Advocacy Update

• Pathologists Rally in DC for Congress to Support Long-term Medicare Pay Reform and Workforce Initiatives
• PathPAC Raises $51,000 During HOD Competition
• CAP Ad Campaign Supports Pathologists Lobbying During Pathologists Leadership Summit
• CAP Responds to Senate Committee’s Request for Information on Oversight and Reforms to Clinical Diagnostics
• 80% of Practices Report Lost Revenue in AMA Change Healthcare Cyberattack Survey Results
• CAP, AMA and over 100 Health Care Organizations Oppose Burdensome Policies in Medicare Savings Program
• CDC Provides Guidance for Recent Avian Flu and Measles Outbreaks
• Take Our News Quiz for April

To prepare for the CAP’s annual Hill Day, CAP members discussed strategies for how they will engage their members of Congress at the Pathologists Leadership Summit on April 13-16. CAP Advocacy leaders prepared pathologists to lobby Congress on three main policies affecting the specialty: A long-term fix for Medicare cuts to pathology services, a long-term fix to stabilize clinical laboratory services reimbursements, and greater immigration flexibilities for physicians so they can continue to practice in the United States – especially in health care shortage and rural areas.

CAP members not attending the Pathologists Leadership Summit can support their colleagues in Washington, DC, by taking action remotely. The CAP sent an action alert to members on April 15 urging them to contact their legislators on these three main policies.

In his opening remarks, CAP President Donald Karcher, MD, FCAP, described the significance of pathologists advocating for their profession and educating legislators on the impact of their payment policies.

“With the ever-evolving demands and challenges placed on pathologists, it can be difficult to stay current with the trends and latest issues affecting our specialty. The Pathologists Leadership Summit is the only pathology meeting where you will learn how to harness your individual voice and strengthen our collective power to effect change in your practice, patients, communities, and the profession,” Dr. Karcher said.

Diana Cardona, MD, FCAP, vice-Chair of CGPA and Todd Askew, senior vice president of the Advocacy Group for the American Medical Association (AMA) co-led a session about shifting our focus to broader Medicare physician payment reform. The session discussed how the CAP is working with the AMA to push for a Medicare Inflationary Update for physicians, and improvements in the physician fee schedule budget neutrality requirements.

Gregary Bocsi, DO, FCAP, Chair of the Quality and Clinical Data Registry Affairs Committee and Mary Le, MD, FCAP, Vice Chair of Federal State Affairs Committee co-lead a session about how The Saving Access to Laboratory Services Act (SALSA) will enable sustainable reimbursement for laboratory services that will support the strong clinical laboratory infrastructure needed to protect patient access and public health, while fostering innovation to improve patient care.

Dr. Cardona and Matthew Foster, MD, MMM, FCAP Chair of Federal and State Affairs Committee co-lead a session on how the Conrad State 30 and Physician Access Reauthorization Act would reauthorize the Conrad 30 waiver program for three years, make improvements to the program, and increase the number of waivers granted to each state which would allow non-US International Medical Graduates (IMGs) to provide necessary patient care immediately upon finishing their training.

Dr. Karcher, Joe Saad, MD, FCAP, Council on Government and Political Affairs Chair along with Helena Duncan, CAP Senior Director of Quality and David Steury, Health Policy Director for Rep. Diana DeGette (CO-D) participated in a timely topic discussion about the recent Food and Drug Administration (FDA) final rule on laboratory-developed tests (LDTs), the CAP’s position on the rule and what this means to the broader laboratory community.

Over 150 meetings with CAP members and lawmakers on Capitol Hill will take place on April 16.

Advocacy Update will provide more coverage of the Pathologists Leadership Summit in the next issue.

The 2024 Pathologists Leadership Summit kicked off on April 13 with the Spring House of Delegates (HOD) meeting with hundreds of pathologists from around the country participating in-person.

The meeting started with HOD Speaker Sang Wu, MD, FCAP by opening the Spring session which was followed by a discussion on workload and staffing shortage challenges.

The Board of Governors candidate forum posed questions to the CAP members running for the four open Governor positions in this summer’s election.

Then Dr. Saad provided an overview of the current political landscape, the CAP’s advocacy agenda, private-sector advocacy, and Hill Day asks for participants including late-breaking topics.

At the close of the HOD session, Dr. Wu announced the two winning teams from the Back the PAC HOD competition. The Coastal Team won in the category of dollars raised, raising a total of $11,165 from Alabama, Connecticut, Florida, Georgia, North Carolina, South Carolina, US Navy, and Virginia Delegates. The Frontier Team, made up of Arkansas, Kansas, Kentucky, Louisiana, Mississippi, Nebraska, New Mexico, Oklahoma, Puerto Rico, Tennessee, Texas, US Army won for the highest participation rate, with 25% of the team supporting the PAC during the competition. Overall, the HOD raised a record-breaking $51,021 for PathPAC. The goal of the competition was to garner more support for the CAP’s political action committee (PAC) and further raise awareness for PathPAC’s role to advance the CAP’s legislative objectives. PathPAC is nonpartisan and the only PAC representing pathologists at the federal level.

The audience sharpened their leadership skills, learned about the importance of cultural competency and how to improve diagnostic excellence through patient pathology reports during the second day of the Pathologists Leadership Summit on April 14.

In the weeks leading up to the Pathologists Leadership Summit, the CAP placed several advertisements raising awareness about the pathologists’ role in patient care that targeted policy influencers in Washington. The main messages in the ads emphasized that pathologists diagnose disease to inform care and treatment decisions for patients however, constant Medicare cuts hinder access to these life-saving diagnoses.

The coordinated ad campaign sought to complement the CAP’s Hill Day activities on April 16.

Outdoor digital ads were displayed in the downtown D.C. area. Targeted digital ads were also placed on LinkedIn, YouTube, Hulu, Google Display Ads and Google search. This comprehensive ad campaign will continue for two more weeks after the Pathologists Leadership Summit concludes.

On April 10, the CAP responded to the Senate Health, Education, Labor, and Pension (HELP) Committee and ranking member Sen. Bill Cassidy’s (R-LA) request for information regarding oversight and reforms to clinical diagnostics. In a letter, the CAP outlined its positions on the oversight of LDTs, legislative updates to CLIA, alternatives to the Food and Drug Administration (FDA) rulemaking, and artificial intelligence in diagnostics. Overall, the CAP continues to advocate for an approach to oversight that protects patients, ensures continued access to safe and innovative diagnostic tests, and is the least burdensome for pathologists and their laboratories.

Oversight of LDTs

The CAP believes that a legislative and regulatory framework for LDTs should include a role for the FDA according to a test's risk level to a patient. This can be done by restricting direct FDA regulatory oversight to the highest-risk LDTs, providing flexibility in FDA oversight of lower-risk LDTs and, where possible, leveraging the existing CLIA framework to avoid duplication in regulatory requirements.

CAP Opposition to CLIA ‘Modernization’

The CAP is strongly opposed to opening up CLIA for legislative changes to allow for oversight of LDTs. Congress and previous Administrations, as well as the current Administration, have firmly held that oversight of LDTs should remain with the FDA due to the agency’s expertise in

approving diagnostic tests for patients. In January 2024, the FDA and CMS clearly delineated each agency’s authority and areas of expertise: the CMS regulates laboratory operations for patient testing, and the FDA oversees test development and production.

Alternative Proposals to FDA Rulemaking

The CAP supports the Verifying Accurate Leading-edge IVCT Development Act of 2023.

Should the FDA fail to modify the proposed rule to incorporate all the CAP’s requested changes, Congress should pass legislation to regulate laboratory developed tests. Any legislation Congress passes should create a tiered risk-based structure for oversight of LDTs, include a targeted role for the FDA, introduce significant flexibility in LDT oversight, and utilize whenever possible current laboratory reporting requirements. Legislation such as H.R. 2369, the VALID Act of 2023 (“VALID”) utilizes such a tier-based approach.

Artificial Intelligence and Diagnostics

The CAP urges a balance in the advancement in technology and innovation with patient safety and regulatory oversight. Regulations for AI will need to ensure the appropriate levels of safety can be reliably determined and maintained. The CAP has advocated for a risk-based approach to the FDA in ensuring safe and effective devices using any AI/ML technologies because of the myriad of uses in pathology and laboratory medicine, from digital pathology to next generation sequencing.

On April 10, the American Medical Association (AMA) released informal survey findings showing the impact of the Change Healthcare cyberattack. The informal survey involved a convenience sample of more than 1,400 respondents that demonstrates significant problems continue, especially for small practices (practices with 10 or fewer physicians). According to the survey, which was conducted from March 26 to April 3, restricted functionality since the cyberattack has resulted in issues with claims and benefits, and negative effects on revenue.

Issues with claims and benefits:

• 36% of respondents reporting suspension in claim payment
• 32% unable to submit claims
• 22% unable to verify eligibility for benefits

Negative effects on revenue:

• 85% had to commit additional staff time and resources to complete revenue cycle tasks
• 80% reported lost revenue from unpaid claims
• 51% lost revenue from the inability to charge patient co-pays or remaining obligations
• 55% had to use personal funds to cover practice expenses
• 44% were unable to purchase supplies
• 31% were unable to make payroll

In addition to using personal funds, respondents reported utilizing advance payments, temporary funding assistance, and loans. Respondents have received assistance from the Centers for Medicare & Medicaid Services (12%), state Medicaid plans (0.7%), UnitedHealth Group/Optum (25%), and other health plans (4.5%).

Last week, the AMA convened stakeholders, including the CAP, to discuss issues with the Centers for Medicare and Medicaid Services (CMS) and Change Healthcare, providing updates for physicians and practices. Additionally, Change Healthcare is allegedly being extorted by a second ransomware gang after an initial attack back on February 21. Change Healthcare has stated this is an issue that continues to unfold in real time as critical health care services have been disrupted for over 6 weeks since the first attack.

UnitedHealth Group has stated that it continues to make progress in mitigating the impact to consumers and care providers, while expanding financial assistance to affected providers. Visit their dedicated webpage for information about the temporary funding.

The CAP has continually monitored the impact the attack has had on pathology practices and laboratories and continues to share resources to assist pathologists managing the fallout and will continue to work with the AMA and others to gather and disseminate the latest information on new developments.

For more information, the AMA press release is here. Click here for additional resources to help pathologists navigate these ongoing issues.

The CAP, American Medical Association (AMA), and over one hundred physician and health care organizations came out in strong opposition to two recently finalized policies in the 2024 Medicare Physician Payment Schedule pertaining to certified electronic health record technology (CEHRT) utilization requirements for Accountable Care Organizations (ACOs), Alternative Payment Model (APM) entities, and their participating practices.

In a letter the groups say: “We have serious concerns that these policies will significantly increase burden and jeopardize participation in the Medicare Shared Savings Program (MSSP) and other Medicare Advanced APMs with a disproportionate impact on small practices and the patients they serve.”

The Medicare Shared Savings Program is the Centers for Medicare & Medicaid Services (CMS) payment system that moves away from volume and toward value and outcomes. ACOs are groups of doctors, hospitals, and other health care providers who collaborate to give coordinated high-quality care to people with Medicare, while avoiding unnecessary services and medical errors. When an ACO succeeds in both delivering high-quality care and spending health care dollars more wisely, the ACO may be eligible to share in the savings it achieves for the Medicare program (also known as performance payments).

The first policy requires that all MSSP participants report Merit-based Incentive Payment System promoting interoperability data starting with the 2025 performance year. The second policy updates the CEHRT use criteria. The groups are requesting that the CMS delay both policies until at least the 2027 performance year and establish additional flexibilities.

Measles Outbreak

On March 18, 2024, the US Centers for Disease Control and Prevention (CDC) issued a Health Alert Network message to inform clinicians and public health officials of an increase in global and US measles cases and to provide guidance on measles prevention.

From January 1 to March 14, 2024, CDC has been notified of 58 confirmed US cases of measles across 17 jurisdictions, including seven outbreaks in seven jurisdictions compared to 58 total cases and four outbreaks reported the entire year in 2023. Among the 58 cases reported in 2024, 54 (93%) were linked to international travel. Most cases reported in 2024 have been among children aged 12 months and older who had not received measles-mumps-rubella (MMR) vaccine.

Visit Lab Tools for Measles for information on collecting and shipping specimens from suspected measles cases.

Avian Flu Outbreak

On April 5, the CDC also issued a Health Alert Network Health Advisory to inform clinicians, state health departments, and the public of a recently confirmed human infection with highly pathogenic avian influenza (HPAI) A(H5N1) virus in the United States following exposure to presumably infected dairy cattle in multiple states.

Recommendations for Testing - Avian Flu (H5N1)

Clinicians should consider the possibility of HPAI A(H5N1) virus infection in persons showing signs or symptoms of acute respiratory illness who have relevant exposure history. This includes persons who have had contact with potentially infected sick or dead birds, livestock, or other animals within the week before symptom onset.

Patients who meet Epidemiologic criteria AND either Clinical OR Public Health Response criteria below should be tested for HPAI A(H5N1) virus infection by reverse-transcription polymerase chain reaction (RT-PCR) assay using H5-specific primers and probes at your state or local public health department. Testing for other potential causes of acute respiratory illness should also be considered depending upon the local epidemiology of circulating respiratory viruses, including SARS-CoV-2.

For more information: Human Infection with Avian Influenza A Virus: Information for Health Professionals and Laboratorians.

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