Advocacy Update

• August Recess Rally: Over 1,100 Messages from the CAP Encourage Congress to Stop the FDA’s Final LDT Rule
• New CAP Webinar Series: Understanding the Impact of the FDA’s LDT Risk Classification on Your Laboratory
• AMP Files Lawsuit Against FDA by Challenging LDT Oversight Regulation
• Court Blocks FTC Noncompete Rule
• CMS, MAC’s Proposed Change in Coverage for Organ Transplantation Rejection Test Not Finalized
• CDC Releases Recommendations for Mpox Specimen Testing
• Take Our News Quiz for September

More than 340 CAP members initially took action during our August Recess Rally and responded to a specific alert to stop the implementation of the Food and Drug Administration’s (FDA) final laboratory-developed test (LDT) rule. Over 1,100 messages were sent to members of Congress, including those from 29 CAP members who took action for the first time.

The CAP is urging Congress to enact legislation like the Verifying Accurate Leading-edge IVCT Development (VALID) Act before the end of the year. The VALID Act creates a tiered risk-based structure for oversight of LDTs, includes a targeted role for the FDA, and utilizes current laboratory reporting requirements when possible. Questions about FDA LDT oversight? Visit our Laboratory-Developed Test Oversight page.

Haven’t taken action yet? Click here to engage and advocate!

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 webinar series begins on September 18 and will focus on the FDA risk classification system.

Last April, the FDA released its regulation on the oversight of LDTs, which the CAP opposes and is advocating to stop from going into effect. Laboratories and pathologists—many having never worked with the FDA—now have questions and concerns as they face implementation of the LDT regulation’s first phase in May 2025.

The first webinar in our series on September 18, Noon-1 PM CT, will help laboratories understand FDA risk classification systems. We 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.

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

The Association for Molecular Pathology (AMP) filed a federal lawsuit challenging the FDA and its final rulemaking on the oversight of LDTs on August 19. This is the second lawsuit filed against the FDA and its LDT regulation. The American Clinical Laboratory Association had filed a similar lawsuit on June 4.

In a statement, AMP said they brought this lawsuit because the FDA final rule exceeded the agency’s authority and to avert the significant and harmful disruption to laboratory medicine.

The CAP is reviewing the legal action by AMP, which included an 83-page complaint filed in the US District Court for the Southern District of Texas. Learn more about the CAP’s laboratory-developed test oversight advocacy.

On August 20, a federal judge permanently blocked the implementation of a Federal Trade Commission (FTC) regulation that would have banned new noncompete agreements for all workers and require companies to let current and past employees know they will not enforce them. The US Chamber of Commerce, Business Roundtable, and other business entities had challenged the FTC rule in court.

In her ruling, the US District Court for the Northern District of Texas judge deciding the case stated that: “The FTC lacks substantive rulemaking authority with respect to unfair methods of competition. The role of an administrative agency is to do as told by Congress, not to do what the agency thinks it should do.” The FTC is considering a potential appeal.

On April 23, the FTC issued its final rule to ban noncompete agreements that prevent employees from working for competitors or starting a competing business after they leave a job. The FTC determined that it was an unfair method of competition, and therefore a violation of Section 5 of the FTC Act, for employers to enter into noncompetes with workers and to enforce certain noncompetes. The rule was set to go into effect on September 4.

On August 16, the CMS and Medicare Administrative Contractors (MACs) decided to not finalize the MolDx: Molecular Testing for Solid Organ Allograft Rejection proposed local coverage determination (LCD) issued on August 10, 2023. This is in response to public comments.

The CMS stated: “Due to the importance of identifying solid organ allograft rejection early and to ensure the public has additional opportunities to comment on the policy, the MACs intend to issue a new LCD in the coming months. When posted, the new proposed LCD will be available for review in the Medicare Coverage Database (MCD).”

At this time, the CMS or MACs have not changed coverage for these blood tests that monitor for organ transplantation rejection when ordered by their physicians in medically appropriate circumstances.

Patients with transplanted hearts, lungs, or kidneys who meet Medicare’s existing local coverage criteria can continue to access these blood tests, including under the following circumstances:

• When there are signs or symptoms of rejection.
• After a physician-assessed pretest, including for surveillance testing.
• After an indeterminate biopsy.
• As a replacement for a biopsy when deemed clinically appropriate by the patient’s qualified physician.
• For evaluation of the adequacy of immunosuppression.

On August 7, the Centers for Disease Control and Prevention (CDC) issued a health alert for all laboratories performing mpox testing using an orthopoxvirus or monkeypox virus (MPXV) generic test without any additional clade-specific testing occurring.

The CDC recommends that laboratories send clinical specimens collected from patients who traveled from the Democratic Republic of the Congo (DRC), its neighboring countries, or any country with clade I mpox cases, or had close or intimate contact with symptomatic people from these countries, to a laboratory that can perform clade-specific testing as quickly as possible. If clade-specific testing is warranted but is not available in a jurisdiction, specimen submission to a capable public health laboratory or to CDC is encouraged. Specimen submission to CDC can be coordinated through your state or local health department. Due to mutations that may impact clade-specific PCR tests, laboratories should use a test that targets a viral essential gene (e.g., the CDC NVO test) as part of a testing strategy to ensure mpox cases are not missed.

Click here for more information, including recommendations for clinicians, health departments, laboratories, and the public.

Are you up to speed on CAP advocacy news? Take our new monthly news quiz and see how many you can get right and share your results on social media.

Take the quiz.