Pacemaker Defib denials in California external review

What the reviewers wrote

Where the denial was overturned

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: The patient has requested reimbursement and prospective authorization and coverage for a wearable defibrillator. A recent study found that the management of patients with ventricular arrhythmias and the prevision of sudden cardiac death note that for patients with recent myocardial infarction (MI), newly diagnosed non-ischemic cardiomyopathy (NICM), recent revascularization, myocarditis, and secondary cardiomyopathy are at increased risk of ventricular tachycardia/sudden cardiac arrest (SCA).

The parent of an enrollee has requested authorization and coverage for a portable automated external defibrillator (AED).The 2016 study by Ackerman and colleagues evaluated sudden death in the young and found that home AEDs are important for these patients. Most pediatric cardiologists recommend that families obtain AEDs for their children with long QT and carry them, as AEDs are not always readily available in public. AEDs have been proven to save lives. Survival is greatest when the AED is placed within three minutes of a witnessed collapse.

Where the denial was upheld

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for a leadless pacemaker. Initial data for leadless pacemakers is promising, with low incidence of complications. However, the pooled data is from small observational studies with relatively limited follow-up periods of less than one year. To date, there have been no randomized controlled trials that have directly compared the safety and efficacy of leadless pacemakers versus transvenous pacing systems, the recommended first-line option for treatment. Furthermore, according to registry data, the life span of currently available leadless pacemakers is estimated to be approximately 10 years.

The enrollee requested authorization and coverage for bioimpedance-derived physiologic cardiovascular analysis, which allows for remote monitoring of the enrollee’s implanted cardiovascular device. The enrollee has a history of dyslipidemia, systolic congestive heart failure, status post cardiac resynchronization therapy defibrillator; and atrial fibrillation with rapid ventricular response, resulting in inappropriate automatic implantable cardioverter defibrillator shocks. The enrollee had two prior accessory pathway ablations for atrial fibrillation-related ventricular tachycardia/ventricular fibrillation, and atrioventricular nodal ablation for recurrent ventricular tachycardia arrest. His systolic function has since normalized. The fluid status monitoring feature on the enrollee’s device previously indicated persistent fluid retention. This, along with transaminitis, has improved.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Pacemaker Defib, then check the rights and deadlines that apply to your plan.