CAP Advocacy, the Second Trump Administration and the 119th Congress

A US District Court judge nullified the Food and Drug Administration (FDA) regulation on the oversight of laboratory-developed tests (LDT), agreeing with plaintiffs' and the College of American Pathologists' (CAP) arguments that the rule should be vacated.  

The "One Big Beautiful Bill Act" included an increase to Medicare payments to physicians by 2.5% in 2026. The temporary pay increase provides some relief while the CAP advocates for stabilization of the Medicare payment system through long-term reform.

Laboratories got a brief reprieve from Medicare cuts of up to 15% when Congress enacted legislation to end a government shutdown in November. The CAP continues to advocate to prevent the cuts from taking effect in the future while we work to enact permanent reforms to fix the Medicare clinical laboratory fee schedule.

• Virtual Hill Day: 37 attendees and 45 meetings
• In-person Hill Day: 138 attendees and 180 meetings
• Action Alerts: 11 in total (9 federal, 2 state focused in Oregon and Indiana)
• Action Alerts sent: 19,165
• Total advocates: 2,202
• Federal legislators contacted: All 100 Senators and 391/435 members of the House of Representatives
• New advocates: 627

In one of his first actions, President Trump signed an EO that halted agency rulemaking and initiated review of former President Biden’s rulemaking (both final and pending rules). Another EO required that new rules be accompanied by repeal of 10 existing rules and that total incremental costs of new and repealed rules are "significantly less than zero."

On April 9, President Trump issued a memo directing agencies to find "potentially unlawful regulations" and repeal them. The memo directed agency heads to finalize repeal of regulations without notice and comment, where doing so is consistent with the "good cause" exception in the Administrative Procedure Act (APA). This directive followed a March 3 policy statement by the Department of Health and Human Services (HHS) announcing increasing flexibility to use the good cause exception to bypass the public comment process. 

The CAP analysis is balancing opportunities for regulatory relief and monitoring for unintended effects for required rulemaking – such as with Medicare payment rules – or more limited opportunities for stakeholder feedback.

The CAP identified repeal of the FDA LDT rule in its February letter to HHS Secretary Kennedy as the most important opportunity for regulatory relief for laboratories. On March 31, a US District Court Judge nullified the FDA rule, agreeing with the plaintiffs and the CAP’s amicus brief filed in October 2024.

As a direct result of the EOs, on April 11, the Office of Management and Budget (OMB) announced an opportunity for public input on regulations that should be rescinded or replaced. The CAP submitted comments on removing information-blocking rules that may inadvertently harm patients. The CAP also sent the Centers for Medicare & Medicaid Services (CMS) recommendations to reduce regulatory burdens on pathologists and laboratories. Read those comments here.

At the outset of his administration, President Trump instructed federal health agencies to pause all external communications – consistent with other presidents. However, the length of this communications blackout and the extension to nearly all forms of communication (including health advisories, weekly scientific reports, updates to websites and social media posts) were more wide-ranging than in the past, according to current and former officials and other people familiar with the matter. Agency staff did not attend public meetings (i.e. the recent AMA CPT meeting) but are now beginning to participate more routinely. 

During the communications blackout, the CAP continued to engage with federal agencies to conduct routine operations related to our many important federal government collaborations. We are also building relationships with new leaders and staff and monitoring for any updates.

On January 27, the OMB issued a memo ordering a temporary halt to “all federal financial assistance,” which disrupted a vast swath of federal programs. While that memo was later rescinded, residual impacts remained.

President Trump also signed an EO that directed agency heads to review all funding provided to non-governmental organizations. The EO directed the heads of agencies to align future funding decisions with the interests, goals, and priorities of the Trump Administration.

Additionally, the National Institutes of Health (NIH) issued supplemental policy guidance on February 7 that limited the amount of indirect funding for research projects to 15%, affecting laboratory funding, among other items. On March 5, a US District Court in Massachusetts issued a preliminary injunction blocking the policy’s implementation. The President also included the 15% indirect cap in his FY 2026 budget proposal sent to Congress. 

Because many CAP members and laboratories receive funding through this mechanism, the CAP and over 40 other leading medical organizations sent a joint letter to the NIH expressing concerns over the policy. The letter recognized NIH's longstanding commitment to funding scientific research that advances medical breakthroughs and that NIH has played a significant role in advancing medical research and life-saving treatments to improve patient care. The letter expressed concerns about the implications of the policy that could halt scientific innovation. 

On January 20, President Trump signed an EO that commanded agencies to pursue more stringent vetting and screening procedures for people immigrating to the US, seeking a visa, or applying for refugee status. US Immigration and Customs Enforcement (ICE) has ramped up arrests, detentions, and deportations.  

Relatedly, President Trump signed an EO that called for immediate removal of undocumented individuals in the US. Importantly, on January 21, Acting Department of Homeland Security Secretary Benjamine Huffman rescinded long-standing policy that designated certain sites (such as hospitals and health care facilities) as “protected areas” or “sensitive locations” where immigration enforcement should be avoided. 

Roughly a quarter of first-year pathology residents are international medical graduates (IMGs). Given the important role of IMGs in providing access to laboratory services, the CAP advocated for reauthorization of the Conrad 30 Waiver Program during the CAP's annual Hill Day. The program allows non-US IMGs to provide necessary patient care in underserved communities for at least three years before applying for an immigrant visa or permanent residence.

On January 20, President Trump signed an EO to withdraw the US from the World Health Organization (WHO). The US is the largest financial contributor to the WHO, along with the important involvement of US staff and health care monitoring and treatment mechanisms. Combined with cuts to health-related US Agency for International Development (USAID) funds, the impact on international health care programs has been substantial. Experts warn such cuts could become most noticeable in emergency programs that enable countries to respond quickly to disease outbreaks and information sharing. For the US, lack of involvement means reduced opportunities to collaborate and influence global health goals, as well as surveillance and monitoring. The EO directed US officials to identify credible and transparent US and international partners to assume necessary activities previously undertaken by the WHO. For the WHO, loss of US funding has necessitated cuts to WHO staff and projects.

In late March, HHS sent termination notices to state and local health departments for $11 billion in public health funds authorized by the 118th Congress. Twenty-three states and the District of Columbia filed a lawsuit to preserve the funds, which they are using to address a wide array of public health emergencies. The judge issued a preliminary injunction that barred HHS from rescinded the funds while the case is pending and noted many of the funding terminations were illegal. 

President Trump campaigned on instituting tariffs as a means of raising revenue and equalizing trade deficits. The administration started threatening tariffs on other countries near the end of the first quarter of this year and released a list of tariffs levied on each country. A series of conflicting and confusing tariff policies ensued. Tariffs on some countries were paused or delayed. Other countries reached trade agreements with the US.  

President Trump’s tariffs have the potential to raise the costs of imported instruments, reagents, and supplies used in laboratories and to further add to the pressure from rising employee salaries and benefits. Additionally, the CAP imports supplies from a handful of countries to assemble our proficiency testing (PT) kits. In turn, countries purchase PT kits from the CAP, as well as laboratories throughout the US. At the 2025 House of Delegates and Pathologists Leadership Summit, pathologists said rising costs of laboratory supplies are evidence that new US trade policies are impacting laboratory budgets.

Costs for hospitals and health systems may also surge due to increased import expenses. Notably, the American Hospital Association (AHA) has called for the Trump Administration to exempt medical devices from tariffs on imports from Canada, China, and Mexico. In a letter sent to President Trump, the AHA said disruption to the supply of devices from China would curtail hospitals’ ability to perform life-saving surgeries, protect patients and health care workers from contagion, and diagnose and monitor patient conditions. The AHA is particularly concerned about products that are already in short supply despite ongoing efforts to strengthen the domestic supply chain. 

CAP staff is continuing to monitor for any impact on our members and is collaborating with CAP PT and Accreditation. The CAP is also working with coalitions and other organizations like AdvaMed to find ways to reduce tariffs to mitigate the impact to our members so there are lesser impacts on PT, but also so the medical supply chain is not interrupted.

In addition to the letter to Secretary Kennedy, the CAP sent letters to the leaders of the following health-related agencies – introducing the CAP and requesting a meeting:

• Mehmet Oz, MD, MBA; Administrator of Centers for Medicare and Medicaid Services (CMS)
• Martin Makary, MD, MPH; Director of the Food and Drug Administration (FDA)

The CAP leadership met with a senior leader at CMS on June 23. We highlighted the following CAP priorities:

• Retaining physician involvement in Medicare coding and valuation,  
• Collaborating reforms to the Quality Payment and Value-Based Programs,  
• Refining the Clinical Laboratory Improvement Amendments (CLIA) regulations,  
• Releasing the independent dispute resolution final rule and working with pathologists to determine how to best include laboratory services in price transparency requirements, and
• Streamlining and improving the prior authorization process and promoting care coordination among private payers.

The CAP met with FDA Administrator Makary in late August. In its letter to Dr. Makary, the CAP emphasized the following issues:

• Ensuring that the FDA continues its high-quality review and monitoring standards,  
• Preserving the FDA’s critical role in surveillance and public health,  
• Providing transparent information on artificial intelligence-enabled devices and recognizing the leadership role of pathologists in selecting and implementing these devices.   

Several Trump administration actions have focused on reducing the number of federal employees. The President established the Department of Government Efficiency (DOGE) and charged advisor Elon Musk with implementing efficiencies and reducing the federal budget. Initial reductions focused on workers who were in a 2-year probationary period because they were new to federal employment or in a new position. The Trump administration also offered nearly all remaining federal workers the opportunity to resign from their posts and retain full pay and benefits through September 30. Federal agencies have not provided comprehensive information on which staff teams or units were laid off or left. In addition, several media outlets are reporting on agencies asking some employees to return to work. While Mr. Musk completed his federal service, DOGE-related efforts are continuing.

President Trump implemented an EO mandating agencies to work with DOGE to implement a “workforce optimization initiative” to cut staff and limit hiring, including requiring agencies to hire only one person for every four people who depart. Agencies were instructed to determine positions not required by law and implement large-scale reductions in force.  

The CAP is hearing concerns from members about laboratory staff layoffs and departures in the Veteran's Administration health system (including cytotechnologists and other critical employees). Pathologists are expressing concerns about the ability to replace laboratory staff and its impact on care for patients. The CAP is closely monitoring and collecting additional feedback from membership.

On March 27, HHS announced plans for a dramatic restructuring to fulfill DOGE goals. When combined with the staff layoffs and departures, HHS predicted a reduction from 82,000 to 62,000 full-time HHS employees by June 30. Planned reductions at FDA are around 3,500 employees. The CDC was second most with a loss of 2,400 employees. NIH was third with reductions of 1,200 employees, and CMS with a loss of 300 positions. A US District Court Judge in San Francisco issued a preliminary halt of the reorganization, saying that agencies may not make large-scale reorganizations and reductions without working with Congress. The American Public Health Association (APHA), federal unions, and city governments filed the case. In addition, 20 Democratic state attorneys general have filed a lawsuit in the US District Court in Rhode Island against the layoffs and reorganization plan. The Trump administration prevailed on appeal of the San Francisco judge’s decision to the Supreme Court. Federal HHS reorganization plans, however, are in flux due to questions about the need for Congressional involvement and the status of ongoing lawsuits. 

Connected with the President’s proposed FY 2026 budget, HHS has proposed eliminating the Cancer Prevention and Control program (including the National Program of Cancer Registries)

within the CDC. The state-run registries enable the CDC to collect and publish national cancer incidence and survival data. HHS is proposing elimination of the cancer registries and other cancer detection and control programs at the same time as it is focusing its goal to “Make America Healthy Again.”  

The CAP joined the Cancer Leadership Council (a patient-centered forum to which the CAP belongs including patient advocacy partners and physician groups) urging the Trump administration to preserve funding for these programs. These programs are vital for early detection, disease reporting, and comprehensive cancer control. Eliminating the CDC's cancer initiative would undermine screening efforts, delay early detection, and slow progress in reducing cancer risks. The CAP, along with physician and patient advocacy partners, continue to push for sustained funding. 

The CAP defeated a deeply flawed Medicare coverage policy that had hindered pathologists from providing special histochemical and immunohistochemical stains for certain testing after years of persistent advocacy. Specifically, Noridian Healthcare Solutions, a Medicare Administrative Contractor (MAC) for 13 states in the West and Midwest, had agreed to expand Medicare coverage for the use of special stains in certain breast, lung, and prostate cancer pathology services effective November 2. The CAP formally requested this change in January 2022. With Noridian’s latest action, the CAP successfully reversed the policy responsible for denying coverage of certain special stains in 28 states and four MACs.

Our coverage Advocacy program successfully affected two new Medicare local coverage determinations (LCDs) for inherited aortic disease. Medicare will now cover diagnostic tests used to evaluate and manage care for patients suspected of having Hereditary Transthyretin Amyloidosis (hATTR). 

• Genetic Testing for Heritable Thoracic Aortic Disease (L39933, MolDx).
• Molecular Testing for Identification and Management of Hereditary Transthyretin Amyloidosis (L39935, MolDx).

The LCDs went into effect August 17 in 23 states. 

The Centers for Medicare & Medicaid Services agreed with the CAP to exclude pathology time-based codes from an efficiency adjustment policy. The time-based pathology clinical consultation codes (80503, 80504, 80505, and 80506) were removed from this adjustment.