Art Keel

n engl j med 372;22nejm.orgmay 28, 2015PERSPECTI VE2083Screening for Lung Cancer with Low-Dose CTLung cancer is the third most common cancer and the lead-ing cause of cancer-related deaths intheUnitedStates.Attention to lung cancer is especially rele-vantfortheMedicarepopula-tion, because the median age at diagnosis is 70 years. A suitable screeningtesthaslongbeen soughttoaccuratelydetectlung canceratearlierstages,when treatments are more effective and survivalismorelikely.Current-ly,morethanhalfofcasesare diagnosedafterthecancerhas metastasized.1Althoughlow-dosecomputed tomography (CT) has been stud-iedinseveralscreeningtrials, the National Lung Screening Tri-al (NLST), sponsored by the Na-tionalCancerInstitute,isthe only trial to date that has shown thatscreeningwithlow-doseCT reduceslung-cancermortality.2 Thatstudyprovidedtheprimary evidencetosupportaGradeB recommendation (indicating high certaintythatthenetbenefitis moderateor...moderatecer-taintythatthenetbenefitis moderatetosubstantial)bythe U.S.PreventiveServicesTask Force(USPSTF)oneofthree requirements for adding coverage ofapreventiveservicetothe Medicareprogram.Forsucha service to be covered by Medicare, theCentersforMedicareand MedicaidServices(CMS)must alsodeterminethatitisreason-ableandnecessaryforthepre-ventionorearlydetectionofan illness or disability and that it is appropriateforMedicarebenefi-ciariesunderconditionsestab-lishedinanationalcoverage determination.TheNLSTenrolledawell- definedpopulation(smokersor former smokers 55 to 74 years of age with a cigarette-smoking his-toryofatleast30pack-years), usedspecificimagingprotocols, and employed a multidisciplinary team of investigators. Such strict parameters, although standard in studies,createchallengesfor translatingresearchintopolicy andultimatelyintopractice.In this instance, there were three key implementationchallengesthat CMS had to address in its cover-age policy.First, eligible patients must be accuratelyidentifiedforscreen-ingtobesuccessful.Although ageistypicallystraightforward to measure, incongruity between the NLST which provided data for patients up to 77 years of age andscreeningrecommenda-tionsmaypotentiallycompound implementationproblems.The USPSTFextendeditsscreening recommendationtoincludeper-sons up to 80 years of age not on thebasisofempiricaldatabut on the basis of results of simula-tionmodelsthatassumed100% adherencetolong-term,annual screening a potentially unreal-isticlevelthateventheNLST could not achieve (it reported 95% adherence to three annual screen-ing tests). Under our national cov-eragedetermination,at-riskpa-tients55to77yearsofageare eligible for a Medicare benefit.Inaddition,apatientssmok-inghistorywhichisusually self-reported and subject to recall biasisparticularlychalleng-ing yet critical to determine, since screeningtrialsinpatientswith alessextensivesmokinghistory havenotshownthathealthout-comeswereimproved.3,4Screen-ing persons at lower risk for lung cancer, a practice known as down-wardeligibilitycreep,mayvery well degrade the overall benefits of screening.To facilitate a focused discus-sion of patient-specific issues such asage,smokinghistory,and willingnesstoadheretoalong-Screening for Lung Cancer with Low-Dose CT Translating Science into Medicare Coverage PolicyJoseph Chin, M.D., Tamara Syrek Jensen, J.D., Lori Ashby, M.A., Jamie Hermansen, M.P.P., Joseph D. Hutter, M.D., and Patrick H. Conway, M.D.CMS has established a mechanism toprovide responsible access to high-qualitylung-cancer screening with low-dose CTin the Medicare population while datacontinue to be collected.The New England Journal of Medicine Downloaded from nejm.org on August 3, 2015. For personal use only. No other uses without permission. Copyright 2015 Massachusetts Medical Society. All rights reserved. PERSPECTI VEn engl j med 372;22nejm.orgmay 28, 20152084term screening program and un-dergo additional diagnostic tests andtreatmentifnecessary,CMS coversadistinctvisitforformal shareddecisionmakingusing dedicated evidence-based decision aids.Shareddecisionmaking involves engaging the patient in dialogueandpermitsacareful determinationoftheappropri-ateness of screening. As targeted decisionaidsaredevelopedand tested,theeffectofthesevisits on appropriate screening and long-term population outcomes can be measured to inform refinement of their structure and delivery.The second challenge was that lung-cancerscreeningmustbe performedaspartofacohesive screeningprogramtoenhance its likelihood of success. Radiolo-gistsshouldnotonlyproperly furnishandinterpretthelow-doseCTbutalsoreinforcethe importanceofadherencetoevi-dence-basedscreening,smoking cessation,andfollow-upevalua-tions. NLST investigators report-edthatparticipantswithposi-tivescreeningresultsalways receivedfollow-uprecommenda-tionsfromNLSTradiologists.5 Low-dose CT, though a key com-ponentofscreening,mayprovide no benefit if nodule identification andreportingarenotstandard-izedandevidence-basedalgo-rithms are not used to determine thesubsequentcourseofaction and follow-up.Accordingly, in its national cov-erage determination, CMS set spe-cificcriteriaforradiologistsand imaging centers and required use ofastandardizednodule-identi-fication-and-reportingsystemand datacollection.AlthoughCMS onlyrequirescollectionofdata thatwillallowphysicianstode-terminetheappropriatenessof screening, it also emphasizes the need to collect sufficient data on healthoutcomesandadverse events and to establish a broader screening registry with this infor-mationtostimulatecontinuous quality improvement.These requirements are among many important checks, since the new Medicare coverage represents the first wide implementation of lung-cancerscreeningwithlow-doseCT.TheMedicareEvidence DevelopmentandCoverageAdvi-soryCommittee(MEDCAC)was concernedaboutimplementing broadscreeningintheMedicare populationonthebasisofre-sultsfromonepositivetrial; MEDCACemphasizedtheneed for additional evidence on harms from evaluation offalsepositive resultsandextrapulmonicfind-ings in older adults. The data to becollectedwillfacilitatemoni-toringofsubsequentdiagnostic workup,treatments,andout-comesbyallowinglinkageof clinicaldatatoadministrative claimsdata.TheAmericanCol-lege of Radiology has recognized theneedforenhancedradiolo-gist involvement and data collec-tioninthecasesofotherimag-ing tests as seen in the Breast ImagingCenterofExcellence program and the National Mam-mographyDatabaseandhas developed a similar approach for lung-cancer screening as well.Finally,duringthecourseof screening, a patient may encoun-ter physicians from a number of different specialties, including pri-marycare,radiology,pulmonol-ogy, surgery, and oncology. Each physicianhasauniqueroleand responsibility, but communication and coordination will be needed. Since screening begins with shared decision making, active participa-tionofprimarycareclinicians will help address issues that may arise in appropriate patient selec-tionandtomaintaincontinuity of screening-related care.Recognizingtheimportance ofmultidisciplinaryinvolvement, CMS directly engaged stakehold-ersfrommultipleprofessional societiesandhealthadvocacy organizationsandaskedthem toprovideinputintotheele-mentsofascientificallysound, sustainablescreeningprogram. Theknowledgeandcommit-mentoftheseexperts,whoin-cluded NLST investigators, were invaluableinourdevelopment ofthebasicstructureandcom-ponents of Medicares lung-can-cerscreeningbenefit,including the establishment of an indepen-dent,multidisciplinarygover-nancebody.Thesuccessofthis typeofapproachhasbeendem-onstratedbytheNationalColo-rectalCancerRoundtable,acol-laborative partnership with more than60memberorganizations established by the American Can-cerSocietyandtheCentersfor DiseaseControlandPrevention. Amultisocietygovernancebody or national coalition will increase multidisciplinary involvement and help ensure that screening proto-cols continue to evolve and that progressismadeinreducing lung-cancer mortality in the Unit-ed States.The NLST provided the initial evidencetosupportlung-cancer screening with low-dose CT. The nextstepistoaddressthechal-lenges ahead to ensure that pop-ulation screening confers similar benefits over time and minimiz-esrisk.Bycreatinganewpre-Screening for Lung Cancer with Low-Dose CTThe New England Journal of Medicine Downloaded from nejm.org on August 3, 2015. For personal use only. No other uses without permission. Copyright 2015 Massachusetts Medical Society. All rights reserved. n engl j med 372;22nejm.orgmay 28, 2015PERSPECTI VE2085ventive benefit with specific evi-dence-basedcoveragecriteria, CMShasestablishedamecha-nismtoprovideresponsibleac-cess to high-quality lung-cancer screeningwithlow-doseCTin theMedicarepopulationwhile trialscontinueinEuropeand data on long-term screening out-comesintheUnitedStatesare collectedtoinformdecisions aboutscreeningfrequencyand duration. However, the primary re-sponsibility for ensuring appropri-ateintegratedscreeninginwhich benefitsoutweighharmsulti-mately rests with practicing phy-sicians,informedpatients,and the multidisciplinary stakeholders involved in screening efforts.Theviewsexpressedinthisarticleare those of the authors and do not necessarily represent the views or policies of the Cen-ters for Medicare and Medicaid Services.Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.From the Center for Clinical Standards and Quality, Centers for Medicare and Medicaid Services, Woodlawn, MD.1.Surveillance,Epidemiology,andEndRe-sults (SEER) Program. SEER stat fact sheets: lung and bronchus cancer (http://www.seer .cancer.gov/statfacts/html/lungb.html).2.TheNationalLungScreeningTrialRe-search Team. Reduced lung-cancer mortality withlow-dosecomputedtomographic screening. N Engl J Med 2011;365:395-409.3.InfanteM,CavutoS,LutmanFR,etal. A randomized study of lung cancer screen-ingwithspiralcomputedtomography: three-yearresultsfromtheDANTEtrial. AmJRespirCritCareMed2009;180:445- 53.4.SaghirZ,DirksenA,AshrafH,etal.CT screeningforlungcancerbringsforward earlydiseasetherandomisedDanish Lung Cancer Screening Trial: status after five annual screening rounds with low-dose CT. Thorax 2012;67:296-301.5.NationalLungScreeningTrialResearch Team.TheNationalLungScreeningTrial: overview and study design. Radiology 2011; 258:243-53.DOI: 10.1056/NEJMp1502598Copyright 2015 Massachusetts Medical Society.Screening for Lung Cancer with Low-Dose CTThe New England Journal of Medicine Downloaded from nejm.org on August 3, 2015. For personal use only. No other uses without permission. Copyright 2015 Massachusetts Medical Society. All rights reserved.