Advocacy Update

• BREAKING: Congress Set to Delay Cuts to Medicare Clinical Lab Fees Until 2026
• Key Questions on FDA LDT Oversight Answered by a Former FDA Director: CAP Webinar
• Engage and Advocate: October Recess Rally Preview!
• CAP24 HOD Keynote Speaker: The Hill Editor Bob Cusack Shares Insider Knowledge of Today’s Politics
• Reminder: Check your MIPS Final Score Today!
• AMA Webinar: How to Protect your Practice and Patients from Cybersecurity Threats
• Take Our News Quiz for September

Medicare cuts to the clinical laboratory fee schedule would be delayed for one year if legislation to avert a government shutdown is signed into law later this week. A bill to keep the government open released by House lawmakers on September 22 included legislative language to also delay the Medicare cuts to lab fees. The CAP has opposed the cuts and is actively lobbying Congress to enact a permanent solution. In the meantime, the CAP supports temporary measures that prevent the Medicare cuts of up to 15% to certain laboratory tests.

The three-month government funding bill is expected to pass both chambers of Congress before lawmakers adjourn for their October recess on September 27. The legislative text can be found here with the delay to Medicare cuts language printed on page 39.

Did you miss the “Understanding the Impact of the FDA’s LDT Risk Classification on Your Laboratory” webinar on September 18? Watch the recording on-demand featuring CAP President Donald Karcher, MD, FCAP and Timothy Stenzel, MD, PhD, (Retired) Director, Office of In Vitro Diagnostics at the FDA as they discuss differences in classifications used by the FDA and CLIA, requirements under the FDA risk categories, and what activities the FDA includes in its general and special controls.

Top questions from webinar participants answered during the Q&A session included:

• How does the FDA risk classification system apply to immunohistochemistry testing?
• What if a test is classified in two different risk categories? For example, FISH testing can be both low-risk and high-risk.
• Is there a difference between tests currently under forensic use-only versus for employment and insurance testing purposes? Things like drugs for abuse testing and/or federally mandated drug tests?
• What exactly is required for stage 1 of the FDA LDT oversight regulation?

They also covered examples for how the FDA classification system applies to:

• Lactic acid tests.
• BCR/Abl1 monitoring tests.
• High throughput sequencing based tumor profiling tests.
• Chromogenic in situ hybridization, nucleic acid amplification, HER2/Neu gene tests

Over 3,000 people registered for our first webinar with over 150 questions submitted! Don’t miss the next in our series titled: “Ready Your Laboratory for the FDA’s Stage 1: Adverse Event Reporting Requirement” on November 7, 2024, Noon–1:00 PM CT. Register now!

Lawmakers return to their states for the remaining weeks before Election Day. 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. Your representatives and senators in Congress will only act on these issues if they hear from you and they are listening as they campaign for your vote!

When Congress returns to Washington in November, they will have a packed agenda with competing priorities. They need to hear from you, so pathology issues are top of mind when they get back to Capitol Hill. Here is how you make your voice heard next month.

• Action Alerts: Sign up for the CAP’s Action Alerts to send pre-written or personalized messages directly to your legislators. This is a fast and easy way to raise your concerns about the FDA’s final rule on LDTs, advocate for a fix to clinical laboratory fee cuts, and Medicare payment reform. These alerts are crucial as Congress prepares for the lame-duck session.
• Virtual and In-District Meetings: During the October recess, schedule meetings with your lawmakers to directly discuss the impact of LDT regulation and Medicare reimbursement cuts on your practice and patient care. CAP’s toolkit offers templates and talking points to help you organize effective meetings. Use these discussions to make sure legislators are ready to act when they return to DC.
• Hosting Laboratory Tours: Inviting lawmakers to tour your laboratory during the recess provides a powerful, hands-on opportunity to show them how regulatory and financial challenges affect diagnostic care in real time. This is especially impactful before the lame-duck session when lawmakers will be making important decisions on LDTs and Medicare cuts. CAP’s laboratory tour toolkit provides all the resources you need to plan and execute a successful tour.
• Op-eds and Social Media Campaigns: Writing op-eds or sharing your concerns on social media allows you to raise public awareness and put additional pressure on lawmakers. CAP provides guidance for drafting op-eds and social media messages that effectively convey the importance of LDTs and Medicare funding to patient care. Tag your representatives and use these platforms to amplify your voice.
• Joining PathNET: For CAP members looking to deepen their involvement, PathNET is a valuable grassroots advocacy network. PathNET keeps you informed on legislative developments and provides opportunities to engage directly with lawmakers. As a member of PathNET, you will also have the option to sign up for grassroots text alerts so you can be sure you don’t miss a single action alert.
• Advocate from the comfort of home (or anywhere!) Ensure you never miss an advocacy action alert by signing up for the CAP’s grassroots text alerts.
• Attend town halls or community events where legislators are listening to voters' concerns.
• CAP24. Attend CAP24. There are a variety of opportunities at CAP24 to learn more about CAP Advocacy and the legislative landscape. Swing by the CAP Advocacy booth to share your LDT story and attend the Advocacy Town Hall.

Remember that your member of Congress wants to hear from you, as a constituent and a physician, especially on health care policy. Be on the lookout during October for different ways to engage and advocate! Questions? Email pathnet@cap.org.

On October 19, join either in-person, virtually, or on-demand for the House of Delegates/Residents Forum Luncheon sponsored by PathPAC at CAP24. During the luncheon, you will hear from Bob Cusack, Editor-in-Chief of The Hill. He has developed a nuanced, insider's knowledge of policy and politics evolving from his post at one of the most respected news organizations in congressional circles. Mr. Cusack's illuminating presentations are the definitive source for learning what's happening behind-the-scenes in the halls of Congress, how it could affect you, and what makes Washington's leaders tick. Register today!

In August, the Centers for Medicare & Medicaid Services (CMS) released the final 2023 performance feedback for Merit-Based Incentive Payment Systems (MIPS) participants. MIPS participants can log into their QPP account to view their final score and payment adjustment. If an individual or group believes there was an error in the calculation of their payment adjustment (eg, non-patient-facing status was not applied), targeted reviews can be submitted until 8 PM on October 11 via their QPP account.

Feedback includes the final score for individuals or groups who submitted data to the CMS for MIPS in 2023 and the payment adjustment that will be applied in 2025. For questions about special status, reweighting, and how scores are calculated, please visit the QPP Resource Library or contact the CMS Help Desk for assistance.

After the Change Healthcare cyberattack earlier this year, cybersecurity has become a central concern for physicians and patients alike. Join the American Medical Association (AMA) on October 18 at 12:30 PM CT to learn about how to implement appropriate cybersecurity measures to protect your practice as well as your patients against the cybersecurity challenges of today. Also, hear about advocacy that is underway to strengthen cybersecurity systems and provide support to physician practices for enhancing their cyber hygiene.

Speakers:

• Christian Dameff, MD, Department of Emergency Medicine, School of Medicine, University of California, San Diego
• Greg Garcia, executive director for cybersecurity, Health Sector Coordinating Council

If you are unable to attend live, a recording of the presentation will be emailed out to all registrants. Register now!

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