Advocacy News

• White House reporter Tamara Keith joins HOD/PLS keynote lineup
• CMS clarifies remote cytology practices for laboratories
• Dr. Reddy leads laboratory tour with Rep. Sean Casten
• Maryland PSA testing bill fails to advance
• CAP urges CMS to include laboratory supplies in domestic PPE proposal
• White House AI framework outlines federal policy direction
• New CMS "no fax, snail mail" rule changes billing, not clinical care

Tamara Keith, NPR White House correspondent and co-host of the NPR Politics Podcast, will deliver a keynote on Monday, April 27, at the House of Delegates & Pathologists Leadership Summit.

The impact: You'll get an insider’s view of today’s political landscape and how decisions in Washington shape health care.

•    Keith has covered multiple administrations and reported on major events, including the COVID-19 pandemic and high-stakes congressional battles.

The bottom line: Do not miss Tamara Keith’s session at HOD/PLS for insights directly from the White House press corps.

What’s happening: CMS has responded to the CAP’s request for clarification on remote cytology practices following recent federal policy updates, including requirements related to CLIA certification for laboratories.

What CMS said:

• CMS officials stated that remote Rapid Adequacy Assessments, also known as rapid on-site evaluation (ROSE), require a separate CLIA certificate for the off-site location where the pathologist performs the review, including virtual slide review.
• They noted that adequacy assessment does not count as a separate examination for workload limit purposes.
• For surgical pathology cell blocks, CMS indicated that remote review by a pathologist may be performed without a separate CLIA certificate if directed by the laboratory director.

The impact: Many laboratories rely on remote workflows to support patient access and timely diagnosis. CMS’s interpretation may affect how labs structure remote adequacy assessments and manage CLIA certification compliance.

Vijaya B. Reddy, MD, MBA, FCAP, led a recent tour of Rush System for Health Department of Pathology and Laboratory Medicine, guiding U.S. Rep. Sean Casten (IL) through the lab and offering a firsthand look at the work happening inside.

The impact: These visits help connect federal policymakers with the role laboratories and pathologists play in patient care and health care delivery.

• This was Dr. Reddy’s first time leading a tour, sharing insight into laboratory operations and the specialty’s contributions to diagnosis and patient care.

The bottom line: These tours help showcase the value of pathology and laboratory medicine to decision-makers.

A Maryland state bill (SB 78) that would have imposed new standards on prostate-specific antigen (PSA) testing failed to advance after opposition from the College of American Pathologists, urology groups, and the Maryland State Medical Association.

SB 78 would have mandated:

FDA-approved PSA testing assays.
Calibration to World Health Organization (WHO) standards.
Reporting in nanograms per milliliter.
Disclosure of test methodology, manufacturer, and lot number to ordering physicians.

The impact: The CAP opposed SB 78 citing concerns that the bill would have created new administrative burdens for laboratories without improving patient care.

The bil's detailed reporting and documentation rules would have added operational complexity for labs.
Pathologists warned the requirements could slow testing workflows and create obstacles for timely PSA results.

What we're saying: In a Feb. 9 letter opposing the legislation to Maryland Sen. Arthur Carr Ellis, CAP President Qihui "Jim" Zhai, MD, FCAP, said:

"Overall, the proposed legislation (SB 78) includes highly prescriptive and onerous administrative requirements that are unlikely to meaningfully address the inherent limitations of PSA as a prostate cancer biomarker. Instead, it would compel an unnecessary administrative burden, operational complexity, and potential barriers to patient care."

CMS is seeking input on a proposal for Medicare-participating hospitals to strengthen the domestic supply chain for American-made personal protective equipment (PPE) and essential medicines, with additional funding for participants.

The big picture: The initiative builds on efforts launched after the COVID-19 pandemic to secure reliable access to critical medical supplies and reduce dependence on foreign manufacturing.

The impact: The proposal could shape how critical medical supplies are developed domestically, with implications for whether laboratory equipment is included.

• Laboratory equipment is essential to public health and should be included alongside PPE and medications.
• The proposal currently focuses on hospitals, but both hospital-based and private laboratories could be affected if excluded.

What we're doing: The CAP submitted comments to CMS advocating for the inclusion of laboratories in the program and reimbursement for certain laboratory supplies.

The Trump administration released a national AI framework to guide Congress as lawmakers begin drafting federal legislation. 

The big picture: The framework sets a federal approach to AI policy, including innovation, oversight, and the role of state laws.

The impact: Key provisions could shape how AI is governed in health care:

• The framework supports regulatory sandboxes, controlled testing environments where companies can pilot new products under the supervision of a regulator, to accelerate development.
• It also recommends using existing federal agencies to oversee AI, rather than creating a new regulator, to avoid duplicative oversight.

Yes, but: The framework also calls for preempting some state AI laws to create a national standard.

• That could override state-level protections that may benefit pathologists, while also removing regulations that may be burdensome.

What’s next: Lawmakers are already moving to translate the framework into legislation.

• House Republicans say they will use the White House AI framework as a blueprint for a bipartisan bill.
• A Senate proposal aligns with the approach, but the path forward remains unclear given the 60-vote threshold.

The bottom line: The framework jump-starts federal AI policymaking, with potential implications for how AI is regulated in pathology and across health care.

CMS finalized national standards for electronic claims attachments and signatures, phasing out fax and mail for claims documentation.

• The rule sets a new, standardized way to send supporting materials to health plans, including medical records, imaging, clinical notes, telemedicine documentation, and laboratory results, without changing clinical workflows.

The big picture: This is part of an effort to modernize health care administrative operations and reduce administrative burden across the system.

The impact: Less friction, more consistency.

• The rule standardizes how claims attachments are submitted.
• It reduces reliance on manual processes like fax and mail.
• It improves efficiency between providers and health plans.
• It affects billing and claims workflows, not your clinical workflow.

Key provisions:

• It establishes standards for electronic claims attachments, including secure, authenticated electronic signatures.
• It replaces fax- and mail-based submission of claims attachments with electronic exchange.

What’s next: Time to prepare.

• The rule is effective on May 19, 2026.
• Compliance is required on May 19, 2028.
• Review the CMS fact sheet on the final rule and coordinate with your billing and IT teams on implementation plans.

The bottom line: This is a billing and administrative change, not a clinical one.