Code-level coverage tied to selection criteria

Code-level coverage is conditional on meeting the policy selection criteria; CPT and HCPCS codes listed as covered (e.g., 93580, 93581, 93582, C1817) are payable only when the member meets the clinical inclusion criteria and documented indications in this policy. Codes listed as not covered (e.g., 0613T, C9783, Nit-Occlud Lê VSD coil, Neovasc Reducer, AngioVac System for excluded indications) remain noncovered when used for investigational or excluded indications.

• Covered CPT/HCPCS codes payable only if selection criteria and documentation met (see policy covered indications).
• Do NOT submit covered procedure codes when indications are for excluded/experimental uses (e.g., PFO for migraine prophylaxis).

Prior authorization should cite device, indication, and evidence

Prior authorization is expected for device-based procedures in many jurisdictions and should explicitly cite: the device name, the indication (including supporting clinical details), and the evidence or trial/device-specific rationale for use (e.g., Amplatzer PFO Occluder with RESPECT trial data). When requesting authorization, include documentation that demonstrates how the member meets the policy's selection criteria.

• Include device brand/model (e.g., AMPLATZER PFO Occluder) in request.
• State the precise indication (e.g., cryptogenic stroke with age and imaging criteria) and reference relevant trial evidence if applicable.

Prior authorization recommended for CS Reducer (Neovasc Reducer)

Prior authorization is recommended for the Neovasc Coronary Sinus Reducer (CS Reducer) because available evidence is limited and its use is generally considered investigational or of uncertain net clinical benefit. Requests should document that the patient has refractory angina despite optimal medical therapy and is not a candidate for further revascularization.

• Document: duration of refractory angina (≥ 3 months), objective evidence of ischemia, and that revascularization is not feasible.
• Attach prior failed/insufficient trials of guideline-directed medical therapy and procedural notes showing non-amenability to revascularization.

Prior authorization not specified in these chunks — verify payer rules

Some policy segments do not specify a formal prior authorization requirement; in those cases, clinical documentation standards and code-level coverage rules still apply and payers may require prior authorization through separate administrative processes. Confirm payer-specific PA rules where absent from this document segment.

• If prior authorization is not specified in policy text, verify benefit plan rules or prior authorization portals before scheduling.
• Lack of PA language in this section does not imply automatic coverage—use documented selection criteria to determine medical necessity.

Use of non–FDA-approved devices — investigational/not covered

Procedures using devices that are not FDA-approved for the intended indication are considered experimental/investigational and are not covered under this policy. Requests involving off-label or non–FDA-approved devices should include justification and supporting evidence but are generally expected to be denied.

• Do not bill covered-device codes for procedures performed with non–FDA-approved devices for excluded indications (e.g., PFO closure for migraine).
• If proposing use of a non‑approved device, provide high-quality evidence and an explanation why no approved alternative is suitable (review will typically classify as investigational).

Specialist evaluation required prior to PFO occluder use

For PFO closure with FDA-approved devices (e.g., Amplatzer PFO Occluder), documentation must include specialist evaluations by both a neurologist and a cardiologist to exclude other causes of ischemic stroke, consistent with FDA labeling and trial protocols.

• Submit neurology and cardiology consult notes stating thorough etiologic evaluation and rationale that PFO is the most likely cause of stroke.
• Include neurovascular imaging reports and documentation excluding high-risk alternative stroke mechanisms.

Evidence limitations may affect coverage

Evidence limitations (small studies, single-center cohorts, heterogeneous outcomes, or moderate-to-low GRADE assessments) may affect coverage determinations. Where evidence is limited or safety data are incomplete, payers may restrict coverage, require prior authorization with additional documentation, or deem the procedure investigational.

• For devices with limited/low-quality evidence (e.g., CS Reducer, AngioVac left-sided use), include RCT data if available or otherwise robust observational evidence.
• Be prepared for request denials or requests for more information when device safety/efficacy data are inconclusive.

Not provided in this document segment — confirm administrative procedures separately

This document segment does not provide exhaustive administrative instructions (e.g., specific payer prior authorization forms or submission portals). Providers must follow their contracted payer's operational procedures in addition to meeting the clinical documentation described here.

• Confirm payer-specific submission workflows, required forms, and timelines externally to this policy.
• Maintain copies of all submitted supporting clinical documentation for appeals if needed.

Required procedural and pre-procedure documentation

Pre-procedural and procedural documentation is required to support medical necessity and appropriate device selection. Key items include echocardiographic ASD/PFO morphology, balloon sizing/stretched diameter assessments, and intra-procedural imaging (TEE/ICE) reports.

• Include TEE/ICE reports describing septal anatomy, rim adequacy, defect size, and shunt quantification.
• Provide balloon-stretched diameter measurements and rationale for chosen device size/model.

Required pre-procedure evaluation and follow-up (per trial/approval)

Follow-up and pre-procedure evaluations should mirror trial and device-approval protocols: document baseline and scheduled follow-up visits (discharge, 1 month, 6 months, 12 months, 18 months, yearly) and post-procedure imaging per device trials (e.g., RESPECT schedule for Amplatzer).

• Attach follow-up visit schedule and TEE bubble study results (e.g., 6-month closure assessment) when applicable.
• Document anti-platelet/anticoagulation plans and duration as per device labeling or trial protocols.

Pre-procedure evaluation documentation — rule out alternative mechanisms

Pre-procedure evaluation documentation must demonstrate exclusion of other stroke mechanisms, characterization of PFO anatomy, and reasoning that closure is indicated. This includes neurovascular imaging, cardiac rhythm monitoring results, and specialist opinions.

• Submit CT/MR neuroimaging that supports embolic-appearing infarct.
• Provide Holter/telemetry data ruling out atrial fibrillation as an alternative cause if available.

PFO closure patient selection documentation

Patient selection documentation for PFO closure should reflect the trial and guideline-based elements: patient age, cryptogenic stroke with embolic-appearing infarct, absence of alternative mechanism after specialist work-up, and echocardiographic features (e.g., large shunt, atrial septal aneurysm) when applicable.

• Include patient age (typically 16–60 years where recommended), timing of index stroke (often ≤ 6 months), and description of embolic-appearing infarct.
• Document that medical therapy options were considered and discuss risks/benefits with the patient; if medical therapy chosen, document regimen.

Pre-procedural planning notes

Pre-procedural planning notes should address technical considerations described in the literature, such as optimal transeptal puncture height, cerebral protection strategies, and extracorporeal support planning when left-sided or high-risk procedures are contemplated.

• Document plans for cerebral protection (e.g., Sentinel) when extracting left‑sided masses or performing high embolic-risk maneuvers.
• Note contingency plans (surgical backup, extracorporeal support) and operator/center experience level.

Medical therapy as comparator/precedent for PFO closure

Medical therapy is an established comparator and, in some cases, a reasonable alternative to device-based interventions. Randomized trials compared PFO closure with medical therapy; documentation should show whether medical therapy was offered and the regimen used when closure is being considered.

• When PFO closure is requested, include history of medical therapy offered (antiplatelet or anticoagulation), duration, and patient preference.
• If medical therapy is pursued instead of closure, document the chosen regimen and rationale.

Medical therapy as an alternative prior step

Medical therapy can be an alternative prior step to device closure; trials have compared closure to antiplatelet or anticoagulation strategies. Providers should document that medical management was considered and, if applicable, attempted.

• Document prior anti-platelet or anticoagulant use and reasons for failure or contraindication if closure is being requested subsequently.
• If anticoagulation is chosen due to contraindication to closure, include bleeding-risk assessment.

Surgical-first / specialty limitation for VSDs

For certain defects (e.g., most VSDs), a surgical-first approach remains preferred; transcatheter closure is reserved for select cases (high surgical risk or lesions not amenable to surgical repair) and should be performed at experienced centers with surgical backup.

• Document why surgical repair is unsuitable or high-risk when proposing transcatheter VSD closure.
• Confirm center experience and availability of cardiothoracic surgical backup in procedural planning notes.

Step therapy: confirm failure of standard therapies before device use

When step therapy applies (noted for some device types), prior authorization should confirm failure of standard therapies before device implantation (e.g., refractory angina despite optimal medical therapy and non-amenability to revascularization before CS Reducer).

• Provide documentation of optimal medical therapy trials and objective ischemia evidence prior to CS Reducer authorization.
• Document heart-team decision that patient is not a candidate for further revascularization.

No step therapy sequencing requirements provided in this segment

This policy segment does not establish a comprehensive step-therapy sequencing requirement across all devices; where step therapy is not specified, follow device-specific guidance and payer benefit rules.

• Absence of stated step-therapy sequencing in this section does not preclude the payer from applying plan-level step edits.
• If in doubt, obtain prior authorization and clarify required pre-steps with the payer.

No step therapy requirements are described

No additional step therapy requirements are described in these chunks for other device categories; providers should rely on the explicit selection criteria and consult payer administratively for any plan-level utilization management controls.

• Follow documented selection criteria in policy for clinical necessity.
• Confirm with payer for any additional utilization management rules not documented here.