Skip to main content

Florida Repeals Laboratory Licensure Requirements Effective July 1st

Thousands of laboratories nationwide will be happy to hear that Florida, which licenses in-state as well as out-of-state laboratories, has repealed its laboratory licensure requirements.  As of July 1, 2018, laboratories doing business in Florida need only maintain CLIA certification.

The repeal will save laboratories time and money.  Florida's application process was widely considered to be burdensome for laboratories, due to Florida' lengthy and often confusing initial licensure/renewal application and its change of ownership/control requirements.  If a laboratory failed to meet Florida's strict deadlines for submission, Florida's Agency for Health Care Administration (AHCA) routinely imposed fines and in some cases revoked or denied licensure.  Further, according to the legislative history, as of July 1, 2017, the AHCA licensed over 3,900 laboratories and collected an average of $1.54 million per year in recurring fees and an average of $321,900 per year in recurring biennial assessments.

The repeal also did away with Florida's requirement that laboratories report results directly to the ordering provider or other authorized person, as well as the authorization for laboratories to disclose results without patient consent to other providers involved in the patient's care and treatment.  However, the laboratory-specific kickback provisions remain in effect, and they include the prohibition on providing personnel to perform services in a provider's office or a dialysis facility and on leasing space in a provider's office or a dialysis facility.

Subscribe To Viewpoints

Content Publishers

Karen S. Lovitch

Member / Chair, Health Law Practice

Karen S. Lovitch is a Mintz attorney who represents health care companies in regulatory, transactional, and operational matters. She advises them on health care regulations such as the Stark Law and the Clinical Laboratory Improvement Amendments of 1988.