CLIA Registration Fees are Increasing

All of us are aware that the price of everything has increased in the last four years, be it food from the store or test tubes for the laboratory. A recent report from the U.S. Department of Labor published June 12th, 2024, shows inflation rates have varied between a low of 3.3% and a high of 7% from 2021-2024 (Current U.S. Inflation Rates: 2000-2024 [usinflationcalculator.com]), or simply put, prices of everything have risen an average of 5% a year over the last four years, making the cost of doing business about 20% higher than it was just four years ago.

The Centers for Medicare & Medicaid Services (CMS), which runs the Clinical Laboratory Improvement Act (CLIA) certification program is not immune to inflationary pressures. The program, which is designed to be self-sustaining by federal statute (Federal Register :: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories), announced a fee increase along with other changes to the laboratory accreditation program in rules published in December of 2023. Beginning January 27, 2024, laboratories will see an approximate 18% increase in the biannual registration fees. The fees are based on both the scope of laboratory activities and the number of tests processed per year (clia-certificate-fee-schedule.pdf [cms.gov]).