Advocacy Update

• Pathologists Meet with Congress
• Thank You for Attending Pathologists Leadership Summit!
• CAP Asks White House to Target FDA Oversight of LDTs on Highest Risk Tests
• CAP Opposes Expansion of CLIA Oversight of Personnel, Supports AI Regulation at CLIAC Meeting
• House Committee Examines Change Healthcare Cyberattack
• Illinois Senate Passes Network Adequacy Bill, House Action Pending
• CAP Advocate Spotlight: Dr. Valdes
• Take Our News Quiz for April

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.

CAP members made their cases speaking with legislative staff outlining our advocacy priorities: Medicare physician payment reform, the Saving Access to Laboratory Services (SALSA) Act, and Conrad State 30 and Physician Access Reauthorization Act which are all vital to the success of the practice of pathology.

They reported receiving positive responses during the CAP’s annual Hill Day, which concluded the 2024 Pathologists Leadership Summit. The four-day, in-person meeting included close to 200 pathologists attending the House of Delegates, educational courses, and advocacy sessions.

Looking to Help Us with these Issues?

If you couldn’t attend the Pathologists Leadership Summit Hill Day, please visit the CAP’s advocacy action center to support our advocacy. It’s easy and takes little time to advocate on the issues impacting how you practice and your ability to provide patients with quality care.

We are incredibly grateful for a dedicated community of pathologist advocates and leaders. As a thank you for making the 2024 Pathologists Leadership Summit a place of reflection, learning and advocacy, download this high-resolution photo of pathologists who joined us for a historic Hill Day.

Thanks again for joining us. Your support and participation are what make the summit meaningful and successful for the future of pathology.

Leaders from the CAP met with officials from the White House Office for Management and Budget on April 18 to discuss our grave concerns with the Food and Drug Administration (FDA) proposed rulemaking on the oversight of laboratory-developed tests (LDTs). The proposed rule was under White House review and the CAP advocated for practical ways LDT oversight could be conducted more effectively.

CAP President Donald Karcher, MD, FCAP; Council on Government and Professional Affairs (CGPA) Chair Joe Saad, MD, FCAP; and CGPA Vice-Chair Diana Cardona, MD, FCAP, spoke with the White House officials. They said that the proposed rule, as written, would significantly burden clinical laboratories, making it very difficult and unacceptably costly for these laboratories to continue to develop much-needed and innovative LDTs, resulting in patients being deprived of these life-saving tests.

Instead, the CAP advocated for a better approach with a regulatory framework that focuses the FDA’s resources mostly on the highest-risk LDTs and provides significant flexibility in their oversight of lower-risk LDTs to preserve quality, patient safety, innovation, and patient access.

Read the CAP’s comments that followed the meeting and were sent to the Office for Management and Budget on April 19.

The CAP believes that the White House is close to concluding its review of the FDA proposal. Once the final regulation is released, the CAP will provide its members with an initial analysis of regulation and how it will impact laboratories.

At an April 10 meeting of the Clinical Laboratory Improvement Advisory Committee (CLIAC), managed by the Centers for Disease Control and Prevention (CDC), Diana Cardona, MD, MBA, FCAP governor of the board of the CAP, delivered the CAP’s positions on the three topics up for consideration by the committee:

• Opposition to expansion of CLIA oversight to include preanalytic testing personnel qualification as the CAP has not identified quality or other issues that could be resolved through expansion of regulatory oversight.
• Support of slowing down or pausing a regulatory framework for Artificial Intelligence (AI) and Machine Learning (ML) that requires verification and validation of AI/ML-based tools and centers the role of the pathologist in clinical decision-making
• How clinical guidelines and standards such as the CAP Checklist can best be used to improve quality and not be referenced in regulations.

The advice and guidance CLIAC provides to the Department of Health and Human Services (HHS) pertains to general issues related to improvement in clinical laboratory quality and laboratory medicine practice. In addition, the committee provides advice and guidance on specific questions related to possible revision of the CLIA standards. Please see the CLIAC Recommendations Table for a full listing of all CLIAC Recommendations and their status.

The House Energy and Commerce Subcommittee on Health held a hearing on April 16 to examine health sector cybersecurity in the wake of the Change Healthcare attack and address barriers to implementation of cybersecurity protections.

On February 21, Change Healthcare suffered a cybersecurity attack that resulted in disruptions in claims processing, delayed prior authorization requests, and other major impacts on physician practices. The CAP has continually monitored the impact the attack has had on pathology practices and laboratories and is sharing resources to assist pathologists managing the fallout. It is worth noting that at the April 16 hearing, members of Congress decried the absence of UnitedHealth Group (which owns Change Healthcare) as they did not send officials to take questions from lawmakers.

During the hearing they discussed the causes and policy implications of ransomware attacks on the health care sector. Some of the points made at this hearing are as follows:

Health care organizations typically do not invest in cybersecurity measures, and federal incentives are needed to rectify this The large size of consolidated health care companies, such as Change Healthcare, may exacerbate cybersecurity risk There is a need for federal privacy regulationThere are international implications for cyberattacks, as a lot of hackers are from hostile countries or will sell hacked data to hostile countries

Most recently, the Department of Health and Human Services compiled information, resources, and tools from health plans and payers for providers in need of assistance – find that document online here. The following are additional resources to help pathologists navigate these ongoing issues can be found here.

On April 11, the Illinois State Senate, by an overwhelming majority, passed health plan network adequacy legislation, advocated by a multi-specialty coalition of medical societies, including the Illinois Society of Pathologists (ISP) and the CAP. The bill was opposed by the Illinois health insurance industry. The legislation now moves to the Illinois House for consideration.

The legislation requires health plans to submit to the Illinois Department of Insurance information demonstrating that they have contracted with hospital-based physician specialists, including pathologists, radiologists, anesthesiologists, and emergency room physicians at in-network hospitals and facilities. The Illinois Department of Insurance currently conducts network adequacy assessments of health plans but does not scrutinize health plans for provision of in-network pathology/laboratory services, or for other on-site physician specialty services at hospitals and in-network facilities.

The ISP, with the assistance of CAP, submitted a memorandum and provided testimony detailing support for the legislation.

Leilani Valdes, MD, MBA, FCAP is a first-term CAP Governor and Chair of the Council on Membership and Professional Development and active participant in PathNET. PathNET is CAP Advocacy's grassroots advocacy network and a resource for CAP members to connect with their elected officials at the federal and state level.

What was your first experience advocating for CAP like?

“Are you really going to Washington, DC? If so, I’m going with you,” said my husband after I announced that I had been asked to attend Advocacy School (the precursor to the CAP Policy Meeting and the CAP Pathology Leadership Summit). At the time, my member of Congress held a very influential position as the chair of the Ways and Means Committee, and the CAP was very interested in having a pathologist constituent go to the Hill to advocate for our issues. My very supportive husband would not normally have asked to come along, but I happened to be in my third trimester with our third child, and he was not okay with me making the journey alone. This act of support was no small sacrifice for our family. We had to secure childcare for our two young children, and he would need to take time off work. However, we both understood the importance of supporting my future career. I was incredibly grateful to have him walking to our various appointments on the Hill as I advocated for our issues for the first time. I remember him commenting on how impressed he was with the training I received in the Advocacy School sessions prior to Hill Day and how helpful the CAP Advocacy staff were on our visits. After years of attending these sessions and participating in Hill Day visits, I am inspired by the strong work done by our CAP Advocacy office and the outstanding professionals who work to address our issues.

What different ways have you advocated for the practice of pathology?

Throughout the years I have visited the Hill, visited the field offices of my representatives, and supported PathPAC events and fundraisers. It is the combination of all the advocacy efforts in Washington and at a grassroots level that helps us build relationships which ultimately shape our specialty and how we practice. In addition, as immediate past president of the Texas Society of Pathologists, I’ve followed in my mother’s footsteps and attended First Tuesdays at the Texas capital advocating for statewide pathology issues, most recently regarding network adequacy. Being from a small community allows me to know my representative and senator on a personal basis. These relationships ensured that we had face-to-face meetings with them to discuss our issues during the legislative sessions.

What is one of your most memorable advocacy experiences?

Just one? For more than a decade, I’ve had the privilege to work with the CAP to advocate for a broad range of legislative reforms including payment and practice measures. On one occasion, my representative asked me to brief him on our issues as we walked to a hearing where he needed to vote. We talked and walked to and from the hearing only pausing when he was inside the hearing room voting.

While numerous additional memorable experiences come to mind, communicating the value of this work has always been part of my passion. I loved having the opportunity to communicate about the power of advocating for our issues. If you see me at the PLS, I’d be happy to share more “in the halls of Congress” stories with you.

What advice would you give to CAP members who are interested in getting involved but are hesitant to do so?

I believe that every pathologist should attend the Pathologist Leadership Summit and attend Hill Day at least once. The experience is unlike any other and is eye-opening. After that, some pathologists like me will make it a priority to be as active as possible to support our advocacy efforts. Other pathologists, like my father, will leave the experience with a deeper understanding of the legislative advocacy process and the importance of supporting these efforts through PathPAC contributions and grassroots advocacy efforts.

Follow Dr. Valdes’ lead and join PathNET to receive important action alerts, updates on legislative issues impacting pathology, and to learn about other ways to get engaged in grassroots advocacy all year long. Opt-in for PathNET text alerts here. PathNET volunteers also have opportunities to receive recognition for the advocacy work they do.

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