Extracranial Carotid Angioplasty/Stenting

Transcription

1 Applies t all prducts administered r underwritten by Blue Crss and Blue Shield f Luisiana and its subsidiary, HMO Luisiana, Inc.(cllectively referred t as the Cmpany ), unless therwise prvided in the applicable cntract. Medical technlgy is cnstantly evlving, and we reserve the right t review and update Medical Plicy peridically. Nte: Endvascular Prcedures fr Intracranial Arterial Disease (Athersclersis and Aneurysms) is addressed separately in medical plicy Nte: Endvascular Therapies fr Extracranial Vertebral Artery Disease is addressed separately in medical plicy When Services May Be Eligible fr Cverage Cverage fr eligible medical treatments r prcedures, drugs, devices r bilgical prducts may be prvided nly if: Benefits are available in the member s cntract/certificate, and Medical necessity criteria and guidelines are met. Based n review f available data, the Cmpany may cnsider cartid artery angiplasty and stent placement in patients wh can be safely treated r crssed by this apprach and have n angigraphically visible intramural thrmbus t be eligible fr cverage. Patient Selectin Criteria The use f cartid artery angiplasty and stent placement in patients wh have n angigraphically visible intramural thrmbus will be cnsidered fr cverage when the fllwing criteria are met: Symptmatic, severe stensis (> 50% stensis) r asymptmatic precclusive disease (> 80%) in patients with anatmic cntraindicatin fr cartid endarterectmy (CEA) (e.g., prir raditherapy r neck surgery, lesins surgically inaccessible, high bifurcatin requiring mandibular dislcatin, spinal immbility, r trachestmy); r Symptmatic, severe stensis (> 50% stensis) r asymptmatic precclusive disease (> 80%) in a patient with significant medical disease that wuld make the patient high risk fr surgery, including ne r mre f the fllwing cnditins: Age > 80 years; r Cngestive heart failure (New Yrk Heart Assciatin [NYHA] class III/IV) and/r left ventricular ejectin fractin < 30%; r Open heart surgery needed within 6 weeks; r Recent mycardial infarctin (> 24 hurs and < 4 weeks); r Unstable angina (Canadian Cardivascular Sciety [CCS] class III/IV); r Severe chrnic bstructive pulmnary disease; r Cntralateral cartid cclusin requiring treatment; r Cntralateral laryngeal nerve palsy. Symptmatic, severe stensis (> 50%) r asymptmatic precclusive disease (> 80%) and ne f the fllwing cnditins: Significant tandem lesin that may require endvascular therapy; r Page 1 f 8

2 Restensis after CEA; r Stensis secndary t arterial dissectin; r Stensis secndary t fibrmuscular dysplasia; r Stensis secndary t Takayasu arteritis; r Pseudaneurysm. When Services Are Cnsidered Investigatinal Cverage is nt available fr investigatinal medical treatments r prcedures, drugs, devices r bilgical prducts. Based n review f available data, the Cmpany cnsiders use f cartid artery angiplasty and stent placement fr all ther indicatins, including but nt limited t the fllwing, t be investigatinal*: Patients with cartid stensis wh are suitable candidates fr CEA; r Asymptmatic stensis f any degree, except when patient selectin criteria are met; r Symptmatic stensis assciated with an intracranial vascular malfrmatin; r Symptmatic stensis in a patient with a subacute cerebral infarctin; r Symptmatic stensis in a patient with a significant cntraindicatin t angigraphy; r Cartid stensis with angigraphically visible intraluminal thrmbus; r Cartid stensis that cannt be safely reached r crssed by endvascular apprach; r Cartid stensis in a patient when patient selectin criteria are nt met. Backgrund/Overview Cmbined with ptimal medical management, cartid angiplasty with r withut stenting has been evaluated as an alternative t CEA. Cartid artery stenting (CAS) invlves the intrductin f caxial systems f catheters, micrcatheters, ballns, and ther devices. The prcedure is mst ften perfrmed thrugh the femral artery, but a transcervical apprach can als be used t avid traversing the artic arch. The prcedure typically takes 20 t 40 minutes. Interventinalists almst unifrmly use an emblic prtectin device (EPD) t reduce the risk f strke caused by thrmbemblic material disldged during CAS. EPDs can be deplyed prximally (with flw reversal) r distally (using a filter). Cartid angiplasty is rarely perfrmed withut stent placement. The prpsed advantages f CAS ver CEA include: General anesthesia is nt used (althugh CEA can be perfrmed under lcal r reginal anesthesia) Cranial nerve palsies are infrequent sequelae (althugh almst all fllwing CEA reslve ver time) Simultaneus prcedures may be perfrmed n the crnary and cartid arteries. FDA r Other Gvernmental Regulatry Apprval U.S. Fd and Drug Administratin (FDA) A number f CAS and EPDs have been apprved by the U.S. FDA thrugh the premarket apprval r the 510(k) prcess. Examples are prvided in Table 1. Page 2 f 8

3 Table 1. FDA-Apprved Cartid Artery Stents and Emblic Prtectin Devices Manufacturer Stents and Devices PMA/510(k) Date Guidant, nw Abbtt Vascular Acculink and RX Acculink cartid stents Aug 2004 Guidant, nw Abbtt Vascular Accunet and RX Accunet cerebral prtectin filters Aug 2004 Abbtt Vascular Xact RX cartid stent system Sep 2005 Abbtt Vascular Embshield emblic prtectin system Sep 2005 Crdis Crp. Precise nitinl cartid stent system Sep 2006 Crdis Crp. AngiGuard XP and RX embli capture guidewire systems Sep 2006 EndTex Interventinal Systems NexStent cartid stent ver-the-wire and mnrail delivery Oct 2006 systems Bstn Scientific FilterWire EZ emblic prtectin system Oct 2006 ev3, Arterial Evlutin Technlgy Prtégé Rx and SpideRx Jan 2007 Bstn Scientific Cartid Wallstent Oct 2008 GORE GORE Flw Reversal System Feb 2009 GORE GORE Emblic Filter May 2011 Medtrnic/Invatec M.Ma Ultra Prximal Cerebral Prtectin Device Oct 2009 Silk Rad Medical ENROUTE Transcartid Stent System and ENROUTE Transcartid Neurprtectin System May 2015 FDA: Fd and Drug Administratin; PMA: premarket apprval. Each FDA-apprved cartid stent is indicated fr cmbined use with an EPD t reduce risk f strke in patients cnsidered at increased risk fr periprcedural cmplicatins frm CEA wh are symptmatic with greater than 50% stensis, r asymptmatic with greater than 80% stensis with degree f stensis assessed by ultrasund r angigram, with cmputed tmgraphy angigraphy als used. Patients are cnsidered at increased risk fr cmplicatins during CEA if affected by any item frm a list f anatmic features and cmrbid cnditins included in each stent system s Infrmatin fr Prescribers. The RX AcculinkCartid Stent System is als apprved fr use in cnventinal risk patients (nt cnsidered at increased risk fr cmplicatins during CEA) with symptms and 70% r mre stensis by ultrasund r 50% r mre stensis by angigram, and asymptmatic patients with 70% r mre stensis by ultrasund r 60% r mre stensis by angigram. FDA-apprved stents and EPDs differ in the deplyment methds used nce they reach the target lesin, with the rapid exchange devices designed fr mre rapid stent and filter expansin. FDA has mandated pstmarketing studies fr EPDs, including lnger fllw-up fr patients already reprted t FDA and additinal registry studies, primarily t cmpare utcmes as a functin f clinician training and facility experience. Each manufacturer s system is available in varius cnfiguratins (e.g., straight r tapered) and sizes (diameters and lengths) t match the vessel lumen that will receive the stent. In 2015, the ENROUTE Transcartid Neurprtectin System was cleared fr marketing by FDA thrugh the 510(k) prcess. ENROUTE is a flw reversal device designed t be placed via direct cartid access. FDA prduct cdes: NIM (stents) and NTE (EPDs). Page 3 f 8

4 Centers fr Medicare and Medicaid Services (CMS) In 2001, the CMS issued natinal cverage plicy that restricted cverage fr cartid angiplasty and stenting t patients participating in a clinical trial with categry B investigatinal device exemptin (IDE) designatin frm the FDA. Percutaneus transluminal angiplasty f the vertebral and cerebral arteries remained nncvered. When FDA apprved the first (Guidant) devices, Medicare cverage under the IDE was n lnger available fr that manufacturer s devices and was nt applicable t FDA-required pstapprval studies. Thus, in 2004, Medicare bradened its natinal cverage plicy and determined that the evidence is adequate t cnclude that percutaneus transluminal angiplasty (PTA) with cartid stent placement is reasnable and necessary when perfrmed cnsistent with FDA apprval f the cartid stent device and in an FDA required pst-apprval study. Fr unapprved stents and EPDs, the prir plicy remained in effect and restricted cverage t patients participating in an FDA-apprved categry B IDE trial f stent placement in the cervical cartid artery. While the Medicare decisin differed frm the cnclusins f this evidence review, Medicare made a public plicy decisin that making available new, effective therapies aimed at addressing treatment and preventin f cerebrvascular disease was imprtant t Medicare beneficiaries. Medicare als nted that it recgnized the value in supprting pstapprval studies as the cllected data may prvide an pprtunity fr practitiners t determine which patients are mst apprpriate fr CAS and t reinfrce IDE trial data n health utcmes and adverse events. CMS prvides a cntinually updated listing f facilities eligible fr Medicare reimbursement that meet CMS's minimum facility standards fr perfrming CAS fr high-risk patients. In 2005, CMS determined that CAS with EPD was reasnable and necessary fr patients at high-risk fr CEA wh als have symptmatic cartid artery stensis 70% r mre. CMS limited cverage fr these patients t prcedures perfrmed using FDA-apprved devices. CMS als limited cverage fr patients at high risk fr CEA with symptmatic cartid artery stensis between 50% and 70%, and fr patients at high risk fr CEA with asymptmatic stensis 80% r mre, t FDA-apprved categry B IDE clinical trials fr unapprved devices, r t FDA-required pstapprval studies fr apprved devices. CMS defined patients at high-risk fr CEA as having significant cmrbidities and/r anatmic risk factrs (i.e., recurrent stensis and/r previus radical neck dissectin) wh wuld be pr candidates fr CEA in the pinin f a surgen. In 2007, a decisin mem reaffirmed CMS s previus decisin fllwing a request t expand cverage while clarifying that CAS is nly cvered when used with an EPD and is, therefre, nt cvered if deplyment f the distal EPD is nt technically pssible. In 2008, in a sixth recnsideratin, and in 2009, in a seventh recnsideratin, CMS reaffirmed its prir cverage decisins. In 2012, CMS cnvened a Medicare Evidence Develpment & Cverage Advisry Cmmittee panel t cnsider management f cartid athersclersis. Medicare Evidence Develpment & Cverage Advisry Cmmittee panel members vted n specific questins using a scale f 1 (lw cnfidence) t 5 (high Page 4 f 8

5 cnfidence). Fr symptmatic patients nt cnsidered at high-risk, the mean scres t the questin f whether CAS is the favred treatment strategy in this ppulatin was 1.85 and fr CEA 3.6. Fr asymptmatic patients nt cnsidered high-risk, the evidence was judged t have nt reached a level f certainty t determine a favred treatment. Ratinale/Surce This medical plicy was develped thrugh cnsideratin f peer-reviewed medical literature generally recgnized by the relevant medical cmmunity, U.S. FDA apprval status, natinally accepted standards f medical practice and accepted standards f medical practice in this cmmunity, Blue Crss and Blue Shield Assciatin technlgy assessment prgram (TEC) and ther nn-affiliated technlgy evaluatin centers, reference t federal regulatins, ther plan medical plicies, and accredited natinal guidelines. References 1. Blue Crss and Blue Shield Assciatin, Medical Plicy Reference Manual, Extracranial Cartid Artery Stenting, , 05: Blue Crss and Blue Shield Assciatin. Angiplasty and Stenting f the Cervical Cartid Artery with Distal Emblic Prtectin f the Cerebral Circulatin. TEC Assessment, February 2005; 19(15). 3. Ecker RD, Brwn RD, et al. Cst f Treating High-Risk Symptmatic Cartid Artery Stensis: Stent Insertin and Angiplasty Cmpared with Endarterectmy. J f Neursurg. 2004; 101(6): Kvacic JC, Ry PR, et al. Percutaneus Cartid Artery Stenting: A Strategy in Evlutin. Int Med J. 2005; 35(3): Levy EI, Hanel RA, et al. Frequency and Management f Recurrent Stensis after Cartid Artery Stent Implantatin. J Neursurg.2005; 102(1): Hbsn RW 2nd, Hward VJ, et al. Cartid Artery Stenting is assciated with Increased Cmplicatins in Octgenarians: 30-day Strke and Death Rates in the CREST Lead-In Phase. J Vasc Surg. 2004; 40(6): Lin PH, Bush RL, et al. Cartid Artery Stenting with Rutine Cerebral Prtectin in High-Risk Patients. Am J Surg. 2004; 188(6): ALhaddad IA. Cartid Artery Surgery vs. Stent: A Cardivascular Perspective. Catheter Cardivasc Interv. 2004; 63(3): Faries PL, Dayal R, et al. Cntinuity in the Treatment f Cartid Artery Disease: Results f a Cartid Stenting Prgram Initiated by Vascular Surgens. Ann Vasc Surg. 2004; 18(6): Barr J, Cnnrs III JJ, et al. Quality Imprvement Guidelines fr the Perfrmance f Cervical Cartid Angiplasty and Stent Placement. J Vasc Interv Radil. 2003; 14:S321-S Sacc RL, Adams R, Albers G et al. Guidelines fr preventin f strke in patients with ischemic strke r transient ischemic attack: a statement fr healthcare prfessinals frm the American Heart Assciatin/American Strke Assciatin Cuncil n Strke: c-spnsred by the Cuncil n Cardivascular Radilgy and Interventin: the American Academy f Neurlgy affirms the value f this guideline. Strke 2006; 37(2): Plicy Histry 04/05/2005 Medical Directr review 04/19/2005 Medical Plicy Cmmittee review 05/23/2005 Managed Care Advisry Cuncil apprval 08/03/2005 Medical Directr review 08/16/2005 Medical Plicy Cmmittee review. Cverage eligibility revised t cnsider cverage fr cartid artery angiplasty and stent placement (CAS) in patients wh can be safely treated r crssed by this apprach and have n angigraphically visible intramural thrmbus. 08/24/2005 Managed Care Advisry Cuncil apprval Page 5 f 8

6 07/07/2006 Frmat revisin, including FDA and r ther gvernmental regulatry apprval and ratinale/surce. Cverage eligibility unchanged. 04/04/2007 Medical Directr review 04/18/2007 Medical Plicy Cmmittee apprval. Cverage eligibility unchanged. CMS infrmatin added t gvernmental regulatry apprval, ratinale updated. 04/02/2008 Medical Directr review 04/16/2008 Medical Plicy Cmmittee apprval. N change t cverage eligibility. 04/02/2009 Medical Directr review 04/15/2009 Medical Plicy Cmmittee apprval. N change t cverage eligibility. 04/08/2010 Medical Plicy Cmmittee apprval 04/21/2010 Medical Plicy Implementatin Cmmittee apprval. Cverage eligibility unchanged. 04/07/2011 Medical Plicy Cmmittee review 04/13/2011 Medical Plicy Implementatin Cmmittee apprval. Cverage eligibility unchanged. 04/12/2012 Medical Plicy Cmmittee review 04/25/2012 Medical Plicy Implementatin Cmmittee apprval. Cverage eligibility unchanged. 01/23/2013 Cding updated 04/04/2013 Medical Plicy Cmmittee review 04/24/2013 Medical Plicy Implementatin Cmmittee apprval. Cverage eligibility unchanged. 04/03/2014 Medical Plicy Cmmittee review 04/23/2014 Medical Plicy Implementatin Cmmittee apprval. Cverage eligibility unchanged. 05/07/2015 Medical Plicy Cmmittee review 05/20/2015 Medical Plicy Implementatin Cmmittee apprval. Cverage eligibility unchanged. 08/03/2015 Cding update: ICD10 Diagnsis cde sectin added; ICD9 Prcedure cde sectin remved. 03/24/2016 Cding update: cdes and will be remved frm this plicy 05/05/2016 Medical Plicy Cmmittee review 05/18/2016 Medical Plicy Implementatin Cmmittee apprval. Cverage eligibility unchanged. 01/01/2017 Cding update: Remving ICD-9 Diagnsis Cdes 07/06/2017 Medical Plicy Cmmittee review 07/19/2017 Medical Plicy Implementatin Cmmittee apprval. Fr symptmatic, severe stensis (> 50% stensis) r asymptmatic precclusive disease (> 80%), in patients with anatmic cntraindicatin fr cartid endarterectmy (e.g., prir raditherapy r neck surgery, lesins surgically inaccessible, and spinal immbility, r trachestmy was added t the first cverage criteria bullet. Fr symptmatic, severe stensis (> 50% stensis) r asymptmatic precclusive disease (> 80%) in a patient with significant medical disease that wuld make the patient high risk fr surgery, remved lesins distal r prximal t the usual lcatin frm the criteria. Fr symptmatic, severe stensis (> 50%) r asymptmatic precclusive disease (> 80%), remved the secnd cverage criteria bullet, Radiatin-induced stensis (fllwing radiatin t the neck r radical neck dissectin). Fr the use f cartid artery angiplasty and stent placement, Patients with cartid stensis wh are suitable candidates fr cartid endarterectmy was added t the investigatinal indicatins. 07/05/2018 Medical Plicy Cmmittee review 07/11/2018 Medical Plicy Implementatin Cmmittee apprval. Cverage eligibility unchanged. Next Scheduled Review Date: 07/2019 Page 6 f 8

7 Cding The five character cdes included in the Blue Crss Blue Shield f Luisiana Medical Plicy Cverage Guidelines are btained frm Current Prcedural Terminlgy (CPT ), cpyright 2017 by the American Medical Assciatin (AMA). CPT is develped by the AMA as a listing f descriptive terms and five character identifying cdes and mdifiers fr reprting medical services and prcedures perfrmed by physician. The respnsibility fr the cntent f Blue Crss Blue Shield f Luisiana Medical Plicy Cverage Guidelines is with Blue Crss and Blue Shield f Luisiana and n endrsement by the AMA is intended r shuld be implied. The AMA disclaims respnsibility fr any cnsequences r liability attributable r related t any use, nnuse r interpretatin f infrmatin cntained in Blue Crss Blue Shield f Luisiana Medical Plicy Cverage Guidelines. Fee schedules, relative value units, cnversin factrs and/r related cmpnents are nt assigned by the AMA, are nt part f CPT, and the AMA is nt recmmending their use. The AMA des nt directly r indirectly practice medicine r dispense medical services. The AMA assumes n liability fr data cntained r nt cntained herein. Any use f CPT utside f Blue Crss Blue Shield f Luisiana Medical Plicy Cverage Guidelines shuld refer t the mst current Current Prcedural Terminlgy which cntains the cmplete and mst current listing f CPT cdes and descriptive terms. Applicable FARS/DFARS apply. CPT is a registered trademark f the American Medical Assciatin. Cdes used t identify services assciated with this plicy may include (but may nt be limited t) the fllwing: Cde Type Cde CPT HCPCS ICD-10 Diagnsis 0075T, 0076T, 36221, 36222, 36223, 36224, 36225, 36226, 36227, 36228, 37215, 37216, 37217, N Cdes I I I65.21-I65.29 I I I65.8 Page 7 f 8 I I I63.59 *Investigatinal A medical treatment, prcedure, drug, device, r bilgical prduct is Investigatinal if the effectiveness has nt been clearly tested and it has nt been incrprated int standard medical practice. Any determinatin we make that a medical treatment, prcedure, drug, device, r bilgical prduct is Investigatinal will be based n a cnsideratin f the fllwing: A. Whether the medical treatment, prcedure, drug, device, r bilgical prduct can be lawfully marketed withut apprval f the U.S. Fd and Drug Administratin (FDA) and whether such apprval has been granted at the time the medical treatment, prcedure, drug, device, r bilgical prduct is sught t be furnished; r B. Whether the medical treatment, prcedure, drug, device, r bilgical prduct requires further studies r clinical trials t determine its maximum tlerated dse, txicity, safety, effectiveness, r effectiveness as cmpared with the standard means f treatment r diagnsis, must imprve health utcmes, accrding t the cnsensus f pinin amng experts as shwn by reliable evidence, including: 1. Cnsultatin with the Blue Crss and Blue Shield Assciatin technlgy assessment prgram (TEC) r ther nnaffiliated technlgy evaluatin center(s); 2. Credible scientific evidence published in peer-reviewed medical literature generally recgnized by the relevant medical cmmunity; r 3. Reference t federal regulatins. **Medically Necessary (r Medical Necessity ) - Health care services, treatment, prcedures, equipment, drugs, devices, items r supplies that a Prvider, exercising prudent clinical judgment, wuld prvide t a patient fr the purpse f preventing, evaluating, diagnsing r treating an illness, injury, disease r its symptms, and that are: A. In accrdance with natinally accepted standards f medical practice;

8 B. Clinically apprpriate, in terms f type, frequency, extent, level f care, site and duratin, and cnsidered effective fr the patient's illness, injury r disease; and C. Nt primarily fr the persnal cmfrt r cnvenience f the patient, physician r ther health care prvider, and nt mre cstly than an alternative service r sequence f services at least as likely t prduce equivalent therapeutic r diagnstic results as t the diagnsis r treatment f that patient's illness, injury r disease. Fr these purpses, natinally accepted standards f medical practice means standards that are based n credible scientific evidence published in peer-reviewed medical literature generally recgnized by the relevant medical cmmunity, Physician Specialty Sciety recmmendatins and the views f Physicians practicing in relevant clinical areas and any ther relevant factrs. Indicated trademarks are the registered trademarks f their respective wners. NOTICE: Medical Plicies are scientific based pinins, prvided slely fr cverage and infrmatinal purpses. Medical Plicies shuld nt be cnstrued t suggest that the Cmpany recmmends, advcates, requires, encurages, r discurages any particular treatment, prcedure, r service, r any particular curse f treatment, prcedure, r service. Page 8 f 8