Diagnostic testing helps health care providers screen for or monitor specific diseases or conditions. It also helps assess patient health to make clinical decisions for patient care. The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certificated by their state as well as the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing. Laboratories can obtain multiple types of CLIA certificates, based on the kinds of diagnostic tests they conduct.
The Food and Drug Administration (FDA), Center for Medicaid Services (CMS) and the Center for Disease Control (CDC). Each agency has a unique role in assuring quality laboratory testing.
All laboratory testing performed on humans with the exception of that conducted for research is regulated by the CMS as designated by the Clinical Laboratory Improvement Amendments (CLIA) of 1988. The CLIA require every “facility that tests human specimens for the purpose of providing information for the diagnosis, prevention, or treatment of disease or impairment of, or the assessment” of health to meet certain federal requirements.
If a pharmacy wishes to provide tests such as hemoglobin A1c or fasting lipid profiles, it is considered a laboratory and must possess a CLIA certificate. Application materials may be downloaded as a Portable Document Format, or PDF, file from the CLIA Web site or may be requested by mail from the CLIA state survey agency. Materials provided include the application form, instructions for completion, commonly performed waived tests, and associated CPT codes.
Additional regulations exist in many states for CLIA-waived testing; therefore, individual state agencies should be consulted for information concerning their requirements. Completed applications should be mailed to the appropriate state agency and will be processed within 30 days. Once obtained, the CLIA waiver must be displayed in the laboratory site designated as the home base.
All reagents, test cassettes, and logbooks must be kept in this site and are subject to inspection. Owing to a new initiative, 2% of CLIA-waived laboratories are subject to annual inspection. Other inspections may be held to investigate complaints or to verify that only waived tests are being performed. In addition to the CLIA-specific regulations, there may be additional state or federal regulations that need to be followed, such as the Occupational Safety and Health Administration regulations.
Although little has been published concerning pharmacists billing using a CLIA waiver, a PIN can be assigned based on their CLIA number. The list of recognized provider or supplier types found at the CMS Web site includes Independent Clinical Laboratory (CLIA). The CLIA laboratories are directed to contact their Medicare carrier for a CMS-855B enrollment application.
An imbedded hot link provides needed contact information for these carriers or can be downloaded on the CMS Web page (www.cms.gov/forms/). A hard copy of the completed form must be mailed to the Medicare carrier. At the same time, the state agencies must be contacted for any additional forms and required information. Some state agencies will provide assistance in Medicaid enrollment. Once the carrier has accepted the application and received proof of the CLIA certificate, billings for laboratory services will be permitted.
Clinical Laboratory Improvement Amendments (CLIA)