Advocacy Update

• CAP Supports Lawsuit by California Pathologists
• CAP Fixes Post-Graduate Resident Histopathology Rule Problem
• From Capitol Hill to Australia: Advocating for Pathology
• Consortium, CAP Engage on Cervical Cancer Screenings Recommendations
• FDA Releases Draft Guidance on Validation of IVDs
• FDA Releases NEW Artificial Intelligence Draft Guidance
• 2025 MIPS Updates

The CAP strongly supports the lawsuit filed by the California Society of Pathologists and Lincoln Luk, MD, FCAP against L.A. Care Health Plan in California Superior Court. This lawsuit seeks to revise L.A. Care Health Plan policy and compensate pathologists for the professional component of clinical pathology services.

The lawsuit alleges that the insurer policy violates provisions of the Knox Keene Act that require health plans to pay out-of-network providers for emergency services and, in some instances, inpatient care, as well as provisions that require health plans to cover diagnostic laboratory services for plan members.

Read more on the filing online.

The CAP will provide additional updates on this issue as new information emerges.

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 state 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.

From Capitol Hill to Australia, advocating for pathologists remains a critical issue, from Medicare to payments and training. Listen to our conversation with Daniel Owens, Vice President of the Royal College of Pathologists of Australasia. In this episode, Owens visits Washington, DC, to learn about the CAP's advocacy work in the nation's capital and discuss how pathologist leaders can advocate on behalf of pathologists and patients.

Listen online

The CAP will be submitting comments on the US Preventive Services Task Force (USPSTF) draft recommendation statement on screening for cervical cancer. The recommended changes include HPV primary screening every five years as the preferred screening strategy starting at the age of 30 years and self-collected HPV testing. The USPSTF said these updates will increase testing among the generally under screened for the first time.

The CAP has agreed to sign a comment letter that is being submitted by the Cytopathology Education and Technology Consortium (CETC). The initial draft of the letter is consistent with the CAP policy on cervical cancer screening.

The US Drug and Food Administration (FDA) has released draft guidance on Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency. This draft guidance gives recommendations for the validation of in vitro diagnostic devices (IVDs) that test for emerging pathogens during a federally declared public health emergency. The guidance follows recommendations from two independent assessments of FDA's response to COVID-19.

The FDA also released a template to help test manufacturers understand the FDA's current thinking on test validation study data submitted as part of an Emergency Use Authorization request to the FDA.

The CAP is currently reviewing the guidance to determine its consistency with CAP policy on this issue and plans to submit comments. For emerging pathogens, like COVID-19, the CAP has advocated for laboratories to operate without the hindrance of unnecessary regulatory burden. Comments are due March 7, 2025.

Download the draft guidance document online.

The Federal Drug Administration (FDA) has released a draft guidance entitled "Artificial Intelligence Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations." This draft guidance, when finalized, will provide recommendations regarding the contents of marketing submissions for devices that include artificial intelligence (AI)-enabled device software functions, including documentation and information that will support the FDA’s evaluation of safety and effectiveness.

To support the development of appropriate documentation for FDA's assessment of the device, this draft guidance also proposes recommendations for the design, development, and implementation of AI-enabled devices that sponsors may wish to consider using throughout the total product lifecycle (TPLC). Comments may be submitted online until April 7, 2025.

The CAP previously advocated for transparency in AI and has advocated for the FDA to take the necessary steps to ensure regulatory burden is not transferred to pathologists.

The CAP is now analyzing how the proposed guidance will impact pathologists and will continue providing updates.

2024 MIPS Data Submission and 2025 Payment Adjustments

The Centers for Medicare & Medicaid Services (CMS) has opened data submission for the 2024 performance year of the Quality Payment Program (QPP). Data can be submitted until 8 PM ET on March 31, 2025. If you enrolled in the CAP’s Pathologists Quality Registry for 2024 MIPS reporting, registry staff will be following up with your practice in the coming weeks about completing your MIPS submission to the CMS.

2025 MIPS payment adjustments are now in effect based on each MIPS eligible pathologist’s 2023 MIPS final score. Payment adjustments will be applied to payments may for Part B covered professional services payable under the Physician Fee Schedule from January 1 to December 31, 2025. Payment adjustments are determined by the final score associated with a pathologist’s TIN/NPI combination. For more information see the CMS 2025 MIPS Payment Adjustment User Guide.

2025 MIPS REPORTING

• Through CAP advocacy, the CMS removed the 7-point cap for scoring certain topped out MIPS quality measures in specialty sets with limited measures. Measures in the Pathology Specialty Measures Set measures are now worth up to 10 points in 2025. This will be applicable to QPP 249, 250, 395, 396, 397, and 440.
• Performance Threshold remains at 75 points to avoid a penalty, and data completeness remains at 75%. View all CMS' 2025 QPP updates here.