Previous Advocacy Updates

Congress just released a 2025 spending plan that included relief from Medicare payment cuts to physician services. The CAP applauded the proposal and continues to press lawmakers to enact the relief ahead of an expected 2.5% cut to Medicare pay for pathology services effective on January 1, 2025.

The FDA published guidance for premarket submission of artificial intelligence/machine learning (AI/ML) medical software on December 3. The guidance details information manufacturers should include in an FDA premarket submission so that they can alter their AI/ML software over time without needing to complete another FDA marketing submission.

A bipartisan group of 40 senators signed a November 21 letter to Senate leadership urging them to address the 2.8% Medicare payment cut set to go into effect January 1, 2025. More than 650 CAP members asked their senators to sign the letter in 1,300 messages sent to lawmakers earlier this month.

The CAP has asked leaders of the Trump Transition Team to recommend the incoming administration rescind the Food and Drug Administration's (FDA) proposed regulation of laboratory-developed tests (LDTs), citing significant concerns about the rule’s potential to limit patient access to critical diagnostic services.

The CAP strongly urged Congress to increase Medicare payment for pathology services and stop the Food and Drug Administration (FDA) oversight rule for laboratory-developed tests (LDTs) during a coordinated lobbying effort on November 14.

Special repost: The CAP worked with physician colleagues across the American Medical Association (AMA) to enact new policies on prior authorization, artificial intelligence, and information blocking during the 2024 AMA Interim Meeting November 8-12.

Newly released payment regulations from the Centers for Medicare & Medicaid Services (CMS) include additional payment and expanded coverage policies advocated for by the CAP. Following the CAP’s initial analysis on November 1, there are more changes affecting pathologists and laboratories detailed in the 2025 final Physician Fee Schedule and Quality Payment Program Regulation and the Hospital Outpatient Prospective Payment System (HOPPS) and Ambulatory Surgical Center Payment System Final Rule.

The Centers for Medicare & Medicaid Services (CMS) adopted several payment policies advocated for by the CAP in the 2025 final Physician Fee Schedule and Quality Payment Program regulation released November 1. As a result of the CAP’s advocacy efforts, for example, the CMS updated the relative value units (RVUs) for three apheresis services and increased non-physician cost components for key pathology and laboratory labor types.

Special repost: The Centers for Medicare & Medicaid Services (CMS) adopted several payment policies advocated for by the CAP in the 2025 final Physician Fee Schedule and Quality Payment Program regulation released late in the day on November 1. As a result of the CAP’s advocacy efforts, for example, the CMS updated the relative value units (RVUs) for three apheresis services and increased non-physician cost components for key pathology and laboratory labor types.

Pathologists attending CAP24 received updates on legislative and regulatory achievements and how the CAP is tackling the challenges ahead through its advocacy programs. CAP leaders discussed the latest updates on Food and Drug Administration (FDA) regulation for laboratory-developed tests (LDTs), Medicare payment, and the release of a new CAP report on health insurer interference in patient care.

Special Issue: The Food and Drug Administration (FDA) filed a legal brief defending its regulation of laboratory-developed tests (LDTs) on October 25. The CAP has urged the federal court to throw out the regulation because it is arbitrary and capricious.

On October 15, the CAP released a new report detailing how insurer interference impacts pathologists and patients. Insurer interference happens when private insurance companies dictate medical decisions to boost revenue under the guise of controlling costs. Pathologists report more of these instances in the private health sector, with insurers restricting patient-physician and physician-physician relationships by limiting the number of in-network physicians or exclusively contracting with providers and facilities. These disruptions create barriers that prevent pathologists from providing patients with the necessary care.

October Recess Rally is off to a strong start! Over 1,000 pathologists have taken action through CAP's Action Center writing their local legislators opposing gene patent reform, fighting Medicare cuts, and encouraging Congress to stop the Food and Drug Administration (FDA) laboratory-developed test (LDT) final rule. Over 400 members of Congress have received close to 4,000 letters from pathologists discussing the critical issues affecting pathology since August.

Not signed up for PathNET? It’s the best and easiest way to get updates on new action alerts. You can even get text alerts sent directly to your phone. Through PathNET, pathologists can build relationships with their federal and state legislators to help ensure laboratory regulations do not place undue burden on the profession but still ensure accuracy and safety.

On October 7, the CAP filed an amicus brief in a US District Court against the Food and Drug Administration (FDA) and its regulation of laboratory-developed tests (LDTs). The CAP joined the American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP) in challenging the LDT rulemaking by the FDA, which acted arbitrarily and capriciously in violation of the Administrative Procedure Act.

Special report: Today, the CAP filed an amicus brief in a US District Court against the Food and Drug Administration (FDA) and its regulation of laboratory-developed tests (LDTs). The CAP joined the American Clinical Laboratory Association (ACLA) and Association for Molecular Pathology (AMP) in challenging the LDT rulemaking by the FDA, which acted arbitrarily and capriciously in violation of the Administrative Procedure Act.

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!

Lawsuits over the federal oversight of laboratory-developed tests (LDTs) filed by the American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP) will be consolidated by the courts, according to a motion filed in the US District Court Eastern District of Texas on September 9. As the two entities challenge and seek to stop the Food and Drug Administration’s (FDA’s) regulation on the oversight of LDTs, the FDA proposed combining the cases, and ACLA and AMP agreed to consolidate.

On September 3, the CAP issued a press release commending the introduction of the Provider Stability Reimbursement Act in the US Senate and urged Congress to enact the legislation to help prevent across-the-board Medicare cuts to physicians in future years. CAP President Donald Karcher, MD, FCAP, issued the following statement thanking sponsors Sens. John Boozman (R-AR), Peter Welch (D-VT), Thom Tillis (R-NC), Angus King (I-ME), Roger Marshall, MD (R-KS), and Jeanne Shaheen (D-NH) following the bill’s introduction:

“We are encouraged that Congress is considering long-term fixes to Medicare’s broken payment system, which has cut reimbursements for physician services year after year. Coupled with the absence of an annual update for inflation, reductions to reimbursement unrelated to the actual cost of providing care have no place in the Medicare program. The Provider Stability Reimbursement Act would be a crucial step toward stabilizing the Medicare program for patients and the physicians providing care for them. The CAP appreciates the work of Sens. Boozman, Welch, Tillis, King, Marshall, and Shaheen for leading the introduction of this important bill in the Senate.”

More than 340 CAP members initially took action during our August Recess Rally and responded to a specific alert to stop the implementation of the Food and Drug Administration’s (FDA) final laboratory-developed test (LDT) rule. Over 1,100 messages were sent to members of Congress, including those from 29 CAP members who took action for the first time.