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

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1 CLINICAL APPROPRIATENESS GUIDELINES ADVANCED IMAGING Apprpriate Use Criteria: Vascular Imaging 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 Vascular Imaging... 7 General Infrmatin/Overview... 7 Scpe... 7 Technlgy Cnsideratins... 7 Definitins... 7 Clinical Indicatins... 9 General Vascular... 9 Cngenital r develpmental vascular anmalies... 9 Traumatic vascular injury... 9 Tumr... 9 Vasculitis Prcedure-related Imaging Prcedure-related Imaging Brain, Head and Neck Aneurysm intracranial Arterial thrmbemblic disease Arterivenus malfrmatin r arterivenus fistula Cartid aneurysm r dissectin Cartid stensis r cclusin Cerebrvascular accident r transient ischemic attack Dissectin intracranial Fibrmuscular dysplasia Hematma Hemrrhage intracranial r subarachnid Hrner s syndrme Pulsatile tinnitus Stensis r cclusin intracranial arteries Trigeminal neuralgia Venus thrmbsis r cmpressin extracranial Venus thrmbsis r cmpressin intracranial Vertebrbasilar aneurysm r dissectin Vertebrbasilar stensis r cclusin Chest Cpyright AIM Specialty Health. All Rights Reserved. 2

3 Artic aneurysm r dissectin Athermatus disease (Adult nly) Pulmnary emblism Other vascular indicatins chest Abdmen and Pelvis Aneurysm f the abdminal arta Aneurysm f the iliac vessels Arterivenus malfrmatin r fistula Dissectin f the abdminal arta r branch vessel Hematma/hemrrhage abdminal arta and/r branch vessel Mesenteric ischemia Prtal hypertensin Pseudaneurysm abdminal arta r branch vessel Renal artery stensis Stensis r cclusin f the abdminal arta r branch vessels Unexplained bld lss in the abdmen r pelvis Venus thrmbsis r cclusin Visceral artery aneurysm Upper Extremity Sten-cclusive disease Other vascular indicatins in upper extremity Lwer Extremity Peripheral arterial disease lwer extremity Other vascular indicatins in lwer extremity MR Angigraphy f the Spinal Canal MR Angigraphy f the Spinal Canal 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 Repeated imaging f the same anatmical area by different prviders fr the same member ver a shrt perid f time Cpyright AIM Specialty Health. All Rights Reserved. 5

6 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 Vascular Imaging General Infrmatin/Overview Scpe These guidelines address advanced vascular imaging 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 Duplex ultrasund is frequently chsen as the primary mdality fr screening and diagnsis f vascular disease, particularly arterial stensis. It is als suitable fr analysis in subclinical arterial plaque buildup and as such is useful fr evaluating patients with high cardivascular disease risk. Duplex ultrasund is nninvasive, des nt use inizing radiatin, and can be perfrmed with several Dppler mdalities. Duplex ultrasund is less accurate in the artiliac regin, especially in cases f patient besity r intestinal gas, and als in the presence f multiple sequential vascular lesins. Additinal mdalities are ften required fr preperative arterial mapping. Cmputed tmgraphy angigraphy (CTA) and magnetic resnance angigraphy (MRA) scans bth prvide high cntrast and can yield a 3D map f vasculature, making them useful fr imaging prir t interventin. MRA imaging with gadlinium-enhanced cntrast detects arterial stensis mre accurately than duplex ultrasund. Specific MR sequences are als available that allw MRA t be perfrmed withut cntrast r with nn-gadlinium cntrast agents if expsure t gadlinium is a ptential cncern. CTA ffers faster image acquisitin and is less susceptible than MRA t respiratin r mtin artifact. CTA is reliable fr vascular lesin lcalizatin and severity, but MRA yields imprved sft tissue reslutin and, unlike CTA, is nt sensitive t calcificatin. Fr example, in the case f vasculitis, the vessel wall edema wuld be better visualized with MRA. Hwever, the surrunding sft tissues are nt well evaluated with MRA and wuld be better visualized with CTA. MRA has becme the preferred technique fr imaging peripheral vascular disease, as newer imaging sequences are able t vercme issues such as lng acquisitin times and artifact. Disadvantages f CTA include expsure t inizing radiatin and risks assciated with infusin f idinated cntrast media, including allergic reactins r renal cmprmise. 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 MRA. Infusin f gadlinium may als cnfer an unacceptable risk in persns with advanced renal disease. Ankle brachial index, the rati f bld pressure at the ankle t bld pressure in the brachial artery, is a nninvasive metric used in the diagnsis f peripheral artery disease, particularly lwer extremity arterial disease, and a predictr f cardivascular disease risk. Digital subtractin angigraphy, a type f catheter angigraphy, has lng been the gld standard fr vascular imaging. In cntrast t the mdalities described abve, digital subtractin angigraphy allws fr treatment in additin t diagnsis f sme vascular pathlgies. Due t assciated risks it is used much less frequently than CTA r MRA, but may be indicated in imaging f belw-the-knee arterial disease, r when nninvasive imaging mdalities have yielded cnflicting r incnclusive results. Definitins Phases f the care cntinuum are bradly defined as fllws: Screening testing in the absence f signs r symptms f disease Cpyright AIM Specialty Health. All Rights Reserved. 7

8 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 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 Cpyright AIM Specialty Health. All Rights Reserved. 8

9 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%. 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 vascular imaging 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. General Vascular Cngenital r develpmental vascular anmalies Advanced imaging is cnsidered medically necessary fr diagnsis and management when the results f imaging will impact treatment decisins. - CTA r MRA brain, neck, chest, abdmen and pelvis, r extremities (based n lcatin) - CT r MRI brain - CT r MRI chest Traumatic vascular injury Advanced imaging is cnsidered medically necessary fr evaluatin when the results f imaging will impact management. Tumr - CTA r MRA brain, neck, chest, abdmen and pelvis, r extremities (based n lcatin) - CT chest Advanced imaging is cnsidered medically necessary fr evaluatin f the fllwing: Bld supply t established tumr Vascular invasin r cmpressin by tumr - CTA r MRA brain, neck, chest, abdmen and pelvis, r extremities (based n lcatin) Cpyright AIM Specialty Health. All Rights Reserved. 9

10 Vasculitis Advanced imaging is cnsidered medically necessary fr diagnsis and management when the results f imaging will impact treatment decisins. - CTA r MRA brain, neck, chest, abdmen and pelvis, r extremities (based n lcatin) - MRI brain - CT chest Prcedure-related Imaging Prcedure-related Imaging Fr prcedures related t artic aneurysm r dissectin, see Aneurysm and Dissectin indicatins fr the apprpriate anatmic regin. Advanced imaging is cnsidered medically necessary in ANY f the fllwing scenaris: Vascular anatmic delineatin prir t surgical and interventinal prcedures Evaluatin f the arta prir t transcatheter artic valve implantatin/replacement (TAVI/TAVR) Evaluatin fr suspected vascular cmplicatins fllwing a prcedure - CTA r MRA brain, neck, chest, abdmen and pelvis, r extremities (based n specific prcedure) - CTA r MRA chest, abdmen and pelvis prir t TAVI/TAVR* *Alternative studies fr this indicatin include CT r MRI chest, CT abdmen and pelvis, CTA abdminal arta with bilateral lwer extremity runff Exclusins Advanced imaging is cnsidered nt medically necessary in EITHER f the fllwing scenaris: Screening fr cartid disease using CTA r MRA in preparatin fr crnary artery bypass graft (CABG) surgery is cnsidered nt medically necessary. MR vengraphy r CT vengraphy in preparatin fr a neursurgical r percutaneus prcedure t treat multiple sclersis is cnsidered nt medically necessary. Ratinale The purpse f vascular imaging in multiple sclersis is fr preperative planning prir t stenting r angiplasty f the venus sinus. Evidence-based guidelines strngly recmmend against perfrming this prcedure based n lack f evidence. 2 Stenting r angiplasty f the venus sinus ( liberatin therapy ) is based n an unprven hypthesis that multiple sclersis is related t chrnic cerebrspinal venus insufficiency, which leads t irn buildup in the central nervus system and an immune r inflammatry reactin. The FDA issued a warning in 2012 abut liberatin therapy, stating there is a lack f evidence t supprt its use and the criteria used t diagnse chrnic cerebrspinal venus insufficiency have nt been adequately established. Stenting r angiplasty f the venus sinus has been assciated with deaths and serius cmplicatins, including migratin f stents t the heart r ther parts f the bdy, venus injury, bld clts, cranial nerve damage, and abdminal bleeding in patients wh have been treated fr chrnic cerebrspinal venus insufficiency. The FDA cncluded that these prcedures put patients at risk withut clear evidence that they might benefit. 3 Cpyright AIM Specialty Health. All Rights Reserved. 10

11 Brain, Head and Neck Aneurysm intracranial Screening Persns with 2 r mre first-degree relatives with intracranial aneurysm r subarachnid hemrrhage Persns with a heritable cnditin that is assciated with intracranial aneurysm (examples include autsmal dminant plycystic kidney disease and Ehlers-Danls syndrme type IV) Diagnsis Evaluatin f neurlgic signs r symptms suggestive f intracranial aneurysm (fr islated headache, see Brain Imaging) Management Evaluatin fr aneurysm prgressin based n new r wrsening neurlgic symptms Preperative evaluatin Initial pstperative evaluatin Surveillance Initial evaluatin at 6 t 12 mnths fllwing diagnsis, then every 1 t 2 years - CTA r MRA brain - CT r MRI brain Ratinale SCREENING The incidence f intracranial aneurysm may be as high as 19% in patients with a significant family histry f intracranial aneurysms as cmpared t 2% t 3.5% in the general ppulatin. 4,5 As a result, the American Heart and Strke Fundatin, American Academy f Neurlgy, and the American Assciatin f Neurlgical Surgens strngly recmmend screening in patients with 2 family members with intracranial aneurysm r subarachnid hemrrhage by CTA r MRA. 6,7 Evidence des nt supprt screening in patients with nly 1 affected family member and n additinal risk factrs as incidence is lw (1.14%), and early detectin was nt assciated with imprved utcmes. 8 A 2016 prspective trial evaluated screening MRA in first-degree relatives f patients with ruptured intracranial aneurysms. Of the 305 ttal exams, unruptured intracranial aneurysms were seen in 2.3% f patients (95% CI, 1.02%-4.76%) and less than 1% f the screened ppulatin required an endvascular prcedure r surgical interventin. 9 In patients with autsmal dminant plycystic kidney disease, the incidence fr intracranial aneurysm may be as high as 10%, and there is general agreement that these patients shuld be screened. The evidence supprting aneurysm screening in patients with ther hereditary syndrmes, including Ehlers-Danls, primrdial dwarfism, r gluccrticidremediable aldsternism, is less cmpelling. The American Heart Assciatin and American Strke Assciatin recmmend advanced imaging screening fr patients with autsmal dminant plycystic kidney disease as well as cnsideratin fr screening in patients with micrcephalic stedysplastic primrdial dwarfism. Rutine screening is nt specifically recmmended fr ther hereditary syndrmes. 6 Bth CTA and MRA are highly sensitive fr aneurysm screening with sensitivities abve 95%. 10,11 As MRA des nt require inizing radiatin r cntrast, it cnfers greater ptential net benefit and is generally preferred unless cntraindicated. DIAGNOSIS The use f advanced imaging fr diagnsis f clinically suspected aneurysm as well as management (including periperative evaluatin) f knwn aneurysm is apprpriate. Bth MRA and CTA can reliably detect intracranial aneurysms > 5mm, 10,11 s mdality selectin is ften based n factrs such as patient preference, radiatin sensitivity, cntrast risk, and availability. Fr patients with a suspected subarachnid hemrrhage, CT head withut intravenus cntrast is the mst apprpriate initial imaging mdality. 7 Cpyright AIM Specialty Health. All Rights Reserved. 11

12 SURVEILLANCE Vascular Imaging In the absence f new r wrsening symptms, the American Heart Assciatin and American Strke Assciatin recmmend aneurysm surveillance at 6 t 12 mnths fllwing diagnsis, then every 1 t 2 years r as fllw up after treatment with clips, endvascular cil, r stenting as medically necessary. In patients with unruptured intracranial aneurysm, apprximately 12% will have cntinued grwth f their aneurysms and a 24-fld increased risk f rupture. 12 Surveillance is als recmmended after surgical interventin by the American Heart Assciatin and American Strke Assciatin as well as the American Cllege f Radilgy. Either MRA r CTA may be used fr surveillance f untreated intracranial aneurysm, althugh fllw up using the same imaging mdality n which the aneurysm was initially fund is preferred. In patients with treated aneurysms, MRA head withut intravenus cntrast is superir t CTA fr the evaluatin f ciled aneurysms, while CTA head with intravenus cntrast is preferred fr evaluatin f clipped aneurysms. 7 Arterial thrmbemblic disease Advanced imaging is cnsidered medically necessary when the results f imaging are essential t establish a diagnsis and/r direct management. - CTA r MRA brain fr intracranial arterial disease - CTA r MRA neck fr extracranial arterial disease Arterivenus malfrmatin r arterivenus fistula Advanced imaging is cnsidered medically necessary when the results f imaging are essential t establish a diagnsis and/r direct management. - CTA r MRA brain - CT r MRI brain Cartid aneurysm r dissectin Advanced imaging is cnsidered medically necessary when the results f imaging are essential t establish a diagnsis and/r direct management. - CTA r MRA neck Cartid stensis r cclusin Advanced imaging is cnsidered medically necessary fr diagnsis and management f knwn r suspected sten-cclusive disease fllwing abnrmal r equivcal duplex Dppler study, unless the diagnsis is supprted by clinical exam findings. Nte: Screening fr cartid disease utilizing vascular imaging is nt apprpriate. - CTA r MRA neck Ratinale In the absence f symptms, multiple high-quality evidence-based guidelines d nt recmmend screening fr highgrade cartid stensis in lw r average risk patients Hwever, the recmmendatins are incnsistent with regard t screening f high-risk patients. The U.S. Preventive Services Task Frce des nt recmmend screening fr asymptmatic cartid artery stensis in the general adult ppulatin. 14 While Brtt et al. 15 suggested that duplex ultrasund might be cnsidered in patients withut symptms but with 2 r mre risk factrs, the authrs nte that it is unclear whether establishing a diagnsis wuld justify actins that affect clinical utcmes. Cpyright AIM Specialty Health. All Rights Reserved. 12

13 Cerebrvascular accident r transient ischemic attack Als see Brain Imaging guidelines. Advanced imaging is cnsidered medically necessary fr the diagnsis r management f underlying vascular pathlgy fllwing transient ischemic attack r cnfirmed cerebrvascular accident. - CTA r MRA brain Dissectin intracranial Advanced imaging is cnsidered medically necessary when the results f imaging are essential t establish a diagnsis and/r direct management. - CTA r MRA brain Fibrmuscular dysplasia Advanced imaging is cnsidered medically necessary when the results f imaging are essential t establish a diagnsis and/r direct management. - CTA r MRA neck Hematma Advanced imaging is cnsidered medically necessary when the results f imaging are essential t establish a diagnsis and/r direct management. - CT r MRI brain fr parenchymal evaluatin - CTA r MRA brain fr vascular evaluatin Hemrrhage intracranial r subarachnid Advanced imaging is cnsidered medically necessary when the results f imaging are essential t establish a diagnsis and/r direct management. - CT r MRI brain fr parenchymal evaluatin - CTA r MRA brain fr vascular evaluatin Hrner s syndrme Als see Brain Imaging guidelines. Advanced imaging is cnsidered medically necessary when the results f imaging are essential t establish a diagnsis and/r direct management. - CTA r MRA neck Cpyright AIM Specialty Health. All Rights Reserved. 13

14 Pulsatile tinnitus Als see Brain Imaging and Head & Neck Imaging guidelines. Advanced imaging is cnsidered medically necessary when the results f imaging are essential t establish a diagnsis and/r direct management. - CTA r MRA brain - MRI brain - CT rbit/sella/psterir fssa Stensis r cclusin intracranial arteries Includes athersclertic disease, Myamya disease, sickle cell anemia, and idipathic prgressive arteripathy f childhd. Advanced imaging is cnsidered medically necessary when the results f imaging are essential t establish a diagnsis and/r direct management. - CTA r MRA brain Trigeminal neuralgia Advanced imaging is cnsidered medically necessary when the results f imaging are essential t establish a diagnsis and/r direct management. - CTA r MRA brain Venus thrmbsis r cmpressin extracranial Advanced imaging is cnsidered medically necessary when the results f imaging are essential t establish a diagnsis and/r direct management. - CTA r MRA neck Venus thrmbsis r cmpressin intracranial Includes dural venus sinus thrmbsis, venus sinus thrmbsis, and cerebral vein thrmbsis ADULT Advanced imaging is cnsidered medically necessary fr management f knwn venus thrmbsis and fr diagnsis based n ANY f the fllwing: Headache and abnrmal neurlgic findings Headache r abnrmal neurlgic findings when ANY f the fllwing risk factrs are present: Behcet s disease Cagulpathy such as prtein S, prtein C, r antithrmbin 3 deficiencies, and antiphsphlipid antibdy syndrme Irn deficiency anemia Knwn malignancy Cpyright AIM Specialty Health. All Rights Reserved. 14

15 Medicatin use assciated with thrmbsis such as ral cntraceptives and all-trans retinic acid Meningitis/intracranial infectin Pregnancy Prir episdes f venus sinus thrmbsis Trauma PEDIATRIC Advanced imaging is cnsidered medically necessary when the results f imaging are essential t establish a diagnsis and/r direct management. - CTA r MRA brain - CT r MRI brain Vertebrbasilar aneurysm r dissectin Advanced imaging is cnsidered medically necessary fr evaluatin when the results f imaging will impact management. - CTA r MRA neck Vertebrbasilar stensis r cclusin Advanced imaging is cnsidered medically necessary fr evaluatin when the results f imaging will impact management. Chest - CTA r MRA neck Artic aneurysm r dissectin Advanced imaging is cnsidered medically necessary in ANY f the fllwing scenaris: ADULT Suspected artic aneurysm r dissectin Evaluatin fr disease prgressin based n signs r symptms Preperative planning fr aneurysm r dissectin repair Fllwing surgical repair f artic dissectin r aneurysm within the preceding year when imaging has nt been perfrmed within the prir 6 mnths Stent graft evaluatin Annual surveillance f stable patients with cnfirmed artic dissectin Onging surveillance f stable patients with cnfirmed thracic artic aneurysm wh have nt undergne imaging f the thracic arta within the preceding 6 mnths PEDIATRIC Peridic screening in high risk patients (thse with cnnective tissue disease r carctatin f the arta) Cpyright AIM Specialty Health. All Rights Reserved. 15

16 Evaluatin when there is cncern fr cmplicatins (such as dissectin) Further characterizatin f suspected aneurysm based n prir diagnstic r imaging study Patient with cnfirmed artic dissectin experiencing new r wrsening symptms Peridic surveillance in patients with knwn aneurysm Pre- and pstperative evaluatin - CT, CTA, MRI r MRA chest Vascular Imaging Nte: Echcardigram is generally recmmended as a first line mdality fr evaluatin f the ascending arta in pediatric patients. Ratinale Althugh it cannt cmpletely evaluate the thracic arta, transthracic echcardigraphy (TTE) is the mst frequently used technique fr measuring prximal segments in clinical practice. Given the wide availability and lack f inizing radiatin, TTE is an excellent imaging mdality fr measurement f the artic rt diameter and fr fllwing knwn thracic artic aneurysms t assist in determining the timing f surgery. Since the predminant area f dilatin is ften in the prximal arta, TTE may suffice fr screening. Transthracic echcardigraphy may be limited in patients with abnrmal chest wall cnfiguratins, pulmnary emphysema, and besity; transesphageal echcardigraphy can ffer imprved visualizatin in these patients. 16 CT and CTA are imprtant mdalities in the diagnsis and management f artic disease. In several reprts, CT was fund t have a pled sensitivity f 100% and a pled specificity f 98% fr the detectin f thracic artic dissectin r intramural hematma. MRI reliably demnstrates the relevant features f artic disease, such as artic diameter and the relatinship f artic branches t an aneurysm r dissectin. Advantages f MRI include the lack f inizing radiatin and ability t avid the use f idinated cntrast. Disadvantages include lnger image acquisitin times and reduced ability t mnitr ptentially unstable patients. 16 When planning fr endvascular repair f a thracic artic aneurysm, CTA is the imaging mdality f chice. It allws fr accurate measurement f the length f the aneurysmal segment, evaluatin f invlved branches, and assessment f the healthy artic segments abve and belw the graft. When evaluating patients after repair, CT r CTA is the study f chice. MRI may be safely dne t evaluate nitinl-based stent grafts, but may nt be used fr evaluatin f stainless steel grafts and is unable t visualize metallic stent struts. Fllwing endvascular repair, imaging is apprpriate at 1 mnth, 6 mnths, 12 mnths, and annually thereafter fr aneurysm. Annual evaluatin is apprpriate fllwing endvascular repair f artic dissectin. Fllwing surgical repair, less-frequent imaging may be perfrmed after 1 year f stability has been established. Athermatus disease (Adult nly) Advanced imaging is cnsidered medically necessary fr evaluatin f the thracic arta as a surce f distal embli when a cardiac surce has nt been identified n echcardigraphy. - CTA chest - MRA when CTA cntraindicated Pulmnary emblism ADULT Advanced imaging is cnsidered medically necessary in ANY f the fllwing scenaris: Pulmnary emblism likely based n mdified Wells criteria 17 (> 4 pints) Pulmnary emblism unlikely based n mdified Wells criteria 17 ( 4 pints) with a psitive D- dimer Suspected pulmnary emblism in pregnancy Cpyright AIM Specialty Health. All Rights Reserved. 16

17 PEDIATRIC Advanced imaging is cnsidered medically necessary in ANY f the fllwing scenaris: Mderate r high clinical suspicin f pulmnary emblism Cncern fr recurrent emblism in patients n adequate medical therapy - CT r CTA chest Ratinale Clinical signs and symptms f pulmnary emblism are ntriusly nnspecific, and relatively few patients will present with the classic cnstellatin f pleuritic chest pain, dyspnea, and hypxia. Furthermre, incidence f the cnditin is rare relative t mimics like pneumnia, pleurisy, pericarditis, and mycardial infarctin. Vascular imaging plays an imprtant rle in establishing the diagnsis f pulmnary emblism, but there is evidence that vascular imaging is verutilized in select patient ppulatins where diagnstic yield can be less than 3% LOW PRE-TEST PROBABILITY OF PULMONARY EMBOLISM Cnsensus exists amng multiple high-quality evidence-based guidelines that CTA r ther frms f vascular imaging are nt indicated in patients with a lw pretest prbability f pulmnary emblism. The American Cllege f Physicians recmmends clinicians use validated clinical predictin rules t estimate the pretest prbability in patients with suspected pulmnary emblism. Clinicians shuld nt btain D-dimer measurements r imaging studies in patients with a lw pretest prbability f pulmnary emblism and wh meet all Pulmnary Emblism Rule-ut Criteria. Clinicians shuld btain a high-sensitivity D-dimer measurement as the initial diagnstic test in patients wh have an intermediate pretest prbability f pulmnary emblism r in patients with lw pretest prbability f pulmnary emblism wh d nt meet all Pulmnary Emblism Rule-ut Criteria. Clinicians shuld nt use imaging studies as the initial test in patients wh have a lw r intermediate pretest prbability f pulmnary emblism In a 2016 meta-analysis, Crawfrd et al. cncluded that a negative D-dimer test is valuable in ruling ut pulmnary emblism in patients wh present t the emergency setting with a lw pretest prbability. They nted high levels f false-psitive results, especially amng thse ver the age f 65 years with estimates f specificity frm 23% t 63%. N empirical evidence was available, hwever, t supprt an increase in the diagnstic threshld f interpretatin f D- dimer results fr thse ver the age f 65 years. 19,27 In a 2016 multicenter prspective chrt management study f 808 cnsecutive patients with suspected pulmnary emblism, Bates et al. evaluated whether pulmnary emblism can be safely excluded in patients with negative D-dimer testing withut incrprating clinical prbability assessment. Ninety-nine (12%) were diagnsed with venus thrmbemblism at presentatin. Fur hundred and twenty (52%) had a negative D-dimer level at presentatin and were treated withut anticagulatin; f these, 1 had venus thrmbemblism during fllw up. The negative predictive value f D-dimer testing fr pulmnary emblism was 99.8% (95% CI, 98.7%-99.9%) 28,29 MODERATE TO HIGH PRE-TEST PROBABILITY OF PULMONARY EMBOLISM Cnsensus exists amng multiple high-quality evidence-based guidelines that CT/CTA is indicated in patients with intermediate r high clinical suspicin fr pulmnary emblism. CT shuld be ffered t patients in whm pulmnary emblism is suspected with a likely Wells scre r with an unlikely tw-level pulmnary emblism Wells scre and psitive D-dimer. 25,30-34 Patients with intermediate r high pretest prbability f pulmnary emblism require diagnstic imaging studies, 35 and additinal diagnstic testing shuld be cnsidered if CT is negative. 21 In patients with an elevated D-dimer level, imaging shuld be btained. 36,37 The American Cllege f Radilgy gives CT pulmnary angigraphy and ptimized CT chest with intravenus cntrast a scre f 9, in patients with a psitive plasma D-dimer test. 38 MRI OR MRA FOR EVALUATION OF PULMONARY EMBOLISM There is n cnsistent evidence that MRA r MRI have cmparable reliability r diagnstic accuracy t either CTA r ventilatin-perfusin scintigraphy. In a 2016 systematic review/meta-analysis, Li et al. cncluded that MRA can be used fr the diagnsis f acute pulmnary emblism; hwever, due t limited sensitivity, it cannt be used as a stand-alne test t exclude acute pulmnary emblism. Five studies were included in the meta-analysis. The pled sensitivity 0.83 ( ) and specificity 0.99 ( ) demnstrated that MRA had limited sensitivity and high specificity in the detectin f acute pulmnary emblism. 39 Zhu et al. cnducted a meta-analysis f 15 studies fr patient accuracy and 9 studies fr vessel accuracy n MRI. Authrs cncluded that MRI exhibits a high diagnstic capability with prximal arteries, but lacks sensitivity fr peripheral emblism. The patient-based analysis yielded an verall sensitivity f 0.75 ( ) and 0.84 ( ) fr all patients and patients with technically adequate images, respectively. The verall specificity was 0.80 ( ) and 0.97 ( ). On average, MRI was technically inadequate in 18.89% f patients (range, 2.10%-27.70%). 40,41 Cpyright AIM Specialty Health. All Rights Reserved. 17

18 Other vascular indicatins chest Vascular Imaging Advanced imaging is cnsidered medically necessary fr diagnsis and management f ANY f the fllwing cnditins when the results f imaging will impact treatment decisins. Hematma Pulmnary arterial hypertensin Pulmnary arterivenus malfrmatin Pulmnary sequestratin Subclavian steal syndrme Superir vena cava syndrme Systemic venus thrmbsis r cclusin Thracic utlet syndrme - CTA r MRA chest - CT r MRI chest (alternative mdalities fr evaluatin f superir vena cava syndrme and thracic utlet syndrme) Abdmen and Pelvis Aneurysm f the abdminal arta ADULT Advanced imaging is cnsidered medically necessary in ANY f the fllwing scenaris: Fllwing incnclusive ultrasund in patients with suspected aneurysm/dilatin f the abdminal arta Fllw-up imaging f patients with an established aneurysm/dilatin when mst recent ultrasund imaging is incnclusive Preperative assessment r prir t percutaneus endvascular stent graft placement Annual pst-perative surveillance f stable patients wh have undergne pen surgical repair when mst recent ultrasund imaging is incnclusive Pst-perative surveillance f stable patients wh have been treated with endvascular stent graft Suspected cmplicatin f an aneurysm/dilatin, such as aneurysmal rupture r infectin (requiring urgent imaging) Stent graft evaluatin when endleak suspected PEDIATRIC Advanced imaging is cnsidered medically necessary fllwing nndiagnstic ultrasund in ANY f the fllwing scenaris: Annual screening in patients with cnnective tissue disease Fllw-up imaging f patients with an established aneurysm/dilatin Preperative r pst-perative evaluatin Suspected cmplicatin f an aneurysm/dilatin Cpyright AIM Specialty Health. All Rights Reserved. 18

19 - CT, CTA, MRI r MRA abdmen - CTA abdminal arta with bilateral lwer extremity runff (adults nly) Ratinale Given its wide availability and ability t diagnse r exclude a wide variety f causes f symptms, ultrasund is generally the initial mdality used in the evaluatin f abdminal artic aneurysm (AAA). Several studies have reprted high sensitivity and specificity, 94%-100% and 98%-100%, respectively. 42 CT is less peratr-dependent and allws fr mre reprducible measurements ver serial scans, in additin t prviding detail abut many aneurysm features relevant t clinical decisin making. When endvascular repair f an aneurysm is planned, cntrast-enhanced CT r CTA is essential fr prcedural planning. This mdality allws accurate measurements t be taken at the prximal and distal landing sites fr the stent graft as well as fr evaluatin f the relatinship between the aneurysm and artic branches, and fr evaluatin f the iliac arteries. 16 MRI and MRA are able t reliably depict the anatmic features f aneurysms such that these mdalities are well suited t artic evaluatin. Limitatins include ptential fr artifact due t lnger image acquisitin times, and less accessibility fr mnitring f ptentially unstable patients. Given the lack f inizing radiatin and absence f a need fr idinated cntrast use, these mdalities may be cnsidered in cases where serial fllw-up studies are needed. 16 A high-quality evidence-based guideline recmmends fllw up surveillance f AAA at 12-mnth intervals fr AAA f 35 t 44 mm in diameter and at 6-mnth intervals fr AAA 45 t 54 mm in diameter. 16 Fllwing endvascular repair, surveillance is recmmended after 1 mnth, 6 mnths, 12 mnths, and annually thereafter. Shrter intervals may be apprpriate when there are abnrmal findings warranting clser surveillance. If there is n evidence f endleak r AAA sac enlargement in the first year after endvascular repair, using duplex ultrasund fr annual screening supplemented with CT at 5-year intervals may be cnsidered. Fllwing pen surgical repair, surveillance may be cnsidered at apprximately 5-year intervals and may be perfrmed with duplex ultrasund r CT. 16 Fur randmized trials cmpared the utcmes f ppulatin-based studies with r withut screening fr AAA. The prevalence f AAA was 5.5% in these studies, and AAA screening in men greater than 65 years f age was assciated with a statistically significant decline in AAA-related mrtality ver 10 years. N similar benefit was seen in wmen, thugh wmen were included in nly 1 f the trials and cmprised a small number f patients (9342 ut f a ttal 127,891 patients). Rescreening f patients has demnstrated few psitive results, suggesting that a single ultrasund scan shuld be sufficient fr screening. 16,42 CTA abdmen and pelvis with intravenus cntrast is the gld standard fr preperative endvascular aneurysm repair planning and fr mnitring fllwing endvascular aneurysm repair prcedure in patients with AAA. 43 MRA abdmen and pelvis withut and with intravenus cntrast is an apprpriate alternative t CTA abdmen and pelvis with intravenus cntrast fr patients underging planning fr endvascular aneurysm repair and fr mnitring fllwing endvascular aneurysm repair prcedure where idnated cntrast is cntraindicated. 43 Fllwing endvascular aneurysm repair, the mst widely used surveillance regimen includes multiphasic cntrast-enhanced CT at 1, 6, 12 mnths, and annually thereafter. 43 Aneurysm f the iliac vessels ADULT Advanced imaging is cnsidered medically necessary in ANY f the fllwing scenaris: Fllwing incnclusive ultrasund in patients with suspected aneurysm/dilatin f the iliac r femral vessels Fllw-up imaging f patients with an established aneurysm/dilatin when mst recent ultrasund imaging is incnclusive Preperative assessment r prir t percutaneus endvascular stent graft placement Annual pst-perative surveillance f stable patients wh have undergne pen surgical repair when mst recent ultrasund imaging is incnclusive Pstperative surveillance f stable patients wh have been treated with endvascular stent graft Suspected cmplicatin f an aneurysm/dilatin, such as aneurysmal rupture r infectin requiring urgent imaging Cpyright AIM Specialty Health. All Rights Reserved. 19

20 PEDIATRIC Advanced imaging is cnsidered medically necessary fllwing nndiagnstic ultrasund in ANY f the fllwing scenaris: Annual screening in patients with cnnective tissue disease Fllw-up imaging f patients with an established aneurysm/dilatin Pre/pstperative evaluatin Suspected cmplicatin f an aneurysm/dilatin - CTA r MRA pelvis - CTA abdminal arta with bilateral lwer extremity runff (adults nly) Arterivenus malfrmatin r fistula Advanced imaging is cnsidered medically necessary fr evaluatin when the results f imaging will impact management. - CTA r MRA abdmen and/r pelvis Dissectin f the abdminal arta r branch vessel Advanced imaging is cnsidered medically necessary fr evaluatin when the results f imaging will impact management. - CT, CTA r MRA abdmen and/r pelvis - CTA abdminal arta with bilateral lwer extremity runff Hematma/hemrrhage abdminal arta and/r branch vessel Advanced imaging is cnsidered medically necessary fr evaluatin when the results f imaging will impact management. - CT, CTA r MRA abdmen and/r pelvis - CTA abdminal arta with bilateral lwer extremity runff Mesenteric ischemia Advanced imaging is cnsidered medically necessary fr evaluatin when the results f imaging will impact management. - CTA r MRA abdmen and pelvis Ratinale In patients with suspected mesenteric ischemia, CTA abdmen with intravenus cntrast shuld be the first-line imaging test. 44 Cpyright AIM Specialty Health. All Rights Reserved. 20

21 MRA may be cnsidered an alternative t CTA fr diagnsis f suspected chrnic mesenteric ischemia, althugh there is sme evidence that images btained with MRA are nt as accurate r cmplete as thse btained with CTA. 45 Prtal hypertensin Advanced imaging is cnsidered medically necessary fr evaluatin when the results f imaging will impact management. - CTA r MRA abdmen Pseudaneurysm abdminal arta r branch vessel Advanced imaging is cnsidered medically necessary fr evaluatin when the results f imaging will impact management. - CTA r MRA abdmen and/r pelvis - CTA abdminal arta with bilateral lwer extremity runff Renal artery stensis Advanced imaging is cnsidered medically necessary in ANY f the fllwing scenaris: Fllwing an abnrmal renal Dppler ultrasund suggestive f renal artery stensis Refractry hypertensin, in patients receiving therapeutic dses f 3 r mre anti-hypertensive medicatins with dcumentatin f at least 2 abnrmal serial bld pressure measurements Hypertensin with renal failure r prgressive renal insufficiency Abrupt nset f hypertensin Accelerated r malignant hypertensin Hypertensin develping in patients yunger than age 30 Generalized arterisclertic cclusive disease with hypertensin Deterirating renal functin n angitensin cnverting enzyme inhibitin Abdminal bruit, suspected t riginate in the renal artery Recurrent, unexplained episdes f flash pulmnary edema Unilateral small renal size (greater than 1.5 cm difference in renal size n ultrasund) - CTA r MRA abdmen Nte: Dppler ultrasund f the renal arteries can ften detect renal artery stensis and shuld be cnsidered fr initial evaluatin. Stensis r cclusin f the abdminal arta r branch vessels Advanced imaging is cnsidered medically necessary when the results f imaging are essential t establish a diagnsis and/r direct management. - CTA r MRA abdmen and/r pelvis Cpyright AIM Specialty Health. All Rights Reserved. 21