Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary:A enrollee has requested authorization and coverage for transcatheter closure of patent foramen ovale (PFO) for treatment of the enrollees PFO. Findings:  The physician reviewer found that Based on the records provided for review, the patient had a stroke and has been found to have a PFO with no documented recurrence since starting treatment with Plavix. Although there is an association with PFO and cryptogenic strokes and migraines, the peer-reviewed literature does not consistently demonstrate improved outcomes with PFO closure compared to medical therapy. For example, per the randomized prospective CLOSURE ONE trial, did not demonstrate relative benefit of PFO closure using a Starflex device compared to medical therapy. In addition, the RESPECT trial showed no significant benefit of closure of a PFO using the Amplatzer PFO occluder compared to medical therapy alone in the intention-to-treat analysis. Similar results were found in a recent randomized trial by Meier and colleagues. Therefore, the use of percutaneous closure devices for treatment of a PFO in the setting of a documented transient ischemic attack or cryptogenic stroke is not likely to be more beneficial than standard therapy. PFO closure may be appropriate when alternative therapies such as aspirin or warfarin are not tolerated, alternative therapies are contraindicated, alternative therapies have failed, or in a clinical trial. The records provided do not document that the patient has a contraindication to aspirin or anticoagulation. For the reasons provided, the request for transcatheter closure of PFO is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Final Result: Two of three reviewers determined that the requested procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: Physician reviewer number one is board certified in internal medicine with sub-specialty certification in cardiovascular disease and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.Physician reviewer number two is board certified in internal medicine with sub-specialty certification in cardiovascular disease and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.Physician reviewer number three is board certified in internal medicine with sub-specialty certification in cardiovascular disease and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.