Medical & Imaging Labs NAICS 621511, 621512

May 15, 2025 - FDA Rule Regulating Laboratory Developed Tests Struck Down

• A Texas federal court struck down the FDA’s final rule that established the agency’s regulatory framework for ensuring the safety and effectiveness of laboratory-developed tests (LDTs). This decision, which asserts that the FDA does not have responsibility for the authorization and oversight of LDTs, removes established guardrails for diagnostic safety and accuracy, according to Medical Technology News. The FDA’s final rule was opposed by a significant portion of the laboratory industry, which argued it would slow development of critical diagnostics and force labs to scale back the number of tests they could perform, decreasing patient access to care, according to Medical Technology News. The court remanded the matter to US Health and Human Services Secretary Robert F. Kennedy Jr.
• Medicare payments to Medicare Advantage plans are expected to increase an average of 3.7%, or over $16 billion in 2025, according to the Centers for Medicare & Medicaid Services. Medical and imaging laboratories are likely to benefit from the increase in expenditures. The finalized the Calendar Year 2025 Rate Announcement for Medicare Advantage is projected to result in payments of between $500 and $600 billion in Medicare Advantage payments to private health plans in 2025.

• The Food and Drug Administration (FDA) has finalized a plan to regulate laboratory-developed medical tests due to concerns about reliability and risks to patients. The agency says that inaccurate results may force patients to unnecessarily start a new treatment or delay care. Major industry players, including academic medical centers that develop their own tests and large commercial laboratories, have opposed the plan, and some analysts expect the opponents to sue the FDA to prevent the new rules from going into effect.
• Medical and imaging laboratory industry revenue increased 6.5% year over year and 1.1% quarter over quarter during the fourth quarter of 2024, according to the US Census Bureau. Medical and imaging laboratory industry employment and average wages for nonsupervisory employees increased slightly during the first three months of 2025, according to the US Bureau of Labor Statistics (BLS). Medical and imaging labs increased prices slightly during 2024, according to the BLS.