Appeal type: Experimental/Investigational
Decision: Overturned

Reviewer #1:

Diagnosis: Patent foramen ovale (PFO)

Treatment: procedure code 93580, transcatheter closure of a PFO using a cardiac occlusion device

The insurer denied coverage for procedure code 93580, transcatheter closure of a PFO using a cardiac occlusion device

The denial is overturned

This patient is an adult with a past medical history that includes cryptogenic stroke, patent foramen ovale (PFO), dyslipidemia, and hypertension. His workup for causes of stroke was reportedly unremarkable other than the presence of the PFO; those initial details are not included in the review materials. A transesophageal echocardiogram (TEE) revealed a small shunt (subsequently interpreted as moderate in office note. With transcranial Doppler testing, a small shunt was noted at rest; this increased to moderate-to-large (Grade 4) in intensity with Valsalva. Coverage for procedure code 93580, transcatheter closure of a patent foramen ovale using a cardiac occlusion device, was requested by his cardiologist.

As both parties are in agreement on the relevance of those trials, they are summarized briefly here.

The RESPECT trial demonstrated a 45% relative risk reduction with closure device when compared to medical therapy alone (although, due to the low event rate, this represented an absolute reduction of only 0.49 events per 100 patient-years) after median 5.9 years of follow-up. Inclusion criteria did not include those criteria mentioned in the Elevance Health review; rather they included cryptogenic stroke, age 18-60, confirmed PFO by TEE, and randomization within 270 days of stroke. The Amplatzer device was used. 

The DEFENSE PFO Trial demonstrated zero strokes in the closure group, compared with 10.5% of patients with strokes in the medication-only group at 2 years of follow-up. Inclusion criteria included ischemic stroke within 6 months, with no identifiable cause other than "high-risk PFO" as determined by TEE; high-risk was defined as atrial septal aneurysm, hypermobility, or a large PFO size greater than or equal to 2 millimeters (&gt;=2mm).  The Amplatzer device was used.

The REDUCE Trial demonstrated strokes in 1.4% of patients in the closure group, compared to 5.4% of patients in the antiplatelet only group at 3.2 years of follow-up. Inclusion criteria included age 18-59, cryptogenic stroke within 180 days, and PFO with right-left shunt by TEE. Atrial septal aneurysm was not an inclusion criterion. Gore devices (Helex or Cardioform) were used.

The CLOSE trial demonstrated zero strokes in the closure group, compared to 5.9% of patients in the medication-only groups. Of note, inclusion criteria in this study appear to be identical to those criteria noted in the Elevance Health Position Statement, for which closure devices are covered by Blue Cross / Blue Shield.  11 different devices were used.

Transcatheter closure of a patent foramen ovale using a cardiac occlusion device does have final approval from the appropriate regulatory bodies for the patient's diagnosis.  

This patient is a good candidate for procedure code 93580, transcatheter closure of a patient foramen ovale using a cardiac occlusion device. 

A cardiac occlusion device appears to be the best available treatment for the patient at this time. It offers a meaningful reduction in the risk of recurrent stroke when compared to medical therapy alone, which had been the standard of care otherwise.

The primary adverse event, recurrent or new stroke, is meaningfully reduced by PFO closure when compared to medical therapy alone. 

The denial of procedure code 93580, transcatheter closure of a patent foramen ovale (PFO) using a cardiac occlusion device and coverage for the requested service/treatment should be overturned. This treatment is likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are not substantially increased over standard treatments.