CurrentDell Children's Health PlanPolicy N/A

CLIA Requirements for Claims Payment

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This policy governs how Dell Children's Health Plan evaluates laboratory claims based on provider CLIA certification, accreditation level, applicable laboratory procedure qualifications, and required modifiers.

Policy Summary

PayerDell Children's Health Plan

PolicyCLIA Requirements for Claims Payment

Policy CodePolicy N/A

Change TypeImplementation of CLIA claim payment requirements

Effective DateAugust 1, 2024

Next Review DateN/A

Key ActionMaintain a valid CLIA certification and ensure the certification level supports the laboratory procedure codes billed.

SourceLink

POLICY UPDATE CHANGES

The plan is implementing CLIA certification status and accreditation-level requirements when processing laboratory claims.

3CLIA accreditation levels addressed

4CLIA-related denial codes

120 daysAppeal filing period

QWWaived-test modifier

CLIA Claim Payment Criteria

Policy Summary

PayerDell Children's Health Plan

PolicyCLIA Requirements for Claims Payment

Policy CodePolicy N/A

Change TypeImplementation of CLIA claim payment requirements

Effective DateAugust 1, 2024

Next Review DateN/A

Key ActionMaintain a valid CLIA certification and ensure the certification level supports the laboratory procedure codes billed.

SourceLink

On This Page

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CurrentDell Children's Health PlanPolicy N/A

CLIA Requirements for Claims Payment

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Sign up for all dellchildrenshealthplan policy alerts

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Policy Summary

PayerDell Children's Health Plan

PolicyCLIA Requirements for Claims Payment

Policy CodePolicy N/A

Change TypeImplementation of CLIA claim payment requirements

Effective DateAugust 1, 2024

Next Review DateN/A

Key ActionMaintain a valid CLIA certification and ensure the certification level supports the laboratory procedure codes billed.

SourceLink

POLICY UPDATE CHANGES

The plan is implementing CLIA certification status and accreditation-level requirements when processing laboratory claims.

3CLIA accreditation levels addressed

4CLIA-related denial codes

120 daysAppeal filing period

QWWaived-test modifier

CLIA Claim Payment Criteria

Policy Summary

PayerDell Children's Health Plan

PolicyCLIA Requirements for Claims Payment

Policy CodePolicy N/A

Change TypeImplementation of CLIA claim payment requirements

Effective DateAugust 1, 2024

Next Review DateN/A

Key ActionMaintain a valid CLIA certification and ensure the certification level supports the laboratory procedure codes billed.

SourceLink

On This Page

CLIA Claim Payment Criteria

Beginning August 1, 2024, laboratory claims are payable only when all applicable CLIA certification, accreditation-level, procedure, modifier, and Laboratory Certification (LC) code requirements are met.

ALL of the following

Provider has a valid CLIA certification on the date of service.
Claims on or after the CLIA certification expiration date will be denied.
The provider's CLIA certification level substantiates the laboratory procedure codes billed.
ONE applicable certification-level pathway
- Waived status: Provider bills approved tests granted waived status under CLIA, including the QW modifier where applicable.
  The approved waived-test list is available at www.cdc.gov/clia/docs/tests-granted-waived-status-under-clia.pdf.
- Partial Accreditation: Provider bills CLIA-waived laboratory codes plus applicable Provider-Performed Microscopy Procedures (PPMP) codes.
  PPMP codes are available at https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/ppmplist.pdf.
- Full Accreditation: Provider may bill all laboratory procedures.
Where applicable, the provider's CLIA certification includes the required Laboratory Certification (LC) codes for the procedure codes billed.
The claims system references the most recent HCPCS crosswalk to verify required LC codes.
If any applicable requirement is not met, the claim is denied.
Denial GP3: Short description—CLIA-PROV NOT CERT.; long description—PROVIDER IS NOT CERTIFIED FOR THE APPROPRIATE PROCEDURE LC CODE. Denial GP4: Short description—CLIA-PROC NOT WAIVED; long description—PROCEDURE IS NOT A WAIVED CODE.

Laboratory Coding Requirements

CLIA-waived test modifierModifierCovered

QW	Modifier used where applicable for approved tests granted waived status under CLIA.

Partial-accreditation procedure codesCPTCovered

PPMP	Provider-Performed Microscopy Procedure codes that may be billed by providers with partial accreditation when applicable.

Laboratory Certification codesHCPCS

LC	Laboratory Certification codes used by the claims system to verify that the provider's CLIA certification supports the laboratory procedure codes billed where applicable.

CLIA-related denial codesmixedNot Covered

GP3	CLIA-PROV NOT CERT; provider is not certified for the appropriate procedure LC code.
GP4	CLIA-PROC NOT WAIVED; procedure is not a waived code.
GP5	CLIA-PROC NOT PPMP; procedure is not a PPMP code.
GP6	CLIA-NO CLIA CERT FOR PROVIDER; no CLIA certification for the provider.

Reconsideration or Appeal

Filing deadlineWithin 120 days of Explanation of Payment (EOP) issuance

Submission methodsPhone, provider portal, or mail

Required appeal documentationInclude a copy of the valid CLIA certificate

Provider Billing Responsibilities

Documentation Required

Maintain valid CLIA certification

Maintain a valid CLIA certification. Claims submitted on or after the certification expiration date will be denied.

Billing Rule

Match procedures to CLIA certification level

Ensure the provider’s CLIA certification level substantiates the laboratory procedure codes billed. Claims may be denied when the certification level does not support the billed procedures.

Billing Rule

Bill approved waived tests

For waived-status testing, bill approved tests granted waived status under CLIA and include the QW modifier where applicable.

Modifier: QW

Billing Rule

Bill within partial accreditation scope

Providers with partial accreditation must bill CLIA-waived laboratory codes plus applicable Provider-Performed Microscopy Procedure (PPMP) codes.

Applicable procedure category: PPMP

Billing Rule

Bill within full accreditation scope

Providers with full accreditation may bill all laboratory procedures.

Documentation Required

Validate LC code eligibility

Verify that the provider’s CLIA certification includes the required Laboratory Certification (LC) codes associated with the procedure codes being billed, where applicable. The claims system references the most recent HCPCS crosswalk for this verification.

Code category: LC

Denial Risk

Address CLIA-related denials

If a CLIA requirement is not met, the claim may be denied under the applicable CLIA denial reason. If you disagree with the denial, submit a reconsideration or appeal within 120 days of the Explanation of Payment (EOP) issuance and include a copy of the valid CLIA certificate.

GP3 — Provider is not certified for the appropriate procedure LC code.
GP4 — Procedure is not a waived code.
GP5 — Procedure is not a PPMP code.
GP6 — No CLIA certification for provider.
Filing methods: phone, provider portal, or mail.

CLIA Terminology

Definitions

CLIAClinical Laboratory Improvement Amendments requirements governing laboratory certification, accreditation, and permitted testing.

Certification focusLaboratory certification status and accreditation level are evaluated when processing laboratory claims.

Testing requirementThe provider's certification level must substantiate the laboratory procedure codes billed.

Definitions

Waived statusA CLIA certification level under which providers may bill approved tests granted waived status.

Billing requirementBill approved waived tests and include the QW modifier where applicable.

Approved testingTests must be granted waived status under CLIA.

Definitions

Partial accreditationA CLIA accreditation level under which providers may bill CLIA-waived laboratory codes plus applicable Provider-Performed Microscopy Procedure (PPMP) codes.

Waived laboratory codesCLIA-waived laboratory codes may be billed under partial accreditation.

PPMP codesApplicable Provider-Performed Microscopy Procedure codes may be billed under partial accreditation.

Definitions

Full accreditationA CLIA accreditation level under which providers may bill all laboratory procedures.

Permitted scopeAll laboratory procedures may be billed when the provider has full accreditation.

Certification supportThe provider's CLIA certification level must substantiate the laboratory procedure codes billed.

Definitions

LC codesLaboratory Certification codes used by the claims system to verify that a provider's CLIA certification supports the laboratory procedure codes billed where applicable.

Eligibility validationThe claims system references the most recent HCPCS crosswalk to validate the required LC codes.

Billing connectionRequired LC codes must be included in the provider's CLIA certification for the procedure codes being billed where applicable.