Phrenic Nerve Stimulation for Central Sleep Apnea

POLICY NUMBER

A.2.02.33

DESCRIPTION

Central sleep apnea (CSA) is characterized by sleep-disordered breathing due to diminished or absent respiratory effort. Central sleep apnea may be idiopathic or secondary (associated with a medical condition, drugs, or high altitude breathing). The use of positive airway pressure devices is currently the most common form of therapy for CSA. An implantable device that stimulates the phrenic nerve in the chest is a potential alternative treatment. The battery-powered device sends signals to the diaphragm in order to stimulate breathing and normalize sleep-related breathing patterns.

Central Sleep Apnea

Central sleep apnea (CSA) is characterized by repetitive cessation or decrease in both airflow and ventilatory effort during sleep. Central sleep apnea may be idiopathic or secondary (associated with a medical condition such as congestive heart failure, drugs, or high altitude breathing). Apneas associated with Cheyne-Stokes respiration are common among patients with heart failure (HF) or who have had strokes, and account for about half of the population with CSA. Central sleep apnea is less common than obstructive sleep apnea. Based on analyses of a large community-based cohort of participants 40 years of age and older in the Sleep Heart Health Study, the estimated prevalence of CSA and obstructive sleep apnea are 0.9% and 47.6%, respectively. Risk factors for CSA include age (>65 years), male gender, history of HF, history of stroke, other medical conditions (acromegaly, renal failure, atrial fibrillation, low cervical tetraplegia, and primary mitochondrial diseases), and opioid use. Individuals with CSA have difficulty maintaining sleep and therefore experience excessive daytime sleepiness, poor concentration, and morning headaches, and are at higher risk for accidents and injuries.

Treatment

The goal of treatment is to normalize sleep-related breathing patterns. Because most cases of CSA are secondary to an underlying condition, central nervous system pathology, or medication side effects, treatment of the underlying condition or removal of the medication, may improve CSA. Treatment recommendations differ depending on the classification of CSA as either hyperventilation-related (most common, including primary CSA and those relating to HF or high altitude breathing) or hypoventilation-related (less common, relating to central nervous system diseases or use of nervous system suppressing drugs such as opioids).

For patients with hyperventilation-related CSA, continuous positive airway pressure (CPAP) is considered first-line therapy. Due to CPAP discomfort, patient compliance may become an issue. Supplemental oxygen during sleep may be considered for patients experiencing hypoxia during sleep or who cannot tolerate CPAP. Patients with CSA due to HF with an ejection fraction >45% and who are not responding with CPAP and oxygen therapy, may consider bilevel positive airway pressure or adaptive servo-ventilation (ASV) as second-line therapy. Bilevel positive airway pressure devices have two pressure settings, one for inhalation and one for exhalation. Adaptive servo-ventilation uses both inspiratory and expiratory pressure, and titrates the pressure to maintain adequate air movement. However, a clinical trial reported increased cardiovascular mortality with ASV in patients with CSA due to HF and with an ejection fraction <45%, and therefore, ASV is not recommended for this group.

For patients with hypoventilation-related CSA, first-line therapy is bilevel positive airway pressure.

Pharmacologic therapy with a respiratory stimulant may be recommended to patients with hyper- or hypoventilation CSA who do not benefit from positive airway pressure devices, though close monitoring is necessary due to the potential for adverse effects such as rapid heart rate, high blood pressure, and panic attacks.

Phrenic Nerve Stimulation

Several phrenic nerve stimulation systems are available for patients who are ventilator dependent. These systems stimulate the phrenic nerve in the chest, which sends signals to the diaphragm to restore a normal breathing pattern. Currently, there is one phrenic nerve stimulation device approved by the U.S. Food and Drug Administration (FDA) for CSA, the remed? System (Zoll Medical). A cardiologist implants the battery-powered device under the skin in the right or left pectoral region using local anesthesia. The device has two leads, one to stimulate a phrenic nerve (either the left pericardiophrenic or right brachiocephalic vein) and one to sense breathing. The device runs on an algorithm that activates automatically at night when the patient is in a sleeping position and suspends therapy when the patient sits up. Patient-specific changes in programming can be conducted externally by a programmer.

In October 2017, the remed? System (Respicardia, Inc [now Zoll Medical]; Minnetonka, MN) was approved by the FDA through the premarket approval application process. The approved indication is for the treatment of moderate to severe CSA in adults. Follow-up will continue for 5 years in the post-approval study. FDA Product code: PSR.

POLICY

The use of phrenic nerve stimulation for central sleep apnea is considered investigational in all situations.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

07/18/2019: Approved by Medical Policy Advisory Committee.

06/16/2020: Policy description updated regarding central sleep apnea and phrenic nerve stimulation systems. Policy statement unchanged.

07/30/2021: Policy description updated. Policy statement unchanged.

06/16/2022: Policy description updated regarding devices. Policy statement unchanged.

07/11/2023: Policy reviewed; no changes.

12/21/2023: Code Reference section updated to add new 2024 CPT codes 33276, 33277, 33278, 33279, 33280, 33281, 33287, 33288, 93150, 93151, 93152, and 93153, effective 01/01/2024.

06/12/2024: Policy description updated. Policy statement unchanged.

08/11/2025: Policy reviewed. Policy statement unchanged. Code Reference section updated to remove deleted CPT codes 0424T, 0425T, 0426T, 0427T, 0428T, 0429T, 0430T, 0431T, 0432T, 0433T, 0434T, 0435T, and 0436T.

SOURCE(S)

Blue Cross Blue Shield Association policy # 2.02.33

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

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