Advocacy News

• How government shutdowns affect pathologists and laboratories
• CAP fights Medicare cuts to pathology
• Exempt physicians from J-1 visa changes, CAP says
• Medical groups to Congress: Protect H-1B physicians
• FDA updates testing guidance for health emergencies
• CDC's accelerated HCV diagnosis roadmap
• CMS issues new CLIA guidance for labs
• CDC sounds alarm on rise in superbugs

Unless President Trump and Congress reach a deal before tomorrow, the federal government will shut down for the first time since 2018.

• Democratic and Republican leaders met at the White House on Monday, but they failed to reach a deal.

Benefit programs like Medicare, Medicaid, and Social Security continue to operate during a shutdown.

• Coverage of Medicare and Medicaid services also continues as normal, but payments could be delayed if a shutdown persists for several weeks. 

A shutdown also affects programs at the Department of Health & Human Services (eg, staff at the National Institutes of Health that admit patients or process grant applications).

• Employees deemed essential workers are required to work without immediate pay.

Go deeper: HHS has outlined its staffing plan for a shutdown.

In a few weeks, the Centers for Medicare & Medicaid Services (CMS) will adopt a new policy that cuts Medicare payment for pathology services unless agency officials reverse course.

Time for action: The CAP is urgently calling on the CMS to abandon its plans after Medicare pay has failed to keep pace with rising inflation.

• The CMS is now reviewing feedback before finalizing its 2026 Medicare Physician Fee Schedule in early November.
  Apply more pressure: Send an Action Alert to Congress that asks them to oppose these cuts, too.
• Your response will help compel lawmakers to convince the administration that these unnecessary cuts will hurt practices and patients.

The CAP has requested that an exception for physician J-1 visa holders be added to a Department of Homeland Security (DHS) proposed rule limiting visa terms.

What we're saying: The CAP emphasizes the importance of international medical graduates (IMGs) in US health care, particularly in underserved and rural areas.

• J-1 visa holders contribute significantly to pathology, with non-US IMGs making up about one-third of the workforce.
• Limiting visa terms could hinder IMGs’ ability to complete necessary fellowship training.

The big picture: With an impending shortage of 86,000 physicians by 2036, the US faces a critical need for primary care and specialty physicians, including pathologists.

• By the numbers: The CAP’s projections indicate a demand for 700– 840 new pathologists annually, yet only 620 residency slots are available each year.

What's next: We urge DHS to protect the substantial investment in training IMGs and to ensure their continued contribution to US patients.

The CAP has joined the AMA and several other medical societies in urging the DHS to exempt physicians from new rules imposing a $100,000 application fee for an H-1B visa.

Background: As of September 21, new H-1B applications require the fee.

Yes, but: DHS has authority to waive fees for applications in the national interest.

• In a joint letter led by the AMA, the groups call for a fair and efficient immigration system that provides a pathway for international physicians.

The big picture: In 2024, 23% of US licensed physicians were foreign-trained, with many practicing in high-need areas, including rural and medically underserved communities.

• Nearly 21 million Americans live in regions where foreign-trained doctors account for at least half of the physician workforce.

The FDA has released new guidance that the government says will enhance the availability of diagnostic tests during public health emergencies.

What's new: The updated protocols should expand access to unapproved in vitro diagnostic tests (IVDs), ensuring timely patient care and effective infection control in emergencies.

• It emphasizes assessing public health needs, potential benefits and risks, available alternative IVDs, and mitigations for false results.
• The guidance aligns with Government Accountability Office recommendations and incorporates lessons from COVID-19 and mpox responses.

What's next: The FDA will review and adjust the enforcement policy to remain flexible in addressing evolving public health needs.

• Enforcement actions may still occur for compliance and safety violations, the FDA says.

The push for expedited diagnosis of the Hepatitis C virus (HCV) is gaining momentum. 

Driving the news: The CDC accepted comments on its new roadmap initiative for Hepatitis C diagnostics through September 24. Various stakeholders, including the CAP, provided input on the diagnosis of HCV infection.

Our take: The CAP agreed that accelerated testing for HCV will be beneficial and provided further recommendations, such as researching laboratory capabilities for molecular testing and improving access to approved point-of-care HCV RNA tests.

The CMS announced it will end enforcement discretion for remote review of digital images of cytology slides, effective March 23, 2026.

The changes will affect labs relying on remote cytology digital slide reviews, requiring them to adjust their operations to comply with CLIA standards. 

• cTnI test cartridge update: The CMS also announced that enforcement discretion related to the cTnI test cartridge for the i-STAT system will also end.

Go deeper: Read the full guidance update.

A new CDC report published in the Annals of Internal Medicine shows a significant surge in drug-resistant bacteria, specifically the NDM-producing carbapenem-resistant Enterobacterales (NDM-CRE).

Researchers say the increase in NDM-CRE cases underscores an urgent need for improved infection control measures and antibiotic stewardship programs.

What's next: The CDC recommends prompt testing to identify the type of carbapenemase, then careful antibiotic selection, as well as best prevention practices to combat this growing threat.