Labcorp Holdings
32 named things its latest annual report says its results depend on, each in the company's own words. 19 of them are also named by other companies we've read.
Customers
Medicare
earns from · 8%named as a riskPAMA has already reduced Medicare reimbursement rates for many tests, and further reductions are expected, although rate reductions are frozen for 2026 and capped at 15% per year for 2027-2029.Risk factors (Item 1A)
Also named by ABT, ARWR, AXGN, BAX, BDX, BMY, BSX, CAH and 48 more
Medicaid
earns from · 8%named as a riskNoncompliance with laws governing billing practices, financial relationships, and other healthcare-related activities could result in civil or criminal penalties, exclusion from Medicare and Medicaid, and restrictions on the use of the Company’s laboratories.Risk factors (Item 1A)
Also named by ABBV, ABT, ARE, ARWR, BAX, BMY, BSX, CHE and 39 more
Managed care organizations (MCOs)
earns from · 37%named as a riskThe Company’s diagnostic testing services are primarily billed to third parties, including MCOs, employer plans, and other health insurance providers.Risk factors (Item 1A)
Also named by ENSG
Pharmaceutical and biotechnology R&D spending
earns from · 22%named as a riskBLS’s revenues are closely tied to R&D spending by pharmaceutical, biotechnology, and medical device companies, which may depend on access to capital and reimbursement from payers.Risk factors (Item 1A)
Suppliers
American Medical Collections Agency (AMCA)
named as a riskThe Company is involved in pending and threatened litigation related to the AMCA Incident, as well as various government and regulatory inquiries and processes.Cybersecurity (Item 1C)
Other companies
Ravgen Inc.
$272.0 millionnamed as a riskIn September 2022, a jury rendered a verdict in favor of Ravgen on the remaining patent at issue and awarded damages of $272.0 million.Risk factors (Item 1A)
Also named by NTRA
Fortrea
named as a riskAdditionally, the Spin-off presents risks that could affect the Company’s business, including exposure to unexpected claims, liabilities, or costs under the Company’s agreements with Fortrea in connection with the Spin-off.Risk factors (Item 1A)
SYNLAB
During 2025, the Company advanced its international strategy through the acquisition of a minority stake in SYNLAB, a leader in medical diagnostic services and specialty testing in Europe.Business (Item 1)
Places
Commodities and inputs
Swiss Franc
exposed to its price · $1,200.0named as a riskThe Company is a party to USD to Swiss Franc cross-currency swap agreements with an aggregate notional amount of $1,200.0, $300.0 maturing in 2029, $300.0 maturing in 2031 and $600.0 maturing in 2034, as a hedge against the impact of foreign exchange movements on its net investment in a Swiss Franc functional currency subsidiary.Market risk (Item 7A)
Canadian Dollar, Euro and British Pound
exposed to its price · Approximately 13.5%named as a riskIn 2025 and 2024, the most significant currency exchange rate exposures were to the CAD, Swiss Franc, Euro, and British Pound.Market risk (Item 7A)
Research animals
depends onnamed as a riskIncreased or changed regulations and restrictions on the import of research animals into various countries, as well as limitations of supply could impact BLS’s ability to conduct preclinical research and could have an adverse effect on BLS’s financial condition, results of operations, and cash flows.Risk factors (Item 1A)
Reagents, test kits and instruments
depends onnamed as a riskFurthermore, from time to time, manufacturers discontinue or recall reagents, test kits, or instruments used by the Company to perform laboratory testing.Risk factors (Item 1A)
Regulators
U.S. Food and Drug Administration (FDA)
subject tonamed as a riskHowever, on April 29, 2024, the FDA issued a final rule asserting authority to regulate LDTs as medical devices, initiating a four-year phase-out of its prior enforcement discretion.Risk factors (Item 1A)
Also named by A, ABBV, ABT, AMGN, ARE, ARWR, ATR, AXGN and 112 more
Centers for Medicare & Medicaid Services (CMS)
subject tonamed as a riskIn most cases, that certification is regulated by CMS through CLIA, which requires that applicable clinical laboratories meet quality assurance, quality control, and personnel standards.Business (Item 1)
Also named by A, ABT, AMGN, AXGN, BAX, BWIN, CNC, COO and 23 more
U.S. Drug Enforcement Administration (DEA)
subject tonamed as a riskThe use of controlled substances is regulated by the U.S. Drug Enforcement Administration under the CSA and its implementing regulations.Business (Item 1)
Also named by CAH, COR, DGX, DHR, HALO, HSIC, IQV, MCK and 7 more
Medicines and Healthcare products Regulatory Agency (MHRA)
subject tonamed as a riskCertain BLS services, including chemistry, manufacturing, and controls services, must conform to cGMP standards and are subject to periodic inspections by the FDA, the MHRA, and other global regulatory authorities.Business (Item 1)
SAMHSA
subject toTo the extent that the Company’s laboratories perform such testing, each must be certified as meeting SAMHSA standards.Business (Item 1)
Laws and programs
Protecting Access to Medicare Act (PAMA)
subject to · approximately $245.0 millionnamed as a riskPAMA resulted in a net reduction in reimbursement revenue of approximately $245.0 million between 2018-2020 from all payers affected by the CLFS.Business (Item 1)
Consolidated Appropriations Act
subject to · capped at 15% per year for 2027 to 2029named as a riskAmong other things, under the Consolidated Appropriations Act that became law on February 3, 2026, the PAMA data collection period for private payer rates will be January 1, 2025 to June 30, 2025, the period for reporting rates to CMS will be May 1, 2026 to July 31, 2026 to set CLFS prices for 2027 to 2029, and phased-in rate decreases based on PAMA reporting are frozen for 2026, but will resume in 2027 and be capped at 15% per year for 2027 to 2029.Business (Item 1)
HIPAA
subject tonamed as a riskThe Company has implemented policies to comply with HIPAA, but evolving regulations—including a proposed rule to clarify the HIPAA Security Rule—may increase compliance obligations.Risk factors (Item 1A)
Also named by AFL, BAX, BBSI, CI, DHR, DOC, DOCN, DOCU and 19 more
Clinical Laboratory Improvement Amendments (CLIA)
subject tonamed as a riskNoncompliance with CLIA may result in suspension, revocation, or limitation of a laboratory’s certificate, and the ability to bill government and other payers, as well as significant fines or criminal penalties.Risk factors (Item 1A)
EU In Vitro Diagnostic Regulation (IVDR)
subject tonamed as a riskCompliance with these evolving international frameworks may increase costs and affect the Company’s ability to support clinical trials and offer laboratory services.Risk factors (Item 1A)
U.S. Anti-Kickback Statute
subject tonamed as a riskThe U.S. Anti-Kickback Statute prohibits knowingly providing anything of value in return for, or to induce the referral of, Medicare, Medicaid, or other U.S. federal healthcare program business.Business (Item 1)
Stark Law
subject tonamed as a riskUnder another U.S. statute, known as the “Stark” physician self-referral law, physicians who have a financial relationship with a clinical laboratory may not refer Medicare or Medicaid covered testing to the laboratory unless an exception applies, and laboratories may not bill Medicare or Medicaid for such prohibited referrals.Business (Item 1)
DOJ Data Security Program
subject tonamed as a riskThe Company must also comply with restrictions on international data transfers imposed through standards such as the DOJ’s Data Security Program, and emerging laws regulating AI, algorithms, and automated processing, which may increase compliance costs.Risk factors (Item 1A)
Eliminating Kickbacks in Recovery Act
subject tonamed as a riskThis includes potential interpretations of laws such as the Eliminating Kickbacks in Recovery Act, which currently lacks clarifying regulations or exceptions.Risk factors (Item 1A)
EU GDPR
subject tonamed as a riskInternationally, the Company is subject to data protection laws, such as the EU GDPR and the U.K. GDPR, which impose strict requirements and significant penalties for noncompliance.Risk factors (Item 1A)
Also named by RMD
Clinical Laboratory Fee Schedule (CLFS)
subject tonamed as a riskFees for most laboratory services reimbursed by Medicare are established in the CLFS.Business (Item 1)
Medicare Physician Fee Schedule (PFS)
subject tonamed as a riskReimbursement for pathology services performed by Dx under the Medicare PFS is subject to ongoing statutory and regulatory adjustments.Risk factors (Item 1A)
Animal Welfare Act (AWA)
subject tonamed as a riskBLS’s preclinical research activities must comply with animal welfare laws in the jurisdictions where it operates, including the AWA and similar regulations in the U.K., the EU, and China.Risk factors (Item 1A)