a recent cybersecurity attack.

The incident involved a May security vulnerability in the MOVEit software on a third-party application used by WPS for the transfer of files during the Medicare claims process. WPS is among the many organizations in the United States that have been impacted by the MOVEit vulnerability.

The CMS continues to investigate this incident with law enforcement agencies and cybersecurity forensic consultants.

If you have any further questions regarding this incident, please call the Experian dedicated and confidential toll-free response line at 833-931-5700.

Make sure to check out our new resource: Cyberattacks and Cybersecurity in Health Care and check back for the latest information and updates.

Assembly Bill 2107 to authorize pathologists to review digital specimen materials remotely is awaiting Gov. Gavin Newsom’s signature after unanimously passing the California Senate on August 31. The CAP is encouraging Gov. Newsom to sign the bill into law as California is the only state that doesn’t recognize the federal government’s remote sign-out position.

The CAP and the California Society of Pathologists (CSP) previously amended the bill to ensure only pathologists practicing in California licensed laboratories could conduct remote review and recently, amended the bill to lessen concerns from the California Department of Public Health over federal compliance. The CSP and CAP worked closely to argue that the CMS’s enforcement discretion recognizing pathologists’ remote review does not violate CLIA.

CAP President Donald Karcher, MD, FCAP wrote the governor’s office stating, “California is the only state that does not yet recognize CMS’s continued enforcement discretion for pathology’s remote review of digital materials. CMS retains the right as does any federal agency to utilize enforcement discretion to permit reasonable flexibility in the interpretation of its CLIA regulations to respond appropriately to present and future conditions while still complying with statutory requirements. CMS’s enforcement discretion does not violate the federal requirements of CLIA. The CAP urges California to recognize and wholly trust CMS’s judgment, as the sole agency that regulates all clinical laboratory testing pursuant to CLIA, to permit remote review.”

The Governor has until September 30 to sign the bill into law or veto.

The CAP is launching a six-part webinar series to help the pathology and laboratory community understand and prepare for the Food and Drug Administration (FDA) oversight rules for laboratory-developed tests. The first webinar in our series starts tomorrow, September 18, Noon-1 PM CT, will help laboratories understand FDA risk classification systems.

CAP President Donald Karcher, MD, FCAP will moderate the program and pathologist Timothy Stenzel, MD, PhD, (Retired) Director, Office of In Vitro Diagnostics at the FDA will discuss differences in classifications used by the FDA and CLIA, requirements under the FDA risk categories, and what activities the FDA includes in its general and special controls. Our experts will also discuss examples of common tests and how the FDA requirements will apply to them. There will be a Q&A session at the end.

Whether you attend live or watch the on-demand recording at a time more convenient for you, register today for the first event in the series and save the dates for the upcoming webinars through July 2025.

Register now!

Future webinar topics:

• November 7, 2024, Noon–1:00 PM CT, Ready Your Laboratory for the FDA’s Stage 1: Adverse Event Reporting Requirement
• January 9, 2025, Noon–1:00 PM CT, Ready Your Laboratory for the FDA’s Stage 1: Corrective Action and Removal Reporting
• March 20, 2025, Noon–1:00 PM CT, Ready Your Laboratory for the FDA’s Stage 1: Rules for Quality System Complaint Processes
• May 8, 2025, Noon–1:00 PM CT, How Enforcement Discretion Categories & Modification Rules Apply to Your LDTs
• July 10, 2025, Noon–1:00 PM CT, Navigating the FDA’s LDT Oversight Requirements During a Public Health Emergency

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