CMS WISeR documentation checklist · §6.2.4
Operational Guide v7.0, last updated July 24, 2026 · retrieved 2026-09-14
Phrenic Nerve Stimulator (NCD 160.19)
CMS: “To meet coverage criteria, the patient’s medical record must contain documentation that fully supports the medical necessity of services. Subsections 6.2.1 to 6.2.13 list the documentation requirements for example services. For detailed documentation requirements, providers who choose to submit a prior authorization request for a WISeR Select Item or Service should refer to the relevant NCDs and/or their MAC jurisdiction’s LCDs and Local Coverage Articles (LCAs), if available, for guidance. They can be found on the Medicare Coverage Database website.”
For hypoventilation caused by respiratory paralysis resulting from lesions of the brainstem and cervical spinal cord (interruption of neuronal conduction at or above the C3 vertebral level), congenital central hypoventilation syndrome, and other disorders with ventilatory insufficiency (in which there is dependence on intermittent or permanent use of a mechanical ventilation as well as maintenance of a permanent tracheotomy stoma), the general documentation requirements for initial implantation of a phrenic nerve stimulator are as follows:
- Documentation of the etiology of ventilatory insufficiency as well as evaluation (e.g., of diaphragmatic function) and management to date, including the use of mechanical ventilation
- Documentation of intact phrenic nerve and diaphragmatic function, e.g., through a percutaneous nerve conduction study
- Documentation of absence of severe underlying primary pulmonary disease through history and exam, prior and current chest imaging, and pulmonary function testing (when feasible) For central sleep apnea (CSA), the general documentation requirements for initial implantation of a phrenic nerve stimulator are as follows:
- Documentation of etiology of CSA as idiopathic/primary or heart-failure–related CSA (not opioid- or medication-induced)
- Documentation of moderate to severe CSA confirmed by polysomnography
- Documentation of failure of, intolerance of, or contraindication to at least one of the following: a) Continuous positive airway pressure (CPAP) b) Bilevel positive airway pressure (BiPAP) c) Adaptive servo-ventilation (ASV) d) Nocturnal oxygen (for patients who have hypoxemia while sleeping)
- For patients with heart failure (HF): documentation of New York Heart Association (NYHA) class, left ventricular ejection fraction (LVEF), and stable, optimized guideline‐directed medical therapy (GDMT) as applicable
- Documentation of plan for device interaction testing if patient has an implantable cardioverter-defibrillator (ICD), cardiac resynchronization therapy (CRT), or pacemaker
- Assessment and documentation of none of the following contraindications: a) Active infection b) NYHA IV HF or American College of Cardiology (ACC)/American Heart Association (AHA) Stage D c) Recent stroke/transient ischemic attack (TIA) d) Currently on renal dialysis or severe renal disease e) Phrenic nerve palsy or other anatomic barriers f) Opioid or other medication-induced CSA