Advocacy Update

• ACLA Files Lawsuit Against FDA by Challenging LDT Oversight Regulation
• Reminder: FDA Webinar on LDT Enforcement Policy June 5
• Illinois Legislature Unanimously Passes Network Adequacy Bill: Now Pending Governor’s Signature
• Advocacy Win: TSP-CAP Amended Laboratory Operations Bill Enacted
• Texas Congressman Learns Pathology Advocacy Priorities During Lab Tour
• 2024 MIPS Extreme and Uncontrollable Circumstances Portal Open for Cyberattack Victims
• Take Our News Quiz for June 

The American Clinical Laboratory Association (ACLA) filed a federal lawsuit challenging the Food and Drug Administration (FDA) and its final rulemaking on the oversight of laboratory-developed tests (LDTs) on May 29. The CAP is reviewing the legal action by ACLA, which included a 450-page filing in the US District Court for the Eastern District of Texas. The CAP has expressed its continued concerns to various stakeholders over the FDA regulation and the impact it will have on pathologists, laboratories, and patients.

In a statement, ACLA said they brought this lawsuit because the FDA final rule exceeded the agency’s authority and violated the Administrative Procedure Act, which establishes the federal rulemaking process for federal agencies to follow.

Following the release of the FDA final LDT rule, the CAP said it remained concerned that the FDA moved forward without making the additional changes needed to ensure both patient safety and access to accurate and innovative testing. CAP President Donald Karcher, MD, FCAP had said in a statement, "We urge the FDA to reconsider the CAP’s prior feedback in light of the real-world effect its strict regulation will have on pathologists and laboratories meeting the needs of a diverse patient population across the United States. Importantly, FDA must conduct a massive outreach and education campaign on how laboratories can meet these regulatory requirements and still care for patients as the new rules are implemented.”

The CAP will provide additional updates on this issue as new information emerges.

On June 5, the FDA will host a webinar to provide an overview of two draft LDT guidances:

• Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564
• Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency

During the webinar, the FDA will:

• Review the scope and key elements of each draft guidance.
• Provide responses to previously submitted questions.

More information here.

On May 24, the Illinois Legislature unanimously passed health plan network adequacy legislation (SB 2641) advocated by a multispecialty coalition of medical societies, led by the Illinois Society of Pathologists (ISP) and the CAP. The bill was initially opposed by the Illinois health insurance industry, which adopted a neutral position following negotiations and amendments offered by the State Insurance Department. Following the adoption of the amendments, the Department became a proponent of the bill.

The legislation requires health plans to submit to the Illinois Department of Insurance information demonstrating that they have contracted with hospital-based physician specialists, including pathologists, radiologists, anesthesiologists, and emergency room physicians at in-network hospitals. The Illinois Department of Insurance currently conducts network adequacy assessments of health plans but does not scrutinize health plans for provision of in-network pathology/laboratory services, or for other on-site physician specialty services at hospitals and in-network facilities.

The ISP, with the assistance of CAP, submitted a memorandum and provided testimony detailing support for the legislation. The legislation now moves to the Governor, who is expected to sign the measure into law. The bill would go into effect January 1, 2026.

On May 28, Gov. Bill Lee (R) enacted the Tennessee Society of Pathologists (TSP) and the CAP’s amended legislation (SB 2230/HB 2545) removing several laboratory operation concerns.

Previously, the TSP, the CAP, and the Tennessee Medical Association (TMA) significantly amended the bill to remove pathologists’ limitations in laboratory supervision, additional credentialing for medical laboratory supervisors, and unwarranted impediments to hospital laboratory accreditation by the CAP.

As a result, pathologists and supervisors can now oversee up to five rural hospital laboratories consistent with federal law (CLIA) and are further shielded them from burdensome credentialing requirements. Furthermore, rural hospital laboratories with CAP accreditation will be properly recognized under Tennessee law.

The new law will go into effect on July 1, 2024.

Rep. Marc Veasey (D-TX) toured the clinical laboratory at Methodist Dallas Medical Center on May 27, which was hosted by Joe Saad, MD, FCAP, CPE, Chair of Council on Government and Professional Affairs.

They discussed Medicare physician payment reform, the Saving Access to Laboratory Services Act (SALSA), the Conrad 30 waiver program, and the FDA LDT final rule.

Dr. Saad said of the tour: “He was amazed at the complexity, equipment, and highly trained personnel in the lab. He had no idea of the foundational role of pathology in all aspects of patient care. I think he was impressed.”

Laboratory tours are an opportunity for you to build a relationship with your members of Congress and/or their staff, so that when issues of concern come up, you have an avenue to advocate for yourself and your specialty. It is good exposure for the legislator, for your practice, and for the CAP. Interested in hosting a lab tour? Click here for more information.

In response to the February cyberattack on Change Healthcare, the Centers for Medicare and Medicaid Services (CMS) has reopened applications for Extreme and Uncontrollable Circumstances (EUC) exceptions for submission of 2024 Merit-based Incentive Payment System (MIPS) data.

This is a viable option if you have been impacted by the cyberattack and are unable to access your data for MIPS reporting. The 2024 MIPS EUC portal is now open, and physicians have until December 31, 2024, to file a hardship application and avoid a 2026 MIPS negative payment adjustment. For more information visit: 2024 EUC hardship application.

If you would like your practice to reap the benefits of a team of experts offering practice-specific support for complying with MIPS—and receive proper compensation for the value you provide—please contact our representatives today at 800-323-4040, option 3 or email us at registry.inquiries@cap.org to learn about the Pathologists Quality Registry.

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