Percutaneous Transluminal Angioplasty (PTA) And Stenting

Vessel(s)See Table 1 for arteries andveinsWith or Without Stentor Embolic ProtectionDevice (EPD)PlacementCriteria Reference CAS PTA is reasonable and necessary only if performed inMedicare-approved CAS facilities (see the Medicare-ApprovedCarotid Artery Stenting Facilities web page, where facilities arelisted alphabetically by name)In the event a service is rendered as part of a clinical trial subjectto the Medicare clinical trials NCD 310.1, Original Medicare or thelocal Medicare contractor would have primary financialresponsibility for eligible trials. Services rendered in a Medicareapproved clinical trial (under NCD 310.1) are processed byMedicare as the primary payor and the health plan does not knowwhether these trials are Medicare-approved in advance. It is notexpected many CAS PTA with stenting procedures will fall underthis provision, but the health plan relies on the Medicareexplanation of benefits (EOB) to determine if services may beprocessed by the plan as the secondary payer.Carotid artery PTA with stenting for any indication not addressedin one of the above sections, apply the last statement of SectionB.4, which states, “ PTA of the carotid artery concurrent with theplacement of an FDA-approved carotid stent and an FDAapproved or -cleared embolic protection device is not reasonableand necessary for all other patients.”Carotid artery PTA without stenting for any indication notaddressed in one of the above sections, apply NCD 20.7, C.NCD 20.7, B.4. (“The use of an FDA-approved or cleared embolicWithout EPDSurgeryprotection device is required. If deployment of the embolic protectiondevice is not technically possible, and not performed, then theprocedure is not covered by Medicare.”)M-SUR2077

Vessel(s)See Table 1 for arteries andveinsWith or Without Stentor Embolic ProtectionDevice (EPD)PlacementFor cerebral artery stenosis in patients with intracranialatherosclerotic disease NCD 20.7, B.5. (PTA with stenting of intracranial arteries forIntracranial arteries (e.g.,anterior, middle, and posteriorcerebral arteries, vertebral artery[distal], carotid siphon, internalcarotid, basilar artery, andophthalmic artery.)With stentingWithout stentingAll other arteries for anyindication not otherwiseaddressedCriteria Referencecerebral artery stenosis, is not covered except underprovisions of the NCD. If the coverage criteria are not met,including the stenosis level requirements, then coveragewould not be allowed.)Medicare approved Category B IDE studies can be found on theMedicare IDE study registry (try using search term “intracranial” orby using the NCT number, G-number, device or manufacturer name,or other keyword).For other obstructive lesions of the cerebral arteries, as well asPTA with stenting of vertebral arteries: NCD 20.7, C.All indications: NCD 20.7, C.Percutaneous approach:Without stenting Non-covered per NCD 20.7, C.Open approach: See next rowWith stentingSurgery NCD 20.7, D. states coverage eligibility is at the individual localcontractor discretion for percutaneous transluminal angioplasty(PTA) with stenting not addressed by the NCD. The local Medicare contractor Noridian does not address PTA,and there is no active policy by the health plan for several vesselsM-SUR2078

Vessel(s)See Table 1 for arteries andveinsWith or Without Stentor Embolic ProtectionDevice (EPD)PlacementCriteria Reference(e.g., arteries of the thorax, abdomen and some arteries of thelimbs). Therefore, PTA with stenting of all other arteries for anyindication not otherwise addressed may be consideredmedically necessary for Medicare Advantage (e.g., arteries of thethorax, abdomen or limbs not otherwise specified, such aspulmonary arteries). Some of the relevant CPT codes may be used for either open orOpen transluminal angioplastyprocedures (arterial or venous)With or Without stentingpercutaneous approach procedures, but this policy and NCD 20.7are specific to percutaneous transluminal angioplasty procedures.Open angioplasty procedures are outside the scope of this policy,but may be considered medically necessary for MedicareAdvantage - with or without stenting - for any indication.VENOUS PTA AND STENTING:Medicare coverage guidance is not available in the health plan’s service area for venous PTA with stenting. NCD 20.7 states coverageeligibility is at the individual local contractor discretion for PTA with stenting not otherwise addressed. Since Noridian does not addressvenous PTA services with stenting, the health plan’s medical policy may be applied for some uses.All veins (percutaneous only – foropen procedures, see separaterow for “Open transluminalangioplasty procedures (arterial orvenous)”)For arteriovenous dialysis fistulas and grafts when performedthrough a venous approach, with stenting: NCD 20.7, B.1.With stentingFor all other indications: Without stentingSurgeryPercutaneous Angioplasty and Stenting of Veins,Surgery, Policy No. 109 (see “NOTE” below)For any indication not previously addressed:M-SUR2079

Vessel(s)See Table 1 for arteries andveinsWith or Without Stentor Embolic ProtectionDevice (EPD)PlacementCriteria Reference NCD 20.7, C.NOTE: According to Title XVIII of the Social Security Act, §1862(a)(1)(A), only medically reasonable and necessary services are covered by Medicare.In the absence of a NCD, LCD, or other coverage guideline, CMS guidelines allow a Medicare Advantage Organization (MAO) to make coveragedeterminations, applying an objective, evidence-based process, based on authoritative evidence. (Medicare IOM Pub. No. 100-16, Ch. 4, §90.5).The Medicare Advantage Medical Policy - Medicine Policy No. M-149 - provides further details regarding the plan’s evidence-assessment process (seeCross References).SurgeryM-SUR20710

Back toCriteriaTable 1. Arteries and VeinsARTERIESLOWER TORSOArcuate Artery (kidney)Celiac Artery (Celiac Trunk)Common Hepatic ArteryCommon Iliac ArteryExternal Iliac ArteryInferior Mesenteric ArteryInternal Iliac ArteryIntestinal ArteriesLeft Renal ArteryProper Hepatic ArteryRight Renal ArterySplenic ArterySuperior Mesenteric ArteryHEAD AND NECKExternal and Internal Carotid ArteriesFacial ArteryVertebral ArteryCerebral Arteries (anterior, middle, posterior)Carotid SiphonBasilar ArteryOphthalmic ArteryHEART AND CHESTAortaBrachiocephalic Trunk (aka, brachiocephalic artery, orinnominate artery)Left and Right Common Carotid ArteriesLeft and Right Subclavian ArteriesPulmonary Trunk and pulmonary arteriesLeft Coronary ArteryRight Coronary ArteryARM AND HANDAxillary ArteryBrachial ArteryDeep Palmar Arterial ArchInferior Ulnar CollateralArteryPalmar Digital ArteriesRadial ArterySuperficial Palmar ArterialArchSuperior Ulnar CollateralArteryUlnar ArteryArteriovenous (AV) fistulasLEG AND FOOTAnterior Tibial ArteryDeep Femoral Artery (ProfundaFemoris)Dorsal Digital Arteries of FootDorsal Metatarsal ArteriesFemoral ArteryFibular (Peroneal) ArteryLateral Circumflex Femoral ArteryLateral Inferior Genicular ArteryLateral Superior Genicular ArteryMedial Inferior Genicular ArteryMedial Superior Genicular ArteryPopliteal ArteryPosterior Tibial ArteryVEINSFacial VeinLeft External and Internal Jugular VeinsRetromandibular VeinRight External and Internal Jugular VeinInferior and Superior Vena CavaLeft and Right Inferior Pulmonary VeinLeft and Right Subclavian VeinLeft and Right Superior Pulmonary VeinCommon Iliac VeinPopliteal VeinSurgeryExternal and Internal Iliac VeinHepatic Portal VeinHepatic VeinsInferior and Superior MesentericVeinIntestinal VeinsRight and Left Renal VeinsPosterior Tibial VeinSmall Saphenous VeinSplenic VeinAccessory Cephalic VeinAxillary VeinBasilic VeinBrachial VeinCephalic VeinFemoral VeinGreat Saphenous VeinLateral Circumflex Femoral VeinM-SUR207Dorsal Digital Veins of HandDorsal Metacarpal VeinsDorsal Venous Network of HandIntermediate Antebrachial VeinAnterior Tibial VeinDeep Femoral Vein (ProfundaFemoris)Dorsal Digital Veins of FootDorsal Metatarsal VeinsDorsal Venous Arch of Foot11

Back toCriteriaTable 2. MEDICARE NATIONAL COVERAGE CHRONOLOGY OF EVENTS2001200420052006Medicare issued a nationalcoverage policy restrictingcoverage for carotid angioplastyand stenting (CAS) to patientsparticipating in a clinical trial withcategory B investigational deviceexemption (IDE) designation fromthe Food and Drug Administration(FDA).Medicare broadened its coveragepolicy to include PTA with carotidstent placement when performedconsistent with FDA approval of thecarotid stent device and in an FDArequired post-approval study.Effective March 17, 2005, Medicareexpanded coverage of PTA of thecarotid artery when performed onpatients at high risk for CEA whoalso have symptomatic carotidartery stenosis 70% only whenperformed in a CMS approvedfacility for CAS with FDA-approvedcarotid artery stenting systems andembolic protection devicesEffective November 6, 2006,Medicare established coverage forPTA and stenting of intracranialvessels for the treatment ofcerebral artery stenosis 50% inpatients with intracranialatherosclerotic disease whenfurnished in accordance with FDAapproved protocols governingCategory B IDE clinical trials. Allother indications for PTA with orwithout stenting to treat obstructivelesions of the vertebral andcerebral arteries remainnoncovered.2007200820092012Medicare reaffirmed their previousdecision and confirmed CAS is onlycovered when used with an EPD.If deployment of the EPD is nottechnically possible, then coveragewould not be allowed. All othersections of the NCD remainedunchanged.CMS reaffirmed its prior coveragedecisions and made no change tothe NCD regarding coverage ofPTA of the renal arteries.However, it did add clarifyinglanguage to decidedly explaincoverage of PTA with stenting notspecifically addressed or discussedin this NCD is at local Medicarecontractor discretion.CMS reaffirmed prior coveragedecisions for CAS and EPDs.In January 2012, CMS convened aMedicare Evidence Development &Coverage Advisory Committee(MEDCAC) panel to considermanagement of carotidatherosclerosis. After MEDCACpanel members voted on specificquestions, symptomatic patientsnot considered at high-risk, themean scores to the question ofwhether CAS is the favoredSurgeryFor unapproved stents and embolicprotection devices (EPDs), the priorpolicy remained in effect andrestricted coverage to patientsparticipating in an FDA-approvedcategory B IDE trial of stentplacement in the cervical carotidartery.M-SUR20712

Table 2. MEDICARE NATIONAL COVERAGE CHRONOLOGY OF EVENTSLater this same year, Medicarereaffirmed its prior coveragedecisions to continue to cover PTAand stenting of intracranial arteriesfor the treatment of cerebral arterystenosis 50% in patients withintracranial atherosclerotic diseasewhen furnished in accordance withthe FDA-approved protocolsgoverning Category B IDE trials,and continue national noncoverage for all other indicationsfor PTA with or without stenting totreat obstructive lesions of thevertebral and cerebral arteries.Back toCriteriatreatment strategy in thispopulation was 1.85 and for CEA3.6. For asymptomatic patients notconsidered high-risk, the evidencewas judged to have not reached alevel of certainty to determine afavored treatment. No changes tonational coverage policy weremade following this MEDCACmeeting.Finally, in late 2008, Medicareconfirmed its coverage decisionaround PTA and CAS.SurgeryM-SUR20713

POLICY GUIDELINESREQUIRED DOCUMENTATIONThe information below must be submitted for review to determine whether policy criteria aremet. If any of these items are not submitted, it could impact our review and decision outcome:For PTA of lower and upper extremities, coronary artery, renal arteries, or arteriovenousdialysis fistulas and grafts: Description of the planned treatment, including the location of the target areas andtechnique to be used;Location (i.e., specific vessel) of lesion or obstruction;Description of planned treatment, including the type of stent that will be used (ifapplicable).For carotid artery PTA with or without stenting: Description of the planned treatment, including the location of the target areas andtechnique to be used;The name of the device;Facility where services will be rendered;The name of the trial, registry, or study;The six-digit IDE number that begins with a “G” (e.g., G123456) or FDA-approved postapproval study (PAS) number that begins with a “P” (e.g., P040338);o For an IDE study approved prior to January 1, 2015, documentation to support theIDE study was approved by the local MAC must be submitted. A copy of the FDAapproval letter provided to the sponsor or manufacturer of the device is alsobeneficial and may help to expedite claim processing. The category assignment(Category A or Category B IDE) should be represented on this FDA letter.o According to NCD 20.7, carotid artery PTA with or without stent placement is onlycovered under the terms of the NCD, which includes documentation of trials andstudies, applicable registries, and approved facilities. Therefore, this information isrequired for coverage to be considered for approval.o NCT numbers are also useful for individuals participating in trials or registries.For PTA with or without stenting of veins: Description of the planned treatment, including the location of the target areas andtechnique to be used;The name of the device;SurgeryM-SUR20714

Facility where services will be rendered.Intracranial artery PTA with or without stents: Description of the condition being treated (stenosis, aneurysm, stroke, etc.);Location (i.e., specific vessel) of lesion or obstruction;Description of planned treatment, including the type of stent that will be used (ifapplicable).Documentation of the Medicare-approved clinical trial as required by the Medicare NCD20.7 or the six-digit IDE number that begins with a “G” (i.e., G123456);o For an IDE study approved prior to January 1, 2015, documentation to supportthe IDE study was approved by the local MAC must be submitted. A copy of theFDA-approval letter provided to the sponsor or manufacturer of the device is alsobeneficial and may help to expedite claim processing. The category assignment(Category A or Category B IDE) should be represented on this FDA letter.o According to NCD 20.7, intracranial artery PTA with or without stent placement isonly covered when furnished under a Category B IDE clinical trial. Therefore, thisinformation is required for coverage to be considered for approval.REGULATORY STATUSCarotid angioplasty with stenting (CAS)The U.S. Food and Drug Administration (FDA) has approved several carotid artery stents andDEP devices from various manufacturers. The FDA has mandated postmarketing studies forthese devices. Each FDA-approved carotid stent system is indicated for combined use with aDEP device.Intracranial stentsCurrently, approval of intracranial stents by the FDA has been through the humanitarian deviceexemption (HDE) process. This form of FDA approval is available for devices used in thetreatment or diagnosis of conditions that affect fewer than 4,000 individuals in the UnitedStates per year. An approved HDE authorizes marketing of the humanitarian use device(HUD). However, an HUD may only be used after an internal review board (IRB) approval hasbeen obtained for the use of the device for the FDA approved indication. The labeling for anHUD must state that the device is a humanitarian use device and that, although the device isauthorized by Federal Law, the effectiveness of the device for the specific indication has notbeen demonstrated. “CMS does not have a national policy that addresses coverage of HUDs.Currently, contractors have the discretion to provide coverage for these devices in the absenceof a national coverage determination. A HUD is nationally not covered if it falls under thepurview of an NCD which nationally non-covers the device or service for which the HUD maybe used.”[10]SurgeryM-SUR20715

Stents for Intracranial AtherosclerosisThere are currently two devices that have received FDA approval for humanitarian use in thetreatment of intracranial atherosclerosis. Their labeled indications are as follows: NEUROLINK System (Guidant) is "indicated for the treatment of patients with recurrentintracranial stroke attributable to atherosclerotic disease refractory to medical therapy inintracranial vessels ranging from 2.5 to 4.5 mm in diameter with greater than or equal to50% stenosis and that are accessible to the stent system.”Wingspan Stent System with Gateway PTA Balloon Catheter (Boston Scientific) is“indicated for improving cerebral artery lumen diameter in patients with intracranialatherosclerotic disease, refractory to medical therapy, in intracranial vessels with greaterthan or equal to 50% stenosis that are accessible to the system.” The Wingspan StentSystem consists of a highly flexible, microcatheter delivered self-expanding nitinol stent,which may be suitable for lesions in the distal internal carotid and middle cerebral arteries.These arteries are difficult to access with a balloon-mounted stent, such as theNEUROLINK system. In 2008, Boston Scientific Corporation’s submitted a request toMedicare reconsider the NCD 20.7 for percutaneous transluminal angioplasty (PTA) withintracranial stent placement. However, after review, CMS reaffirmed their existingcoverage decision and did not expand coverage as requested. PTA and stenting ofintracranial arteries is only eligible for coverage when furnished in accordance with theFDA-approved protocols governing Category B IDE trials, and non-covered for all otherindications for PTA with or without stenting to treat obstructive lesions of the vertebral andcerebral arteries.[10]Stents for Intracranial AneurysmEndovascular Stents for Use with CoilsThe following devices have received FDA approval for humanitarian use with embolic coils inthe treatment of unruptured wide-neck intracranial aneurysms: The Neuroform Microdelivery Stent System (Boston Scientific) (H020002) The Enterprise Vascular Reconstruction Device and Delivery System (CordisNeurovascular, Inc./DePuy Companies) (H060001) The LVIS or LVIS Jr. Low-Profile Visualized Intraluminal Support Device (MicroVention ,Inc.) (H130005)The Solitaire AB retrievable stent (Covidien) has not received FDA approval for use in theUnited States outside the clinical trial setting. According to the Medicare Benefit PolicyManual, Chapter 14, while U.S. Food and Drug Administration (FDA) approval does notautomatically guarantee coverage under Medicare, in order to be considered for coverage,devices must be either FDA- or Institutional Review Board (IRB)-approved. Therefore, deviceswhich have not received FDA-approval would not be considered medically reasonable ornecessary[7] and stents that have not received FDA approval are non-covered, unless they areused in the context of an FDA-approved investigational (IDE) trial.SurgeryM-SUR20716

Flow-Diverting Stents In 2011, the

as exercise), medication therapy (anti-platelet drugs, statins, antihypertensives), carotid endarterectomy (CEA) and carotid artery stenting (CAS). Carotid Artery Stenting (CAS): A stent is placed by catheter within an atherosclerotic carotid artery. An embolic protection device may be used to minimize debris dislodged during the procedure.