Previous Advocacy Updates

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.

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.

CAP members are asking Congress to intervene before the Food and Drug Administration (FDA) implements its oversight regulations on laboratory-developed tests (LDTs) in a new action alert added to our August Recess Rally. Pathologists can easily use the CAP’s PathNET Action Center to act on the LDT oversight alert and engage in other advocacy activities during a crucial time when legislators are meeting with their constituents throughout an August recess.

August is one of the best times to protect your laboratory from regulatory overreach and advocate to stop payment cuts pathology services. Your representatives and senators in Congress will only act on these issues if they hear from you. While members of Congress have left Washington for August, they are at home meeting with constituents in your community. CAP members must take advantage of opportunities to connect and educate their legislators on pathology’s top legislative objectives.

The CAP recently met with Medicare Administrative Contractor (MAC) Palmetto GBA, a company that handles Medicare claims for the Centers for Medicare & Medicaid Services (CMS), and expressed deep concerns that the MolDX: Molecular Assays for the Diagnosis of Cutaneous Melanoma Local Coverage Determination (LCD) improperly limits the scope and defines the practice of medicine by board-certified pathologists, licensed physicians and surgeons, who are eligible to order laboratory tests.

In a March 1 letter to CMS and Palmetto, the CAP requested that the subspecialty requirement in the LCD – that any molecular test approved for coverage under the LCD be ordered by a board-certified or board-eligible dermatopathologist – be removed from the coverage policy. The CAP stated further that

The Centers for Disease Control and Prevention (CDC) issued a health advisory about a critical shortage of Becton Dickinson (BD) BACTEC™ blood culture media bottles on July 23. The advisory followed an announcement by the Food and Drug Administration (FDA) regarding the disruption in availability of BD BACTEC blood culture media bottles on July 10.

This shortage has the potential to disrupt patient care by leading to delays in diagnosis, misdiagnosis, or other challenges in the clinical management of patients with certain infectious diseases, the CDC said. Those affected by this shortage should immediately begin to assess their situations and develop plans and options to mitigate the potential impact of the shortage on patient care.

On July 10, the House Appropriations Committee requested in legislation that the Food and Drug Administration (FDA) suspend implementation of the laboratory-developed tests final rule that went into effect May 6. The recommendations include partnering with Congress to modernize the regulation of LDTs.

Lawmakers said the FDA’s final rule is a significant shift in the way LDTs are regulated and changes expectations for patients, doctors, and laboratories for the first time since the Clinical Laboratory Improvement Amendments Act was passed in 1988. The Committee wants the FDA to suspend its efforts to implement the rule and continue working with Congress to modernize the regulatory approach for LDTs. The CAP would support a delay that gives Congress time to enact legislation that restricts the FDA and focuses full oversight on tests that are highest risk to patients.

The proposed 2025 Medicare Physician Fee Schedule released on July 10 highlights the continuous advocacy efforts by the CAP to protect the value of pathology services. Due to the CAP’s efforts, the Centers for Medicare & Medicaid Services (CMS) has proposed to increase the relative values of three apheresis services, provide coverage for four new CAR T-cell services, and increase the clinical labor rates for key laboratory clinical labor types. The proposed 2025 Medicare Physician Fee Schedule does, however, include cuts to physicians, including pathologists, and other providers such as independent laboratories. These cuts largely stem from the expiration of two congressional Medicare pay relief packages that were intended to offset the previously finalized cuts in the 2023 and 2024 Medicare Physician Fee Schedules. The CAP strongly opposes these cuts and is actively lobbying Congress to mitigate the decreases before they take effect.

Special Issue: The proposed 2025 Medicare Physician Fee Schedule released on July 10 highlights the continuous advocacy efforts by the CAP to protect the value of pathology services. Due to the CAP’s efforts, the Centers for Medicare & Medicaid Services (CMS) has proposed to increase the relative values of three apheresis services, provide coverage for four new CAR T-cell services, and increase the clinical labor rates for key laboratory clinical labor types. The proposed 2025 Medicare Physician Fee Schedule does, however, include cuts to physicians, including pathologists, and other providers such as independent laboratories. These cuts largely stem from the expiration of two congressional Medicare pay relief packages that were intended to offset the previously finalized cuts in the 2023 and 2024 Medicare Physician Fee Schedules. The CAP strongly opposes these cuts and is actively lobbying Congress to mitigate the decreases before they take effect.

During a Capitol Hill briefing for congressional staffers that took place July 9, the CAP discussed how Congress can promote patient safety without overburdening laboratories through enacting a diagnostic reform package that provides oversight of laboratory-developed tests (LDTs) while still allowing for innovation of new technologies and patient access to accurate testing.

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.