Advocacy Update

• FDA LDT Phaseout Policy Resources and Upcoming Agency Webinars
• Reminder: Preparing for Implementation of FDA’s Laboratory-Developed Test Final Rule Webinar on May 23
• Over 1,100 Messages from the CAP Encourage Congress to Protect Access to Laboratory Services
• AMA Physician Shortage Crisis Webinar May 22
• CDC Advises “Heightened Readiness” for H5N1
• Take Our News Quiz for May

The Food and Drug Administration (FDA) presented an overview of its laboratory-developed tests (LDT) final rule and answered several questions on May 14. The FDA responded to two questions submitted by the CAP regarding tests for unmet needs and oversight requirements for LDTs developed prior to the FDA rule.

If you missed the presentation, the FDA provided printable slides. In the coming weeks, the presentation, recording, and transcript will be available at CDRH (Center for Devices and Radiological Health) Learn under the "In Vitro Diagnostics" tab.

The FDA also announced it intends to hold additional webinars focusing on specific topics related to the phaseout policy.

• June 5, 2024: Draft Guidances on Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration Under Section 564 (applicable to LDTs) and Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency (applicable to IVDs) Register here.
• July 2024: Tentative topic: IVD Classification
• August 2024: Tentative topic: MDRs (Medical Device Reporting), Quality System Complaint Requirements, and Recalls

To submit questions to be answered during the webinars, email CDRHWebinars@fda.hhs.gov at least one week prior to the webinar.

Additional resources can be found here: Laboratory Developed Tests. If you have questions for the FDA about the final rule, you can contact LDTFinalRule@fda.hhs.gov.

The FDA released its final regulation on the oversight of LDTs with some changes advocated for by the CAP. During this live presentation and discussion, CAP leaders will offer their initial analysis of the regulation and discuss the impact on laboratories. Join CAP President Donald Karcher, MD, FCAP; Council on Government and Professional Affairs Chair Joe Saad, MD, FCAP; and Council on Scientific Affairs Chair Bobbi Pritt, MD, MS, FCAP for an informative and engaging 1-hour discussion on Thursday, May 23 at 11am EST/10am CT.

Panelists will discuss:

• Overview of the final rule
• Timeline for implementation
• CAP’s recommendations adopted in final rule
• CAP’s LDT legislative advocacy efforts going forward
• Q & A

Register here! This will be recorded and available to view on-demand for anyone who cannot attend the live session.

Over 350 pathologists responded to an Action Alert from the CAP encouraging members to reach out to their legislators and urge them to support the Saving Access to Laboratory Services Act (SALSA). Over 1,100 messages were sent to members of Congress, including 24 CAP members who took action for the first time.

SALSA is a permanent solution that would set Medicare reimbursement for clinical laboratory services on a sustainable path forward. SALSA will give the Centers for Medicare and Medicaid Services (CMS) new authority to collect private market data through statistically valid sampling from all laboratory segments for the widely available test services where previous data collection was inadequate. By providing a gradual phase-in approach, the bill protects clinical laboratories, the Medicare program, and patients from the impact of dramatic rate increases or decreases.

Grassroots advocacy is at the root of driving changes at the federal and state levels on health care policies that will impact pathologists’ ability to practice and protect the patients they serve. Learn more about CAP’s grassroots advocacy network and how you can take action at PathNET.

On May 22 at 1 PM ET/2 PM CT the American Medical Association (AMA) is having a webinar to educate physicians about how increasing residency training slots, addressing visa issues for international medical graduates, ensuring access to care in rural areas, and addressing factors impacting physician burnout—including Medicare physician payment instability and administrative burdens—can help bolster the physician workforce.

Register here.

On May 13, the Centers for Disease Control and Prevention (CDC) provided an update to partner organizations regarding the spread of H5N1, a Highly Pathogenic Avian Influenza (HPAI). Although an increasing number of animals, and species, are testing positive for the virus, there continues to be only one recorded case of animal-to-human transmission. The CDC recommends a state of “heightened awareness” in the laboratory community while they continue to use their flu surveillance systems to monitor H5N1 activity in humans.

Laboratory testing recommendations can be found in the following CDC document: Evaluating and Managing Patients Exposed to Birds Infected with Avian Influenza Viruses of Public Health Concern

The CAP will continue to monitor and provide updates as needed.

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.

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