Medical & Imaging Labs NAICS 621511, 621512

Mar 10, 2025 - Support For Rollback Of New Regulations Increases

• The College of American Pathologists (CAP) urged the Department of Health and Human Services (HHS) to revoke laboratory developed test (LDT) oversight regulation developed under the Biden administration. Regulators finalized a policy in early 2024 to treat the tests like medical devices, citing the risks to patients from potentially flawed or inaccurate tests. Regulatory experts see the Trump administration as likely to be sympathetic to labs' requests, in part because HHS blocked the Food and Drug Administration from regulating LDTs during Trump's first term, according to Axios news service. The CAP wants HHS to terminate the regulation in light of an executive order from President Donald Trump that calls for federal agencies to “alleviate unnecessary regulatory burdens.” Labs have until May 6, 2025, to comply with the first phase of the plan and set up a system to report adverse events with tests for COVID-19, cancer genes, heart disease and rare medical conditions, among other things.
• 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 5.4% year over year and 4.2% quarter over quarter during the second quarter of 2024, according to the US Census Bureau. Medical and imaging laboratory industry employment increased slightly while wages for nonsupervisory employees decreased slightly during the first month of 2025, according to the US Bureau of Labor Statistics (BLS). Medical and imaging labs increased prices slightly during 2025, according to the BLS.