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Clinical Laboratory Improvement Amendments (CLIA) ID Requirement Policy - Reimbursement Policy - UnitedHealthcare Commercial Plans

Overview

This policy describes the information that is required on certain claims that are reported for laboratory services under the Clinical Laboratory Improvement Amendment (CLIA) 1988 statute and regulations.

All services described in this policy may be subject to additional UnitedHealthcare reimbursement policies including, but not limited to, the CCI Editing Policy, the Laboratory Services Policy, and the Professional/Technical Component Policy.

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* COMM-CLIA-ID-Requirements-Policy.pdf
Click to Download: Clinical Laboratory Improvement Amendments (CLIA) ID Requirement Policy (9/11/2019)

Questions and Answers

Q: How do the Centers for Medicare & Medicaid Services (CMS) determine CLIA applicability?

A: CLIA applicability is determined using the regulatory definition of “laboratory” quoted above. UnitedHealthcare is acknowledging the CDC, FDA, and CMS CLIA regulations.

Specifically, CLIA applies when:

  1. Patient-specific results are reported from the laboratory to another entity; AND
  2. The results are made available “for the diagnosis, prevention, or treatment of any disease or impairment of,or the assessment of the health of, human beings.” As stated above, whether a test service is billed to Medicare has no bearing on CLIA applicability. Therefore, if a facility performs tests for the above-stated purposes, it is considered a laboratory under CLIA and must obtain a certificate that corresponds to the complexity of testing performed.

Q: Where is there more information about the ANSI X12N implementation guidelines?

A: More information can be found at www.x12.org or www.wpc-edi.com.

Q: Will a billed lab service be considered referred even if both labs are wholly or in part owned/operated by the same entity?

A: Yes, the unique CLIA ID and servicing location information is required for every location where testing was performed. (See Referred Laboratory Test and Referring Laboratory definitions for additional information)

Q: Should modifier 90 be applied to all line level service codes for testing referred to another laboratory?

A: Provider should continue to follow the defined coding and billing guidelines for the use of all applicable modifiers.

Q: For the purpose of claim line level submission, how should the X4 and F4 qualifiers be applied?

A: For all billed laboratory services subject to CLIA the as submitted CLIA ID and servicing location will be verified utilizing the CLIA source validation files. The decision to validate using the billing or servicing location submitted on the claim is determined by the qualifier applied to the claim line as follows:

Testing performed at billing location (test not referred):

  • Report the billing laboratory’s CLIA ID number in: Loop 2300, REF02, REF01=X4 for all CLIA-covered laboratory tests submitted on the claim, OR
  • Report the billing laboratory’s CLIA ID number in: Loop 2400, REF02, REF01=X4 for each specific CLIA-covered laboratory tests submitted on the claim,

Testing performed at a location other than the billing location as submitted on the claim (test referred):

  • Report the referral laboratory’s CLIA number in: Loop 2400, REF02, REF01=F4 for CLIA-covered laboratory tests referred to another (referral/rendered) laboratory.

(See Referred Laboratory Test and Referring Laboratory definition for additional information)

Q: Do I need to have CLIA certificate even if I am just performing simple laboratory tests?

A: Yes, the CLIA regulations apply to all laboratories that examine “materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings.” This applies if even one test is to be performed.