Previous Advocacy Updates

Following the Food and Drug Administration (FDA) laboratory-developed test (LDT) final regulation, the agency released: Laboratory Developed Tests: Small Entity Compliance Guide: Guidance for Laboratory Manufacturers and Food and Drug Administration Staff on June 25.

Do you anticipate the Food and Drug Administration’s (FDA) laboratory-developed test final rule creating unnecessary burdens for pathologists or negatively impacting patients’ lives, innovation, or the economy in your community?

Your story could be used to help legislators understand how the oversight of tests should be based on protecting patients and providing access to safe diagnostic tests with a framework that is the least burdensome for pathologists.

The American Medical Association (AMA) House of Delegates focused on three major factors influencing the practice of medicine at its 2024 AMA Annual Meeting in Chicago – Medicare payment reform, cybersecurity attacks on health care systems, and the deployment and use of artificial intelligence in health care. The CAP and its leadership engaged in debates at the AMA meeting on these and other topics to represent the interests of pathologists and the patients we serve.

On June 4, CAP President Donald Karcher, MD, FCAP met with multiple members of the House Energy and Commerce Committee and the Senate Committee on Health, Education, Labor and Pensions. Following the release of the overly burdensome laboratory-developed tests (LDT) regulation by the US Food and Drug Administration (FDA), the CAP has sought to engage with congressional leaders to advocate for legislative solutions that reduce regulatory burdens on laboratories and allow for continued innovation of tests.

The American Clinical Laboratory Association (ACLA) filed a federal lawsuit challenging the Food and Drug Administration (FDA) and its final rulemaking on the oversight of laboratory-developed tests (LDTs) on May 29. The CAP is reviewing the legal action by ACLA, which included a 450-page filing in the US District Court for the Eastern District of Texas. The CAP has expressed its continued concerns to various stakeholders over the FDA regulation and the impact it will have on pathologists, laboratories, and patients.

On May 23, the CAP held a webinar focused on the Food and Drug Administration’s (FDA) laboratory-developed tests (LDT) final rule. Over 1,300 members registered and close to 1,000 members attended the event which featured 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. The presentation and discussion offer insights into the CAP’s initial analysis of the regulation, the timeline for implementation, the impact on laboratories and advocacy efforts around the regulation. If you missed the presentation, you can watch it here. Presentation slides are available for download here.

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.

The Food and Drug Administration (FDA) released its final regulation on the oversight of laboratory-developed tests (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; Council on Scientific Affairs Chair, Brad Karon, MD, PhD, FCAP; and moderator Michael Fraser, PhD, CEO of the College of American Pathologists for an informative and engaging 1-hour discussion on Thursday, May 23 at 11 AM ET/10 AM CT.

The Food and Drug Administration (FDA) released its final regulation on the oversight of laboratory-developed tests (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; Council on Scientific Affairs Chair, Brad S. Karon, MD, PhD, FCAP; and moderator Michael Fraser, PhD, CEO of the College of American Pathologists for an informative and engaging 1-hour discussion on Thursday, May 23 at 11am EST/10am CT.

The Food and Drug Administration (FDA) released the final regulation on the oversight of laboratory-developed tests (LDTs) with some changes advocated for by the CAP. The CAP had opposed the regulation as written and called for several improvements that would ensure patient access to testing and allow for the continued innovation of new tests.

Special Issue: The Food and Drug Administration released the final regulation on the oversight of laboratory-developed tests with some changes advocated for by the CAP. The CAP had opposed the regulation as written and called for several improvements that would ensure patient access to testing and allow for the continued innovation of new tests.

On April 16, CAP members met with their federal lawmakers and advocated to protect the value of pathology services. Pathologists discussed how Congress can mitigate Medicare payment cuts to physicians, set limits on future clinical laboratory fee cuts, and increase the medical workforce to address current shortages during meetings with 172 offices in the Senate and House of Representatives.

To prepare for the CAP’s annual Hill Day, CAP members discussed strategies for how they will engage their members of Congress at the Pathologists Leadership Summit on April 13-16. CAP Advocacy leaders prepared pathologists to lobby Congress on three main policies affecting the specialty: A long-term fix for Medicare cuts to pathology services, a long-term fix to stabilize clinical laboratory services reimbursements, and greater immigration flexibilities for physicians so they can continue to practice in the United States – especially in health care shortage and rural areas.

A new study published by Health Affairs Scholar uncovers an undercount in the workforce of pathologists as a result of omitting subspecialized training over several years. In this paper, “Re-evaluation of the Methodology for Estimating the U.S. Specialty Physician Workforce,” the authors from the CAP and the Association of American Medical Colleges (AAMC) suggest revisiting methodologies and definitions responsible for tracking the physician workforce as similar undercounts may exist in other physician specialties.

UnitedHealthcare is delaying the implementation of new requirements to use Z-codes for reimbursement. After an initial delay, UnitedHealthcare announced the start date as April 1, 2024. The new date of implementation, announced this week, is June 1, 2024. The CAP and affected laboratories had expressed concerns over the ability to submit claims under this new system. As a result, UnitedHealthcare is both working with many laboratories individually and providing additional time. UnitedHealthcare says it will continue to work with impacted laboratories.

On March 21, CAP President Donald Karcher, MD, FCAP, provided testimony to the House Energy and Commerce Subcommittee on Health during a hearing entitled “Evaluating Approaches to Diagnostic Test Regulation and the Impact of FDA’s Proposed Rule.” Dr. Karcher firmly stated the CAP’s opposition to the Food and Drug Administration (FDA) proposed regulation on the oversight of laboratory-developed tests (LDTs) and advocated for policy solutions that target full regulation of only the highest risk LDTs.

CAP President Donald Karcher, MD, FCAP, will provide testimony to the House Energy and Commerce Subcommittee on Health during a hearing entitled “Evaluating Approaches to Diagnostic Test Regulation and the Impact of FDA’s Proposed Rule” on March 21.

On March 8, Congress passed the 2024 Consolidated Appropriations Act that included additional relief from Medicare payment cuts. Physicians will receive a boost in Medicare pay for patient services starting from the legislation’s enactment through the end of 2024.

Following months of direct lobbying by the CAP and physician community, congressional leaders in a federal spending bill released on March proposed additional relief from Medicare payment cuts that went into effect January 1. Throughout 2023 and early 2024, the CAP strenuously lobbied lawmakers to enact short-term Medicare payment relief and now it appears Congress will increase physician pay from current levels by 1.68% if the spending bill becomes law.

Over 300 pathologists responded to an Action Alert by the CAP sent to its grassroots advocacy network encouraging outreach to their legislators to sign a Dear Colleague Letter drafted by Sens. John Boozman (R-AR) and Peter Welch (D-VT). The letter, sent to Senate leadership on February 22, emphasized the urgent need to address the 3.37% cut to Medicare physician payments that went into effect January 1. Thirty-two senators signed the letter.