Advocacy Update

• Lawmakers Ask FDA to Suspend LDT Final Rule
• Oregon Senator Advocates for Pathology Reimbursement in Wake of Change Healthcare Cyberattack
• New Podcast! Designing a Patient-Centered Pathology Report
• Register Today! Proposed 2025 Medicare Physician Fee Schedule Webinar
• CAP’s Advocacy Newsletter Wins 2024 Award for Publication Excellence
• Take Our News Quiz for July

On July 10, the House Appropriations Committee requested in legislation that the Food and Drug Administration (FDA) suspend implementation of the laboratory-developed tests final rule that went into effect May 6. The recommendations include partnering with Congress to modernize the regulation of LDTs.

Lawmakers said the FDA’s final rule is a significant shift in the way LDTs are regulated and changes expectations for patients, doctors, and laboratories for the first time since the Clinical Laboratory Improvement Amendments Act was passed in 1988. The Committee wants the FDA to suspend its efforts to implement the rule and continue working with Congress to modernize the regulatory approach for LDTs. The CAP would support a delay that gives Congress time to enact legislation that restricts the FDA and focuses full oversight on tests that are highest risk to patients.

During a Capitol Hill briefing on July 9, the College of American Pathologists (CAP) discussed how Congress can promote patient safety without overburdening laboratories through enacting a diagnostic reform package that provides oversight of LDTs and allows for innovation of new technologies. CAP President Donald Karcher, MD, FCAP, and Joe Saad, MD, FCAP, President, Surgical Pathologists of Dallas spoke with congressional staff about these issues. The CAP has been diligently lobbying lawmakers for a legislative solution to LDT oversight that limits the authority of the FDA, while maintaining patient safety. Watch the briefing or listen to it as a podcast.

For additional resources visit: Laboratory-Developed Test Oversight

Sen. Ron Wyden, (D-OR), chair of the Senate Finance Committee has asked UnitedHealth Group to explain why health care providers, especially pathologists, in Oregon and nationwide still cannot send claims or receive payments for services delivered to their patients' months after the Change Healthcare cyberattack in February.

In its advocacy with private health insurance plans, the CAP champions policies protecting access to pathology services for patients and protecting against overburdening pathologists with administrative requirements and interfering with the practice of medicine. For additional information visit: Private Sector Advocacy and our Cybersecurity webpage.

In a letter sent to UnitedHealth Group sent on July 2, Wyden wrote: “On May 1, you testified before the Senate Committee on Finance about the cyberattack on Change Healthcare and the improving recovery. I have heard firsthand as recently as June 27, however, that reimbursement for pathology practices in Bend, Oregon, is still blocked, rendering your testimony as wishful thinking and disconnected from the real-world experience of many provider practices.”

Wyden noted on his website that during a recent townhall meeting, Central Oregon Pathology Consultants said more than eight weeks later they still don’t know whether their patients’ data has been compromised and have received contradictory communications from your company as to whether their patients’ data has been compromised.

Wyden asked UnitedHealth Group to answer the following by July 15:

• How many practices still can’t submit claims to payers or receive payments and remittances because of the cyberattack
• When customers will be able to submit claims, process remittances, denials, and post payments
• How UnitedHealth Group plans to make customers whole for claims that now cannot be submitted because of missed deadlines

Pathology reports are pathologists’ main line of connection with patients—their primary stakeholders. Since the 21 Century CURES Act made it so patients can access their pathology reports digitally as soon as they are released, questions have been raised about how to make the reports more discernable for the average person.

However, the pathology report must also speak to the patient’s care team, who use it to determine their treatment. In this podcast, Diana Cardona, MD, MBA, FCAP and Harry Hwang, MD, FCAP discuss the results from two grants The Council of Medical Specialty Societies (CMSS) awarded the CAP that focused on understanding patients’ experience with their pathology report and challenge of redesigning a pathology report that effectively communicates pathology test results to patients and all members of the care team.

They discuss feedback and concerns of the various stakeholder groups for pathologists’ reports and explore potential changes to the standard report format that could work for all parties without placing undue burden on pathologists. The goal is to effectively communicate to patients the value of pathology and laboratory medicine while ensuring the specialty is providing reports to improve patient understanding.

Listen to the podcast here.

On Tuesday, July 30 at Noon ET/ 11 AM CT, the CAP is offering a complementary live webinar where CAP experts will review proposed 2025 Medicare payment regulations, including the proposed Medicare Physician Fee Schedule and the Quality Payment Program regulations, that will impact Medicare payment for services and pathologists’ participation in the quality initiatives. Webinar presenters will be the Council on Government and Professional Affairs Chair A. Joe Saad, MD, CPE, FCAP; Economic Affairs Committee Chair Ronald McLawhon, MD, PhD, FCAP; and Quality and Clinical Data Registry Affairs Committee Chair Gregary Bocsi, DO, FCAP.

Secure your attendance today.

The CAP recently received a communications award for publication excellence at the 36th Annual APEX Awards for Publication Excellence in the Newsletters – Electronic & Email category.

The awards were based on excellence in graphic design, editorial content, and the success of the entry in achieving overall communications effectiveness and excellence. Over 1,100 entries were evaluated, and 439 APEX Awards of Excellence were recognized in 100 individual subcategories. See the list of winners here.

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