Clinical Policy Title: Seasonal influenza testing

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1 Clinical Plicy Title: Seasnal influenza testing Clinical Plicy Number: CCP.1330 Effective Date: Octber 1, 2017 Initial Review Date: August 17, 2017 Mst Recent Review Date: August 1, 2018 Next Review Date: August 2019 Plicy cntains: Seasnal influenza Related plicies: Nne. ABOUT THIS POLICY: Prestige Health Chice has develped clinical plicies t assist with making cverage determinatins. Prestige Health Chice s clinical plicies are based n guidelines frm established industry surces, such as the Centers fr Medicare & Medicaid Services (CMS), state regulatry agencies, the American Medical Assciatin (AMA), medical specialty prfessinal scieties, and peer-reviewed prfessinal literature. These clinical plicies alng with ther surces, such as plan benefits and state and federal laws and regulatry requirements, including any state- r plan-specific definitin f medically necessary, and the specific facts f the particular situatin are cnsidered by Prestige Health Chice when making cverage determinatins. In the event f cnflict between this clinical plicy and plan benefits and/r state r federal laws and/r regulatry requirements, the plan benefits and/r state and federal laws and/r regulatry requirements shall cntrl. Prestige Health Chice s clinical plicies are fr infrmatinal purpses nly and nt intended as medical advice r t direct treatment. Physicians and ther health care prviders are slely respnsible fr the treatment decisins fr their patients. Prestige Health Chice s clinical plicies are reflective f evidence-based medicine at the time f review. As medical science evlves, Prestige Health Chice will update its clinical plicies as necessary. Prestige Health Chice s clinical plicies are nt guarantees f payment. Cverage plicy Prestige Health Chice cnsiders the diagnsis f seasnal influenza by labratry assay (e.g., viral culture, rapid antigen, direct and indirect immunflurescence assays, and reverse-transcriptase plymerase chain reactin-based testing) t be clinically prven and therefre medically necessary when: Results f the assay will influence management decisins such as initiating antiviral and/r antibacterial therapy, perfrming ther diagnstic tests, and/r implementing infectin cntrl measures in patients including but nt limited t (Center fr Disease Cntrl, 2016; Abraham, 2016; Nichlsn, 2014; Pz, 2013; Petrzzin, 2010; Infectius Diseases Sciety f America, 2009) Children <2 years f age. Adults 65 years f age. Persns with chrnic illness. 1

2 Persns with immunsuppressin (e.g., human immundeficiency virus infectin) Wmen wh are pregnant r within 2 weeks pstpartum. Persns <19 years f age wh are receiving lng-term aspirin therapy. American Indians/Alaska Natives. Persns wh are mrbidly bese (i.e., basal metablic index 40). Persns wh are institutinalized (e.g. nursing hmes). Limitatins: Cverage determinatins are subject t benefit limitatins and exclusins as delineated by the state Medicaid authrity. The Flrida Medicaid website may be accessed at All ther uses f labratry assay fr diagnsis f seasnal influenza in adults and children are nt medically necessary. Alternative cvered services: In-netwrk rutine and preventive health services by a primary care r specialty prvider. Backgrund Influenza is an acute respiratry illness caused by influenza A r B viruses that ccurs in utbreaks and epidemics wrldwide, mainly in the winter seasn. During an influenza utbreak, acute febrile respiratry illnesses can be diagnsed as influenza with a high degree f certainty by clinical criteria (Ebell, 2012). In cmparisn, spradic cases f influenza cannt be differentiated frm infectins caused by ther respiratry viruses n clinical grunds alne. Influenza diagnstic tests include viral culture, immunflurescence assays, rapid antigen immunassays, and reverse-transcriptase plymerase chain reactin-based testing (Petrzzin, 2010). Amng these, reverse-transcriptase plymerase chain reactin-based testing is the mst sensitive and specific thugh there are cnstraints f expense and adequate labratry facility and persnnel that can impact access. Rapid antigen and immunflurescence testing (e.g., lateral flw tests such as QuickVu ) can be perfrmed at the site f patient care such as the physicians ffice r emergency department. Early diagnsis at the pint-f-care can have a psitive impact n the efficacy f therapy (in general, earlier treatment is mre effective than later) but these tests are cnstrained by a lack f test sensitivity (Abraham, 2016; Nichlsn 2014, Petrzzin, 2010). Given the limited sensitivity f the rapid antigen tests fr influenza, a negative result shuld be interpreted with cautin given the ptential fr a false-negative result and empiric treatment fr mst 2

3 symptmatic patients may be a fregne cnclusin whether testing is cnducted r nt (Abraham, 2016). Searches Prestige Health Chice searched PubMed and the databases f: UK Natinal Health Services Centre fr Reviews and Disseminatin. Agency fr Healthcare Research and Quality s Natinal Guideline Clearinghuse and ther evidence-based practice centers. The Centers fr Medicare & Medicaid Services. We cnducted searches n June 11, Search terms were: seasnal influenza. We included: Systematic reviews, which pl results frm multiple studies t achieve larger sample sizes and greater precisin f effect estimatin than in smaller primary studies. Systematic reviews use predetermined transparent methds t minimize bias, effectively treating the review as a scientific endeavr, and are thus rated highest in evidence-grading hierarchies. Guidelines based n systematic reviews. Ecnmic analyses, such as cst-effectiveness, and benefit r utility studies (but nt simple cst studies), reprting bth csts and utcmes smetimes referred t as efficiency studies which als rank near the tp f evidence hierarchies. Findings There is scant medical evidence in supprt f rutine pint-f-care testing fr influenza in adults and children presenting with acute febrile respiratry cnditins. Mst analyses d nt supprt rutine r screening use f pint-f-care tests fr influenza; nr d they find cmpelling evidence f efficacy with regard t imprved prescribing f anti-viral medicatins, avidance f rganism resistance, r in imprved clinical utcmes in either adult r child. The Centers fr Disease Cntrl and Preventin (2016) and the Infectius Diseases Sciety f America (2009) have prmulgated guidelines regarding influenza testing and treatment. The Centers fr Disease Cntrl and Preventin identify reverse-transcriptase plymerase chain reactin-based testing as a preferred methd, and nte the current drawbacks f rapid testing mdalities. The Infectius Diseases Sciety f America is mre patient-fcused and identifies wh and when t test and treat. Plicy updates: We did nt identify any new relevant publicatins in Plicy ID changed frm t CCP

4 Summary f clinical evidence: Citatin Centers fr Disease Cntrl and Preventin (2016) Guidance fr clinicians n the use f RT-PCR and ther mlecular assays fr diagnsis f influenza virus infectin Abraham (2016) Influenza in the Emergency Department: vaccinatin, diagnsis, and treatment: clinical practice paper apprved by American Academy f Emergency Medicine Clinical Guidelines Cmmittee. Nichlsn (2014) Cntent, Methds, Recmmendatins Key pints: Influenza testing is nt needed fr all patients with signs and symptms f influenza t make antiviral treatment decisins but is mst apprpriate fr hspitalized patients if a psitive test wuld result in a change in clinical management. Mlecular assays such as reverse-transcriptase plymerase chain reactin are particularly useful t identify influenza virus infectin as a cause f respiratry utbreaks in institutins (e.g., nursing hmes, chrnic care facilities, and hspitals). Althugh reverse-transcriptase plymerase chain reactin is the mst sensitive influenza test and is highly specific, negative results can ccur in persns with influenza fr multiple reasns, s negative reverse-transcriptase plymerase chain reactin results may nt always exclude a diagnsis f influenza. Rapid mlecular assays and sme cmmercially available mlecular assays can prduce results in a reasnable time perid t infrm clinical management (ranging frm apprximately 20 minutes t less than 1.5 hurs). Reprted sensitivities f available rapid mlecular assays range frm %. As with ther mlecular diagnstic tests, if treatment is clinically indicated, antiviral treatment shuld nt be withheld frm patients with suspected influenza while awaiting testing results during perids f peak influenza activity in the cmmunity when the likelihd f influenza is high. Key pints: Key pints: A systematic review inclusive f 163 articles fund rapid antigen detectin fr influenza is a simple bedside test with high specificity, but generally lw sensitivity. The authrs cncluded that if a patient presents with a syndrme cnsistent with influenza and has negative rapid antigen detectin, they shuld either receive a cnfirmatry reverse transcriptase plymerase chain reactin r be treated as if they have influenza. Randmized cntrlled trial and health ecnmic evaluatin f the impact f diagnstic testing fr influenza, respiratry syncytial virus and Streptcccus pneumniae infectin n the management f acute admissins in the elderly and high-risk 18- t 64-yearlds. A systematic review and meta-analysis evaluated the diagnstic accuracy and clinical effectiveness and cst-effectiveness f rapid mlecular and near-patient diagnstic tests fr influenza, respiratry syncytial virus and Streptcccus pneumniae infectins in cmparisn with traditinal labratry culture. The authrs evaluated diagnstic accuracy fr influenza and pneumcccal infectin, reverse-transcriptase plymerase chain reactin fr influenza and sputum culture fr S. pneumniae using samples cllected during the randmized cntrlled trials. There was n evidence f assciatin between diagnstic grup and prescribing r clinical utcmes. Using plymerase chain reactin as "gld standard," Quidel Influenza A + B pint-fcare testing detected 24.4% [95% cnfidence interval (CI) 16.0% t 34.6%] f influenza infectins (specificity 99.7%, 95% CI 99.2% t 99.9%); viral culture detected 21.6% 4

5 Citatin Pz (2013) Guidance fr clinical and public health labratries testing fr influenza virus antiviral drug susceptibility in Eurpe. Ebell (2012) Develpment and validatin f a clinical decisin rule fr the diagnsis f influenza. Fire (2011) Cntent, Methds, Recmmendatins (95% CI 13.5% t 31.6%; specificity 99.8%, 95% CI 99.4% t 100%). Using bld culture as "gld standard," BinaxNOW pneumcccal pint-f-care testing detected 57.1% (95% CI 18.4% t 90.1%) f pneumcccal infectins (specificity 92.5%; 95% CI 90.6% t 94.1%); sputum culture detected 100% (95% CI 2.5% t 100%; specificity 97.2%, 95% CI 94.3% t 98.9%). Overall, pled estimates f sensitivity and specificity f pint-f-care tests fr influenza frm the literature were 74% (95% CI 67% t 80%) and 99% (95% CI 98% t 99%), respectively. Median intervals frm specimen cllectin t test result were 15 minutes [interquartile range (IQR) minutes) fr Quidel Influenza A + B pint-f-care tests, 20 minutes (IQR minutes) fr BinaxNOW pneumcccal pint-f-care tests, 50.8 hurs (IQR hurs) fr semi-nested cnventinal plymerase chain reactin, 29.2 hurs (IQR hurs) fr real-time plymerase chain reactin, hurs (IQR hurs) fr culture f influenza and 84.4 hurs (IQR hurs) and 71.4 hurs (IQR hurs) fr culture f S. pneumniae in bld and sputum, respectively. Csts and quality-adjusted life-years f each diagnstic strategy were similar. Key pints: Guidelines frm the Eurpean Unin and ther Eurpean Ecnmic Area cuntries n hw and when t test fr influenza virus antiviral drug susceptibility. Phentypic neuraminidase enzyme inhibitin assays are recmmended t determine the level f inhibitin f the neuraminidase enzyme by antiviral drugs as a measure f drug susceptibility f the virus. Gentypic assays are recmmended t identify amin acid substitutins in the neuraminidase and M2 in-channel prteins that have been assciated with reduced antiviral susceptibility previusly. Pririty shuld be given t testing fr neuraminidase inhibitr susceptibility. Key pints: A narrative review prmted a clinical decisin rule t imprve the accuracy f a diagnsis f influenza that culd help clinicians avid unnecessary use f diagnstic tests and treatments. The simple heuristics (fever and cugh; fever, cugh, and acute nset) were helpful when psitive but nt when negative. The mst useful and accurate clinical rule assigned 2 pints fr fever plus cugh, 2 pints fr myalgias, and 1 pint each fr duratin <48 hurs and chills r sweats. The risk f influenza was 8% fr 0 t 2 pints, 30% fr 3 pints, and 59% fr 4 t 6 pints; the rule perfrmed similarly in derivatin and validatin grups. Apprximately tw-thirds f patients fell int the lw- r high-risk grup and wuld nt require further diagnstic testing. Key pints: Antiviral agents fr the treatment and chemprphylaxis f influenza --- Recmmendatins frm the Centers fr Disease Cntrl s Advisry Cmmittee n Immunizatin Practices regarding the use f antiviral agents fr the preventin and treatment f influenza summarizes chemprphylaxis f influenza virus infectin and prvides a summary f the effectiveness and safety f antiviral treatment medicatins. 5

6 Citatin recmmendatins f the Advisry Cmmittee n Immunizatin Practices (ACIP). Ebell (2011) A systematic review f clinical decisin rules fr the diagnsis f influenza. Petrzzin (2010) Rapid diagnstic testing fr seasnal influenza: an evidence-based review and cmparisn with unaided clinical diagnsis. Infectius Diseases Sciety f America (2009) Guidelines fr the management f seasnal influenza Cntent, Methds, Recmmendatins The Centers fr Disease Cntrl advises n the use f: 1) Early antiviral treatment f suspected r cnfirmed influenza amng persns with severe influenza (e.g., thse wh have severe, cmplicated, r prgressive illness r wh require hspitalizatin); 2) Early antiviral treatment f suspected r cnfirmed influenza amng persns at higher risk fr influenza cmplicatins; and 3) Either seltamivir r zanamivir fr persns with influenza caused by 2009 H1N1 virus, influenza A (H3N2) virus, r influenza B virus r when the influenza virus type r influenza A virus subtype is unknwn; 4) Antiviral medicatins amng children aged <1 year; 5) Lcal influenza testing and influenza surveillance data, when available, t help guide treatment decisins; and 6) Cnsideratin f antiviral treatment fr utpatients with cnfirmed r suspected influenza wh d nt have knwn risk factrs fr severe illness, if treatment can be initiated within 48 hurs f illness nset. Key pints: A systematic review and meta-analysis evaluated the accuracy f multivariate mdels, clinical decisin rules, r simple heuristics fr the diagnsis f influenza. Simple heuristics such as the s-called fever and cugh rule and the fever, cugh, and acute nset rule were each evaluated by several studies in ppulatins f adults and children. The areas under the receiver perating characteristic curves were 0.70 and 0.79, respectively. The authrs culd nt calculate a single summary estimate as the diagnstic threshld varied amng studies. Key pints: A systematic review fund that a prprietary assay (QuickVue ) diagnstic specificity exceeds that f unaided clinical diagnsis by 29 31%. False-psitive results ccur apprximately 8.2 times mre frequently by unaided clinical diagnsis than by the rapid influenza test alne. These findings were unaffected by seasnal variatins in disease prevalence. Rapid influenza tests reduce diagnstic testing, antibitic use, and emergency department utilizatin while increasing antiviral prescriptin rates. N systematic relatinship between the bradness f clinical diagnstic criteria fr influenza and diagnstic perfrmance was bserved acrss studies. The authrs cncluded that use f rapid influenza tests imprves seasnal influenza diagnstic specificity abve that based n unaided clinical diagnsis irrespective f the bradness f clinical diagnstic criteria, and affects clinical decisin-making. Key pints: If the result will influence clinical management (decisins n initiatin f antiviral treatment, impact n ther diagnstic testing, antibitic treatment decisins, and infectin cntrl practices), with cnsideratin fr the sensitivity and specificity f the test used and infrmatin abut lcal influenza virus circulatin, the fllwing persns shuld be cnsidered fr influenza testing: 6

7 Citatin Cntent, Methds, Recmmendatins During influenza seasn a. Outpatient immuncmpetent persns f any age at high risk fr cmplicatins f influenza (e.g., hspitalizatin r death) presenting with acute febrile respiratry symptms, within five days f illness nset, when virus is usually being shed. Persns at high risk f cmplicatins frm influenza wh shuld be cnsidered fr antiviral therapy. b. Outpatient immuncmprmised persns f any age presenting with febrile respiratry symptms, irrespective f time frm illness nset, because immuncmprmised persns can shed influenza viruses fr weeks t mnths. c. Hspitalized persns f any age (immuncmpetent r immuncmprmised) with fever and respiratry symptms, including thse with a diagnsis f cmmunity-acquired pneumnia, irrespective f time frm illness nset. d. Elderly persns and infants presenting with suspected sepsis r fever f unknwn rigin, irrespective f time frm illness nset. e. Children with fever and respiratry symptms presenting fr medical evaluatin, irrespective f time frm illness nset. f. Persns f any age wh develp fever and respiratry symptms after hspital admissin, irrespective f time frm illness nset. g. Immuncmpetent persns with acute febrile respiratry symptms wh are nt at high risk f develping cmplicatins secndary t influenza infectin may be tested fr purpses f btaining lcal surveillance data. References Prfessinal sciety guidelines/ther: Abraham MK, Perkins J, Vilke GM, Cyne CJ. Influenza in the Emergency Department: Vaccinatin, Diagnsis, and Treatment: Clinical Practice Paper Apprved by American Academy f Emergency Medicine Clinical Guidelines Cmmittee. J Emerg Med Mar;50(3): di: /j.jemermed Epub 2016 Jan 4. Review. PubMed PMID: Center fr Disease Cntrl (CDC). Seasnal influenza (flu). Guidance fr Clinicians n the Use f RT-PCR and Other Mlecular Assays fr Diagnsis f Influenza Virus Infectin. February 20, CDC website: Accessed June 11, Fire AE, Fry A, Shay D, Gubareva L, Bresee JS, Uyeki TM; Centers fr Disease Cntrl and Preventin (CDC). Antiviral agents fr the treatment and chemprphylaxis f influenza --- recmmendatins f the Advisry Cmmittee n Immunizatin Practices (ACIP). MMWR Recmm Rep Jan 21;60(1):1-24. PubMed PMID:

8 Infectius Diseases Sciety f America (IDSA). Guidelines fr the management f seasnal influenza. IDSA website: /Viruses/Influenza/#recmmendatins. Accessed June 11, Peer-reviewed references: Ebell MH, Afns AM, Gnzales R, Stein J, Gentn B, Senn N. Develpment and validatin f a clinical decisin rule fr the diagnsis f influenza. J Am Bard Fam Med. 2012;25(1): Ebell MH, Afns A. A systematic review f clinical decisin rules fr the diagnsis f influenza. Ann Fam Med. 2011;9(1):69-77 Nichlsn KG, Abrams KR, Batham S, et al. Randmized cntrlled trial and health ecnmic evaluatin f the impact f diagnstic testing fr influenza, respiratry syncytial virus and Streptcccus pneumniae infectin n the management f acute admissins in the elderly and high-risk 18- t 64- year-lds. Health Technl Assess. 2014;18(36):1-274, vii-viii. Pz F, Lina B, Andrade HR, et al; Cmmunity Netwrk f Reference Labratries fr Human Influenza in Eurpe. Guidance fr clinical and public health labratries testing fr influenza virus antiviral drug susceptibility in Eurpe. J Clin Virl. 2013;57(1):5-12. Petrzzin JJ, Smith C, Atkinsn MJ. Rapid diagnstic testing fr seasnal influenza: an evidence-based review and cmparisn with unaided clinical diagnsis. J Emerg Med. 2010;39(4): e1. Natinal Cverage Determinatins: N Natinal Cverage Determinatins identified as f the writing f this plicy. Lcal Cverage Determinatins: A Influenza diagnstic tests Cmmnly submitted cdes Belw are the mst cmmnly submitted cdes fr the service(s)/item(s) subject t this plicy. This is nt an exhaustive list f cdes. Prviders are expected t cnsult the apprpriate cding manuals and bill accrdingly. CPT Cde Descriptin Cmments Infectius agent detectin by nucleic acid (DNA r RNA); influenza virus, includes reverse transcriptin, when perfrmed, and amplified prbe technique, 8

9 CPT Cde Descriptin Cmments each type r subtype Infectius agent detectin by nucleic acid (DNA r RNA); influenza virus, fr multiple types r sub-types, includes multiplex reverse transcriptin, when perfrmed, and multiplex amplified prbe technique, first 2 types r sub-types Infectius agent detectin by nucleic acid (DNA r RNA); influenza virus, fr multiple types r sub-types, includes multiplex reverse transcriptin, when perfrmed, and multiplex amplified prbe technique, each additinal influenza virus type r sub-type beynd 2 (List separately in additin t cde fr primary prcedure) Infectius agent antigen detectin by immunassay with direct ptical bservatin; Influenza Infectius agent antigen detectin by immunflurescent technique; influenza B virus Infectius agent antigen detectin by immunflurescent technique; influenza A virus ICD-10 Cde Descriptin Cmments N/A N Applicable Cdes HCPCS Level II Cde N/A Descriptin N Applicable Cdes Cmments 9