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.
For individuals with CSA who receive phrenic nerve stimulation, the evidence includes a systematic review, 1 randomized controlled trial (RCT), and observational studies. Relevant outcomes are change in disease status, functional outcomes, and quality of life. The RCT compared the use of phrenic nerve stimulation to no treatment among patients with CSA of various etiologies. All patients received implantation of the phrenic nerve stimulation system, with activation of the system after 1 month in the intervention group and activation after 6 months in the control group. Activation is delayed 1 month after implantation to allow for lead healing. At 6 months follow-up, the patients with the activated device experienced significant improvements in several sleep metrics and quality of life measures. At 12 months follow-up, patients in the activated device arm showed sustained significant improvements from baseline in sleep metrics and quality of life. A subgroup analysis of patients with heart failure combined 6- and 12-month data from patients in the intervention group and 12- and 18-month data from the control group. Results from this subgroup analysis showed significant improvements in sleep metrics and quality of life at 12 months compared with baseline. Results from observational studies supported the results of the RCT. An invasive procedure would typically be considered only if non-surgical treatments had failed, but there is limited data in which phrenic nerve stimulation was evaluated in patients who had failed the current standard of care, positive airway pressure, or respiratory stimulant medication. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
The use of phrenic nerve stimulation for central sleep apnea is considered investigational in all situations.
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CPT |
33276 |
Insertion of phrenic nerve stimulator system (pulse generator and stimulating lead[s]), including vessel catheterization, all imaging guidance, and pulse generator initial analysis with diagnostic mode activation, when performed (eff 01/01/2024) |
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33277 |
Insertion of phrenic nerve stimulator transvenous sensing lead (List separately in addition to code for primary procedure) (eff 01/01/2024) |
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33278 |
Removal of phrenic nerve stimulator, including vessel catheterization, all imaging guidance, and interrogation and programming, when performed; system, including pulse generator and lead(s) (eff 01/01/2024) |
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33279 |
Removal of phrenic nerve stimulator, including vessel catheterization, all imaging guidance, and interrogation and programming, when performed; transvenous stimulation or sensing lead(s) only (eff 01/01/2024) |
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33280 |
Removal of phrenic nerve stimulator, including vessel catheterization, all imaging guidance, and interrogation and programming, when performed; pulse generator only (eff 01/01/2024) |
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33281 |
Repositioning of phrenic nerve stimulator transvenous lead(s)(eff 01/01/2024) |
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33287 |
Removal and replacement of phrenic nerve stimulator, including vessel catheterization, all imaging guidance, and interrogation and programming, when performed; pulse generator (eff 01/01/2024) |
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33288 |
Removal and replacement of phrenic nerve stimulator, including vessel catheterization, all imaging guidance, and interrogation and programming, when performed; transvenous stimulation or sensing lead(s) (eff 01/01/2024) |
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93150 |
Therapy activation of implanted phrenic nerve stimulator system, including all interrogation and programming (eff 01/01/2024) |
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93151 |
Interrogation and programming (minimum one parameter) of implanted phrenic nerve stimulator system (eff 01/01/2024) |
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93152 |
Interrogation and programming of implanted phrenic nerve stimulator system during polysomnography (eff 01/01/2024) |
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93153 |
Interrogation without programming of implanted phrenic nerve stimulator system (eff 01/01/2024) |
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ICD-10-PCS |
0JH60DZ |
Insertion, subcutaneous tissue and fascia, chest, open, stimulator generator, multiple array. |
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O5H33MZ |
Insertion, upper veins, right innominate vein (brachiocephalic), percutaneous, neurostimulator lead |
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O5H43MZ |
Insertion, upper veins, left innominate vein (brachiocephalic), percutaneous, neurostimulator lead |
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05H03MZ |
Insertion, upper veins, azygos vein percutaneous, neurostimulator lead |
| HCPCS | C1823 | Generator, neurostimulator (implantable), non-rechargeable, with transvenous sensing and stimulation leads |
| Considered investigational for central sleep apnea |
| ICD-10-CM | G47.31 | Primary central sleep apnea (idiopathic 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.1, 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.
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 2 pressure settings, 1 for inhalation and 1 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%,2, 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.
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 1 phrenic nerve stimulation device approved by the U.S. Food and Drug Administration (FDA) for CSA, the remedē 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 2 leads, 1 to stimulate a phrenic nerve (either the left pericardiophrenic or right brachiocephalic vein) and 1 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 remedē System (Respicardia, Inc [now Zoll Medical]; Minnetonka, MN) was approved by the FDA through the premarket approval application process (PMA #P160039). 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.
