QUEST DIAGNOSTICS INC (DGX) Risk Factors

Recent key developments

Concrete developments — dated events, named agreements and instruments, legal proceedings — that QUEST DIAGNOSTICS INC surfaced in its latest filing.

• PAMA reimbursement rates for many clinical laboratory tests under Medicare were reduced during 2018-2020, because CMS relied on laboratory reported data in 2017 that overrepresented independent laboratories and underrepresented hospitals and physician office laboratories, leading to excessive cuts. Congress then delayed PAMA data reporting (2020-2026) and Medicare cuts (2021-2026).2018-2020
• The Results Act introduced in 2025 would reform PAMA and create a true market-based CLFS.2025
• CMS has set goals for value-based reimbursement to be achieved by 2030.2030
• Medicare reimbursement is subject to annual reduction under the Budget Control Act of 2011 and the Statutory Pay-As-You-Go Act of 2010.
• In May 2024, the FDA announced it was phasing out its general enforcement discretion approach for LDTs.May 2024
• In March 2025, a U.S. District Court set aside and vacated the FDA’s LDT rule.March 2025
• As of December 31, 2025, we had approximately $5.7 billion of debt outstanding.December 31, 2025
• Company committed to a multi-year project named Project Nova to modernize 'Order to Cash' business processes and related IT infrastructure, partnering with Epic, a third-party licensor, to assist in the implementation.
• Retrieval-Masters Creditors Bureau, Inc./American Medical Collection Agency (AMCA) informed the Company in June 2019 that an unauthorized user had access to AMCA’s system, which included financial, medical and other personal information.June 2019