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If you have questions about prior authorizations, please call:
Member and Recipient Service Line: 1-877-685-2415
Provider Support Service Line: 1-855-250-1539
Genotyping and Phenotyping Clinical Coverage Policy No.:1S-1 For HIV Drug Resistance Testing
Human Immunodeficiency Virus (HIV) is a ribonucleic acid (RNA) virus characterized by a high replication rate throughout all stages of infection. There are four types of HIV: HIV-1, HIV-2, Human T-cell Lymphotropic Virus (HTLV) type 1, and HTLV type 2. In HIV-1, the reverse transcription enzyme required for replication is error prone, resulting in a high rate of mutations. Viral replication continues in the presence of selective drug(s). This is called drug resistance, and it is one of the most common reasons for failure of HIV therapy. HIV drug resistance testing assesses the HIV strain(s) infecting an individual to determine each strain’s resistance to specific antiretroviral drugs. Two methods are available for testing resistant HIV strains: genotypic and phenotypic. Both isolate the virus from the beneficiary. Genotype tests detect specific mutations in the genome of a beneficiary’s viral isolate that are associated with antiretroviral resistance. Phenotype tests assess how well the beneficiary’s virus grows in the presence of different concentrations of antiretroviral drugs and compares these concentrations with a viral strain used as a control.
Limits
Genotype and phenotype testing for HIV drug resistance is not covered in the following circumstances.
- a. The viral load is less than 1,000 copies/ml.
- b. Combined genotype and phenotype testing for HIV drug resistance is considered investigational but could be considered medically necessary in a complex case where the physician believes both types of testing might provide additional useful information, not provided by one or the other. This will be determined on a case-by-case basis, and with medical documentation supporting why both tests are necessary.The test must be ordered by a treating physician or other qualified treating non-physician practitioner within the scope of their license and in compliance with Medicaid requirements.Coverage is limited to no more than two HIV-1 drug-resistant tissue tests in a 12-month period. If additional testing is needed within a 12-month period, an exception may be requested and must include medical necessity documentation.
The service may be billed on professional or institutional claims.
Place of Service
Inpatient, Outpatient, Office
Additional Service Specifics
CPT 86701 or 86703 is performed initially. CPT 86702 is performed when the results of 86701 are negative and clinical suspicion of HIV-2 exists. CPT 86689 is performed only on samples that show repeated positive results by 86701, 86702, or 86703. Note: The laboratory performing the test(s) shall bill for the service.
How to Submit
N/A - No authorization is required
Resources
Genotyping and Phenotyping Clinical Coverage Policy No.:1S-1 For HIV Drug Resistance Testing
Human Immunodeficiency Virus (HIV) is a ribonucleic acid (RNA) virus characterized by a high replication rate throughout all stages of infection. There are four types of HIV: HIV-1, HIV-2, Human T-cell Lymphotropic Virus (HTLV) type 1, and HTLV type 2. In HIV-1, the reverse transcription enzyme required for replication is error prone, resulting in a high rate of mutations. Viral replication continues in the presence of selective drug(s). This is called drug resistance, and it is one of the most common reasons for failure of HIV therapy. HIV drug resistance testing assesses the HIV strain(s) infecting an individual to determine each strain’s resistance to specific antiretroviral drugs. Two methods are available for testing resistant HIV strains: genotypic and phenotypic. Both isolate the virus from the beneficiary. Genotype tests detect specific mutations in the genome of a beneficiary’s viral isolate that are associated with antiretroviral resistance. Phenotype tests assess how well the beneficiary’s virus grows in the presence of different concentrations of antiretroviral drugs and compares these concentrations with a viral strain used as a control.
Limits
Genotype and phenotype testing for HIV drug resistance is not covered in the following circumstances.
- a. The viral load is less than 1,000 copies/ml.
- b. Combined genotype and phenotype testing for HIV drug resistance is considered investigational but could be considered medically necessary in a complex case where the physician believes both types of testing might provide additional useful information, not provided by one or the other. This will be determined on a case-by-case basis, and with medical documentation supporting why both tests are necessary.The test must be ordered by a treating physician or other qualified treating non-physician practitioner within the scope of their license and in compliance with Medicaid requirements.Coverage is limited to no more than two HIV-1 drug-resistant tissue tests in a 12-month period. If additional testing is needed within a 12-month period, an exception may be requested and must include medical necessity documentation.
The service may be billed on professional or institutional claims.
Place of Service
Inpatient, Outpatient, Office
Additional Service Specifics
CPT 86701 or 86703 is performed initially. CPT 86702 is performed when the results of 86701 are negative and clinical suspicion of HIV-2 exists. CPT 86689 is performed only on samples that show repeated positive results by 86701, 86702, or 86703. Note: The laboratory performing the test(s) shall bill for the service.
How to Submit
N/A - No authorization is required
Resources
Infectious agent enzymatic activity other than virus (eg, sialidase activity in vaginal fluid)
Authorization Guidelines
See the Carolina Complete Health site for specific requirements
Reauthorization Guidelines
See the Carolina Complete Health site for specific requirements
How to Submit
Please submit your request to Carolina Complete Health through Availity
Infectious agent genotype analysis by nucleic acid (DNA or RNA); HIV-1, other region (eg, integrase, fusion)
Authorization Guidelines
See the Carolina Complete Health site for specific requirements
Reauthorization Guidelines
See the Carolina Complete Health site for specific requirements
How to Submit
Please submit your request to Carolina Complete Health through Availity
Infectious agent genotype analysis by nucleic acid (DNA or RNA); cytomegalovirus
Authorization Guidelines
See the Carolina Complete Health site for specific requirements
Reauthorization Guidelines
See the Carolina Complete Health site for specific requirements
How to Submit
Please submit your request to Carolina Complete Health through Availity
Infectious agent genotype analysis by nucleic acid (DNA or RNA); Hepatitis B virus
Authorization Guidelines
See the Carolina Complete Health site for specific requirements
Reauthorization Guidelines
See the Carolina Complete Health site for specific requirements
How to Submit
Please submit your request to Carolina Complete Health through Availity
Infectious agent genotype analysis by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]), mutation identification in targeted region(s)
Authorization Guidelines
Please submit any records and any other information that you believe support the member has met the applicable medical necessity criteria to Trillium.
How to Submit
Please submit your request to EviCore
HIV Tropism Assay
Chemokine receptor 5 (CCR5) and chemokine receptor 4 (CXCR4) are the major chemokine coreceptors used by the human immunodeficiency virus (HIV) to enter into human cells. The HIV tropism assay is a diagnostic test used to determine the viral tropism of HIV-1. The assay can determine whether the HIV infection is CCR5, CXCR4, or dual-or mixed-tropic (D-/Mtropic). Using a small blood sample, this assay amplifies a beneficiary’s HIV genome to make HIV particles specific to the individual beneficiary. These HIV particles are used to infect CCR5- and CXCR4- expressing cell lines. Once the virus infects the cell and undergoes a single round of replication, a receptor gene gives a visible signal that identifies the beneficiary’s viral tropism. A CCR5 co-receptor antagonist is indicated for combination antiretroviral treatment of a beneficiary infected with only CCR5-tropic HIV-1 detectable, who has evidence of viral replication and HIV-1 strains resistant to multiple anti-retroviral agents. CCR5 co-receptor antagonist works by binding to a specific chemokine receptor (CCR5), thus preventing HIV from entering the cell. Note: HIV Tropism testing with a highly sensitive tropism (phenotypic) assay is required for the appropriate use of a CCR5 co-receptor antagonist.
Unit Value
1 unit = 1 test
Limits
CCR5 co-receptor antagonist provides a novel mechanism to inhibit the HIV viral replication cycle. HIV tropism (phenotypic) assay can help determine whether a CCR5 co-receptor antagonist may be an appropriate drug for the beneficiary. Testing must be 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.
Note: HIV Tropism testing with a highly sensitive tropism (phenotypic) assay is required for the appropriate use of a CCR5 co-receptor antagonist.Medicaid will cover a maximum of 1 unit (test) per 12-month period
Exclusions
Medicaid shall not cover HIV tropism (phenotypic) assay for all of the following:
- a. the beneficiary does not meet the specific criteria of this policy;
- b. when using other HIV co-receptor (genotypic) assay techniques; and
- c. to predict disease progression (irrespective of co-receptor antagonist treatment).
Place of Service
Inpatient, Outpatient, Physician's office
How to Submit
N/A - No authorization is required
Resources
Necropsy (autopsy), gross examination only; without CNS
How to Submit
N/A - No authorization is required
Necropsy (autopsy), gross examination only; with brain
How to Submit
N/A - No authorization is required
Necropsy (autopsy), gross examination only; with brain and spinal cord
How to Submit
N/A - No authorization is required
Necropsy (autopsy), gross examination only; infant with brain
How to Submit
N/A - No authorization is required
Necropsy (autopsy), gross examination only; stillborn or newborn with brain
How to Submit
N/A - No authorization is required
Necropsy (autopsy), gross examination only; macerated stillborn
How to Submit
N/A - No authorization is required
Necropsy (autopsy), gross and microscopic; without CNS
How to Submit
N/A - No authorization is required
Necropsy (autopsy), gross and microscopic; with brain
How to Submit
N/A - No authorization is required
Necropsy (autopsy), gross and microscopic; with brain and spinal cord
How to Submit
N/A - No authorization is required
Necropsy (autopsy), gross and microscopic; infant with brain
How to Submit
N/A - No authorization is required
Necropsy (autopsy), gross and microscopic; stillborn or newborn with brain
How to Submit
N/A - No authorization is required
Necropsy (autopsy), limited, gross and/or microscopic; regional
How to Submit
N/A - No authorization is required
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