Previous Advocacy Updates

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.

The CAP is launching a six-part webinar series to help the pathology and laboratory community understand and prepare for the Food and Drug Administration (FDA) oversight rules for laboratory-developed tests. The webinar series begins on September 18 and will focus on the FDA risk classification system.

The CAP is launching a six-part webinar series to help the pathology and laboratory community understand and prepare for the Food and Drug Administration (FDA) oversight rules for laboratory-developed tests. The webinar series begins on September 18 and will focus on the FDA risk classification system.

CAP members are asking Congress to intervene before the Food and Drug Administration (FDA) implements its oversight regulations on laboratory-developed tests (LDTs) in a new action alert added to our August Recess Rally. Pathologists can easily use the CAP’s PathNET Action Center to act on the LDT oversight alert and engage in other advocacy activities during a crucial time when legislators are meeting with their constituents throughout an August recess.

August is one of the best times to protect your laboratory from regulatory overreach and advocate to stop payment cuts pathology services. Your representatives and senators in Congress will only act on these issues if they hear from you. While members of Congress have left Washington for August, they are at home meeting with constituents in your community. CAP members must take advantage of opportunities to connect and educate their legislators on pathology’s top legislative objectives.

The CAP recently met with Medicare Administrative Contractor (MAC) Palmetto GBA, a company that handles Medicare claims for the Centers for Medicare & Medicaid Services (CMS), and expressed deep concerns that the MolDX: Molecular Assays for the Diagnosis of Cutaneous Melanoma Local Coverage Determination (LCD) improperly limits the scope and defines the practice of medicine by board-certified pathologists, licensed physicians and surgeons, who are eligible to order laboratory tests.

In a March 1 letter to CMS and Palmetto, the CAP requested that the subspecialty requirement in the LCD – that any molecular test approved for coverage under the LCD be ordered by a board-certified or board-eligible dermatopathologist – be removed from the coverage policy. The CAP stated further that

The Centers for Disease Control and Prevention (CDC) issued a health advisory about a critical shortage of Becton Dickinson (BD) BACTEC™ blood culture media bottles on July 23. The advisory followed an announcement by the Food and Drug Administration (FDA) regarding the disruption in availability of BD BACTEC blood culture media bottles on July 10.

This shortage has the potential to disrupt patient care by leading to delays in diagnosis, misdiagnosis, or other challenges in the clinical management of patients with certain infectious diseases, the CDC said. Those affected by this shortage should immediately begin to assess their situations and develop plans and options to mitigate the potential impact of the shortage on patient care.

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.

The proposed 2025 Medicare Physician Fee Schedule released on July 10 highlights the continuous advocacy efforts by the CAP to protect the value of pathology services. Due to the CAP’s efforts, the Centers for Medicare & Medicaid Services (CMS) has proposed to increase the relative values of three apheresis services, provide coverage for four new CAR T-cell services, and increase the clinical labor rates for key laboratory clinical labor types. The proposed 2025 Medicare Physician Fee Schedule does, however, include cuts to physicians, including pathologists, and other providers such as independent laboratories. These cuts largely stem from the expiration of two congressional Medicare pay relief packages that were intended to offset the previously finalized cuts in the 2023 and 2024 Medicare Physician Fee Schedules. The CAP strongly opposes these cuts and is actively lobbying Congress to mitigate the decreases before they take effect.

Special Issue: The proposed 2025 Medicare Physician Fee Schedule released on July 10 highlights the continuous advocacy efforts by the CAP to protect the value of pathology services. Due to the CAP’s efforts, the Centers for Medicare & Medicaid Services (CMS) has proposed to increase the relative values of three apheresis services, provide coverage for four new CAR T-cell services, and increase the clinical labor rates for key laboratory clinical labor types. The proposed 2025 Medicare Physician Fee Schedule does, however, include cuts to physicians, including pathologists, and other providers such as independent laboratories. These cuts largely stem from the expiration of two congressional Medicare pay relief packages that were intended to offset the previously finalized cuts in the 2023 and 2024 Medicare Physician Fee Schedules. The CAP strongly opposes these cuts and is actively lobbying Congress to mitigate the decreases before they take effect.

During a Capitol Hill briefing for congressional staffers that took place July 9, the CAP discussed how Congress can promote patient safety without overburdening laboratories through enacting a diagnostic reform package that provides oversight of laboratory-developed tests (LDTs) while still allowing for innovation of new technologies and patient access to accurate testing.

Following the Food and Drug Administration (FDA) laboratory-developed test (LDT) final regulation, the agency released: Laboratory Developed Tests: Small Entity Compliance Guide: Guidance for Laboratory Manufacturers and Food and Drug Administration Staff on June 25.