A Clinical Laboratory Improvement Amendment (CLIA) Certificate of Waiver is a certification that allows a facility, primarily laboratories, to legally examine a person through waived tests in order to assess health, diagnose, and determine treatment.

• ANSI Electronic Claim: The billing laboratory performs all laboratory testing.

• The independent laboratory submits a single claim for CLIA-covered laboratory tests and reports the billing laboratory’s number in:

• X12N 837 (HIPAA version) loop 2300, REF02. REF01 = X4

• ANSI Electronic claim: billing laboratory performs some laboratory testing; some testing is referred to another laboratory. This means the lab can only conduct simple testing that involves uncomplicated laboratory procedures and examinations. Tests other than waived tests cannot be performed. An example of a waived test is the popular blood glucose testing device used to monitor blood glucose levels at home.
• To access the full list of waived tests, visit the FDA website.

• The clinical diagnostic laboratory will not have to submit separate claims for referred and performed services. The CLIA numbers from both the billing and reference laboratories must be submitted on the same claim. The presence of the ‘90’ modifier at the line item service identifies the referral tests. Referral laboratory claims are only permitted for independently billing clinical laboratories, specialty code 69.
• The billing laboratory submits, on the same claim, tests referred to another (referral/rendered) laboratory, with modifier 90 reported on the line item and reports the referral laboratory’s CLIA number in:

• X12N 837 (HIPAA version) loop 2400, REF02. REF01 = F4

Claim Level CLIA  (Billing Laboratory)

• The CLIA number must be set up on the Facility.

• If the the CLIA needs to be in HCFA Box 32B, ask Support to add the CLIA Cross Code for HCFA Box 32B.

• For additional information on CLIA, use this (outside) link: https://www.cms.gov/regulations-and-guidance/legislation/clia?redirect=/clia/

Example:

A physician has ordered the DEF independent laboratory to perform glucose testing and tissue typing for a patient. Since the DEF Laboratory is approved to perform only at the routine chemistry LC level (which includes glucose testing), it refers the tissue-typing test to the GHI laboratory.

• The DEF laboratory submits a single claim for the glucose and tissue typing tests; the line item service for the glucose test is submitted without a ‘90’ modifier since the DEF laboratory performed this test. The CLIA number for the DEF laboratory is entered in the electronic claim in:

• X12N 837 (HIPAA version) loop 2300, REF02. REF01 = X4

• On the same claim, the line item service for the tissue typing test is submitted with a ‘90’ modifier and the referral/rendering GHI laboratory’s CLIA number is entered on the electronic claim in:

• X12N 837 (HIPAA version) loop 2400, REF02. REF01 = F4

Procedure Level CLIA  (Referral Laboratory)

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