Trofile Assay

Trofile Assay A. The “Trofile Assay” is covered for beneficiaries who are HIV-positive and diagnosed with Acquired Immune Deficiency Syndrome (AIDS) who have evidence of viral replication and HIV-1 strain resistance to multiple anti-retroviral agents. B. Medicaid covers “Trofile Assay” for beneficiaries age sixteen (16) and over with the following restrictions/guidelines: 1. The assay is to be obtained only in anticipation of treatment of HIV/AIDS patients with CCR5 antagonist agents who: a) Are “treatment experienced” defined as having been previously treated with anti- retroviral regimen(s), b) Have never received Maraviroc/Selzentry or other CCR5-antagonist agents, and c) Have been deemed to have “virologic failure,” or failed to obtain sufficiently low HIV viral loads despite prior appropriate anti-retroviral therapy. 2. Medicaid covers one (1) assay per beneficiary, per lifetime. Repeated testing or testing in follow-up of therapy with CCR5 agents is not covered. 3. The treating physician has expertise in Infectious Diseases and/or treating HIV patients with anti-retroviral agents; or the treating physician has consulted with an Infectious Disease physician prior to requesting the assay.