Background

70.1 - Background (Rev. 3014, Issued: 08-06-14, Effective: ICD- 10: Upon Implementation of ICD-10 ASC-X12: 01-01-12, Implementation: ICD-10: Upon Implementation of ICD-10 ASC X12: 09-08-14) The Clinical Laboratory Improvements Amendments of 1988 (CLIA), Public Law 100- 578, amended §353 of the Public Health Service Act (PHSA) to extend jurisdiction of the Department of Health and Human Services to regulate all laboratories that examine human specimens to provide information to assess, diagnose, prevent, or treat any disease or impairment. The purpose of the CLIA program is to assure that laboratories testing specimens in interstate commerce consistently provide accurate procedures and services. As a result of CLIA, any laboratory soliciting or accepting specimens in interstate commerce for laboratory testing is required to hold a valid license or letter of exemption from licensure issued by the Secretary of HHS. The term “interstate commerce” means trade, traffic, commerce, transportation, or communication between any state, possession of the United States, the Commonwealth of Puerto Rico, or the District of Columbia, and any place outside thereof, or within the District of Columbia. The CLIA mandates that virtually all laboratories, including physician office laboratories (POLs), meet applicable Federal requirements and have a CLIA certificate in order to receive reimbursement from Federal programs. CLIA also lists requirements for laboratories performing only certain tests to be eligible for a certificate of waiver or a certificate for Physician Performed Microscopy Procedures (PPMP). Since 1992, A/B MACs (B) have been instructed to deny clinical laboratory services billed by independent laboratories which did not meet the CLIA requirements. POLs were excluded from the 1992 instruction but included in 1997. The CLIA number must be included on each claim billed on the ASC X12 837 professional format or Form CMS-1500 claim for laboratory services by any laboratory performing tests covered by CLIA. See §70.2 and 70.10 for more information.