“CLIA” - The Clinical Laboratory Improvement Act and CMS implementing regulations and processes.
A paper claim for laboratory testing requires the presence of the CLIA number of the lab performing the testing in field 64 on UB04 form.
If a valid and appropriate CLIA number is not included with the claim as provided in this letter, the entire claim will not be considered a clean claim and will be rejected as incomplete. This process is consistent with the procedure followed by CMS and is applicable to all products offered by MHS.
• Physician office laboratory services follow CLIA regulations and are required to bill the CLIA or Waiver number on each appropriate service.
• A list of CLIA laboratories can be found at www.cdc.gov/clia/Resources/
Electronic Claim Submission to Carriers
American National Standards Institue (ANSI) X12N 837 (HIPAA version) format electronic claims:
An ANSI claim for laboratory testing will require the presence of the performing (and billing) laboratory’s CLIA number; if tests are referred to another laboratory, the CLIA number of the laboratory where the testing is rendered must also be on the claim.
An ANSI electronic claim for laboratory testing must be submitted using the following format:
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.
The ANSI electronic claim will not be split; 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