Clinical Policy: Diaphragmatic/Phrenic Nerve Stimulation Form

Clinical Policy: Diaphragmatic/Phrenic Nerve Stimulation  
Reference Number: OH.CP.MP.203                                               Coding Implications  

Date of Last Revision: 10/25                                               Revision Log  

See Important Reminder at the end of this policy for important regulatory and legal information.  

Policy Statement  
In compliance with Ohio Medicaid, Buckeye Health Plan must ensure coverage of medically necessary procedures. The plan covers all the services in the amount, duration, and scope that is no less than that covered by FFS Ohio Medicaid and in accordance with 42 CFR 438.210, with limitations, exclusions, and clarifications provided in the Ohio Medicaid Managed Care Provider Agreement and the Ohio Administrative Code.  

Description  
Diaphragmatic/phrenic nerve stimulation, also referred to as diaphragm pacing, is a treatment option used to eliminate or reduce the need for ventilator support in those with chronic ventilatory insufficiency due to bilateral paralysis or severe paresis of the diaphragm. Diaphragmatic/phrenic nerve stimulation uses the phrenic nerves to signal the diaphragm muscles to contract and produce breathing through electrical stimulation.  

Policy/Criteria  
  

  
    2. Upper cervical spinal cord injury (at or above the C3 vertebral level);  
        a. Age 18 years or older;  
        b. Diaphragm movement with stimulation is visible under fluoroscopy or by other radiographic techniques such as ultrasound;  
        c. Stimulation of the diaphragm will allow the individual to breathe without the assistance of a mechanical ventilator for at least four continuous hours a day;  
        d. Intact and sufficient function in the phrenic nerve, lungs, and diaphragm.  

III. It is the policy of health plans affiliated with Centene Corporation that there is insufficient evidence to support the safety and efficacy of diaphragmatic/phrenic nerve stimulation for any other conditions, including but not limited to, central sleep apnea.  

Background  
Diaphragmatic/phrenic nerve stimulator devices are indicated for certain ventilator-dependent individuals who lack voluntary control of their diaphragm muscles to enable independent breathing without the assistance of a mechanical ventilator.  

NeuRx RA/4 Diaphragm Pacing System® (Synapse Biomedical, Inc.)  
The NeuRx RA/4 Diaphragm Pacing System® includes implanted intramuscular diaphragm electrodes, which are connected to an external stimulator.²  

The United States Food and Drug Administration (FDA) approval for distribution of the NeuRx DPS® (Synapse Biomedical, Inc., Oberlin, OH) was granted under a Humanitarian Device Exemption (HDE) on June 17, 2008. The FDA-approved indications are: “For use in patients with stable, high spinal cord injuries with stimulatable diaphragms, but lack control of their diaphragms.” The device is indicated to allow the patients to breathe without the assistance of a mechanical ventilator for at least four continuous hours a day and is for use only in patients 18 years of age or older. This FDA approval is subject to the manufacturer developing an acceptable method of tracking device implantation to individual patient recipients.¹  

In 2011, the FDA approved the NeuRx RA/4 Diaphragm Pacing System® as a humanitarian-use device (HUD) in amyotrophic lateral sclerosis (ALS) following the  

submission of a humanitarian device exemption (HDE) application. The FDA approved indications are: “For use in amyotrophic lateral sclerosis (ALS) patients with a stimulatable diaphragm (both right and left portions) as demonstrated by voluntary contraction or phrenic nerve conduction studies, and who are experiencing chronic hypoventilation (CH), but not progressed to an FVC less than 45% predicted. For use only in patients 21 years of age or older.”²(p.1)  

In 2023, NeuRx RA/4 Diaphragm Pacing System received full FDA approval for use in “patients with stable, high spinal cord injuries with stimulatable diaphragms, but who lack control of their diaphragms.”¹⁴  

Remede® System (ZOLL® Medical Corporation)  
Although the Remede was approved as a treatment option for moderate to severe central sleep apnea in adults by the FDA in 2017, there is insufficient evidence to determine the safety and effectiveness of this system.⁹,¹⁵ Additional high-quality studies are recommended to evaluate the clinical significance and long-term safety and efficacy of the Remede System for central sleep apnea.⁹  

Avery Diaphragm Pacing System (Avery Biomedical Device, Inc.)  
The Avery Diaphragm Pacing System includes receivers and electrodes that are surgically implanted and includes an external transmitter worn over the implanted receivers.³ The different types of Avery systems include the Mark IV Breathing Pacemaker System and the Spirit Diaphragm Pacing System.³ The Mark IV Breathing Pacemaker System is a diaphragmatic/phrenic stimulator system approved for use by the FDA in the United States. The device is approved “for persons who require chronic ventilatory support because of upper motor neuron respiratory muscle paralysis (RMP) or because of central alveolar hypoventilation (CAH) and whose remaining phrenic nerve, lung, and diaphragm function is sufficient to accommodate electrical stimulation.”⁴ In 2019, the Spirit Diaphragm Pacing Transmitter received full FDA approval for the use of this system for patients who have functional lungs and diaphragm muscle and who have an intact phrenic nerve.³,⁵,⁶  

Coding Implications  
Codes referenced in this clinical policy are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the most up-to-date sources of professional coding guidance prior to the submission of claims for reimbursement of covered services.  

| CPT® Codes | Description |
|------------|-------------|
| 64575 | Incision for implantation of neurostimulator electrode array; peripheral nerve, (excludes sacral nerve) |
| 64580 | Incision for implantation of neurostimulator electrode array; neuromuscular |
| 64590 | Insertion or replacement of peripheral or gastric neurostimulator pulse generator or receiver, direct or inductive coupling |

| 64595 | Revision or removal of peripheral or gastric neurostimulator pulse generator or receiver |

| HCPCS ®* Codes | Description |
|----------------|-------------|
| 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 [for phrenic nerve stimulator] |
| L8683 | Radiofrequency transmitter (external) for use with implantable neurostimulator radiofrequency receiver [for phrenic nerve stimulator] |
| 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 |
| L8689 | External recharging system for battery (internal) for use with implantable neurostimulator, replacement only |
| L8695 | External recharging system for battery (external) for use with implantable neurostimulator, replacement only |
| L8696 | Antenna (external) for use with implantable diaphragmatic/phrenic nerve stimulation device, replacement, each |

| Reviews, Revisions, and Approvals | Revision Date | Approval Date |
|----------------------------------|--------------|---------------|
| Policy created and approved. | 08/11 | 08/11 |
| Centene Policy CP.MP. updated with OH Addendum | 11/22 | 12/22 |
| Policy moved to Ohio Specific template and Addendum language integrated into policy template as Policy Statement and Procedure. Annual Review. No material changes in review criteria. | 07/23 | 07/23 |
| Annual review. Criteria I. updated to include the Spirit Diaphragm Pacing Transmitter. Background updated to include information regarding full FDA approval of the Spirit Diaphragm Pacing Transmitter. References reviewed and updated. Reviewed by external specialist. | 07/24 | 07/24 |

| Annual review. Description updated with no clinical significance. Background updated to include information regarding full FDA approval of NeuRx RA/4 Diaphragm Pacing System and added section regarding the Remede System. Added codes L8685, L8686, L8687, L8688 to HCPCs Codes table. Coding reviewed. References reviewed and updated. | 10/25 | 10/25 |

  
21. Avery Biomedical Devices. https://averybiomedical.com/spirit-earns-fda-approval/. Accessed November 23, 2022.