ADVANCED IMAGING CLINICAL APPROPRIATENESS GUIDELINES. Appropriate Use Criteria: Imaging of the Chest. EFFECTIVE JANUARY 1, 2019 Proprietary

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1 CLINICAL APPROPRIATENESS GUIDELINES ADVANCED IMAGING Apprpriate Use Criteria: Imaging f the Chest EFFECTIVE JANUARY 1, 2019 Prprietary 8600 West Bryn Mawr Avenue Suth Twer Suite 800 Chicag, IL Apprpriate.Safe.Affrdable AIM Specialty Health

2 Table f Cntents Descriptin and Applicatin f the Guidelines... 4 Administrative Guidelines... 5 Ordering f Multiple Studies... 5 Simultaneus Ordering f Multiple Studies... 5 Repeated Imaging... 5 Pre-Test Requirements... 6 Histry... 6 Imaging f the Chest... 7 General Infrmatin/Overview... 7 Scpe... 7 Technlgy Cnsideratins... 7 Definitins... 7 Clinical Indicatins... 9 Cngenital and Develpmental Cnditins... 9 Cngenital thracic anmalies... 9 Cngenital pulmnary airway malfrmatin (Pediatric nly)... 9 Chest wall defrmities including pectus excavatum (Pediatric nly)... 9 Pulmnary sequestratin... 9 Infectius and Inflammatry Cnditins Pneumnia Other infectius r inflammatry cnditins Trauma Blunt r penetrating trauma t the thrax Tumr r Neplasm Chest wall mass Pulmnary ndule Other thracic mass lesins Parenchymal Lung Disease nt therwise specified Asbests-related lesins invlving the lungs and pleura (Adult nly) Brnchiectasis Brnchilitis bliterans Interstitial lung disease and pulmnary fibrsis Occupatinal lung disease (Adult nly) Pulmnary emblism Sarcidsis Pleural Cnditins Brnchpleural fistula (Adult nly) Pleural fluid cllectin Pneumthrax, unexplained r recurrent Chest Wall and Diaphragmatic Cnditins Cpyright AIM Specialty Health. All Rights Reserved. 2

3 Breast implant rupture Diaphragmatic hernia Pectralis muscle tear Thracic utlet syndrme Signs and Symptms Cugh (chrnic r persistent) Fever f unknwn rigin Hemptysis Harseness, dysphnia, r vcal crd weakness Hrner s syndrme Paraneplastic syndrme Weight lss Abnrmal Test Findings Imaging abnrmalities Psitive sputum cytlgy Tracheal r brnchial lesin r ther findings n brnchscpy References Cdes Histry Cpyright AIM Specialty Health. All Rights Reserved. 3

4 Descriptin and Applicatin f the Guidelines The AIM Clinical Apprpriateness Guidelines (hereinafter the AIM Clinical Apprpriateness Guidelines r the Guidelines ) are designed t assist prviders in making the mst apprpriate treatment decisin fr a specific clinical cnditin fr an individual. As used by AIM, the Guidelines establish bjective and evidence-based criteria fr medical necessity determinatins where pssible. In the prcess, multiple functins are accmplished: T establish criteria fr when services are medically necessary T assist the practitiner as an educatinal tl T encurage standardizatin f medical practice patterns T curtail the perfrmance f inapprpriate and/r duplicate services T advcate fr patient safety cncerns T enhance the quality f health care T prmte the mst efficient and cst-effective use f services The AIM guideline develpment prcess cmplies with applicable accreditatin standards, including the requirement that the Guidelines be develped with invlvement frm apprpriate prviders with current clinical expertise relevant t the Guidelines under review and be based n the mst up-t-date clinical principles and best practices. Relevant citatins are included in the References sectin attached t each Guideline. AIM reviews all f its Guidelines at least annually. AIM makes its Guidelines publicly available n its website twenty-fur hurs a day, seven days a week. Cpies f the AIM Clinical Apprpriateness Guidelines are als available upn ral r written request. Althugh the Guidelines are publicly-available, AIM cnsiders the Guidelines t be imprtant, prprietary infrmatin f AIM, which cannt be sld, assigned, leased, licensed, reprduced r distributed withut the written cnsent f AIM. AIM applies bjective and evidence-based criteria, and takes individual circumstances and the lcal delivery system int accunt when determining the medical apprpriateness f health care services. The AIM Guidelines are just guidelines fr the prvisin f specialty health services. These criteria are designed t guide bth prviders and reviewers t the mst apprpriate services based n a patient s unique circumstances. In all cases, clinical judgment cnsistent with the standards f gd medical practice shuld be used when applying the Guidelines. Guideline determinatins are made based n the infrmatin prvided at the time f the request. It is expected that medical necessity decisins may change as new infrmatin is prvided r based n unique aspects f the patient s cnditin. The treating clinician has final authrity and respnsibility fr treatment decisins regarding the care f the patient and fr justifying and demnstrating the existence f medical necessity fr the requested service. The Guidelines are nt a substitute fr the experience and judgment f a physician r ther health care prfessinals. Any clinician seeking t apply r cnsult the Guidelines is expected t use independent medical judgment in the cntext f individual clinical circumstances t determine any patient s care r treatment. The Guidelines d nt address cverage, benefit r ther plan specific issues. If requested by a health plan, AIM will review requests based n health plan medical plicy/guidelines in lieu f the AIM Guidelines. The Guidelines may als be used by the health plan r by AIM fr purpses f prvider educatin, r t review the medical necessity f services by any prvider wh has been ntified f the need fr medical necessity review, due t billing practices r claims that are nt cnsistent with ther prviders in terms f frequency r sme ther manner. Cpyright AIM Specialty Health. All Rights Reserved. 4

5 Administrative Guidelines Ordering f Multiple Studies Requests fr multiple imaging studies t evaluate a suspected r identified cnditin and requests fr repeated imaging f the same anatmic area are subject t additinal review t avid unnecessary r inapprpriate imaging. Simultaneus Ordering f Multiple Studies In many situatins, rdering multiple imaging studies at the same time is nt clinically apprpriate because: Current literature and/r standards f medical practice supprt that ne f the requested imaging studies is mre apprpriate in the clinical situatin presented; r One f the imaging studies requested is mre likely t imprve patient utcmes based n current literature and/r standards f medical practice; r Apprpriateness f additinal imaging is dependent n the results f the lead study. When multiple imaging studies are rdered, the request will ften require a peer-t-peer cnversatin t understand the individual circumstances that supprt the medically necessity f perfrming all imaging studies simultaneusly. Examples f multiple imaging studies that may require a peer-t-peer cnversatin include: CT brain and CT sinus fr headache MRI brain and MRA brain fr headache MRI cervical spine and MRI shulder fr pain indicatins MRI lumbar spine and MRI hip fr pain indicatins MRI r CT f multiple spine levels fr pain r radicular indicatins MRI ft and MRI ankle fr pain indicatins Bilateral exams, particularly cmparisn studies There are certain clinical scenaris where simultaneus rdering f multiple imaging studies is cnsistent with current literature and/r standards f medical practice. These include: Onclgic imaging Cnsideratins include the type f malignancy and the pint alng the care cntinuum at which imaging is requested Cnditins which span multiple anatmic regins Examples include certain gastrintestinal indicatins r cngenital spinal anmalies Repeated Imaging In general, repeated imaging f the same anatmic area shuld be limited t evaluatin fllwing an interventin, r when there is a change in clinical status such that imaging is required t determine next steps in management. At times, repeated imaging dne with different techniques r cntrast regimens may be necessary t clarify a finding seen n the riginal study. Repeated imaging f the same anatmic area (with same r similar technlgy) may be subject t additinal review in the fllwing scenaris: Repeated imaging at the same facility due t mtin artifact r ther technical issues Repeated imaging requested at a different facility due t prvider preference r quality cncerns Repeated imaging f the same anatmic area (MRI r CT) based n persistent symptms with n clinical change, treatment, r interventin since the previus study Cpyright AIM Specialty Health. All Rights Reserved. 5

6 Repeated imaging f the same anatmical area by different prviders fr the same member ver a shrt perid f time Pre-Test Requirements Critical t any finding f clinical apprpriateness under the guidelines fr specific imaging exams is a determinatin that the fllwing are true with respect t the imaging request: A clinical evaluatin has been perfrmed prir t the imaging request (which shuld include a cmplete histry and physical exam and review f results frm relevant labratry studies, prir imaging and supplementary testing) t identify suspected r established diseases r cnditins. Fr suspected diseases r cnditins: Based n the clinical evaluatin, there is a reasnable likelihd f disease prir t imaging; and Current literature and standards f medical practice supprt that the requested imaging study is the mst apprpriate methd f narrwing the differential diagnsis generated thrugh the clinical evaluatin and can be reasnably expected t lead t a change in management f the patient; and The imaging requested is reasnably expected t imprve patient utcmes based n current literature and standards f medical practice. Fr established diseases r cnditins: Advanced imaging is needed t determine whether the extent r nature f the disease r cnditin has changed; and Current literature and standards f medical practice supprt that the requested imaging study is the mst apprpriate methd f determining this and can be reasnably expected t lead t a change in management f the patient; and The imaging requested is reasnably expected t imprve patient utcmes based n current literature and standards f medical practice. If these elements are nt established with respect t a given request, the determinatin f apprpriateness will mst likely require a peer-t-peer cnversatin t understand the individual and unique facts that wuld supersede the pre-test requirements set frth abve. During the peert-peer cnversatin, factrs such as patient acuity and setting f service may als be taken int accunt. Histry Status Date Actin Reviewed and revised 07/26/2016 Independent Multispecialty Physician Panel review and revisin Created 03/30/2005 Original effective date Cpyright AIM Specialty Health. All Rights Reserved. 6

7 Imaging f the Chest General Infrmatin/Overview Scpe These guidelines address advanced imaging f the chest in bth adult and pediatric ppulatins. Fr interpretatin f the Guidelines, and where nt therwise nted, adult refers t persns age 19 and lder, and pediatric refers t persns age 18 and yunger. Where separate indicatins exist, they are specified as Adult r Pediatric. Where nt specified, indicatins and prerequisite infrmatin apply t persns f all ages. See the Cding sectin fr a list f mdalities included in these guidelines. Technlgy Cnsideratins Anatmic cverage fr thracic imaging includes the area between the lung apices and the cstphrenic sulci specifically, the lung parenchyma, pleura, mediastinum, and musculskeletal structures f the thrax. Chest imaging studies are nt apprpriate fr cardiac and crnary artery imaging. Fr imaging f the heart, see the AIM guidelines fr the specific CPT cde being requested. Vascular imaging f the thrax is addressed in the Vascular Imaging guidelines. In the majrity f clinical situatins, chest radigraphs shuld have been perfrmed within 30 days f the imaging request. When radigraphs are nt sufficient t guide management, cmputed tmgraphy (CT) is mst ften the study f chice fr imaging the thrax; it is widely available and prvides excellent reslutin f sft tissue and the bny thrax. 1 High-reslutin CT (HRCT) uses thin-sectin acquisitin and high spatial frequency recnstructin t ptimize visualizatin f the fine lung parenchyma and airways. 2 It is primarily indicated fr characterizatin f diffuse lung r small airways disease. HRCT is usually perfrmed withut cntrast and using dynamic (inspiratry and expiratry) breathing, and ften prduces a lwer radiatin dse than a standard chest CT. 3 Lw-dse chest CT (LDCT) als emplys a dse reductin strategy and is primarily used in lung cancer screening. 4,5 Disadvantages f CT include expsure t inizing radiatin and risks assciated with infusin f idinated cntrast media, including allergic reactins r renal cmprmise. Magnetic resnance imaging (MRI) is generally less useful fr thracic imaging; speed f image acquisitin is slwer and mtin artifact in this regin may interfere with image quality. Hwever, it des prvide superir reslutin f the lung apices and chest wall (including breast). It may als be used fr prblem slving fllwing CT, r fr situatins in which CT is cntraindicated. Breast MRI requires a dedicated breast cil. Fr breast imaging related t cancer screening r diagnsis, see Onclgic Imaging guidelines. The presence f implantable devices such as pacemakers r defibrillatrs, a ptential need fr sedatin in pediatric patients, and claustrphbia are the main limitatins f MRI. Infusin f gadlinium may als cnfer an unacceptable risk in persns with advanced renal disease. Definitins Phases f the care cntinuum are bradly defined as fllws: Screening testing in the absence f signs r symptms f disease Diagnsis testing based n a reasnable suspicin f a particular cnditin r disrder, usually due t the presence f signs r symptms Management testing t direct therapy f an established cnditin, which may include preperative r pstperative imaging, r imaging perfrmed t evaluate the respnse t nnsurgical interventin Cpyright AIM Specialty Health. All Rights Reserved. 7

8 Surveillance peridic assessment fllwing cmpletin f therapy, r fr mnitring knwn disease that is stable r asymptmatic Statistical terminlgy 1 Cnfidence interval (CI) range f values which is likely t cntain the cited statistic. Fr example, 92% sensitivity (95% CI, 89%-95%) means that, while the sensitivity was calculated at 92% n the current study, there is a 95% chance that, if a study were t be repeated, the sensitivity n the repeat study wuld be in the range f 89%-95%. Diagnstic accuracy ability f a test t discriminate between the target cnditin and health. Diagnstic accuracy is quantified using sensitivity and specificity, predictive values, and likelihd ratis. Hazard rati dds that an individual in the grup with the higher hazard reaches the utcme first. Hazard rati is analgus t dds rati and is reprted mst cmmnly in time-t-event analysis r survival analysis. A hazard rati f 1 means that the hazard rates f the 2 grups are equivalent. A hazard rati f greater than 1 r less than 1 means that there are differences in the hazard rates between the 2 grups. Likelihd rati rati f an expected test result (psitive r negative) in patients with the disease t an expected test result (psitive r negative) in patients withut the disease. Psitive likelihd ratis, especially thse greater than 10, help rule in a disease (i.e., they substantially raise the pst-test prbability f the disease, and hence make it very likely and the test very useful in identifying the disease). Negative likelihd ratis, especially thse less than 0.1, help rule ut a disease (i.e., they substantially decrease the pst-test prbability f disease, and hence make it very unlikely and the test very useful in excluding the disease). Odds rati dds that an utcme will ccur given a particular expsure, cmpared t the dds f the utcme ccurring in the absence f that expsure. An dds rati f 1 means that the expsure des nt affect the dds f the utcme. An dds rati greater than 1 means that the expsure is assciated with higher dds f the utcme. An dds rati less than 1 means that the expsure is assciated with lwer dds f the utcme. Predictive value likelihd that a given test result crrelates with the presence r absence f disease. Psitive predictive value is defined as the number f true psitives divided by the number f test psitives. Negative predictive value is defined as the number f true negatives divided by the number f test negative patients. Predictive value is dependent n the prevalence f the cnditin. Pretest prbability prbability that a given patient has a disease prir t testing. May be divided int very lw (less than 5%), lw (less than 20%), mderate (20%-75%), and high (greater than 75%) althugh these numbers may vary by cnditin. Relative risk prbability f an utcme when an expsure is present relative t the prbability f the utcme ccurring when the expsure is absent. Relative risk is analgus t dds rati; hwever, relative risk is calculated by using percentages instead f dds. A relative risk f 1 means that there is n difference in risk between the 2 grups. A relative risk f greater than 1 means that the utcme is mre likely t happen in the expsed grup cmpared t the cntrl grup. A relative risk less than 1 means that the utcme is less likely t happen in the expsed grup cmpared t the cntrl grup. Sensitivity cnditinal prbability that the test is psitive, given that the patient has the disease. Defined as the true psitive rate (number f true psitives divided by the number f patients with disease). Excellent r high sensitivity is usually greater than 90%. Cpyright AIM Specialty Health. All Rights Reserved. 8

9 Specificity cnditinal prbability that the test is negative, given that the patient des nt have the disease. Defined as the true negative rate (number f true negatives divided by the number f patients withut the disease). Excellent r high specificity is usually greater than 90%. Clinical Indicatins The fllwing sectin includes indicatins fr which advanced imaging f the chest is cnsidered medically necessary, alng with prerequisite infrmatin and supprting evidence where available. Indicatins, diagnses, r imaging mdalities nt specifically addressed are cnsidered nt medically necessary. It is recgnized that imaging ften detects abnrmalities unrelated t the cnditin being evaluated. Such findings must be cnsidered within the cntext f the clinical situatin when determining whether additinal imaging is required. Cngenital and Develpmental Cnditins Cngenital thracic anmalies Cngenital pulmnary airway malfrmatin (Pediatric nly) Advanced imaging is cnsidered medically necessary fr diagnsis and management f the fllwing cnditins when the results f Cngenital lbar emphysema Cngenital cystic adenmatid malfrmatin Chest wall defrmities including pectus excavatum (Pediatric nly) Advanced imaging is cnsidered medically necessary in EITHER f the fllwing scenaris: Preperative evaluatin Pstperative evaluatin fr cmplicatins r recurrence - CT r MRI chest Pulmnary sequestratin Cpyright AIM Specialty Health. All Rights Reserved. 9

10 Infectius and Inflammatry Cnditins Pneumnia Advanced imaging is cnsidered medically necessary in ANY f the fllwing scenaris: Radigraphs shw n imprvement fllwing at least 4 weeks f medical treatment Recurrence f pneumnia in the same lcatin within 6 mnths Evaluatin f knwn r suspected cmplicatins f pneumnia fllwing nndiagnstic radigraphs Immunsuppressed patients with signs r symptms f pneumnia Ratinale PERSISTENT ABNORMAL RADIOGRAPHS Clinical signs and symptms f pneumnia reslve faster than findings n radigraphy, but may take up t 3 mnths t reslve. 7, 8 It is cmmn fr pneumnia t persist n radigraphs after clinical reslutin, with the rate f radigraphic clearance estimates at 35% within 3 weeks and 84% within 12 weeks. 9, 10 Patients ver age 50 are 2 t 4 times mre likely t have delayed radigraphic reslutin f pneumnia. Therefre, it is imprtant t wait at least 4 weeks after clinical reslutin befre perfrming advanced imaging, t exclude nn-infectius causes f persistent airspace disease. RECURRENT PNEUMONIA Recurrent pneumnia is defined as at least 2 episdes f pneumnia in 1 year r 3 lifetime episdes. Evidence is insufficient t infrm the ptimal timing f imaging in recurrent pneumnia. Brnchscpy can effectively evaluate the mst cmmn causes f recurrent fcal airspace disease, including freign bdies, mucus plugging, and ther intraluminal bstructins. Hwever, practice cnsensus is that CT may be indicated when brnchscpy is incnclusive. Recurrent pneumnia in the same area is likely due t underlying structural disease primarily right middle lbe syndrme (airway disease f uncertain pathphysilgy) (61%) and cngenital lung malfrmatins (21%); diagnstic imaging invlving brnchscpy with r withut CT is indicated. 11,12 Recurrent pneumnia in different areas is mre likely due t systemic illness (60% related t cystic fibrsis, primary ciliary dyskinesia, r severe gastresphageal reflux disease) and a mre extensive clinical/lab wrkup is usually perfrmed prir t diagnstic imaging, which is reserved fr situatins where lab testing (such as immune status assessment, sweat chlride test fr cystic fibrsis, tuberculin skin test, pulmnary functin tests, and echcardigram) is incnclusive. 11,12 Other infectius r inflammatry cnditins Advanced imaging is cnsidered medically necessary fr diagnsis and management f the fllwing cnditins when the results f Lung abscess Sternal wund infectin r dehiscence Mediastinitis Infectius and inflammatry cnditins nt listed elsewhere in this guideline Trauma Blunt r penetrating trauma t the thrax See Vascular Imaging guidelines. Cpyright AIM Specialty Health. All Rights Reserved. 10

11 Tumr r Neplasm The fllwing sectin addresses cnditins which may be indicative f underlying neplasm, as well as benign tumrs f the thrax. Fr cancer screening guidelines and management f dcumented malignancy, please refer t the Onclgic Imaging guidelines. Chest wall mass Advanced imaging is cnsidered medically necessary in ANY f the fllwing scenaris: Palpable chest wall mass with nndiagnstic radigraph r ultrasund Chest wall mass identified n prir imaging when further infrmatin is needed t determine need fr bipsy r surgery Preperative planning fllwing bipsy Nte: Fr breast masses (including gynecmastia), see Onclgic Imaging guidelines fr breast cancer. - CT r MRI chest Pulmnary ndule Advanced imaging is cnsidered medically necessary in the fllwing scenaris: Calcified ndules Fllw up f calcified ndules ther than thse with benign calcificatin patterns* is at the discretin f the rdering prvider *Benign calcificatin patterns include granulmas and ppcrn calcificatins, fr which rutine fllw up is nt medically necessary Nncalcified ndules Yunger than age 35 Ndules 1 cm r with suspicius mrphlgy (includes ndules with irregular r spiculated margins) Age 35 r lder Slid ndules: see Table 1 Subslid ndules: see Table 2 Ndules identified n incmplete thracic CT Less than 6 mm: n fllw-up imaging required 6 mm t 8 mm: 3 t 12 mnth fllw up with cmplete chest CT; subsequent fllw up based n characterizatin f ndule Greater than 8 mm r suspicius mrphlgy*: cmplete chest CT with subsequent fllw up based n characterizatin f ndule *Suspicius mrphlgy includes ndules with irregular r spiculated margins Cpyright AIM Specialty Health. All Rights Reserved. 11

12 (all indicatins) - PET, PET-CT when ALL f the fllwing are criteria are met: Imaging f the Chest Ndule is well-demarcated, slid r part slid, and lacks a benign calcificatin pattern. Size is greater than 8 mm but less than 3 cm in greatest diameter Ndule is surrunded by aerated lung parenchyma There is n assciated adenpathy, atelectasis r pleural effusin Table 1. Fllw-up recmmendatins fr slid nncalcified pulmnary ndules Slid ndule size Risk Slitary Multiple Less than 6 mm Lw N fllw up 6 mm t 8 mm r Lung-RADS 3 High* N/A Optinal fllw-up exam at 12 mnths 1. 6 t 12 mnths t 24 mnths Mre than 8 mm N/A 1. 3 mnths 2. 6 mnths t 24 mnths unless diagnstic PET-CT r tissue sampling perfrmed Any size when prir imaging has dcumented 24 mnths f stability N/A *High risk includes the fllwing: Smking histry (any) First-degree relative with lung cancer N fllw up Significant expsure t asbests, uranium and/r radn, typically thrugh high risk prfessin 1. 3 t 6 mnths t 24 mnths Table 2. Fllw-up recmmendatins fr subslid nncalcified pulmnary ndules Subslid ndule size Slitary grund glass Slitary part slid Multiple subslid Less than 6 mm N rutine fllw up N rutine fllw up 1. 3 t 6 mnths mnths mnths Greater than r equal t 6 mm r Lung-RADS 3 Ratinale 1. 6 t 12 mnths 2. Every 2 years thereafter fr a ttal f 5 years 1. 3 t 6 mnths 2. Every year fr 5 years 1. 3 t 6 mnths 2. Fllw up based n mst suspicius ndule (part slid r grund glass) Abbreviatin: Lung-RADS, American Cllege f Radilgy Lung CT Screening Reprting and Data System. Adapted frm MacMahn H, Naidich DP, G JM, et al. Radilgy. 2017; 284(1): AIM Guidelines fr pulmnary ndules fllw the 2017 recmmendatins f the Fleischner Sciety, a high-quality evidence-based guideline directly applicable t American patients. 13 These recmmendatins apply t asymptmatic Cpyright AIM Specialty Health. All Rights Reserved. 12

13 patients age 35 r lder wh are nt immuncmprmised, wh d nt have cancer, and wh are nt enrlled in a lung cancer screening prgram. Fleischner endrses the use f Lung-RADS guidelines t determine fllw up when pulmnary ndules are detected as part f a lung cancer screening prgram. Fleischner and Lung-RADS are largely cncrdant, and differences have been recnciled and aligned in AIM Guidelines. SOLID PULMONARY NODULE IN ASYMPTOMATIC PATIENTS UNDER AGE 35 Primary lung cancer is rare in persns under age 35 (1% f all cases), and the risks frm radiatin expsure are greater. In yung patients, infectius/inflammatry causes are mre likely than cancer, and use f serial CT shuld be minimized. Exceptins may include ndules greater than 1 cm in size r with suspicius mrphlgy. In such cases, fllw-up imaging is at the rdering prvider's discretin; a single 12-mnth fllw-up CT may be cnsidered t cnfirm stability. Mst ndules smaller than 1 cm will nt be visible n chest radigraphs; hwever, fr larger slid ndules that are clearly visualized and are cnsidered lw risk, fllw up with radigraphy rather than CT may be apprpriate fr lwer radiatin expsure. NODULE SMALLER THAN 6 mm SEEN ON PREVIOUS IMAGING Ndules f this size d nt require rutine fllw up in lw-risk patients. Since the average risk f cancer in slid ndules smaller than 6 mm in high-risk patients is less than 1%, and the relative risk f cancer in a nnsmker is much less (0.15) than in a smker, the risk f malignancy in lw-risk patients is very lw. Fr high-risk patients, sme ndules f this size with suspicius mrphlgy, upper lbe lcatin, r bth may warrant fllw up at 12 mnths. These features may increase cancer risk t 1%-5%. NODULE LARGER THAN 8 mm High-risk patients shuld usually prceed directly t PET-CT r bipsy. CT surveillance is recmmended fr ndules greater than 8 mm when: Ndules have a lw (less than 5%) risk f malignancy (as a rule f thumb, patients lder than age 70, patients years f age with n high-risk features, and patients yunger than age 50 with nly ne high-risk feature) Ndules with intermediate risk (5%-65%) especially when PET-CT is negative r equivcal, and the lesin is t small t bipsy Patients are at high surgical risk Other thracic mass lesins Advanced imaging is cnsidered medically necessary fr diagnsis and management f the fllwing findings r cnditins when the results f Hilar r mediastinal lymphadenpathy r mass Pancast tumr Pleural mass Thymma Benign tumrs (pediatric nly) ADULT - MRI chest fr evaluatin f mediastinal and hilar masses when CT is insufficient fr prblem slving r fr evaluatin f chest wall extensin in Pancast tumr PEDIATRIC - CT r MRI chest Cpyright AIM Specialty Health. All Rights Reserved. 13

14 Parenchymal Lung Disease nt therwise specified Asbests-related lesins invlving the lungs and pleura (Adult nly) Nte: Asbests expsure may als manifest in nnmalignant pulmnary cnditins including interstitial lung disease, pleural effusin, r pleural plaques. Brnchiectasis - Cnsider chest HRCT technique Brnchilitis bliterans Interstitial lung disease and pulmnary fibrsis - Cnsider chest HRCT technique Occupatinal lung disease (Adult nly) Advanced imaging is cnsidered medically necessary fr diagnsis and management f the fllwing cnditins when the results f Silicsis Cal wrker s pneumcnisis Prgressive massive fibrsis Hard metal pneumcnisis Talcsis Caplan s syndrme in patients with rheumatid arthritis Cpyright AIM Specialty Health. All Rights Reserved. 14

15 Pulmnary emblism See Vascular Imaging guidelines. Sarcidsis Pleural Cnditins Brnchpleural fistula (Adult nly) Pleural fluid cllectin Advanced imaging is cnsidered medically necessary fr diagnsis and management f the fllwing cnditins when the results f imaging will impact treatment decisins: Pleural effusin Hemthrax Empyema Chylthrax Nte: Ultrasund shuld be cnsidered as the initial imaging mdality and prir t a diagnstic r therapeutic pleural tap. Pneumthrax, unexplained r recurrent Cpyright AIM Specialty Health. All Rights Reserved. 15

16 Chest Wall and Diaphragmatic Cnditins Breast implant rupture Advanced imaging is cnsidered medically necessary in EITHER f the fllwing scenaris: Detectin f implant rupture in symptmatic patients Screening fr rupture f a silicne breast implant (in asymptmatic patients) beginning 3 years after implantatin, and every ther year thereafter - MRI breast Diaphragmatic hernia Pectralis muscle tear Advanced imaging is cnsidered medically necessary fr preperative planning in patients with suspected full thickness tear f the tendn r mytendinus junctin. - MRI chest Thracic utlet syndrme Als see Vascular Imaging guidelines. - CT r MRI chest fr neurgenic thracic utlet syndrme - CTA r MRA chest fr vascular thracic utlet syndrmes Signs and Symptms Cugh (chrnic r persistent) Advanced imaging is cnsidered medically necessary fr evaluatin f cugh present fr at least 8 weeks in the fllwing scenaris: Cugh nt respnding t apprpriate treatment and unexplained by clinical evaluatin, chest radigraphy, and pulmnary functin testing r spirmetry Cugh in immunsuppressed individuals Nte: Chrnic cugh, in the cntext f ther signs and symptms, shuld be evaluated based n the mst likely disease r diseases respnsible (see indicatin fr brnchiectasis r interstitial lung disease). Cpyright AIM Specialty Health. All Rights Reserved. 16

17 Ratinale CHRONIC COUGH IN ADULTS Advanced imaging cannt diagnse the mst cmmn causes f chrnic cugh and the mst cmmn causes f cugh shuld first be evaluated prir t advanced imaging. 14,15 Likely causes f chrnic cugh withut cnclusive chest X-ray and lung functin include upper airway cugh syndrme, cugh-variant asthma, gastresphageal reflux 14, primary and secndary smking, envirnmental and ccupatinal irritants, and ACE inhibitrs. 15 Stepwise wrkup f chrnic cugh withut cnclusive chest X-ray is recmmended. Befre perfrming HRCT r brnchscpy, cnsider asthma, COPD, upper airway cugh syndrme, and gastresphageal reflux. 14 CHRONIC COUGH IN PEDIATRIC PATIENTS The majrity f pediatric patients with chrnic wet cugh will respnd t antibitic treatment with a number needed t treat f 3. 16,17 Fever f unknwn rigin Advanced imaging is cnsidered medically necessary in EITHER f the fllwing scenaris: Fever f duratin greater than 3 weeks, which is unexplained fllwing a standard diagnstic evaluatin t identify the surce Unexplained fever in immuncmprmised patient Hemptysis Advanced imaging is cnsidered medically necessary fr evaluatin fllwing nndiagnstic chest radigraphs. - MRI chest fr suspected vascular anmaly in pediatric patients Nte: Brnchscpy is a cmplementary mdality t assess hemptysis. Ratinale Hemptysis is defined as the expectratin f bld that riginates frm the trachebrnchial tree r pulmnary parenchyma and is usually categrized based n the vlume and rate f bleeding with massive hemptysis defined as cc f expectrated bld in a 24-hur perid. 18 The mst cmmn causes f hemptysis are brnchiectasis, tuberculsis, pneumnia, and cancer. Radigraphs can identify the cause f hemptysis between 35% and 50% f the time. 19 Guidelines recmmend radigraphy as the preferred initial imaging mdality in patients with nn-massive hemptysis. 20,21 CT is indicated in patients with a negative radigraph and persistent unexplained hemptysis as it is significantly mre sensitive (verall 64%-100%) than any ther imaging mdality. 19 Hemptysis is rare in children and very rarely due t malignant etilgies. The ALARA (as lw as reasnably achievable) principle dictates that radigraphy and brnchscpy shuld bth be cnsidered prir t CT in children. As in adults, hwever, CT is mre sensitive than bth radigraphy and brnchscpy and culd be cnsidered in pediatric cases where the initial wrkup is nndiagnstic. 22 Massive hemptysis is a rare (less than 5% f cases) medical emergency typically evaluated and treated with brnchscpy. 19 CT perfrmed befre r after a nndiagnstic brnchscpy is cmplementary and mre sensitive fr Cpyright AIM Specialty Health. All Rights Reserved. 17

18 the diagnsis as it can visualize the lung parenchyma and mediastinum in additin t the trachebrnchial tree. 21 CT 21, 23 frequently changes management in these patients. Harseness, dysphnia, r vcal crd weakness Als see Head and Neck Imaging guidelines. ADULT Advanced imaging is cnsidered medically necessary fr initial evaluatin in ANY f the fllwing scenaris in adults nly: Fllwing laryngscpy, when findings suggest recurrent laryngeal nerve dysfunctin r identify a suspicius lesin Symptms persisting lnger than ne mnth which are unexplained by laryngscpy Presence f at least ONE f the fllwing high-risk features: PEDIATRIC Tbacc use Alchl abuse Hemptysis Histry f radiatin therapy Knwn head and neck malignancy Advanced imaging is cnsidered medically necessary in EITHER f the fllwing scenaris in pediatric patients nly: Harseness persisting fr lnger than 4 weeks Fllwing laryngscpy, when findings are nndiagnstic r reveal vcal crd paralysis Ratinale Mst harseness is self-limited r caused by a pathlgy that can be identified by laryngscpy. Clinicians shuld visualize the patient s larynx, r refer the patient t a clinician wh can visualize the larynx, when harseness fails t reslve by a maximum f 3 mnths after nset, r irrespective f duratin if a serius underlying cause is suspected. 24,25 Benign lesins f the vcal crds such as cysts, ndules, plyps, and gastresphageal reflux are frequently diagnsed and managed with laryngscpy alne. Accuracy f histry and physical exam in harseness is lw (~5%), laryngscpy increases the accuracy f diagnsis by ~68%. 26 Harseness is cmmn in yung children (15%-24%) and usually due t benign lesins seen n laryngscpy such as vcal crd ndules, which accunt fr apprximately 77% f cases. 24 The American Academy f Otlarynglgy-Head and Neck Surgery recmmends nt btaining CT r MRI in patients with a primary cmplaint f harseness prir t examining the larynx. 27 Hrner s syndrme Als see Brain Imaging and Head and Neck Imaging guidelines. Advanced imaging is cnsidered medically necessary fr evaluatin when the results f imaging will impact treatment decisins. - CT r MRI chest Cpyright AIM Specialty Health. All Rights Reserved. 18

19 Paraneplastic syndrme Advanced imaging is cnsidered medically necessary fr evaluatin when the results f imaging will impact treatment decisins. Ratinale Paraneplastic syndrmes ccur when a tumr secretes biactive substances that result in signs and/r symptms distant frm its site f rigin and unrelated t rgan invasin. 28 They ccur in abut 8% f all cancers and are caused by a variety f neplasms, especially neurendcrine tumrs like small cell lung cancer. Examples f paraneplastic syndrmes include, but are nt limited t, hypercalcemia, syndrme f inapprpriate diuretic hrmne secretin (SIADH), psclnus-myclnus, stiff persn (anti-gad antibdies), myasthenia gravis (Lambert-Eatn), and encephalitis (NMDA receptr antibdy). 28 Advanced imaging (CT r PET-CT) is used t identify the primary neplasm in patients wh present with paraneplastic syndrmes f unknwn etilgy. Chest CT has been shwn t have a sensitivity f 89% and a specificity f 93% fr the detectin f the mst cmmn primary assciated with paraneplastic syndrme: lung cancer. 28 A 2016 systematic review and meta-analysis f 21 studies and 1293 patients examined the cmparative diagnstic accuracy f whle bdy PET r PET-CT in patients presenting with paraneplastic syndrme. Pled sensitivity, specificity, and diagnstic dds rati f 18 F-FDG PET r 18 F-FDG PET/CT fr the detectin f underlying malignancy were 0.81 (95% CI, ), 0.88 (95% CI, ), and (95% CI, ), respectively. The pled glbal diagnstic accuracy (area under the curve) was (SE, 0.018). Five studies examined the perfrmance f cnventinal screening mdalities fr paraneplastic syndrme including CT and fund variable sensitivity ranging frm 30%-82% and 71%-100%. The authrs cmment that there is yet n cnsensus n the value f whle-bdy 18 F-FDG PET r 18 F-FDG PET/CT in patients suspected f harbring a paraneplastic syndrme Further studies are needed t investigate the additinal value f 18 F-FDG PET/CT and its cst effectiveness ver cnventinal screening mdalities. Hwever, they cnclude that 18 F-FDG PET and 18 F-FDG PET/CT have excellent diagnstic accuracy and mderate t high sensitivity and specificity fr the detectin f underlying malignancy in patients suspected f having a paraneplastic syndrme. The systematic review is significantly limited by unexplained hetergeneity in the data, publicatin, and selectin bias alng with differential verificatin using an incnsistent reference standard. 29 Weight lss Als see Abdmen and Pelvis Imaging guidelines. Advanced imaging is cnsidered medically necessary fr evaluatin f unintentinal weight lss exceeding 5% f bdy weight within a 12-mnth interval in EITHER f the fllwing scenaris: Persistence fllwing a negative cmprehensive clinical evaluatin (including a histry and physical examinatin, age apprpriate cancer screening, chest radigraphy, and initial labratry evaluatin) after a perid f bservatin Abnrmal findings suggestive f malignancy n histry, physical exam, imaging r labratry evaluatin Ratinale Persistent unintentinal weight lss is defined as a substantive weight lss ver a perid f 6-12 mnths. 30 Weight lss is nt uncmmn in elderly patients and is typically related t ne f the 7 Ds: dementia, dentitin, depressin, diarrhea, drugs, functinal dysfunctin, r dysphagia. When unintentinal weight lss remains unexplained, it may be due t the 8 th D: acute r chrnic disease. 30 The primary purpse f advanced imaging in the evaluatin f unexplained unintentinal weight lss is t exclude an ccult malignancy nt detected by initial clinical evaluatin and testing, usually in patients with abnrmalities n baseline testing. Screening with CT is f limited value. Instead, diagnstic testing shuld be directed tward areas f cncern based n the histry and physical examinatin. 31 Age apprpriate screening fr malignancy (mammgram, pap smear) shuld als be encuraged. 32 The mst cmmn cause f malignancy in patients with unintentinal weight lss is gastrintestinal primary (47%), and gastrintestinal causes accunt fr 45% f nnmalignant rganic etilgies. 33 Therefre, endscpy and/r clnscpy shuld be cnsidered fr initial evaluatin when there is evidence f a GI surce. Cpyright AIM Specialty Health. All Rights Reserved. 19

20 CT with cntrast is sensitive fr the detectin f lymphma, lung and geniturinary cancers, which are the next mst cmmn causes f malignancy in patients with unintentinal weight lss. Abnrmal Test Findings Imaging abnrmalities Advanced imaging is cnsidered medically necessary fr fllw up f ANY f the fllwing abnrmalities identified n chest X-ray r ther thracic imaging study: Pulmnary mass, structural r parenchymal abnrmality Hilar enlargement r mediastinal widening Hyperlucent lung in pediatric patients Unexplained diaphragmatic elevatin r immbility Psitive sputum cytlgy Advanced imaging is cnsidered medically necessary fr fllw up. Tracheal r brnchial lesin r ther findings n brnchscpy Advanced imaging is cnsidered medically necessary fr fllw up. References 1. American Cllege f Radilgy. ACR-STR Practice Parameter fr the Perfrmance f High-Reslutin Cmputed Tmgraphy (HRCT) f the Lungs in Adults Heitkamp DE, Mhammed TL, Kirsch J, et al. ACR apprpriateness criteria((r))acute respiratry illness in immuncmprmised patients. Jurnal f the American Cllege f Radilgy : JACR. 2012;9(3): Epub 2012/03/06. PMID: Grycki T, Lasek I, Kaminski K, et al. Evaluatin f radiatin dses delivered in different chest CT prtcls. Plish jurnal f radilgy. 2014;79:1-5. Epub 2014/01/24. PMID: Harris M, Clark J, Cte N, et al. British Thracic Sciety guidelines fr the management f cmmunity acquired pneumnia in children: update Thrax. 2011;66 Suppl 2:ii1-23. Epub 2011/10/19. PMID: Rampinelli C, Origgi D, Bellmi M. Lw-dse CT: technique, reading methds and image interpretatin. Cancer imaging : the fficial publicatin f the Internatinal Cancer Imaging Sciety. 2013;12: Epub 2013/02/13. PMID: Šimundić A-M. Measures f Diagnstic Accuracy: Basic Definitins. EJIFCC. 2009;19(4): PMID: PMC Imberger G, McIlry D, Pace NL, et al. Psitive end-expiratry pressure (PEEP) during anaesthesia fr the preventin f mrtality and pstperative pulmnary cmplicatins. Cchrane Database Syst Rev. 2010(9):CD PMID: Cpyright AIM Specialty Health. All Rights Reserved. 20

21 8. Natinal Institute fr Health and Care Excellence. Pneumnia in adults: diagnsis and management United Kingdm: The Natinal Institute fr Health and Care Excellence; Llamas-Alvarez AM, Tenza-Lzan EM, Latur-Perez J. Accuracy f Lung Ultrasngraphy in the Diagnsis f Pneumnia in Adults: Systematic Review and Meta-Analysis. Chest. 2017;151(2): PMID: El Slh AA, Aquilina AT, Gunen H, et al. Radigraphic reslutin f cmmunity-acquired bacterial pneumnia in the elderly. J Am Geriatr Sc. 2004;52(2): Epub 2004/01/20. PMID: Jnes BP, Tay ET, Elikashvili I, et al. Feasibility and Safety f Substituting Lung Ultrasngraphy fr Chest Radigraphy When Diagnsing Pneumnia in Children: A Randmized Cntrlled Trial. Chest. 2016;150(1): Epub 2016/03/01. PMID: Mntella S, Crcine A, Santamaria F. Recurrent Pneumnia in Children: A Reasned Diagnstic Apprach and a Single Centre Experience. Internatinal jurnal f mlecular sciences. 2017;18(2). Epub 2017/02/02. PMID: MacMahn H, Naidich DP, G JM, et al. Guidelines fr Management f Incidental Pulmnary Ndules Detected n CT Images: Frm the Fleischner Sciety Radilgy. 2017;284(1): Epub 2017/02/28. PMID: Kards P, Berck H, Fuchs KH, et al. Guidelines f the German Respiratry Sciety fr diagnsis and treatment f adults suffering frm acute r chrnic cugh. Pneumlgie (Stuttgart, Germany). 2010;64(11): Epub 2010/08/10. PMID: Kahrilas PJ, Altman KW, Chang AB, et al. Chrnic Cugh Due t Gastresphageal Reflux in Adults: CHEST Guideline and Expert Panel Reprt. Chest. 2016;150(6): Epub 2016/09/11. PMID: Mannelli G, Ceccni L, Gall O. Laryngeal preneplastic lesins and cancer: challenging diagnsis. Qualitative literature review and meta-analysis. Crit Rev Oncl Hematl. 2016;106: PMID: Chang AB, Oppenheimer JJ, Weinberger M, et al. Children With Chrnic Wet r Prductive Cugh--Treatment and Investigatins: A Systematic Review. Chest. 2016;149(1): PMID: Ketai LH, Mhammed TL, Kirsch J, et al. ACR apprpriateness criteria hemptysis. J Thrac Imaging. 2014;29(3):W PMID: Larici AR, Franchi P, Occhipinti M, et al. Diagnsis and management f hemptysis. Diagn Interv Radil. 2014;20(4): Epub 2014/05/09. PMID: Jeudy J, Khan AR, Mhammed TL, et al. ACR Apprpriateness Criteria hemptysis. J Thrac Imaging. 2010;25(3):W67-9. PMID: Earwd JS, Thmpsn TD. Hemptysis: evaluatin and management. Am Fam Physician. 2015;91(4): Epub 2015/05/09. PMID: Bannister M. Paediatric haemptysis and the trhinlarynglgist: Systematic review. Int J Pediatr Otrhinlaryngl. 2017;92: PMID: Chalumeau-Lemine L, Khalil A, Prigent H, et al. Impact f multidetectr CT-angigraphy n the emergency management f severe hemptysis. Eur J Radil. 2013;82(11):e Epub 2013/08/13. PMID: Schwartz SR, Chen SM, Dailey SH, et al. Clinical practice guideline: harseness (dysphnia). Otlaryngl Head Neck Surg. 2009;141(3 Suppl 2):S1-s31. Epub 2010/02/06. PMID: Strck C, Buitrag-Tellez C. Multidetectr cmputed tmgraphy in nnmalignant laryngeal disease. Current pinin in tlarynglgy & head and neck surgery. 2012;20(6): Epub 2012/10/23. PMID: Paul BC, Chen S, Sridharan S, et al. Diagnstic accuracy f histry, laryngscpy, and strbscpy. Laryngscpe. 2013;123(1): Epub 2012/10/17. PMID: Rbertsn PJ, Breretn JM, Rbersn DW, et al. Chsing wisely: ur list. Otlaryngl Head Neck Surg. 2013;148(4): PMID: Dimitriadis GK, Angelusi A, Weickert MO, et al. Paraneplastic endcrine syndrmes. Endcrine-related cancer. 2017;24(6):R173-r90. Epub 2017/03/28. PMID: Sheikhbahaei S, Marcus CV, Fragmeni RS, et al. Whle-Bdy (18)F-FDG PET and (18)F-FDG PET/CT in Patients with Suspected Paraneplastic Syndrme: A Systematic Review and Meta-Analysis f Diagnstic Accuracy. Jurnal f nuclear medicine : fficial publicatin, Sciety f Nuclear Medicine. 2017;58(7): Epub 2016/12/17. PMID: Cpyright AIM Specialty Health. All Rights Reserved. 21

22 30. Gaddey HL, Hlder K. Unintentinal weight lss in lder adults. Am Fam Physician. 2014;89(9): Epub 2014/05/03. PMID: Stajkvic S, Aitken EM, Hlryd-Leduc J. Unintentinal weight lss in lder adults. CMAJ : Canadian Medical Assciatin jurnal = jurnal de l'assciatin medicale canadienne. 2011;183(4): Epub 2011/02/18. PMID: Wng CJ. Invluntary weight lss. The Medical clinics f Nrth America. 2014;98(3): Epub 2014/04/25. PMID: Bsch X, Mnclus E, Escda O, et al. Unintentinal weight lss: Clinical characteristics and utcmes in a prspective chrt f 2677 patients. PlS ne. 2017;12(4):e Epub 2017/04/08. PMID: Cdes CPT (Current Prcedural Terminlgy) is a registered trademark f the American Medical Assciatin (AMA). CPT five digit cdes, nmenclature and ther data are cpyright by the American Medical Assciatin. All Rights Reserved. AMA des nt directly r indirectly practice medicine r dispense medical services. AMA assumes n liability fr the data cntained herein r nt cntained herein. The fllwing cdes may be applicable t chest imaging and may nt be all-inclusive. CPT Chest CT withut cntrast Chest CT with cntrast Chest CT withut cntrast, fllwed by re-imaging with cntrast MRI chest, withut cntrast MRI chest, with cntrast MRI chest, withut cntrast, fllwed by re-imaging with cntrast MRI breast withut cntrast material(s); unilateral MRI breast withut cntrast material(s); bilateral MRI breast withut and with cntrast with CAD; unilateral MRI breast withut and with cntrast with CAD; bilateral PET imaging, limited area PET imaging, skull t mid-thigh PET imaging, whle bdy PET imaging, with cncurrently acquired CT fr attenuatin crrectin and anatmic lcalizatin; limited area PET imaging, with cncurrently acquired CT fr attenuatin crrectin and anatmic lcalizatin; skull base t midthigh PET imaging, with cncurrently acquired CT fr attenuatin crrectin and anatmic lcalizatin; whle bdy HCPCS G0297 Lw-dse CT scan (LDCT) fr lung cancer screening ICD-10 Diagnsis Refer t the ICD-10 CM manual Histry Status Date Actin Restructured 01/01/2019 Advanced Imaging guidelines redesigned and rerganized t a cnditin-based structure Reviewed and revised 03/01/2018 Last Independent Multispecialty Physician Panel review and revisin Created 03/30/2005 Original effective date Cpyright AIM Specialty Health. All Rights Reserved. 22