Diaphragmatic/Phrenic Nerve Stimulation (Diaphragm Pacing)
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Clinical coverage criteria and coding guidance for diaphragmatic/phrenic nerve stimulation (diaphragm pacing) devices and systems for members of the health plan; affects providers requesting authorization and billing for implantation and related services.
No material clinical or coverage changes in this revision.
Coverage Criteria for Diaphragmatic/Phrenic Nerve Stimulation
Initial coverage criteria — Avery Mark IV / Spirit
Covered when ALL of the following are met for Mark IV or Spirit systems:
NeuRx RA/4 HDE and FDA-specified coverage criteria
Covered when ALL of the following are met for NeuRx RA/4 (HDE / FDA-specified conditions):
The use of diaphragmatic/phrenic nerve stimulation systems (including the Remedé System) for central sleep apnea or for conditions not otherwise specified in this policy is considered unsupported due to insufficient evidence. The Remedé System, although FDA‑cleared for moderate to severe central sleep apnea in adults, lacks sufficient high‑quality evidence demonstrating safety and effectiveness for this indication in the published literature; additional studies are recommended to establish clinical benefit and long‑term safety.
Requests for coverage of diaphragm pacing or phrenic nerve stimulation for central sleep apnea or other non‑specified conditions will be evaluated against the policy’s specified covered indications (e.g., upper cervical spinal cord injury, central alveolar hypoventilation, or device‑specific ALS criteria). Absent demonstration that the case meets those covered indications, the intervention is not supported by this policy.
Diaphragmatic/phrenic nerve stimulation intended to treat indications other than the specific covered conditions listed in this policy (for example, treatment of central sleep apnea with the Remedé System) is considered not medically necessary because current evidence does not establish clinical benefit for those uses.
Providers seeking coverage for implantation or components for indications outside the policy’s defined criteria should submit supporting clinical evidence; however, by policy stance such requests are expected to be denied unless robust new evidence demonstrates safety and effectiveness for the unlisted indication.
Procedure and Device Coding
| 64575 | Open implantation of neurostimulator electrode array; peripheral nerve (excludes sacral nerve). |
| 64580 | Open implantation of neurostimulator electrode array; neuromuscular. |
| 64590 | Insertion or replacement of peripheral, sacral, or gastric neurostimulator pulse generator or receiver, requiring pocket creation and connection between electrode array and pulse generator or receiver. |
| 64595 | Revision or removal of peripheral, sacral, or gastric neurostimulator pulse generator or receiver, with detachable connection to electrode array. |
| C1778 | Lead, neurostimulator (implantable). |
| C1816 | Receiver and/or transmitter, neurostimulator (implantable). |
| L8680 | Implantable neurostimulator electrode, each. |
| L8681 | Patient programmer (external) for use with implantable programmable neurostimulator pulse generator, replacement only. |
| L8682 | Implantable neurostimulator radiofrequency receiver. |
| L8683 | Radiofrequency transmitter (external) for use with implantable neurostimulator radiofrequency receiver. |
| L8685 | Implantable neurostimulator pulse generator, single array, rechargeable, includes extension. |
| L8686 | Implantable neurostimulator pulse generator, single array, nonrechargeable, includes extension. |
| L8687 | Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension. |
| L8688 | Implantable neurostimulator pulse generator, dual array, nonrechargeable, includes extension. |
Provider Requirements and Authorization
Prior Authorization Required
Prior authorization is required for diaphragmatic/phrenic nerve stimulation implantation and associated device components. Submit prior authorization requests with supporting clinical documentation as specified below.
Required Documentation
Documentation should demonstrate the medical indication and that all coverage criteria are met. Include clinical records such as history and physical, diagnostic imaging or fluoroscopy/ultrasound showing diaphragm movement with stimulation, pulmonary function tests (including forced vital capacity where applicable), neurological evaluation of phrenic nerve function, device-specific eligibility evidence (e.g., HDE criteria for NeuRx RA/4 in ALS), and notes confirming the member’s ability to participate in training and rehabilitation.
- Include fluoroscopy or other radiographic evidence of diaphragm stimulation response.
- For ALS (NeuRx RA/4 HDE): age documentation (>=21 for HDE per source) and FVC values when applicable (not progressed to FVC <45% predicted as applicable).
- Clinical justification for use as an alternative to mechanical ventilation (e.g., upper cervical spinal cord injury at/above C3, central alveolar hypoventilation, ALS per HDE).
Denial Triggers
Requests may be denied if medical necessity criteria are not met or documentation is incomplete. Common denial triggers include absence of an indicated diagnosis (for example, no evidence of upper cervical spinal cord injury at/above C3 or no ALS meeting HDE conditions), lack of radiographic confirmation of diaphragm movement with stimulation, insufficient phrenic nerve/diaphragm function, failure to demonstrate ability to breathe independently for the required duration (where specified), or missing device-specific HDE eligibility information.
- Denial likely if fluoroscopy/ultrasound does not show diaphragm movement with stimulation.
- Denial likely if phrenic nerve, lung, or diaphragm function is not documented as intact and sufficient.
- Denial likely if documentation does not support the device-specific indications (including HDE criteria for NeuRx RA/4).
Definitions and Regulatory Status
Background
Diaphragm pacing (diaphragmatic/phrenic nerve stimulation) uses electrical stimulation of the phrenic nerve or direct stimulation of the diaphragm to produce rhythmic diaphragm contractions with the clinical intent of reducing or eliminating dependence on mechanical ventilation in patients with chronic ventilatory insufficiency due to bilateral diaphragm paralysis or severe diaphragmatic paresis.
Devices vary in design and implantation method: some systems are fully implanted (e.g., Avery/Mark IV and Spirit series) while others use implanted electrodes with an external controller (e.g., NeuRx RA/4). Patient selection requires demonstration of diaphragmatic movement with stimulation (commonly visualized under fluoroscopy or ultrasound) and intact phrenic nerve, lung, and diaphragm function to achieve effective stimulation sufficient for independent breathing.
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