Why It Matters

The American Clinical Laboratory Association (ACLA) is lobbying heavily to sway Congress as it actively debates the RESULTS Act. The passage could prevent up to 15% in Medicare payment cuts affecting roughly 800 laboratory tests. Without action, reimbursement rates drop sharply in 2026.

The clinical laboratory industry faces a deepening workforce crisis with vacancy rates reaching 25 percent nationally. Congress is responding with legislation like the Medical Laboratory Personnel Shortage Relief Act, expanding the policy battleground beyond reimbursement.

ACLA’s sustained spending reflects the sector’s existential stakes on payment reform, regulatory certainty, and workforce viability.

By the Numbers

The American Clinical Laboratory Association (ACLA) spent $610,000 on in-house lobbying during Q3 2025. This represents direct advocacy by ACLA’s own employees rather than external firms. Over its two-decade history since 2003, ACLA has filed 77 disclosure reports and spent $30.1 million total on lobbying efforts.

ACLA employs a hybrid approach, combining internal advocacy with external firm partnerships. Long-term partners include Alston & Bird LLP (focused on Medicare issues), Covington & Burling LLP (regulatory matters), and newer engagement Kountoupes Denham Carr & Reid LLC for data privacy issues.

Historically, ACLA’s advocacy has concentrated on:

  • Medicare/Medicaid (50 instances): Clinical Laboratory Fee Schedule and reimbursement policies
  • Medical/Disease Research/Clinical Labs (54 instances): FDA regulation and Laboratory Developed Tests
  • Health Issues (59 instances): Healthcare reform and data privacy
  • Budget/Appropriations (43 instances): Federal funding for public health programs
  • Disaster Planning/Emergencies (24 instances): Laboratory industry’s role in public health crises

    The Agenda

The American Clinical Laboratory Association (ACLA) is primarily focused on two major legislative and regulatory battles. First, the association is advocating for the RESULTS Act, bipartisan legislation to reform Medicare reimbursement rates for clinical laboratory tests and prevent significant cuts to the Clinical Laboratory Fee Schedule. Second, ACLA is supporting the Freedom for Laboratory Innovation and Testing Act to block FDA regulation of laboratory-developed tests as medical devices.

Historically, ACLA has lobbied extensively on Medicare and Medicaid reimbursement issues, FDA regulation of diagnostic tests including Laboratory Developed Tests, Clinical Laboratory Improvement Amendments standards, healthcare reform, data privacy, and federal funding for public health programs.

Broader Context

Congress is confronting several urgent policy challenges that directly threaten and reshape the clinical laboratory industry. Most significantly, Medicare reimbursement for approximately 820 common lab tests faces cuts of up to 15 percent starting January 2026 without legislative intervention. This threat has galvanized bipartisan support for the RESULTS Act, which aims to reform the flawed payment methodology established by the Protecting Access to Medicare Act (PAMA) in 2014.

Meanwhile, the regulatory landscape has shifted favorably for ACLA’s members. The FDA formally rescinded its controversial rule to regulate laboratory developed tests as medical devices in September 2025, following a federal court order that vacated the rule after industry litigation. However, this victory has not eliminated lobbying pressure, as the Freedom for Laboratory Innovation and Testing Act continues advancing in Congress to prevent future regulatory overreach.

Additionally, clinical laboratories face an acute workforce crisis. The American Society for Clinical Laboratory Science reports vacancy rates approaching 25 percent nationally, with an aging workforce and inadequate educational pipeline. Congressional response includes the Medical Laboratory Personnel Shortage Relief Act of 2025, which would expand loan repayment programs for laboratory professionals.

On the innovation front, several bills create growth opportunities, including the Finn Sawyer Access to Cancer Testing Act for advanced genomic diagnostics and the Right Drug Dose Now Act promoting pharmacogenomic testing integration.

Between The Lines

Congress is actively debating legislation directly impacting ACLA’s core interests. The RESULTS Act (S. 2761/H.R. 5269) enjoys bipartisan support to reform Medicare reimbursement and prevent up to 15% cuts to lab test payments starting January 2026. Representatives Scott Peters, Richard Hudson, and others have championed the bill, with Peters explicitly quoting ACLA President Susan Van Meter. Meanwhile, Representatives Brad Finstad and Dan Crenshaw introduced the Freedom for Laboratory Innovation and Testing Act to block FDA regulation of laboratory developed tests, though the FDA has already rescinded its LDT rule following a federal court order. Additional congressional priorities include the Finn Sawyer Access to Cancer Testing Act for advanced diagnostics coverage and the Medical Laboratory Personnel Shortage Relief Act addressing workforce shortages. Allied organizations including the American Society for Clinical Laboratory Science and American Association of Bioanalysts are also actively lobbying on identical issues, demonstrating unified industry support.

Competitive Landscape

The clinical laboratory industry is presenting a united front on Capitol Hill, with multiple organizations lobbying on identical policy priorities to ACLA. The American Society for Clinical Laboratory Science is actively lobbying on Part B reimbursement, CLIA oversight, workforce shortages, and laboratory developed tests, filing quarterly reports showing $20,000 in expenditures during both Q1 and Q2 2025. The American Society for Clinical Pathology is advocating on Medicare fee schedules, federal LDT oversight, and personnel shortages, with higher quarterly expenditures of $43,000-$45,000. The American Association of Bioanalysts has made PAMA reform and the Clinical Laboratory Fee Schedule its central focus, spending $70,000 quarterly. This collective advocacy demonstrates universal industry concern about Medicare reimbursement stability and regulatory certainty, particularly surrounding passage of the RESULTS Act and FDA’s stance on laboratory developed tests.

The Bottom Line

With bipartisan congressional support emerging on payment reform and a severe workforce shortage affecting the sector, ACLA’s substantial investment reflects genuine stakes for clinical laboratories operating within an increasingly urgent policy landscape. The organization’s two-decade lobbying history and strategic use of both in-house and external lobbying expertise position it as a central player in these debates, though the ultimate outcomes remain uncertain as legislation progresses through Congress.

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