Advocacy Update

• Key 2025 Dates and Events for Pathologists to Watch
• Patient Cybersecurity Protections Proposed in HIPAA Update
• ASTP's HTI-3 Final Rule
• Register for the CAP's Third LDT Webinar on January 9 - Ready Your Laboratory for the FDA's Stage 1: Corrective Action and Removal Reporting
• Early Bird Registration for CAP25
• Apply to the NAM Scholars in Diagnostic Excellence Program
• Register for the AMA Virtual Advocacy Session

On January 3, the 119th Congress kicked off the start of the next legislative session with leadership elections in the House. Over the next several weeks, the CAP will be monitoring upcoming congressional events and legislative changes that will impact pathologists and laboratories. Key events include:

• Presidential Inauguration (January 20, 2025): President-elect Donald Trump will be sworn into office and the new administration begins.
• New Administration Activity: the CAP will track new executive orders and regulatory changes being offered by the new administration.
• Senate Confirmation of Administration Appointments: Numerous political appointments to agencies that oversee health care will occur in the Senate. The CAP will be watching these appointments to determine the impact on our agenda.
• Budget Reconciliation: Republicans in the House and Senate may attempt to pass policy priorities through the budget reconciliation legislative process, which would require a simple majority vote for passage. The GOP now has control of both chambers of Congress.
• March 14, 2025: The last spending bill passed by Congress and signed into law on December 21, 2024, keeps the government open through mid-March. Congress must pass a funding bill to avoid a government shutdown on March 14. The bill would be an opportunity for lawmakers to enact legislation to reverse Medicare payment cuts that has gone into effect for 2025. CAP members ended 2024 by advocating to stop cuts to Medicare payments. During the final weeks of the year, 775 CAP members took action: sending 2,602 messages to over 400 members of Congress.
• LDT lawsuit: The CAP will continue to provide members with updates on the lawsuit against the Food and Drug Administration (FDA) and its regulation on the oversight of laboratory-developed tests (LDTs). The case will likely be decided over the next several months.
• House of Delegates & Pathologists Leadership Summit 2025: The Spring House of Delegates meeting and Pathologists Leadership Summit will take place April 26-29. The final day will be our annual Hill Day where CAP members will directly lobby Congress to address adverse health care policies hurting pathology practices, laboratories, and patients.
• July 1, 2025: The proposed 2026 Medicare Physician Fee Schedule will likely be released during the end of June/early July timeframe.

The CAP will continue to update members on legislative and advocacy issues moving forward.

The US Department of Health and Human Services (HHS), through its Office for Civil Rights, published a proposed rule to improve cybersecurity and better protect the US health care system from a growing number of cyberattacks. The proposed rule would modify the Health Insurance Portability and Accountability Act of 1996 (HIPAA) security rule to require health plans, health care clearinghouses (an organization that enables the exchange of health care data between a provider and a payer (insurance company), and most health care providers and their business associates, to strengthen cybersecurity protections for individuals’ protected health information.

This proposed rule is the latest step taken by HHS to address more frequent cyberattacks targeting the US health care system.

A summary of the proposed rule is available online.

Additional resources:

• Information on the HIPAA Security Rule
• OCR Press Release
• Information on how OCR enforces the HIPAA Security Rule

The US Department of Health and Human Services (HHS) through the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology has released a final rule titled Health Data, Technology, and Interoperability: Protecting Care Access. The rule (also known as the HTI-3 Final Rule), finalizes the information blocking provisions that the CAP commented on in October 2024 as part of the Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) Proposed Rule. Information blocking is a practice that, except as required by law or covered by an exception, is likely to interfere with the access, exchange, or use of electronic health information.

With the HTI-3 Final Rule, the HHS finalized provisions to help providers support patient wishes for the release of their health data. The CAP has advocated for greater flexibility and more expansive use of the legal exceptions to the information blocking regulations. HHS adopted provisions that are consistent with the CAP recommendations.

A summary of the HTI-3 Final Rule is available online. Although this is a final rule, it is subject to administrative review by the incoming Trump Administration.

The CAP will update members on any further developments to this final rule.

There's still time to join the CAP on Thursday, January 9, at 1 PM ET for our third webinar in our laboratory-developed tests series. Learn the necessary steps to comply with the FDA requirements for corrective action and removal reporting specific to laboratory-developed tests. This webinar and others in the series are intended to help laboratories prepare for the FDA final rule.

Presenters are Bobbi Pritt, MD, FCAP, Earle S. Collum, MD, FCAP, and Deeona R. Gaskin, JD, MPH.

Register online

Get ready for sunshine and pathology at CAP25! Join us at the Pathologists’ Meeting September 13-16 in Orlando, Florida. Early bird registration is now open. Register before January 31 and save with the best meeting rate!

Register online

The CAP encourages interested pathologists to apply to the National Academy of Medicine (NAM) Scholars in Diagnostic Excellence Program. This collaborative program is administered by the NAM in partnership with the Council of Medical Specialty Societies (CMSS). There are three information sessions for applicants to learn more.

Register for the first session happening January 16 at 11 AM ET.

Additional information on the program is available online.

Join the American Medical Association (AMA) on January 22 at 8 PM ET for a virtual educational session to jump-start your advocacy in 2025. This AMA webinar will explore the fluid congressional landscape, the effect it will have on health care policy in the new Congress, and how you can be an effective advocate in 2025 and beyond.

Register online