Advocacy Update

• Don’t Miss Our Hot Topic at CAP24! Pathways for Pathologists and Laboratories Under FDA Oversight of LDTs: Practical Aspects
• Hurricane Helene Public Health Emergencies Declared in Several States
• Congress Stops 2025 Cuts to Medicare Clinical Laboratory Fee Schedule
• In Case You Missed It: FDA Webinar - Labeling Requirements for In Vitro Diagnostic Products (IVD), Including LDTs
• CAP Recommends Transparency and Other Changes to Improve Medicare Coverage
• Register Today for Upcoming LDT Webinar! Ready Your Laboratory for the FDA’s Stage 1: Adverse Event Reporting Requirement
• CAP Recommends Integrating CAP Cancer Protocols into ONC Cancer Registry
• October Recess Rally: Top 7 Reasons Why Advocating is Important for Pathologists
• Take Our News Quiz for October

Join Bobbi S. Pritt MD, FCAP from the Mayo Clinic, Jonathan R. Genzen MD, PhD, FCAP from ARUP Laboratories, Inc. and A. Joe Saad MD, CPE, FCAP from Methodist Health System on Tuesday, October 22 at 10:30 AM-12:00 PM, examine how the Food and Drug Administration (FDA) can potentially enforce regulation of laboratory-developed tests (LDTs), propose pathways laboratories might use to comply, and provide an evaluation of the options possible to reduce regulatory burden going forward. This course will review significant aspects of the final rule and its impact on pathologists, laboratories, other care providers, and patients. Don’t miss this must-see course to gain the knowledge you need to be prepared for the future. Register today!

Due to severe flooding and devastating conditions in the Southeast of the United States, the Centers for Disease Control and Prevention (CDC) and Health and Human Services (HHS) have responded with health emergency alerts and resources to the public. The Centers for Medicare & Medicaid Services is giving health care providers in these states greater flexibility to meet the needs of Medicare and Medicaid beneficiaries.

Shipments to and from the CDC in Atlanta may experience disruptions. The Shipping and Export Activities (SEA) at CDC will be operating on a limited shipping schedule and will prioritize shipments for emergencies only. Click here for more information.

Congress passed legislation delaying Medicare cuts to clinical laboratory fees for one year on September 25. The CAP supported congressional action to stop the Medicare cuts set to take effect on January 1, 2025. While pathologists and laboratories preferred that Congress adopt a permanent fix, the CAP is pleased lawmakers enacted a bill preventing decreases of up to 15% from hitting certain laboratory tests next year.

President Joe Biden signed the legislation, which was part of a larger package to avert a federal government shutdown, on September 30 This marks the sixth year in a row Congress has passed a one-year delay to PAMA implementation. While Congress has enacted a patch to prevent these cuts for 2025, the CAP will continue working with legislators on a permanent solution.

On September 24, the Food and Drug Administration (FDA) held a webinar on how to comply with labeling requirements for in vitro diagnostic products (IVD), including laboratory-developed tests (LDTs). The focus of this webinar was on labeling requirements for test systems, under FDA regulations and did not cover labeling requirements for other types of IVDs such as collection devices and general purpose reagents. View the printable slides. Watch the webinar on-demand.

All previous FDA LDT webinars can be viewed here.

On September 20, the CAP made recommendations to improve the Medicare local coverage determination (LCD) process by increasing transparency, broadening stakeholder feedback, and shortening timeframes to ensure Medicare beneficiaries receive the tests and services they need.

In a letter to the Centers for Medicare & Medicaid Services (CMS), the CAP emphasized that Medicare Administrative Contractor (MAC) open public meetings should be an opportunity for all physicians and other stakeholders to identify and address issues related to the scientific evidence, clinical practice, and the needs of patients within the context of a local coverage policy. At CMS’ request, the CAP provided examples of MAC meetings conducted that violated open public meetings policy.

Importantly, the CAP also explained that a reasonable timeframe for completing LCD reconsideration requests is necessary to keep pace with advances in science and to provide Medicare beneficiaries with the tests and services they need. The CAP recommended that MACs finalize all reconsideration requests within one year from the date a MAC deems a reconsideration request valid. A CAP reconsideration request of the flawed special stains LCD was submitted in 2021 and the revised LCDs from two MACs were just recently finalized.

To summarize, the CAP outlined key measures to the current MAC performance metrics to ensure effectiveness and adherence to LCD guidelines:

• Consistency among MAC open public meetings.
• MAC transparency and use of objective criteria for vetting and selecting subject matter experts for participation on select evidentiary panels.
• Adherence to the requirement that MACs establish a CAC and that MACs maintain a current list of their CAC members.
• Adherence to the established one-year timeframe for completing LCDs and LCD reconsideration requests unless an extension is granted by the CMS.

The CAP remains committed to working with CMS to improve the LCD process and will keep members informed of any updates in the future.

Under the Food and Drug Administration (FDA) regulation, laboratories with laboratory-developed tests (LDTs) must have a process in place for adverse event reporting starting May 6, 2025. The CAP’s second webinar in our series will discuss existing accreditation requirements and ways laboratories can comply with the FDA rules on medical device-related adverse event reporting. Accreditation experts will review best practices that relate to quality management and review real world scenarios. Join us on Nov. 7, Noon-1 PM CT to learn more!

Speakers

• Bobbi S. Pritt, MD, FCAP, chair, Council on Scientific Affairs
• Earle S. Collum, MD, FCAP, vice chair, Council on Accreditation
• Timothy Stenzel, MD, PhD, former Director of the FDA’s Office of In Vitro Diagnostics, current CEO of Grey Haven LLC

Register today!

On September 23, CAP recommended integrating data elements from CAP Cancer Protocols in the US Core Data for Interoperability Plus (USCDI+) Cancer Registry use case, which is the minimum dataset needed to support the current data sharing approaches for cancer registry data. The CAP promoted the CAP Cancer Protocols to the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP) as a solution that can help with cancer registry reporting and standardization.

For more than 30 years, the CAP Cancer Protocols have provided structure for consistent and meaningful information that enables health care professionals to manage and study clinical data for improved patient care. Using the CAP Cancer Protocols in the USCDI+ Cancer Registry domain would help ensure that all pathology reports contain necessary data elements to improve patient care.

Federal agencies, such as the National Cancer Institute and the Centers for Disease Control and Prevention (CDC) have noted their strong recommendation that implementers adhere to the CAP Cancer Protocols when meeting pathology reporting requirements. In a comment letter to the ASTP, the CAP recommended:

• Real-time data reporting that meets quality standards and remains usable for clinical, public health, and research purposes.
• Data elements that could significantly impact the efficiency and accuracy of data collection if they were better specified or constrained.
• Guidance about vocabulary criteria or references to information exchange specifications that would help map the data elements currently used to these USCDI+ Cancer Registry data elements.

The CAP looks forward to working with the ASTP to support high quality laboratory operations and medical care.

Lawmakers have returned to their states for October. This recess from congressional duties in Washington, DC, is a crucial time to protect your laboratory from federal regulatory overreach and to advocate against payment cuts to pathology services. Shy about advocating? Unsure if you should get involved? Check out some compelling reasons below:

1. Advocacy Empowers Pathologists

Advocacy amplifies the voices of people who need to be heard. It involves speaking up so that their perspectives are taken seriously, and their voices listened to. This enables pathologists to become more involved in decisions that affect their practice, patients, and lives. It also creates confidence when advocating within a hospital system or multidisciplinary practice. You can even use the advocacy skills you gain in other areas of your personal and professional life.

2. Advocacy Influences Policy Change

Policy advocacy attempts to initiate, direct, or prevent specific policy changes by influencing the actions of legislators in the local and federal government.

Advocates can drive policy changes in multiple ways:

• Speaking directly to lawmakers by testifying before legislative committees or Capitol Hill briefings, providing expert advice on policy issues, or contacting elected officials through CAP Action Alerts where you can personalize letters that are sent directly to their inboxes.
• Educating political leaders of the burdens on pathology through social media platforms. Retweet or share CAP Advocacy posts and tag your local member of Congress asking them to take action.

3. Advocacy Raises Awareness

CAP Advocacy is essential because it shines a light on issues people would otherwise ignore or fail to notice. Advocates can share their personal stories, experiences, and challenges of working in the field of pathology. CAP advocates can use education to influence beliefs and gain passionate supporters in Congress.

5. Advocacy Provides Support and Resources

Advocacy work is more than supporting the rights of a specific group. A core function is connecting people with services or resources they need to find their way through challenging circumstances. An advocate can work to defend pathologists’ interests - like helping them receive the pay they deserve - so they remain in practice for the benefit of local patients.

6. Advocacy Fosters Accountability

Advocacy efforts can pressure people in power to act responsibly. Lawmakers often get pressure from industries, their own party, or a desire to win an election that might cause them to act on legislation (or not act) that could cause additional burdens on the practice of pathology. Consistently advocating on behalf of pathologists forces local legislators to listen to their constituents and act positively on their behalf for the good of their own community.

7. Advocacy Drives Systemic Change

Advocacy can cause fundamental shifts with long-term impacts on society. Stopping Medicare cuts for pathologists or getting new legislation around the regulation of laboratory-developed tests drives change that will affect not only the practice of pathology but countless patients in communities across the United States who deserve timely, accurate tests to manage disease states. A systemic change can help unburden pathologists, drive more medical students into pathology and create easier access to testing for healthier communities.

For more ways to engage and active your advocacy muscles while Congress is in your home district during their October recess, click here.

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