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July 14, 2014

Clinical Laboratory Improvement Amendments (CLIA): Requirements

Under the Clinical Laboratory Improvement Amendments (CLIA) legislation, Medicare requires entities that perform clinical laboratory testing to be certified by the Secretary of the Department of Health and Human Services (DHHS).  This includes laboratory testing performed in physician offices as well as by independent clinical laboratories.  CLIA certificates are issued through designated state agencies. 

The CLIA program has five types of laboratory certifi­cates:

Certificate Type

Description

Certificate of Waiver  (CW)

Issued to a laboratory to perform only waived tests.  Waived tests are those tests that have been determined so simple and accurate that there is little risk of error if the test is performed incor­rectly. Examples of waived tests include certain testing methods for glucose and cholesterol, pregnancy tests, fecal occult blood tests, and some urine tests. Routine on-site surveys are not required for a CW Certificate un­less there is a complaint but the laboratory must follow the manufacturer’s instructions for test performance.

Provider-Performed Microscopy Procedures (PPMP)

Issued to a laboratory in which a physician, midlevel practitioner or dentist performs no tests other than the microscopy procedures. This certificate permits the laboratory to also perform waived tests.  This certificate permits the labora­tory to also perform waived tests. Routine on-site surveys are not required for a PPMP Certificate, but these laboratories are subject to moderate complexity requirements and can be surveyed as part of a routine survey for non-waived tests or a complaint is alleged.

Certificate of Registration (COR)

Issued to a laboratory that enables the entity to conduct moderate or high complexity laboratory testing or both until the entity is determined by survey to be in compliance with the CLIA regulations

Certificate of Compliance (COC)

Issued to a laboratory after an inspection that finds the laboratory to be in compliance with all applicable CLIA requirements.  Laboratories with a Certificate of Compliance that perform moderate and/or high complexity testing are required to be surveyed biennially. Surveys are conducted by CMS or its agent and are outcome- ori­ented. CMS conducts surveys to determine a labora­tory’s regulatory compliance and assist laboratories in improving patient care through education and by emphasizing those standards that will have a direct im­pact on the laboratory’s quality test performance. The surveyor determines whether the laboratory is meeting the requirements of the CLIA regulations based on:

  • Observation of the laboratory’s (past and current) practices;
  • Interviews with the laboratory’s personnel; and
  • Review of the laboratory’s relevant documented records.

Certificate of Accreditation (COA)

Issued to a laboratory that performs moderate and/or high complexity testing and that meets the standards of a private non-profit accreditation program approved by CMS may file for a COA. Approved non-profit accreditation programs are programs that are determined by CMS to have requirements that are equal to or more stringent than those of the CLIA program. The accreditation program inspects the laboratory on a biennial basis. There are six CMS approved accrediting organizations. Periodically, each organization must be re-approved to ensure equivalency is maintained and each year CMS evaluates their performance in enforcing CLIA requirements to verify that it is sustained.

To obtain a CLIA certificate, contact the appropriate entity for the state in which you are providing services:

State of Ohio:
Ohio Department of Health
Laboratory Certification Number
246 N. High St.
Columbus, OH 43215
Telephone: 614-564-1845
Fax: 614-564-2478
E-mail: CLIA@odh.ohio.gov

State of Kentucky:
Kentucky CLIA Program
Office of Inspector General
275 E. Main St., 5E-A
Frankfort, KY 40621
Telephone: 502-564-7963, extension 3305
Fax: 502-564-6546
Contact: Kerri Verden, KerriL.Verden@ky.gov

Submitting claims for laboratory tests:

  • Some, but not all, CLIA-waived tests must be submitted with HCPCS modifier QW.  Some common tests that do not require HCPCS modifier include: CPT codes 81002, 81025, 82270, 82272, 82962, 83026, 84830, 85013, and 85651.
  • Access the list of CLIA-waived testsExternal Website from the CMS website, under Downloads.
  • The “CPT Code” column indicates whether HCPCS modifier QW applies.
  • If HCPCS modifier QW applies, submit this modifier first, and any other applicable modifiers next.
  • Submit the CLIA number for the location where the test was performed:
    • Electronic claims: Loop 2300 or 2400, REF/X4, 02
    • Paper claims: Item 23

Reference:

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