Advocacy Update

• Pathologists Quality Registry by the CAP Earns Historic Benchmarks from CMS
• Key Histocompatibility, Personnel, and Sanction Revisions in CLIA Updates Rule
• 2024 Pathologists Leadership Summit Approved for 13.5 CME Credits, Register Today!
• Meet the CAP Advocacy Chairs: Federal and State Affairs Committee Chair Matthew R. Foster, MD, MMM, FCAP
• Take Our News Quiz for February

The Center for Medicare and Medicaid Services (CMS) alerted the CAP that its Pathologists Quality Registry earned historical benchmarks for two more of their registry-specific Qualified Clinical Data Registry (QCDR) measures. This brings the total benchmarked QCDR measures to four. Benchmarking is critical for pathologists looking to maximize their scores while minimizing burden. Measures with a benchmark are worth up to 10 points, therefore increasing practices’ opportunities to earn a positive payment adjustment. The Pathologists Quality Registry is the only registry with benchmarked QCDR measures for pathology and remains the highest scoring option for pathology practices.

More information about benchmarks can be found on the CMS’ website. Visit 2024 Pathology Quality Measures for information on pathology-specific measures and specifications. Check out the CAP’s Quality Payment Program for Pathologists for more information and to see how you can participate in the registry.

In late December, the Centers for Medicare & Medicare Services (CMS) finalized a regulation adopting a new fee structure and CLIA updates proposals concerning histocompatibility, personnel, and alternative sanctions for certificate of waiver laboratories. In total, CLIA covers about 320,000 laboratories, and the CLIA program's objective is to ensure quality laboratory testing. These are the first significant updates to the CLIA regulations since its inception in 1992.

Some changes within the rule are meant to provide more flexibility for clinical testing under CLIA. The rule also clarifies confusing provisions and removes grandfathered and other obsolete personnel degrees along with practices.

Key Provisions within the Final Rule

Fees: Created a new fee structure that would consider travel and inspection cost.

Personnel: Defined the doctorate-level degree by providing an educational requirement of three years

• Accepted Doctorate of Clinical Laboratory Services (DCLS) as a qualifying degree for high-complexity laboratory directors.
  • The CMS does not consider DCLS the same as a MD or DO, therefore, DCLS degree holders as other individuals with nonmedical doctoral degrees must qualify under the doctoral degree requirements.
• Allowed non-scientific degree individuals to qualify for roles within CLIA if they meet a qualification algorithm. (This applies to the roles of technical supervision, testing personnel, and moderate-complexity laboratory director).
• Created a new category for nurses to qualify as testing personnel in moderate complexity testing labs and Point of Care testing in hospitals, and for respiratory therapists as Technical Supervisor to oversee blood gas labs.
• Updated Laboratory Director responsibilities, including requirements for in-person visits. Laboratory Director’s must make an in-person visit to the laboratory at least once every 6 months, with at least 4 months between visits, but can come more often than that if they choose to.

Histology: Updated the histocompatibility requirements to reflect current day practices especially related to crossmatching.

Certificate of Waiver (COW Laboratories Sanctions): Allowed alternative sanctions for waived laboratories (including civil monetary penalties, a directed plan of correction and onsite monitoring).

Although the CAP supported many of the changes in the final rule, particularly around the creation of a pathway for nurses to qualify as testing personnel, flexibility for nonscientific degrees and clarification of doctorate-level degrees within CLIA, the CAP strongly opposes allowing individuals with the DCLS degree to qualify for high-complexity laboratory director positions under CLIA. The CAP has stated that the DCLS degree will cause confusion among the public about the distinctions between a clinical pathologist and those with a DCLS. The CAP had detailed its opposition in an August 29, 2022 letter to the CMS.

Most of these regulations were made effective January 27, 2024, however, personnel changes will be made effective December 28, 2024. Questions about the CLIA program should be submitted to LabExcellence@cms.hhs.gov.

The CAP has designated the Pathologists Leadership Summit as an educational activity for a maximum of 13.50 American Medical Association (AMA) PRA Category 1 Credits. AMA PRA Category 1 Credit is used for meeting CME requirements established by hospital credentialing bodies, state medical boards, medical specialty certifying boards, medical specialty societies, Joint Commission, and other organizations.

The 2024 Pathologists Leadership Summit, (in-person only), April 13-16 in Washington, DC., not only offers the education and training you need to grow personally and professionally but provides you with unparalleled access to put those tools into action on Capitol Hill. Meet directly with your legislators and their staff on Hill Day to advocate for pathology and its critical impact on patient care. Register today!

The goal of the Federal and State Affairs Committee (FSAC) is to identify federal and state legislative and state regulatory activities that impact pathology, including advocacy strategies that advance the public policy interests of pathologists; and to improve the effectiveness of the CAP's federal and state advocacy efforts, including implementation of advocacy training programs and recruitment of pathologists for grassroots efforts and PathNET. This committee reports to the Council on Government and Professional Affairs.

1. How did you become interested in serving as FSAC Chair? I subscribe to the old adage that decisions are made by the people who show up. From an early age, I recognized that giving your time to get involved with advocacy meant learning how to be a positive influence and change agent and that this meant taking a long view rather than just constantly searching for quick wins or temporary solutions. I became directly involved with the CAP over 10 years ago as the in-office ancillary services exception to the Stark Law was just starting to be used to justify the development and rapid expansion of pod labs. I was looking for a constructive way to help tell my story of how this was negatively impacting care in my community and also hopefully influence those with an ability to make a difference. Advocacy offered the chance to get involved and a constructive vehicle to at least be heard. Being chair of FSAC was not something on my radar screen when I joined FSAC, I was just happy to be there and frankly in awe of the knowledge and experience of this group.

2. What do you hope to accomplish during your time serving as FSAC Chair? I We need to be proactive and not reactive. While out of necessity, continuing to champion solutions to recurring financial challenges, our committee will proactively identify new and important issues. This is a major point of focus. All too often we as a small specialty can play defense, reacting to another negative development and go into damage control mode. We have so much to offer and our role in medicine is absolutely critical therefore we are proactively engaging in quality, safety, artificial intelligence, immigration and visa reform, workforce shortages, graduate medical education, and laboratory stewardship for example.

There are fundamental challenges that health care faces that affect pathology, such as immigration and visa reform, renewed efforts at gene patenting, FDA (Food and Drug Administration) regulations of laboratory-developed tests, and other federal legislation that impacts quality and safety of laboratories. At the state level, scope of practice discussions have the potential to change the role of laboratorians and minimize the training and skill of a board-certified pathologist. Finally, the emergence of AI (artificial intelligence) requires thoughtful and deliberate discussion. There are so many opinions on how this will impact pathologists and laboratory medicine. I anticipate FSAC taking an active role in helping to shape both policy and legislation as it emerges.

3. How does CAP advocacy make a difference in the practice of pathology? Perhaps a better way to frame this would be where would we be without the work of CAP advocacy? The ability to work with many key stakeholders to form a workable solution to seemingly intractable problems is one of the fundamental strengths of the CAP. For example, the CAP helped mitigate physician fee schedule cuts, sought compromise on laboratory developed tests address surprise billing and scope of practice and continues to be the trusted go to source of policy makers and legislators about issues facing the laboratory community.

The CAP is the only pathology organization that has an active lobbying presence on Capitol Hill. With over 30 staff in the DC office and an incredible team of talented politically savvy and experienced people, they bring energy and political insider knowledge to support pathologists and enhance our profession. They form the backbone for why the CAP is making a difference and why the CAP is so vital to the entire pathology and laboratory community. They cannot do their work without the support and active engagement of CAP members. Through the House of Delegates and other forums, members actively engage in expressing their concerns and ideas which help shape policy and influence advocacy approaches, tactics, and strategy. The CAPs engagement with regulatory bodies like the Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA) mean developing relationships that foster trust in the CAP as a willing partner who looks for compromise while not sacrificing core values or the high standard, we expect for ourselves as physicians.

4. What do you think are the most important aspects of advocacy (grassroots, PathPAC, meetings with legislators, attending Pathologists Leadership Summit) CAP members need to be involved in to move the needle? This is a bit like asking me to pick a favorite child. They are all important! The common theme though is building relationships. Taking time out of your busy day to day life to speak about something you care about. Asking and answering the question: How do the issues facing health care impact you and importantly your patients? Attending the Pathologists Leadership Summit is a great way to get engaged, stay engaged, or get re-energized when the day-to-day grind of modern medicine inevitably wears us down. It is a hopeful experience. Of course, not everyone can attend. But, reading and paying attention to and responding to action alerts sent out by the CAP, going to a local political event, and getting to know legislators and their staff are great ways to start building those relationships. PathPAC contributions are also an important facet of the modern political landscape and a good way to feel like you are helping make a difference for our specialty.

Finally, I think one often overlooked component of advocacy is the timeline. Today, we are looking for quick wins and what have you done for me lately? It should come as no surprise that in the current political dynamic in Congress legislation and policy move very slowly. It is a continual effort over sometimes many years that results in major wins for the laboratory community. Patience, persistence and keeping focused on our role as advocates for our patients is fundamental.

5. Why did you choose a career in pathology? Interestingly, I worked in a basic science research lab in the pathology department at The University of North Carolina at Chapel Hill through my undergraduate years and when I went to medical school, people would inevitably ask me “what kind of doctor do you want to be.” My standard answer was “I am not sure yet, but I know I don’t want to be a pathologist.” Yet… as I learned more about surgical pathology, the blood bank and laboratory medicine during my 3rd and 4th year, I realized that it was the perfect fit for my interests; requiring a breadth and depth of medical knowledge and balancing the science of medicine with robust and varied clinical interaction. I am so fortunate to have had mentors who supported, encouraged, and challenged me and it has been an incredibly rewarding career. I truly regard medicine as a calling, and we are meant to serve. For me pathology was a way I could make a tremendous impact through science, service, and trust.

6. If you could invite 3 people to dinner (living or dead) who would they be? Only three people? This is really tough. I admit I thought about Travis Kelce and Taylor Swift, but they would probably just talk among themselves. Limiting it to three: Tina Fey, she is funny, authentic and both incredibly talented and super smart. William Ury, professor at Harvard and founder of the project on negotiation, his inspiring work has been fundamental at creating win-win solutions to seemingly intractable problems throughout the world. Anthony Bourdain, his talent both as a chef and as an astute observer would make for a memorable evening.

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