Clinical Laboratory Improvement Amendments (CLIA) ID

UnitedHealthcare® Commercial and Individual Exchange

Reimbursement Policy

CMS 1500

Policy Number 2024R6000B

Clinical Laboratory Improvement Amendments (CLIA) ID Requirement Policy,

Professional

IMPORTANT NOTE ABOUT THIS REIMBURSEMENT POLICY

You are responsible for submission of accurate claims. This reimbursement policy is intended to ensure that you are

reimbursed based on the code or codes that correctly describe the health care services provided. UnitedHealthcare

reimbursement policies may use Current Procedural Terminology (CPT®*), Centers for Medicare and Medicaid Services

(CMS) or other coding guidelines. References to CPT or other sources are for definitional purposes only and do not imply

any right to reimbursement.

This reimbursement policy applies to all health care services billed on CMS 1500 forms and, when specified, to those billed

on UB04 forms. Coding methodology, industry-standard reimbursement logic, regulatory requirements, benefits design and

other factors are considered in developing reimbursement policy.

This information is intended to serve only as a general reference resource regarding UnitedHealthcare’s reimbursement

policy for the services described and is not intended to address every aspect of a reimbursement situation. Accordingly,

UnitedHealthcare may use reasonable discretion in interpreting and applying this policy to health care services provided in

a particular case. Further, the policy does not address all issues related to reimbursement for health care services provided

to UnitedHealthcare enrollees. Other factors affecting reimbursement may supplement, modify or, in some cases,

supersede this policy. These factors may include, but are not limited to: legislative mandates, the physician or other provider

contracts, the enrollee’s benefit coverage documents and/or other reimbursement, medical or drug policies. Finally, this

policy may not be implemented exactly the same way on the different electronic claims processing systems used by

UnitedHealthcare due to programming or other constraints; however, UnitedHealthcare strives to minimize these variations.

UnitedHealthcare may modify this reimbursement policy at any time by publishing a new version of the policy on this

Website. However, the information presented in this policy is accurate and current as of the date of publication.

Medical Association

Table of Contents

Application 1

Policy 2

Overview 2

Reimbursement Guidelines 2

Definitions 3

Questions and Answers 3

Attachments 4

Resources 4

History 5

Application

This reimbursement policy applies to services reported using the 1500 Health Insurance Claim Form (a/k/a CMS-1500)

or its electronic equivalent or its successor form. This policy applies to all products, all network and non-network

physicians and other qualified health care professionals, including, but not limited to, non-network authorized and

percent of charge contract physicians and other qualified health care professionals.

UnitedHealthcare® Commercial and Individual Exchange

Reimbursement Policy

CMS 1500

Policy Number 2024R6000B

UnitedHealthcare Commercial

This Reimbursement Policy applies to all UnitedHealthcare Commercial benefit plans.

UnitedHealthcare Individual Exchange

This Reimbursement Policy applies to all Individual Exchange benefit plans.

Policy

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.

Reimbursement Guidelines

Background

CLIA was established to strengthen federal oversight of clinical laboratories to ensure the accuracy and reliability of

patient test results. CLIA applies 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. CLIA regulatory

requirements vary according to the kind of test(s) each laboratory conducts. All entities that meet the definition of a

“Laboratory” under the CLIA statutes and regulations must obtain an appropriate CLIA certificate prior to conducting

patient testing.

Purpose

For purposes of this policy, a valid CLIA Certificate Identification number will be required for reimbursement of clinical

laboratory services reported on a1500 Health Insurance Claim Form (a/k/a CMS-1500) or its electronic equivalent.

Claims Submission Process

Laboratory service providers must ensure that the required CLIA information is submitted using the correct loops,

segments, and associated line level qualifiers (X4 and F4). Please refer to the ANSI X12N 837 Professional Claim

guidelines and the Medicare Claims Processing Manual Chapters 1, 16, 26 and 35 for more information.

Additional information regarding CLIA, applying for or renewing a certificate, or regarding assigned test complexity

levels can be found at the following website.

Clinical Laboratory Amendments (CLIA) Website

Modifier QW

Inclusion of this modifier when any applicable laboratory service is reported on a CMS 1500 claim form will be

necessary to evaluate the claim to determine eligibility for benefit coverage of the laboratory services performed based

UnitedHealthcare® Commercial and Individual Exchange

Reimbursement Policy

CMS 1500

Policy Number 2024R6000B

upon the CLIA certification. Additional information regarding the categorization of laboratory tests by CLIA may be

found at the website below.

CLIA Categorization of Laboratory Tests

Summary

Any claim that does not contain the CLIA ID, invalid ID, and/or the complete servicing provider demographic information

will be considered incomplete and rejected or denied. Claim line edits will also be applied if the lab certification level

does not support the billed service code. Laboratory service providers who do not meet the reporting requirements

and/or do not have the appropriate level of CLIA certification for the services reported will not be reimbursed.

Definitions

Clinical Laboratory Improvement

Amendments (CLIA)

The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory

testing (except research) performed on humans in the U.S. through the

Clinical Laboratory Improvement Amendments (CLIA). In total, CLIA covers

approximately 260,000 laboratory entities. The Division of Clinical Laboratory

Improvement & Quality, within the Quality, Safety & Oversight Group, under

the Center for Clinical Standards and Quality (CCSQ) has the responsibility

for implementing the CLIA Program. More information is available at: Clinical

Laboratory Amendments (CLIA) Website

CLIA Waived Test

As defined by CLIA, waived tests are categorized as “simple

laboratory examinations and procedures that have an insignificant risk

of an erroneous result. https://www.cms.gov/medicare/regulations-

guidance/transmittals/2024-transmittals/r12534cp

Laboratory

The CLIA regulations define a laboratory to be “a facility for the biological,

microbiological, serological, chemical, immunopharmacological,

hematological, biophysical, cytological, pathological, or other examination of

materials derived from the human body for the purposes of providing

information for the diagnosis, prevention, or treatment of any disease or

impairment of, or the assessment of the health of, human beings. These

examinations also include procedures to determine, measure, or otherwise

describe the presence or absence of various substances or organisms in the

body”

Modifier QW

CLIA Waived Test.

Referred Laboratory Test

A billed laboratory service will be considered referred when the testing is

performed by a servicing location other than the billing location. The

appropriate claim line qualifier should be applied to indicate which location

(billing or servicing) on the electronic claim applies to the submitted CLIA ID

for the billed service code.

Referring Laboratory

A credentialed laboratory that receives a specimen to be tested and that

refers the specimen to another credentialed laboratory for performance of the

laboratory test.

Reference Laboratory

A credentialed laboratory that receives a specimen from another, referring

laboratory for testing and that actually performs the test.

UnitedHealthcare® Commercial and Individual Exchange

Reimbursement Policy

CMS 1500

Policy Number 2024R6000B

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,

• 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?

UnitedHealthcare® Commercial and Individual Exchange

Reimbursement Policy

CMS 1500

Policy Number 2024R6000B

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.

Attachments

List of CLIA Waived Tests

https://www.cms.gov/medicare/regulations-guidance/transmittals/2024-

transmittals/r12534cp

Resources

Centers for Medicare and Medicaid Services, CMS Manual System and other CMS publications and services

Centers for Medicare and Medicaid Services, Clinical Laboratory Improvement Amendments (CLIA) publications

US Food and Drug Administration (FDA)

Centers for Disease Control and Prevention (CDC)

ANSI X12N 837 Professional Claim Guidelines

History

4/1/2024

Template Update

• Transferred content to shared policy template that applies to both UnitedHealthcare

Commercial and Individual Exchange benefit plans.

• Updated Application section to indicate this Reimbursement Policy applies to:

o All UnitedHealthcare Commercial benefit plans

o All Individual Exchange benefit plans

3/31/2024

Policy Version Change

Attachments: Updated

History Section: Entries prior to 3/31/2022 archived

1/1/2024

Policy Version Change

Logo Updated

Attachments: Updated

History Section: Entries prior to 1/1/2022 archived

9/5/2023

Policy Version Change

Attachments: Updated

7/6/2023

Policy Version Change

Attachments: Updated

4/10/2023

Policy Version Change

Attachments: Updated

9/26/2022

Policy Version Change

Definitions: Updated

Attachments: Updated

UnitedHealthcare® Commercial and Individual Exchange

Reimbursement Policy

CMS 1500

Policy Number 2024R6000B

6/26/2022

Policy Version Change

Definitions: Updated

Attachments: Updated

8/1/2016–12/31/2016

Policy implemented by UnitedHealthcare Employer & Individual

4/13/2016

Policy approved by the Payment Policy Oversight Committee