Advocacy News

• Stopping pay cuts to pathologists in 30 seconds
• CAP advocates on AI monitoring
• CMS seeking input on Medicare Advantage modernization
• Rural health leaders push to improve MA prior authorization
• CDC changes Hepatitis B vaccine guidelines
• Administration creates new initiative to manage chronic diseases

The Centers for Medicare & Medicaid Services (CMS) planned "efficiency adjustment" in the Medicare Fee Schedule final rule will reduce pathology payments by 2.5% in 2026. In just 30 seconds, you can take action to stop it.

Use your voice before the end of the year to tell Congress to stop the cuts. 

Watch: Diana M. Cardona, MD, MBA, FCAP, discuss the effects of the efficiency adjustment and how to protect access to pathology services.

The bottom line: When pathologists speak up, Congress listens. Every action alert you send strengthens the specialty and access to accurate, timely diagnoses.

Act Now

As the use of artificial intelligence in medicine increases, the CAP notes that pathologists' current responsibilities are analogous to the work required to monitor the performance of AI-enabled medical devices. 

On December 1, the CAP submitted comments in response to the FDA's request on evaluating AI-enabled medical devices.

• The FDA's initiative focuses on identifying effective strategies to detect, assess, and mitigate performance changes over time and ensuring that such technologies remain safe, effective, and trustworthy throughout their life cycle.

What we're saying: Our response highlights the unique insights from pathologists and laboratory medicine that the FDA should consider in its assessment of measuring and evaluating AI-enabled medical device performance in the real world

• The CAP underscores that AI systems should enhance, not replace, human expertise in diagnostics.
• The CAP’s experience, including that of our members as CLIA laboratory directors, section directors, and peer reviewers for CAP's Laboratory Accreditation Program, provides valuable insight into successful strategies and potential challenges for measuring and evaluating real-world performance of AI-enabled medical devices. 

What's next: The CAP is committed to working with the FDA to develop frameworks for measuring AI performance in clinical diagnostics.

The Centers for Medicare & Medicaid Services (CMS) is inviting public feedback through a Request for Information on modernizing Medicare Advantage plans. 

The RFI seeks feedback on options to improve competition, refine risk adjustment, and align quality incentives to deliver greater value to beneficiaries and taxpayers. 

• The public is encouraged to share input on ways CMS could achieve these efforts through either a time-limited model test under the CMS Innovation Center’s authority or potential program-wide regulatory changes. 

What's next: The CAP will submit comments in response by the January 26 deadline, voicing our concerns about the Medicare Advantage program and providing recommendations on strengthening network adequacy, improving prior authorization processes, and holding private payers who administer MA plans accountable.

National rural health organizations are calling on Congress to advance the Improving Seniors' Timely Access to Care Act (S 1816/HR 3514). The bipartisan legislation is being championed by leading organizations to expedite care for seniors in rural communities.

If passed, the bill would modernize the prior authorization process within the Medicare Advantage insurance program.

What they're saying: In a letter, a dozen organizations urged lawmakers to support the bill to ensure timely access to care for rural Medicare beneficiaries.

• The CAP has also advocated for the bill. CAP members can contact their representatives to support the measure using our Action Center.

By the numbers: Over 10 million Medicare beneficiaries live in rural areas, with 42% enrolled in Medicare Advantage, and face higher rates of chronic conditions and fewer healthcare resources than urban populations.

• Prior authorization in Medicare Advantage exacerbates these disparities, leading to delays and increased health care costs.
• Nearly four in five clinicians in rural communities report increases in insurer-required administrative tasks over the past five years, heightening administrative burdens.

Rural health care challenges: Many rural facilities operate with limited staff and funding, making it difficult to manage administrative tasks, including prior authorization.

• 81% of rural clinicians report negative impacts on patient health due to insurer requirements.
• 89% of physicians note increased burnout from these administrative burdens.

The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) voted to end the universal recommendation for administering the Hepatitis B vaccine to newborns.

In an 8–3 vote, ACIP revised its guidance to recommend individualized decision-making, advising parents of infants born to mothers who test negative for Hepatitis B to consult with a health-care provider about when, or whether, to give the Hepatitis B birth dose.

New ACIP language:

For infants born to HBsAg-negative women: ACIP recommends individual-based decision-making, in consultation with a health care provider, for parents deciding when or if to give the HBV vaccine, including the birth dose. 

• Parents and health care providers should consider vaccine benefits, vaccine risks, and infection risks.
• For those not receiving the HBV birth dose, the initial dose is suggested no earlier than 2 months of age.

Yes, but: The change does not prohibit newborns from receiving the vaccine within 24 hours of birth. 

• Instead, it removes automatic administration, meaning parents will now need to request the birth dose.
• The shift may affect vaccination coverage, though significant changes are not anticipated.

The FDA and CMS are partnering to launch a first-of-its-kind pilot program, the ACCESS (Advancing Chronic Care with Effective, Scalable Solutions) Model. 

This initiative aims to expand access to innovative care options for managing chronic diseases such as high blood pressure and diabetes, which affect over two-thirds of Medicare beneficiaries.

• The pilot will evaluate a new, risk-based enforcement approach that supports digital health devices intended for use to improve patient outcomes.
• The model emphasizes outcome-aligned payment approaches.
• It supports the use of digital technologies in health care.
• The pilot could significantly improve care for millions of Americans managing chronic diseases.

The initiative will also include a new digital health pilot program, the "Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot."

• Participating manufacturers may request that the FDA exercise enforcement discretion for certain requirements, such as premarket authorization and investigational device requirements, while manufacturers collect and share real-world data demonstrating the device’s performance. 

What they're saying: "We are piloting an approach to encourage the use of digital technologies that meet people where they are," said FDA Commissioner Marty Makary, MD, MPH.

The big picture: The program will run for 10 years starting July 1, 2026.

Go deeper: Read more about the voluntary model.