Closure Devices for Patent Foramen Ovale and Atrial Septal Defects
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This draft policy governs medical necessity, prior authorization, and coding for transcatheter closure devices used to treat patent foramen ovale (PFO) and atrial septal defects (ASD) for Medicare Advantage and commercial products.
No material clinical or coverage changes in this revision.
Medical Necessity Criteria
PFO — Medically Necessary Criteria
Covered when ALL of the following are met:
Exclusion conditions must be documented absent.
ASD — Medically Necessary Criteria
ASD transcatheter closure may be considered medically necessary when using an FDA‑approved device and the payer’s online authorization tool medical necessity criteria are met.
Submit documentation via the online authorization tool showing criteria are satisfied.
Exclusions that would preclude coverage for transcatheter PFO or ASD closure include the presence of uncontrolled vascular risk factors (for example, uncontrolled diabetes or uncontrolled hypertension), other sources of right-to-left shunt (including an atrial septal defect or a fenestrated septum), active endocarditis or other untreated infections, and the presence of an inferior vena cava filter.
If services are determined to be not medically necessary (or are non-covered benefits), the member may not be charged for those services unless the member was informed in advance and agreed in writing to proceed at their own expense; verify member-specific benefits in the subscriber agreement or member certificate and contact the provider call center for questions about coverage.
PFO closure to treat migraine is not supported by sufficient evidence. Randomized trials, including sham-controlled studies and a blinded-endpoint trial, did not consistently demonstrate meaningful improvements in migraine outcomes after PFO closure, and the overall evidence is insufficient to conclude a net health benefit.
Some services addressed by this policy may ultimately be determined to be not medically necessary or excluded benefits. In such cases, follow the payer’s notification and billing rules: do not bill the member unless they were informed and provided written agreement to accept financial responsibility prior to the service.
Billing and Code Information
| 93580 | Percutaneous transcatheter closure of congenital interatrial communication (ie, Fontan fenestration, atrial septal defect) with implant |
Prior Authorization, Documentation, and Denial Risk
Prior authorization required for CPT 93580
Prior authorization is required for Medicare Advantage plans and recommended for commercial products when CPT 93580 is used; obtain authorization via the payer’s online authorization tool for participating providers.
- Applies when CPT 93580 is used for PFO or ASD procedures.
- Authorization is obtained via the payer’s online tool for participating providers.
Prior authorization guidance — policy is informational
This policy is informational and does not itself specify additional prior authorization code requirements beyond stating that the online authorization tool must be used for authorization decisions.
- Refer to the payer’s online authorization tool for the specific medical necessity criteria and authorization decisions.
Use online authorization tool and cite CPT 93580
Submit authorization requests through the payer’s online tool and ensure the requested CPT code (93580) is indicated for the planned procedure.
- Confirm participating-provider access to the online authorization tool before submission.
- Include the intended procedure code (CPT 93580) on the authorization request.
Verify benefits and eligibility before scheduling
Verify member-specific benefits and eligibility with the provider call center before scheduling procedures to avoid coverage surprises.
- Benefits and eligibility are determined by the member's subscriber agreement, member certificate, or employer agreement.
- Provider call center can confirm member-specific benefits.
Required clinical documentation for PFO
For PFO closure, submit echocardiographic confirmation of PFO with shunt quantification or atrial septal aneurysm description, plus neurologist and cardiologist documentation that the ischemic stroke is cryptogenic after exclusion of other causes and records of the evaluations used to exclude alternate stroke causes.
- Echo evidence: large shunt (>30 microbubbles in left atrium within 3 cardiac cycles) or septum primum excursion >10 mm on transesophageal exam.
- Clinical determinations from both neurologist and cardiologist confirming cryptogenic ischemic stroke and exclusion of other identifiable causes.
Submit online-tool medical necessity documentation for ASD
For ASD transcatheter closure, submit documentation demonstrating that the online authorization tool’s medical necessity criteria are met when CPT 93580 is used.
- Include the authorization tool outputs or the supporting clinical data referenced by the online tool.
- Ensure the device used is FDA-approved as required by the tool’s criteria.
Confirm member benefits and eligibility
Benefits and eligibility are determined by the member’s subscriber agreement, member certificate, and/or employer agreement; contact the provider call center for member-specific benefit verification.
- These documents supersede the medical policy for coverage determination.
- Do not assume coverage without confirming member-specific benefits.
Denial risk: insufficient PFO documentation or exclusion present
A lack of documentation showing that the PFO medical necessity criteria are met—such as age outside 18–60, no documented cryptogenic ischemic stroke after evaluation, absence of qualifying shunt or atrial septal aneurysm, or presence of exclusion conditions—may result in denial.
- Exclusion conditions include uncontrolled vascular risk factors, other sources of right-to-left shunts, active infections, or an inferior vena cava filter.
- Ensure clear documentation of age, echo findings, and neurologic/cardiac evaluations to avoid denial.
Denial risk: missing ASD authorization or criteria documentation
For ASD closure, failure to obtain prior authorization or to demonstrate that the online authorization tool’s medical necessity criteria are met when CPT 93580 is used may trigger denial.
- Use the online tool and submit the required supporting documentation showing the tool’s criteria are satisfied.
- Confirm the device is FDA-approved for the indication.
Member charge and denial risk — obtain written agreement before billing
If services are determined to be not medically necessary or are non-covered benefits, do not charge the member unless the member was informed and agreed in writing in advance to proceed at their own expense.
- Obtain written member agreement before providing non-covered or not medically necessary services to allow patient billing.
- Refer to provider participation and billing agreements for applicable provisions.
Clinical Background
Patent foramen ovale (PFO) is a common postnatal communication between the right and left atria, present in approximately 25% of adults, that can permit paradoxical embolism and has been associated with cryptogenic ischemic stroke. Atrial septal defects (ASD) are developmental defects causing free interatrial communication (most commonly a secundum ASD near the fossa ovalis) that can produce a left-to-right shunt, right ventricular volume overload, and symptoms such as dyspnea and atrial fibrillation. Transcatheter device closure is an established alternative to surgery or medical therapy for select patients with PFO or ASD, with randomized and observational evidence supporting PFO closure to reduce recurrent ischemic stroke in appropriately selected patients and support for ASD closure when patients meet indications for closure.
Key Terms and Definitions
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