“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 https://www.cdc.gov/clia/docs/tests-granted-waived-status-under-clia.pdf
Electronic Claim Submission to Carriers
American National Standards Institue (ANSI) X12N 837 (HIPAA version) format electronic claims:
CLIA number:
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
Clia number in CMS 1500
On each claim, the CLIA number of the laboratory that is actually performing the testing must be reported in item 23 on the CMS-1500 form. Referral laboratory claims are permitted only for independently billing clinical laboratories, specialty code 69.
Paper Claim Submission
An independent clinical laboratory may file a paper claim form shall file Form CMS-1500 for a referred laboratory service (as it would any laboratory service). The line item services must be submitted with a modifier 90.
An independent clinical laboratory that submits claims in paper format) may not combine non-referred (i.e., self-performed) and referred services on the same CMS 1500 claim form. When the referring laboratory bills for both non-referred and referred tests, it shall submit two separate claims, one claim for non-referred tests, the other for referred tests. If billing for services that have been referred to more than one laboratory, the referring laboratory shall submit a separate claim for each laboratory to which services were referred (unless one or more of the reference laboratories are separately billing Medicare).
A paper claim that contains both non-referred and referred tests is returned as unprocessable. When the referring laboratory is the billing laboratory, the reference laboratory’s name, address, and ZIP Code shall be reported in item 32 on the CMS-1500 claim form to show where the service (test) was actually performed. The NPI shall be reported in item 32a. Also, the CLIA number of the reference laboratory shall be reported in item 23 on the CMS-1500 claim form. A paper claim that does not have the name, address, and ZIP Code of the reference laboratory in item 32 and NPI in 32a or the CLIA number of the reference laboratory in item 23 is returned as unprocessable.
EXAMPLE: A physician has ordered the ABC Laboratory to perform carcinoembryonic antigen (CEA) and hemoglobin testing for a patient. Since the ABC Laboratory is approved to perform tests only within the hematology LC level (which includes the hemoglobin test), it refers the CEA testing (which is a routine chemistry LC) to the XYZ laboratory.
Result: The ABC laboratory submits a claim for the hemoglobin test and reports its CLIA number in item 23 on the CMS-1500 form. Since the ABC laboratory referred the CEA test to the XYZ laboratory to perform, the ABC laboratory (billing laboratory) submits a second claim for the CEA testing, reporting XYZ’s CLIA number in item 23 on the CMS-1500 form. The XYZ laboratory’s name, address, and ZIP Code are also reported in item 32 and the NPI is reported in item 32a on Form CMS-1500 to show where the service (test) was actually rendered.
NOTE: Effective for claims submitted with a receipt date on and after April 1, 2015, the billing physician or supplier must report the name, address, and NPI of the performing physician or supplier in Item 32a on anti-markup and reference laboratory claims, even if the performing physician or supplier is enrolled in a different B/MAC jurisdiction.
Electronic Claim Submission to A/B MACs (B)
Electronic Claim Submission
SC X12 837 professional claim format (HIPAA compliant version):
CLIA number:
An electronic 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 electronic claim for laboratory testing must be submitted using the following rules:
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
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
Reference Laboratory’s Address:
An electronic claim for laboratory testing requires the presence of the performing and billing laboratory’s, name and address. The performing laboratory for a service with a line item CPT 90 modifier requires provider information for the appropriate 837 loop.
NOTE: Effective for claims submitted with a receipt date on and after April 1, 2015, the billing physician or supplier must report the name, address, and NPI of the performing physician or supplier on the claim on reference laboratory claims, even if the performing physician or supplier is enrolled in a different B/MAC jurisdiction. See Pub. 100-04, Chapter 1, § 10.1.1 for more information regarding claims filing jurisdiction.
http://www.cms1500claimbilling.com/2016/07/clia-number-on-ub-04-form.html