CurrentAlliance HealthPolicy 1S-2

HIV Tropism Assay (phenotypic)

This policy governs coverage of HIV-1 tropism (phenotypic) assays for NC Medicaid beneficiaries, specifying when testing is covered, not covered, and any eligibility and procedural requirements.

Policy Summary

PayerAlliance Health

PolicyHIV Tropism Assay (phenotypic)

Policy CodePolicy 1S-2

Change TypeNo material change

Effective Date

Next Review Date

Key ActionOrder a highly sensitive phenotypic tropism assay to confirm CCR5-tropic virus before initiating a CCR5 co-receptor antagonist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

>=1,000minimum viral load

>=2 regimenstreatment failure

No prior approvalprior approval

Required for CCR5phenotypic assay

1/12 monthsmax units

Not coveredgenotypic assays

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Coverage Criteria for HIV Tropism Assay (phenotypic)

Specific criteria covered by Medicaid

Covered when ANY of the following are met:

Specific Coverage Criteria: a. Beneficiary has treatment failure of at least two other Highly Active Antiretroviral Therapy (HAART) regimens; b. Beneficiary has limited or no other treatment options available due to resistance or treatment intolerance and is failing to achieve adequate virologic suppression on their current regimen; c. The assay is used to confirm CCR5-tropic HIV-1 infection prior to initiation of a CCR5 co-receptor antagonist; d. Viral load is at least 1,000 copies/ml; e. Assay may be considered for a beneficiary exhibiting virologic failure on a CCR5 co-receptor antagonist.see node text

From Subsection 3.2.1

General Criteria Covered

Covered when ALL of the following general medical necessity criteria are met:

General Medical Necessity: a. The procedure, product, or service is individualized, specific, and consistent with symptoms or confirmed diagnosis of the illness or injury under treatment, and not in excess of the beneficiary's needs; b. The procedure, product, or service can be safely furnished, and no equally effective and more conservative or less costly treatment is available statewide; c. The procedure, product, or service is furnished in a manner not primarily intended for the convenience of the beneficiary, the beneficiary's caretaker, or the provider.see node text

From Section 3.1

Standard coverage criteria

Covered when ALL of the following are met

Ordering and clinical rationale: Test is ordered by a qualified treating physician or other qualified treating nonphysician practitioner acting within the scope of their license and in compliance with Medicaid requirements; testing is used to determine appropriateness of a CCR5 co-receptor antagonist; a highly sensitive phenotypic tropism assay is required for this purpose.

From Subsection 5.3

Frequency limitation: Medicaid will cover a maximum of 1 unit (test) per 12-month period.1 per 12 months

From Subsection 5.4

Prior authorization: No prior approval is required for HIV tropism (phenotypic) assay.

From Subsection 5.1

Medicaid shall not cover HIV tropism (phenotypic) assay when testing is performed using other HIV co-receptor (genotypic) assay techniques. Claims for tropism testing reported as genotypic co-receptor assays are excluded and may be denied.

Medicaid shall not cover the procedure, product, or service when the beneficiary does not meet Medicaid eligibility (Section 2.0), does not meet the coverage criteria in Section 3.0, or when the service duplicates another provider's procedure, product, or service. Services that are experimental, investigational, or part of a clinical trial are also not covered.

Medicaid Additional Criteria Not Covered: None apply.

There are no place-of-service exclusions for HIV tropism (phenotypic) assay; allowed places of service include inpatient, outpatient, and physician's office as described in the Medicaid billing guidance.

Use of tropism testing solely to predict disease progression, independent of determining suitability for a co-receptor antagonist, is considered not medically necessary and is not covered.

Coding and Billing Codes

Codes (section exists but specific codes not provided in this part)mixed

No codes listed

CPT (Unlisted) CodesCPTCovered

87999

CPT Code(s) = 87999

ICD-10-CM Diagnosis CodesICD-10

B20	Human immunodeficiency virus [HIV] disease (must be primary diagnosis)
Z1624	Secondary diagnosis option
Z1630	Secondary diagnosis option
Z1633	Secondary diagnosis option

Unlisted CPT reportingCPT

Unlisted CPT

Refer to CPT Codebook 'Unlisted Procedure or Service' and include Special Report per current CPT edition

Unlisted HCPCS reportingHCPCS

Unlisted HCPCS

Refer to HCPCS National Level II 'Unlisted Procedure or Service' and include Special Report per current HCPCS edition

inv-14: Viral load — operational threshold for coverage

Operational thresholdViral load (VL) must be at least 1,000 copies/mL for coverage

Context of thresholdApplies when using HIV tropism (phenotypic) assay to evaluate suitability for CCR5 antagonist or other covered indications

Measurement unitsCopies per milliliter (copies/mL) of blood plasma as reported by standard VL assays (eg, bDNA, RT-PCR)

Related coverage nodeOne of several specific criteria; meeting VL >=1,000 copies/mL alone qualifies for coverage if other general medical necessity requirements are met

Provider Actions, Documentation, and Billing Requirements

Prior Authorization

Prior Approval — Not Required

Medicaid shall not require prior approval for HIV tropism (phenotypic) assay.

Prior approval not required for HIV tropism (phenotypic) assay

Billing Rule

Unlisted Procedures / Special Report

Providers must follow CPT/HCPCS instructions for reporting unlisted procedures or services and include the required Special Report documentation per the current CPT and HCPCS editions. Failure to include the Special Report may result in claim processing delays or denials.

Follow CPT 'Unlisted Procedure or Service' and Special Report instructions.
Follow HCPCS 'Unlisted Procedure or Service' and Special Report instructions.

Definitions

inv-31: Co-receptor tropism definition

DefinitionCo-receptor tropism: the ability of a particular HIV-1 virus to infect a target cell using a specific co-receptor (CCR5, CXCR4, or both)

CCR5-tropicVirus infects cells that express only CCR5

CXCR4-tropicVirus infects cells that express only CXCR4

Dual-/Mixed-tropicVirus can infect cells expressing both CCR5 and CXCR4

inv-32: Viral load definition

DefinitionViral load (VL): amount of HIV RNA in a blood sample reported as number of HIV RNA copies per milliliter of blood plasma

Clinical use

Background

HIV-1 enters target cells primarily through the co-receptors CCR5 and CXCR4. Tropism assays are intended to determine whether a beneficiary’s circulating virus is CCR5-tropic, CXCR4-tropic, or dual/mixed, which guides clinical decisions about CCR5 co-receptor antagonist therapy. Phenotypic tropism testing amplifies patient virus and assesses its ability to infect cell lines expressing CCR5 or CXCR4; a highly sensitive phenotypic assay is required to determine suitability for CCR5 antagonist treatment in patients with virologic replication and limited alternative treatment options.

Policy Summary

PayerAlliance Health

PolicyHIV Tropism Assay (phenotypic)

Policy CodePolicy 1S-2

Change TypeNo material change

Effective Date

Next Review Date

Key ActionOrder a highly sensitive phenotypic tropism assay to confirm CCR5-tropic virus before initiating a CCR5 co-receptor antagonist.

SourceLink

On This Page

Include Special Report and all supporting documentation when billing unlisted codes.

Denial Risk

Grounds for Denial

Claims may be denied if the beneficiary does not meet eligibility or coverage criteria, if services duplicate another provider's services, if services are experimental or investigational, or if duplicate services are submitted. Also may be denied for failure to submit required documentation (including Special Report for unlisted codes).

Denial grounds: beneficiary not eligible or does not meet policy criteria.
Denial grounds: duplicate services or experimental/clinical trial services.
Denial grounds: missing required documentation (including Special Report).

Denial Risk

Technique-Specific Noncoverage

HIV tropism (phenotypic) assay using other HIV co-receptor (genotypic) assay techniques is not covered and will be subject to denial.

Genotypic co-receptor assay techniques are not covered under this policy and are subject to denial.

Documentation Required

Eligibility and Medical Necessity Documentation

Verify beneficiary eligibility and document medical necessity per the general criteria. Documentation must show the service is individualized, specific, consistent with the beneficiary's symptoms or confirmed diagnosis, and that no equally effective, more conservative, or less costly treatment is available statewide. For beneficiaries under 21, include EPSDT justification when requesting services beyond standard policy limits.

Document beneficiary eligibility and how the service meets General Criteria (individualized, necessary, safe, not primarily for convenience).
For beneficiaries <21, document EPSDT criteria to justify exceptions to limits.

Documentation Required

Clinical Indications to Document

Document clinical indications supporting coverage: prior failure of at least two HAART regimens OR limited/no other options due to resistance or intolerance with inadequate virologic suppression; intent to use a CCR5 co-receptor antagonist where the assay will confirm CCR5-tropic HIV-1 infection; viral load ≥ 1,000 copies/mL; or virologic failure on a CCR5 co-receptor antagonist.

Prior failure of ≥2 HAART regimens.
Limited/no other options due to resistance or intolerance with failing virologic suppression.
Assay used to confirm CCR5-tropic HIV-1 prior to CCR5 antagonist initiation.
Viral load ≥ 1,000 copies/mL.
Consider assay for beneficiaries exhibiting virologic failure on a CCR5 antagonist.

Step Therapy

Treatment Failure / Step Criteria

Coverage is targeted to beneficiaries who have failed at least two other HAART regimens or who have limited/no other treatment options due to resistance or intolerance. Ensure documentation of prior regimens and failure.

Treatment failure/step criteria: failed ≥2 HAART regimens or limited/no other options due to resistance or intolerance.

Documentation Required

Tropism Testing to Guide CCR5 Antagonist Use

HIV tropism (phenotypic) assay with a highly sensitive phenotypic method is required to guide use of CCR5 co-receptor antagonists. Testing must be ordered by a qualified treating physician or qualified nonphysician practitioner acting within the scope of their license.

Highly sensitive phenotypic assay required before initiating CCR5 co-receptor antagonist.
Testing must be ordered by a qualified treating provider within scope of license.

Billing Rule

Claims and Diagnostic Coding

Providers must comply with NCTracks Provider Claims and Billing Assistance Guide, Medicaid bulletins, fee schedules, and clinical coverage policies. Submit claims as Professional (CMS-1500/837P) or Institutional (UB-04/837I) as appropriate and follow National Uniform Billing Guidelines for institutional claims. Use current ICD-10-CM/PCS codes to the highest level of specificity that supports medical necessity. For HIV diagnosis, report B20 as the primary diagnosis and include one of Z1624, Z1630, or Z1633 as the secondary diagnosis on the claim.

Claim types: Professional (CMS-1500/837P) or Institutional (UB-04/837I).
Institutional claims must follow National Uniform Billing Guidelines.
Report ICD-10-CM codes to highest specificity; use B20 as primary plus Z1624 or Z1630 or Z1633 as secondary.

Billing Rule

Reimbursement Documentation

Provider(s) shall bill their usual and customary charges. For a schedule of rates and reimbursement information, refer to the state Medicaid website.

Bill usual and customary charges.
Refer to state Medicaid rate schedule for reimbursement: https://medicaid.ncdhhs.gov/

Indicator of number of infected cells, disease progression, and treatment response

Assay methodsMeasured by assays such as branched chain DNA (bDNA) and reverse transcriptase-polymerase chain reaction (RT-PCR)

inv-33: Highly sensitive phenotypic tropism assay definition

DefinitionHighly sensitive phenotypic tropism assay: a phenotypic test required to assess HIV co-receptor usage for appropriate use of a CCR5 co-receptor antagonist

PurposeHelps determine whether a CCR5 co-receptor antagonist may be an appropriate drug for the beneficiary

Ordering requirementMust be ordered by a qualified treating physician or qualified treating nonphysician practitioner acting within scope of license and in compliance with Medicaid requirements