CMS Issues Clinical Laboratory Improvement Amendments of 1988 Final Rule
The Department of Health and Human Services (HHS) Centers for Medicare and Medicaid Services (CMS) has issued a final rule that updates the Clinical Laboratory Improvement Amendments of 1988 (CLIA) fees, amends provisions governing alternative sanctions, changes CLIA histocompatibility and personnel requirements, and clarifies CLIA regulations.
The purpose of CLIA is to ensure the accuracy and reliability of laboratory testing. All laboratory testing performed on humans – apart from research – in the United States is regulated by the CMS through CLIA. Currently, around 320,000 laboratory entities in the United States are regulated by CLIA, from small labs in physician offices to large independent laboratories.
The final rule authorizes new fees to cover administrative costs for surveys, including follow-up, specialties, and complaint surveys, as well as desk reviews and certificate replacements. Current fees have been increased by 18% and the cost of the Certificate of Waiver laboratories certificate fee has been increased by $25. The final rule implements changes to the histocompatibility and personnel requirements to incorporate technological changes and address obsolete regulations. One notable update from the proposed rule is the removal of the inclusion of a nursing degree as a qualification for high complexity testing personnel. The CMS removed the qualification following feedback from the American Hospital Association and the College of American Pathologists that argued that nurse training does not provide adequate knowledge and the skills required to interpret complex test results.
The final rule gives the CMS discretion in imposing alternative sanctions such as civil money penalties, a directed plan of correction, a directed portion of a plan of correction, and onsite state monitoring for certificate of waiver (COW) laboratories, instead of being limited to imposing principal sanctions of revocation, suspension or limitation of a laboratory’s CLIA certificate. CoW laboratories only perform waived tests – simple laboratory examinations that have an insignificant risk of an erroneous result. These laboratories have not been subject to routine inspections under the CLIA program.
The majority of the updated regulations are effective on January 27, 2024.
