CAROTID AND INTRACRANIAL ARTERY STENTING
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This policy governs coverage and medical necessity criteria for carotid and intracranial artery stenting procedures (including TCAR and TF‑CAS), transcatheter extracranial vertebral or intrathoracic carotid stents, and intracranial angioplasty/stenting for Priority Health members.
Carotid artery stenting: Priority Health considers stenting of the carotid artery medically necessary when the applicable InterQual® criteria are met
Intracranial angioplasty and stenting: Priority Health considers intracranial angioplasty and stenting medically necessary when the applicable InterQual® criteria are met
Coverage and Medical Necessity Criteria
Medical necessity criteria
Covered when InterQual® procedure-specific criteria are met.
Includes Transfemoral CAS (TF-CAS) and Transcarotid Artery Revascularization (TCAR); transcatheter placement of extracranial vertebral or intrathoracic carotid artery stents is managed by TurningPoint Healthcare Solutions LLC (see Authorization pathway).
InterQual procedure-level criteria and evidence appraisal inform determination; guideline support may be limited and additional review may be required.
Not covered as standard therapy under this policy.
Medically Necessary Criteria (delegated to InterQual)
Covered when the applicable InterQual criteria are met for the specific procedure.
See InterQual for detailed, procedure‑specific clinical criteria to support medical necessity determinations.
See InterQual for detailed, procedure‑specific clinical criteria to support medical necessity determinations.
Priority Health considers percutaneous balloon dilatation of intracranial vasospasm to be investigational and experimental. This therapy is not established as standard treatment in the policy and is not covered as routine care.
This regulatory excerpt lists FDA product and decision identifiers (K-numbers) for embolic protection devices and related systems. The section is informational and does not state coverage, exclusion, or medical-necessity determinations.
The listing documents device names and associated FDA 510(k) identifiers (for example, MO.MA Ultra Proximal Cerebral Protection Device K092177, Guardwire K072990, FilterWire EZ K063313). No coverage or exclusion language is provided in this regulatory excerpt.
This regulatory excerpt supplies device names, manufacturers, K-numbers and clearance dates for embolic protection devices and capture guidewires (examples include FilterWire EZ, ANGIOGUARD, and SPIDERFX). The excerpt contains only regulatory clearance information and does not specify coverage criteria.
The section enumerates FDA 510(k) identifiers and clearance dates for embolic protection systems (for example, Emboshield NAV6 K191173 and ANGIOGUARD K220654). It is a regulatory device listing and does not include statements about medical necessity or coverage decisions.
This excerpt continues device clearance listings (including ACCUNET K153086 and multiple K-numbers for Emboshield NAV6 and SPIDERFX). The content is informational regarding FDA clearances and does not provide coverage or exclusion determinations.
The regulatory section lists additional K-numbers and named embolic protection systems (ACCUNET, Emboshield NAV6, and related clearances). No policy statements of 'not medically necessary' or explicit coverage guidance are included in this excerpt.
This regulatory listing documents FDA K-number clearances and device names for embolic protection systems and related guidewires. The section is informational; it does not include statements declaring devices or procedures as not medically necessary.
The following CPT codes for balloon dilatation of intracranial vasospasm are designated Not Medically Necessary in this policy: 61640, 61641, 61642.
Procedures that do not meet the applicable InterQual® criteria for the requested intervention will not satisfy this policy's medical necessity requirements and may be denied. Providers should use InterQual criteria to document clinical indications when requesting coverage.
The policy text explicitly labels percutaneous balloon dilatation of intracranial vasospasm as investigational/experimental, indicating it is not an established, covered therapy under this policy.
This regulatory excerpt provides FDA device names and 510(k) identifiers (for example, MO.MA K092177, Guardwire K072990, FilterWire EZ K063313). It contains no statements declaring the listed devices or related procedures as not medically necessary.
The excerpt lists device families and their FDA 510(k) identifiers (for example, Emboshield NAV6 and SPIDERFX) along with clearance dates. No not-medically-necessary determinations are made in this regulatory listing.
This regulatory passage documents multiple K-number clearances for embolic protection systems (including ACCUNET and Emboshield NAV6). The excerpt is limited to clearance information and does not state coverage exclusions.
The policy identifies specific CPT codes for intracranial vasospasm dilation—61640, 61641, 61642—and considers these codes not medically necessary for coverage.
Any carotid or intracranial stenting procedure that does not meet the applicable InterQual® criteria is considered not medically necessary under this policy. Providers must document how the case meets InterQual criteria to support medical necessity.
Regulatory, Device and Billing Codes
| P240029 | CGuard™ Prime Carotid Stent PMA/decision number |
| P240009 | Neuroguard IEP® 3-in-1 Carotid Stent decision number |
| P180010 | ENROUTE Transcarotid Stent PMA/decision number |
| P140026 | ENROUTE Transcarotid Stent System decision/PMA references |
| P040038 | XACT Carotid Stent System PMA/decision number |
| P040012 | ACCULINK Carotid Stent System PMA/decision number |
| P030047 | CORDIS PRECISE Nitinol Stent System PMA/decision number |
| K222694 | EmPro EPS / Nanoparasol EPS (NTE) product code |
| K210282 | WIRION product code |
| K120480 | listed for GORE FLOW REVERSAL / GORE EMBOLIC FILTER entries |
| K103500 | listed for GORE FLOW REVERSAL / GORE EMBOLIC FILTER entries |
| K123156 | listed for GORE FLOW REVERSAL / FIBERNET EMBOLIC PROTECTION DEVICE / MO.MA entries |
| K083300 | listed for GORE and other embolic protection device entries |
| K111987 | listed for FIBERNET / MO.MA and other device entries |
| K082348 | listed for FIBERNET / MO.MA and related devices |
| K092177 | listed for MO.MA Ultra Proximal Cerebral Protection Device / related entries |
| K072990 | listed for GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM / CAROTID entries |
| K063313 | listed for FilterWire EZ Embolic Protection System entries |
| K092177 | MO.MA Ultra Proximal Cerebral Protection Device (Invatec S.p.A.) |
| K072990 | GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM- CAROTID (Medtronic, Inc.) |
| K063313 | FilterWire EZ Embolic Protection System (Boston Scientific) |
| K220654 | ANGIOGUARD XP / ANGIOGUARD RX (Cordis) |
| K101651 | ANGIOGUARD RX / related clearance |
| K111010 | SPIDERFX EMBOLIC PROTECTION DEVICE (Ev3) |
| K063204 | SPIDERFX / related clearance entries |
| K052659 | Additional related K-number listed with SPIDERFX entries |
| K191173 | Emboshield NAV6 Embolic Protection (clearance referenced) |
| K141678 | Additional clearance number referenced in list |
| K063313 | FilterWire EZ Embolic Protection System (3.5-5.5 mm) (Boston Scientific) (NTE) |
| K220654 | ANGIOGUARD XP / ANGIOGUARD RX Emboli Capture Guidewire (Cordis) |
| K101651 | ANGIOGUARD XP / ANGIOGUARD RX Emboli Capture Guidewire (Cordis) |
| K062531 | ANGIOGUARD XP / ANGIOGUARD RX Emboli Capture Guidewire (Cordis) (NTE) |
| K111010 | SPIDERFX EMBOLIC PROTECTION DEVICE (Ev3, Inc.) |
| K063204 | SPIDERFX EMBOLIC PROTECTION DEVICE (Ev3, Inc.) |
| K052659 | SPIDERFX EMBOLIC PROTECTION DEVICE (Ev3, Inc.) (NTE) |
| K191173 | Emboshield NAV6 Embolic Protection System (incl. BareWire filter delivery wire) (Abbott Laboratories) |
| K141678 | Emboshield NAV6 Embolic Protection System (Abbott Laboratories) |
| K121015 | Emboshield NAV6 related clearance (Abbott Laboratories) |
| K220654 | FDA 510(k) identifier associated with ANGIOGUARD XP / ANGIOGUARD RX (Cordis) |
| K101651 | FDA 510(k) identifier listed for AngioGuard/guidewire entries |
| K062531 | FDA 510(k) identifier (NTE) listed with Cordis guidewire entries |
| K111010 | FDA 510(k) identifier for SPIDERFX EMBOLIC PROTECTION DEVICE (Ev3, Inc.) |
| K063204 | FDA 510(k) identifier for SPIDERFX |
| K052659 | FDA 510(k) identifier for SPIDERFX |
| K191173 | FDA 510(k) identifier for Emboshield NAV6 Embolic Protection System (Abbott Laboratories) |
| K141678 | FDA 510(k) identifier for Emboshield NAV6 |
| K121015 | FDA 510(k) identifier for Emboshield NAV6 |
| K110909 | FDA 510(k) identifier for Emboshield NAV6 |
| K191173 | Emboshield NAV6 Embolic Protection System (incl. BareWire filter delivery wire) (Abbott Laboratories) |
| K141678 | Ancillary K-number listed with Emboshield NAV6 |
| K121015 | Ancillary K-number listed with Emboshield NAV6 |
| K110909 | Ancillary K-number listed with Emboshield NAV6 |
| K090665 | Ancillary K-number listed with Emboshield NAV6 |
| K081523 | Ancillary K-number listed with Emboshield NAV6 |
| K052454 | Ancillary K-number listed with Emboshield NAV6 |
| K153086 | ACCUNET Embolic Protection System / RX ACCUNET |
| K081549 | ACCUNET related K-number |
| K111010 | SPIDERFX EMBOLIC PROTECTION DEVICE (Ev3, Inc.) |
| K110909 | FDA K-number listed for ACCUNET/embolic protection devices |
| K090665 | FDA K-number listed for ACCUNET/embolic protection devices |
| K081523 | FDA K-number listed for ACCUNET/embolic protection devices |
| K052454 | FDA K-number listed for ACCUNET/embolic protection devices |
| K153086 | FDA K-number listed for ACCUNET Embolic Protection System / RX ACCUNET |
| K081549 | FDA K-number listed for ACCUNET Embolic Protection System |
| K052165 | FDA K-number listed for ACCUNET Embolic Protection System |
| K042908 | FDA K-number listed for ACCUNET Embolic Protection System |
| K063204 | FDA K-number listed for PROTECTION DEVICE (Ev3, Inc.) |
| K052659 | FDA K-number listed for PROTECTION DEVICE (Ev3, Inc.) |
| 37215 | Transcatheter placement of intravascular stent(s), cervical carotid artery; with distal embolic protection |
| 37216 | Transcatheter placement of intravascular stent(s), cervical carotid artery; without distal embolic protection |
| 37217 | Transcatheter placement of intravascular stent(s), intrathoracic common carotid artery or innominate artery by retrograde treatment |
| 37218 | Transcatheter placement of intravascular stent(s), intrathoracic common carotid artery or innominate artery, open or percutaneous antegrade approach |
| 61630 | Balloon angioplasty, intracranial (e.g., atherosclerotic stenosis), percutaneous |
| 61635 | Transcatheter placement of intravascular stent(s), intracranial, including balloon angioplasty if performed |
| 61640 | Balloon dilatation of intracranial vasospasm, percutaneous; initial vessel |
| 61641 | Balloon dilatation of intracranial vasospasm, percutaneous; each additional vessel in same vascular family |
| 61642 | Balloon dilatation of intracranial vasospasm, percutaneous; each additional vessel in different vascular family |
| I63.031 - I63.039 | Cerebral infarction due to thrombosis of carotid artery (range) |
| I63.131 - I63.139 | Cerebral infarction due to embolism of carotid artery (range) |
| I63.231 - I63.239 | Cerebral infarction due to unspecified occlusion or stenosis of carotid arteries (range) |
| I65.21 - I65.29 | Occlusion and stenosis of carotid artery (range) |
| I65.8 | Occlusion and stenosis of other precerebral arteries |
Authorization, Documentation and Denial Guidance for Providers
Authorization pathway — TurningPoint lookup
Transcatheter placement of extracranial vertebral or intrathoracic carotid artery stents is managed by TurningPoint Healthcare Solutions LLC; use Priority Health Prism → Authorizations → Authorization Criteria Lookup to access TurningPoint and determine authorization requirements.
- Authorization pathway for extracranial vertebral/intrathoracic stents managed by TurningPoint via Priority Health Prism.
Prior authorization — none indicated in device listings
This regulatory listing and device clearance sections do not specify a standing prior‑authorization rule for the devices listed; when prior authorization is required it will be identified via Priority Health Prism or plan‑specific documentation.
- No explicit prior authorization requirement stated in the FDA device/K‑number listings.
Prior authorization not specified in this excerpt
The device regulatory excerpts list FDA 510(k)/K‑number clearances but do not state a provider prior‑authorization workflow; check Priority Health Prism for any procedure‑ or plan‑specific authorization requirements.
- Regulatory device listings include K092177, K072990, K063313 and others but do not define prior authorization.
Prior authorization — none specified (device listings)
The regulatory device section enumerates multiple FDA K‑numbers and device names without a stated prior authorization requirement; treat these listings as informational and follow Prism for authorization rules.
- FDA K‑numbers and device names listed are informational; authorization status must be verified in Priority Health systems.
FDA device clearances — informational only
FDA device clearances are presented for informational purposes in the regulatory listing; the document does not establish prior authorization mandates for the named devices.
- Clearance entries (e.g., Emboshield NAV6 K191173, ACCUNET K153086) are informational and not an authorization instruction.
Document device-specific FDA 510(k) K‑numbers
The document lists specific FDA 510(k)/K‑numbers (examples include K191173, K141678, K121015, K110909, K090665, K081523, K052454, K153086, K111010, K063204, K052659, K062531, K101651, K052165, K042908, K042218) that should be cited in device identification and claims when relevant.
- Cite the exact FDA K‑number(s) associated with the embolic protection device used (examples shown above).
- Device K‑numbers are listed across the regulatory section and should be included in documentation when relevant to coding or review.
Prior authorization — none specified for embolic protection systems
The regulatory listings for embolic protection systems do not include a standing prior authorization requirement; they provide device clearances and identifiers only.
- Emboshield NAV6, ACCUNET, SPIDERFX and related K‑numbers are listed without authorization instructions.
Determine prior authorization via Priority Health Prism
Prior authorization may be required for certain procedures or devices; providers should use Priority Health Prism Authorization Criteria Lookup to access InterQual or TurningPoint guidance and submit medical‑necessity documentation when required.
- Use Priority Health Prism → Authorizations → Authorization Criteria Lookup to determine if prior authorization is required.
- When required, submit documentation demonstrating medical necessity per InterQual or TurningPoint criteria.
Use and document InterQual criteria for medical necessity
Medical necessity and prior authorization determinations for carotid and intracranial procedures are governed by the applicable InterQual clinical criteria referenced in this policy; document which InterQual criteria were applied.
- Use the InterQual ‘Angioplasty and Stent, Carotid or Vertebral’ and ‘Endovascular Intervention, Intracranial’ criteria as applicable.
- Record the specific InterQual criteria and results used to support medical necessity in the authorization or claim documentation.
Document baseline medical management prior to invasive therapy
Standard medical management (antiplatelet therapy, blood pressure and lipid control, and lifestyle measures) is described as the baseline approach when clinically appropriate prior to invasive revascularization.
- Ensure conservative/medical therapy has been considered and documented where clinically appropriate prior to stenting.
- Document antiplatelet regimen, BP and lipid control efforts, and lifestyle counseling when relevant to medical‑necessity review.
Step therapy — none specified
No step‑therapy requirements are specified in the policy text or regulatory device listings.
- The policy and device sections do not impose step‑therapy rules; follow InterQual and plan benefit requirements instead.
Confirm member benefits and CMS guidance in documentation
Follow member benefit terms and applicable CMS NCD/LCD guidance; document that the patient’s coverage permits the requested service because group‑specific plan documents may supersede this policy.
- Confirm member benefits and plan‑specific provisions before requesting authorization.
- Include references to applicable CMS NCD/LCDs when relevant to Medicare members (e.g., PTA NCD 20.7).
Document device identification and FDA K‑number on records/claims
Regulatory device listings should be recorded in clinical and coding records when relevant: document the specific device used and the corresponding FDA K‑number on claims and in the medical record.
- When an embolic protection device is used, record the device name and its FDA K‑number (examples: Emboshield NAV6 K191173; ACCUNET K153086).
- Include device identification in operative notes and billing records if device‑specific review or coding depends on it.
Submit medical‑necessity request and seek prior plan approval for investigational care
When prior authorization is required, submit a request demonstrating medical necessity; individual case review may allow coverage for investigational treatments only with prior plan approval and review by a Priority Health medical director or clinical pharmacist.
- Requests for investigational or unproven treatments require prior plan approval and review by Priority Health clinical leadership.
- Provide complete medical rationale and InterQual or TurningPoint documentation when seeking individual consideration.
Denial risk — investigational/individual review required
Requests for experimental, investigational, or unproven treatments will be denied unless prior plan approval via individual case review is obtained; all such determinations are made by a Priority Health medical director or clinical pharmacist.
- Do not bill or assume coverage for investigational procedures without prior plan approval.
- Individual case review is required for exceptions to investigational exclusions.
Denial risk — non‑adherence to InterQual criteria
If the applicable InterQual criteria are not met, the procedure would not satisfy this policy's medical necessity condition and may be denied.
- Document which InterQual criteria were evaluated and include supporting clinical data to avoid denials tied to InterQual adjudication.
- Procedures failing InterQual criteria are at risk for denial.
Device listings are informational — no documentation mandates stated
No provider‑level authorization or documentation requirements are specified within the raw FDA device/K‑number listings; those chunks are informational device clearances only.
- Device listings (FDA K‑numbers and dates) do not prescribe documentation workflows; follow policy sections on authorization and documentation for requirements.
Denial risk — intracranial vasospasm balloon dilatation is investigational (CPT 61640‑61642)
The regulatory excerpts reiterate that percutaneous balloon dilatation of intracranial vasospasm is considered investigational/experimental and listed CPT codes 61640–61642 are identified as not medically necessary.
Document the specific InterQual/TurningPoint criteria used in authorization requests
When using Priority Health Prism for authorizations, document the specific InterQual or TurningPoint guideline page or criteria used to support the request.
- Include the InterQual criteria name (e.g., 'Angioplasty and Stent, Carotid or Vertebral' or 'Endovascular Intervention, Intracranial') in authorization submissions.
- Attach the InterQual decision output or relevant clinical fields to the prior‑authorization request.
Verify eligibility and plan benefit limitations
Benefit limitations and group‑specific plan documents may override this policy; confirm eligibility and benefit coverage before performing or billing for the procedure.
- Verify coverage via benefits and eligibility prior to scheduling procedures.
- Include plan‑specific references in the authorization or claim when relevant.
Clinical Background and Definitions
Background: The carotid arteries supply blood to the brain, and significant atherosclerotic stenosis increases ischemic stroke risk. Diagnostic options include duplex ultrasound, CT angiography, digital subtraction angiography, and MR angiography. Management begins with standard medical therapy (antiplatelet agents, blood pressure and lipid control, and lifestyle measures); for selected patients with severe symptomatic disease, revascularization via carotid endarterectomy or carotid stenting (transfemoral or transcarotid approaches) may be appropriate. InterQual® procedural criteria are used by Priority Health to determine medical necessity for carotid and intracranial endovascular interventions.
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