Real Time RT-PCR, novel influenza A (H1N1) testing (87798) is covered according to the following guidance from the Centers for Disease Control and Prevention (CDC):

The CDC recommends that testing be given to persons with influenza-like illness (ILI) with suspected novel influenza A (H1N1) virus infection when they have severe illness (e.g., hospitalized patients) and patients who are at high risk.

A person who is at high-risk for complications of novel influenza (H1N1) virus infection is defined according to CDC guidance as follows.  As more epidemiologic and clinical data become available, these risk groups may be revised.

• Children younger than 5 years old. The risk for severe complications from seasonal influenza is highest among children younger than 2 years old.
• Persons with the following conditions:
  
  • Chronic pulmonary (including asthma), cardiovascular (except hypertension), renal, hepatic, hematological (including sickle cell disease), neurologic, neuromuscular, or metabolic disorders (including diabetes mellitus);
  • Immunosuppression, including that caused by medications or by HIV;
  • Pregnant women and women who are breast feeding
  • Persons younger than 19 years of age who are receiving long-term aspirin therapy;

Payment may be made for one (1) FDA approved Influenza A H1N1, RNA, RT-PCR test (87798 X 2) per patient per influenza season to identify the H1N1 subtype of the Influenza A virus.  Payment may not be made for simultaneous testing (i.e., Rapid Influenza A and B diagnostic (RIDT) tests [87804, 87275, 87276] at the same time as the H1N1 RT-PCR test [87798]).  However, if rapid testing is performed yielding a positive result for the A-type of influenza, the H1N1 RT-PCR test may be performed subsequently to identify the H1N1 subtype of the Influenza A virus.  Testing in excess of one H1N1 RT-PCR as well as the simultaneous rapid testing and H1N1 RT-PCR testing are considered not medically necessary and noncovered.  A participating, preferred or network provider cannot bill the member for the denied tests in these cases unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost.  The member must agree in writing to assume financial responsibility, in advance of receiving the service.  The signed agreement should be maintained in the provider's records.

No payment may be made for Influenza A and B RNA, QL, RT-PCR tests (87798 X 2) as they have not received FDA approval for commercial use.  A participating, preferred, or network provider cannot bill the member for the denied tests.

Description

A number of different laboratory diagnostic tests can be used for detecting the presence of influenza viruses in respiratory specimens, including direct antigen detection tests, virus isolation in cell culture, or detection of influenza-specific RNA by real-time reverse transcriptase-polymerase chain reaction (RT-PCR).  These tests differ in their sensitivity and specificity in detecting influenza viruses as well as in their commercial availability, the amount of time needed from specimen collection until results are available, and the tests’ ability to distinguish between different influenza virus types (A versus B) and influenza A subtypes (e.g. novel H1N1 versus seasonal H1N1 versus seasonal H3N2 viruses.

Rapid influenza diagnostic tests (RIDTs) are antigen detection tests that detect influenza viral nucleoprotein antigen. Most commercially available RIDTs can provide results within 30 minutes or less. Thus, results are available in a clinically relevant time period to inform clinical decisions. These assays may be referred to as “point-of care” tests.  Commercially available RIDTs can either:  i) detect and distinguish between influenza A and B viruses; ii) detect both influenza A and B but not distinguish between influenza A and B viruses; or, iii) detect only influenza A viruses.  None of the currently FDA approved RIDTs can distinguish between influenza A virus subtypes (e.g. seasonal influenza A (H3N2) versus seasonal influenza A (H1N1) viruses), and RIDTs cannot provide any information about antiviral drug susceptibility. For detection of seasonal influenza A virus infection in respiratory specimens, RIDTs have low to moderate sensitivity compared to viral culture or RT-PCR (i.e., Influenza A and B RNA, QL, RT-PCR).  The sensitivities of RIDTs to detect influenza B viruses are lower than for detection of influenza A viruses. The sensitivities of RIDTs appear to be higher for specimens collected from children than specimens collected from adults.

At this time, there are only two FDA authorized assays for confirmation of novel influenza A(H1N1) virus infection, including the CDC rat-PCR Swine Flu Panel assay and Focus Diagnostics’ (the infectious disease diagnostics business of Quest Diagnostics Incorporated) Influenza A H1N1 (2009) Real Time RT-PCR test.  The Focus Diagnostics test uses reverse transcriptase polymerase chain reaction, or RT-PCR, to amplify viral RNA to make it detectable in a specimen. It targets two separate regions of the hemagglutinin ("H1") gene of the 2009 H1N1 influenza virus to differentiate the presence of the pandemic virus from seasonal human influenza A virus. If RNA of Influenza A virus and the 2009 Influenza H1 gene are detected, the specimen is reported as positive for 2009 H1N1 influenza infection. The expected turnaround time for reporting a result is within approximately 24 hours of receipt of a specimen by the Focus Diagnostics laboratory in Cypress, California.

Centers for Disease Control and Prevention (CDC), Interim Guidance for the Detection of Novel Influenza A Virus Using Rapid Influenza Diagnostic Tests