CMS Pub. 100-04, ch. 16, § 70.1

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.