Hypoglossal Nerve Stimulator Implantation denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: A male enrollee has requested authorization and coverage for implantation of a cranial nerve neurostimulator for treatment of the enrollee’s obstructive sleep apnea. Findings: The physician reviewer found that there is sufficient support in the medical literature for the requested services in this clinical setting. Although traditional upper airway surgical procedures target the anatomic component of obstruction, upper airway stimulation tackles the twin goals of improving anatomic and neuromuscular pathology. After decades of trials demonstrating proof of concept of hypoglossal nerve stimulation in animal and human subjects, the three and four year results of a large multicenter, prospective trial were published in January 2016 and February 2017.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for implantation of a hypoglossal nerve stimulator. Obstructive sleep apnea (OSA) is an increasingly prevalent clinical problem with significant effects. Continuous positive airway pressure (CPAP) has demonstrated excellent efficacy and safety for treatment of OSA. In patients who do not tolerate CPAP and fail to improve with an oral appliance, surgical intervention may be required. Although traditional upper airway surgical procedures target the anatomic component of obstruction, upper airway stimulation tackles the twin goals of improving anatomic and neuromuscular pathology. As reported in the published medical literature, the STAR trial demonstrated that hypoglossal nerve stimulation led to significant improvements in objective and subjective measurements of the severity of OSA.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for implantation of a hypoglossal nerve stimulator for treatment of the enrollee’s obstructive sleep apnea (OSA). Findings: 2/3 of the physician reviewers found that review of the current literature indicates that use of hypoglossal nerve stimulation in treatment of OSA shows promise. However, criteria for the use of this therapy includes that patients have moderate to severe OSA with an AHI between 20 and 60, BMI of less than 32, and failure of trial of CPAP therapy. This patient has an AHI of 76.7 which is greater than the U.S. Food and Drug Administration (FDA) criteria of less than 60 and greater than 50, which is used for most study criteria. In addition, the medical records provided do not demonstrate the patient has failed treatment with standard therapies including CPAP.

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for implantation of a hypoglossal nerve stimulator. Findings: Two physician reviewers found that CPAP is the most common type of therapy for patients with severe OSA. Hypoglossal nerve stimulation therapy has been proven by the U.S. Food and Drug Administration (FDA) to be an effective modality of treatment of OSA in patients with tongue-based obstruction.

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 Hypoglossal Nerve Stimulator Implantation, then check the rights and deadlines that apply to your plan.