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Advocacy Update

January 21, 2025

In this Issue:

Advocacy Win: CAP Protocols Added to Federal Cancer Registry

The USCDI+ Cancer Registry Version 1 (January 2025) Minimum Data Element List has been updated by the Department of Health and Human Services (HHS) to include CAP Cancer Protocols. The finalized data element list reflects input received during the July - September 2024 public comment period, ensuring an interoperable framework of the minimum data elements needed for Cancer Registry incidence reporting. The update includes:

  • Enhanced descriptions for select data elements
  • Improved alignment with standards like FHIR, mCODE, and CAP protocols for real-time reporting.
  • Enhanced interoperability to support clinical, public health, and research initiatives.

As part of the release of USCDI+ Cancer Registry, HHS noted that laboratory systems can integrate the CAP electronic Cancer Protocols (eCP) to submit structured data to registries.

The CAP commented on the previous version and promoted the CAP Cancer Protocols. The CAP looks forward to working to support high quality laboratory operations and medical care.

ICYMI: CAP Fixes Post-Graduate Resident Histopathology Rule Problem

The Centers for Medicare & Medicaid Services (CMS) has addressed a personnel requirement problem the CAP had sought to fix in the agency’s histopathology interpretive guidelines.

In late December, the CMS communicated to the CAP that it was updating the interpretive guidelines that had prohibited post-graduate pathology residents from interpreting tests. In 2023, the CMS removed a regulatory requirement resulting in post-graduate residents no longer being qualified to read slides. The revised language now clearly states that post-graduate residents do indeed qualify. The histopathology guidelines now states that the “CMS considers those individuals who have completed their residency and are waiting to obtain their board certification to qualify under this regulation.”

The CAP has published its professional competency checklist assessment to reflect this change.

Post-Inauguration: Advocating in a New Administration

With a new administration and the 119th Congress underway, 2025 is a critical year for pathologists. The CAP, representing over 19,000 board-certified pathologists is proactively working with policymakers in the new Trump Administration and Congress on several key health care policy priorities that protect the practice of pathology.

The CAP has shared the Top 6 Priority Issues with the new Congress and Administration. These key issues include reversing payment cuts to pathology services and strengthening the pathology and laboratory workforce.

The CAP previously sent a letter to the Trump Transition Team, outlining the key priorities, including recommendations to rescind the Food and Drug Administration's (FDA) final regulation for laboratory-developed tests (LDTs), citing significant concerns about the rule’s potential to limit patient access to critical diagnostic services.

The CAP will continue updating members on our ongoing advocacy efforts.

CDC: Accelerated Use of H5N1 and Influenza A(H5) Subtyping Tests

Over the past few weeks, increasing activity related to seasonal influenza A(H5) and sporadic human infections with avian influenza(H5N1) caused the US Centers for Disease Control and Prevention (CDC) to release two laboratory advisories:

  • Accelerated Use of Avian Influenza A(H5N1): CDC recommends a shortened timeline for subtyping all influenza A specimens among hospitalized patients and increasing efforts at clinical laboratories to identify non-seasonal influenza. To prevent delays in identifying human infections with avian influenza A(H5N1) viruses, clinicians and laboratorians are reminded to test for influenza A-positive specimens from hospitalized patients, particularly those in an intensive care unit (ICU). The full January 16 advisory is available on the CDC website.
  • Use of Influenza A(H5) Subtyping Tests by Clinical Laboratories: CDC continues to distribute an FDA 510k-cleared IVD influenza A(H5) assay to state and jurisdictional public health laboratories to test patients for influenza A(H5) virus. CDC is also aware of recent development and use of IVDs offered as LDTs independent of state and jurisdictional public health laboratories to diagnose influenza A(H5) virus in patient specimens. CDC notes in its December 27, 2024 message that it is critical to immediately contact the state, local, territorial, or tribal public health authority if a positive result for influenza A(H5) virus is obtained using an LDT to initiate important time-critical actions.

Additional Resources:

If you are a clinical or public health laboratory professional and have questions, please contact CDC's Laboratory Outreach Communication System.

HHS Releases New AI Strategic Plan

The US Department of Health and Human Services (HHS) has released a new AI Strategic Plan. The Strategic Plan is a framework and roadmap for HHS on AI and calls for sharing national health AI-specific guidelines, creating sandboxes for industry collaboration, evaluating "approaches to bolster AI quality assurance in medical products," and improving health sector cybersecurity to promote the safe, responsible, and effective use of AI in health care. Additional information on the plan is available online.

The plan is subject to review with the new Presidential administration.

The CAP is assessing the plan and its potential impact on pathologists. We will provide more information as it becomes available.

Registration Open for Spring HOD, Pathologists Leadership Summit

With a new administration, ongoing threats to payment for pathology services, and burdensome regulations on our laboratories, it’s clear that 2025 will be a critical year for pathology. Help shape the future of pathology and join the CAP at the Spring House of Delegates meeting and Pathologists Leadership Summit happening April 26-29. Join your fellow members and colleagues as we advocate for fair policies and drive change on Capitol Hill on behalf of pathologists and patients.

Register today

Watch Now: The CAP's Third LDT Webinar

Did you miss the third webinar in our laboratory-developed tests series Ready Your Laboratory for the FDA's Stage 1: Corrective Action and Removal Reporting? Watch the on-demand recording to learn the necessary steps to comply with the FDA requirements for corrective action and removal reporting specific to laboratory-developed tests. This webinar and others in the series are intended to help laboratories prepare for the FDA final rule.

Download the presentation

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