Independent Clinical Laboratory Improvement Act (CLIA)

10.2.2.3 – Independent Clinical Laboratory Improvement Act (CLIA) Labs (Rev. 11891; Issued: 03-09-23; Effective: 04-21-23; Implementation: 06-19-23) Independent CLIA labs are a certified supplier type that enroll via the Form CMS-855B. In the context of provider enrollment, it is important to keep in mind when reviewing this section 10.2.2.3 the distinction between (1) a CLIA lab enrolling as an independent Medicare supplier and (2) a different provider/supplier type (e.g., physician group, rural health clinic) that has a CLIA certificate and whose laboratory services are under the same ownership and at the same location as the main provider/supplier. A. General Background Information As explained in CMS Publication (Pub.) 100-07, chapter 6, sections 6000 and 6002, the Clinical Laboratory Improvement Amendments of 1988 amended the Public Health Service Act (42 U.S.C. 263a) to extend jurisdiction of the Department of Health and Human Services (HHS) to regulate all laboratories that test human specimens for the purpose of providing information for diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings. Except as provided at 42 CFR § 493.3, entities that meet the definition of a laboratory at 42 CFR § 493.2 must meet applicable federal requirements and have a CLIA certificate in order to operate. Regulations implementing CLIA are codified under 42 CFR Part 493. These regulations require that all laboratories or entities performing laboratory testing: • Pay user fees as assessed by CMS to finance the entire cost of administering the CLIA program; • Submit specific information to HHS or its designee; • Comply with specific administrative and program requirements; • Submit to surveys to assess compliance with CLIA requirements; • Be subject to specified enforcement actions; and • (1) Apply for CLIA certificates based on the complexity of testing performed in the laboratory or based on accreditation by a CMS-approved accreditation organization, or (2) be licensed or approved in accordance with state requirements if located in a state with a CMS-approved state laboratory licensure program. Section 6141 of the Omnibus Budget Reconciliation Act of 1989 requires that laboratories participating in the Medicare program comply with CLIA requirements. Therefore, all laboratories, with the exception of laboratories located in and licensed or approved by a state with a CMS-approved state laboratory licensure program (CLIA-exempt laboratories) must obtain a CLIA certificate to operate and to be eligible for payment under Medicare and Medicaid. Although CLIA-exempt laboratories do not need a CLIA certificate to operate, they are assigned a CLIA identification number for Medicare and Medicaid payment purposes. As stated in Pub. 100-07, chapter 6, section 6002, certain types of laboratories and laboratory tests are NOT subject to meeting CLIA requirements. These include: • Any facility or component of a facility that performs testing strictly for forensic purposes; • Research laboratories that test human specimens but do not report patient specific results for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of individual patients; • Components or functions of laboratories certified by the Substance Abuse and Mental Health Services Administration (SAMHSA), in which drug testing is performed that meets SAMHSA guidelines and regulations. (However, all other testing conducted by a SAMHSA certified laboratory is subject to this rule.); • Laboratories under the jurisdiction of the Department of Veterans Affairs; • Department of Defense (DoD) laboratories are subject to requirements that CMS has determined to be comparable to those in CLIA. The DoD is responsible for assuring compliance with these requirements and for oversight of its laboratories under a Memorandum of Understanding (MOU) between the Secretary of HHS and the Secretary of DoD; • Laboratory testing conducted in conjunction with the provision of home health or hospice care in an individual’s home, where the home health agency or hospice employee merely assists the individual in performing a test, since tests performed by individuals in the home are not subject to CLIA (see Pub. 100-7, chapter 6, section 6010.1.2.1); • Laboratories located in and licensed or approved by a state with a CMS-approved laboratory licensure program is approved by CMS (i.e., CLIA exempt as approved under 42 CFR part 493, Subpart E); • Facilities which serve only as collection stations. A collection station receives specimens to be forwarded to a laboratory performing diagnostic tests; • Radiological facilities that perform only imaging procedures (e.g., x-rays, ultrasounds, magnetic resonance imaging, computerized tomography); • Facilities performing only physiological testing (e.g., spirometry, slit-lamp test for eyes, breath analysis, pulse oximetry); and • Any facility or component of a facility that performs substance use disorder testing (such as for alcohol and/or drugs) solely for employment purposes (such as disciplinary, administrative, or legal action). B. Certificates See Pub. 100-07, chapter 6, sections 6006 through 6006.7, 6008, and 6014 for information regarding the various types of CLIA certificates. C. Independent CLIA Lab Enrollment 1. Integrated Labs vs. Independent Labs Labs that are “integrated” into an existing provider or supplier do not require a separate Form CMS-855B enrollment. “Integrated” labs typically are those that have exactly the same ownership and physical location as another enrolled supplier or provider. (Common examples include: (1) hospital labs and (2) a lab at a physician's office.) If a lab is considered “integrated,” the parent provider/supplier shall identify the lab as a practice location in Section 4 of its Form CMS-855 and list the applicable CLIA number. If the lab is not “integrated,” the lab must enroll as an independent CLIA lab via the Form CMS- 855B application. The contractor shall advise the lab that it must contact the applicable CLIA office; the lab cannot be enrolled until it receives a CLIA number. The contractor shall also ensure that the lab is CLIA-certified and, as applicable, state-licensed. 2. Additional Enrollment Policies Unless stated otherwise in this chapter or in another CMS directive: i. Practice Locations - Each practice location at which laboratory tests are performed must submit to the contractor a separate CLIA certificate for that location. (This includes applications submitted via PECOS.) The only exceptions to this requirement are: (1) laboratories within a hospital that are located at contiguous buildings, on the same campus, and under common direction; (2) non-profit or governmental laboratories that engage in limited public health testing; and (3) laboratories that are not at a fixed location (i.e., are mobile). ii. States - The laboratory must submit to the contractor a separate certificate for each state in which testing is performed. D. Procedure to Update CLIA Certificate for an Enrolled CLIA Lab A Medicare-enrolled CLIA lab shall submit any updated CLIA certificate to its contractor with a Form CMS-855. E. Site Visits of Independent CLIA Labs 1. Initial and revalidation applications – If an independent CLIA lab submits an initial or revalidation application, the contractor shall order a site visit through PECOS. This is to ensure that the supplier is (or is still) in compliance with CMS’s enrollment requirements. The scope of the site visit will be consistent with sections 10.6.20(A) and 10.6.20(B) of this chapter. The National Site Visit Contractor (NSVC) will perform the site visit. The contractor shall not convey Medicare billing privileges to the supplier (or, in the case of revalidation, make a final decision regarding the application) prior to the completion of the NSVC’s site visit and the contractor’s review of the results. 2. New/changed location - If an independent CLIA lab is (1) adding a new location or (2) changing the physical location of an existing location, the contractor shall order a site visit of the new/changed location through PECOS. This is to ensure that the new/changed location is in compliance with CMS’s enrollment requirements. The scope of the site visit will be consistent with sections 10.6.20(A) and 10.6.20(B) of this chapter. The NSVC will perform the site visit. The contractor shall not switch the supplier’s enrollment record to “Approved” prior to the completion of the NSVC’s site visit and the contractor’s review of the results. F. Additional Information For additional data on CLIA laboratories, refer to: • 42 CFR Part 493 • Pub. 100-07, chapter 6 • Pub. 100-04, chapter 16 • Form CMS-116 (CLIA Application for Certification)