ModifiedPartners Health ManagementPolicy CP.MP.203

Diaphragmatic/Phrenic Nerve Stimulation

Customize your policy alerts

Sign up for partners_health_management Policy CP.MP.203 alerts

Get alerted when Policy CP.MP.203 changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Medical necessity and coverage criteria for diaphragmatic/phrenic nerve stimulation (diaphragm pacing) devices and associated implantation for members of health plans affiliated with Centene Corporation (Partners Health Management). Affects providers requesting coverage for device implantation and use.

OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

ModifiedPartners Health ManagementPolicy CP.MP.203

Diaphragmatic/Phrenic Nerve Stimulation

Customize your policy alerts

Sign up for partners_health_management Policy CP.MP.203 alerts

Get alerted when Policy CP.MP.203 changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Policy Summary

PayerPartners Health Management

PolicyDiaphragmatic/Phrenic Nerve Stimulation

Policy CodePolicy CP.MP.203

Change TypeDevice expansioncoding and background updates

Effective Date

Next Review Date

Key ActionSubmit prior authorization with clinical documentation demonstrating diagnosis, diaphragm movement with stimulation, intact phrenic nerve/lung/diaphragm function, and ability to achieve required independent breathing (including ≥4 continuous hours/day where specified).

SourceLink

POLICY UPDATE CHANGES

Criteria I. updated to include the Spirit Diaphragm Pacing Transmitter.

Background updated to include information regarding full FDA approval of the NeuRx RA/4 Diaphragm Pacing System and added section regarding the Remedé System.

Added HCPCS codes L8685–L8688 to HCPCS codes table.

3Distinct device systems discussed

>=4 hrs/dayMin daily ventilator independence

4CPT codes referenced

L8680-L8696HCPCS codes referenced

PMA/510(k)Regulatory approvals referenced

Coverage Criteria for Diaphragm/Phrenic Nerve Stimulation

Criteria I — Mark IV / Spirit Diaphragm Pacing Systems

Covered when ALL of the following are met for Mark IV or Spirit systems:

I.A: Stimulation is used as an alternative to mechanical ventilation for an individual with severe, chronic respiratory failure due to upper cervical spinal cord injury (at or above the C3 vertebral level) OR central alveolar hypoventilation disorder.

I.B: Diaphragm movement with stimulation is visible under fluoroscopy.

I.C: Intact and sufficient function in the phrenic nerve, lungs, and diaphragm.

I.D: Stimulation of the diaphragm either directly or through the phrenic nerve results in sufficient muscle activity to accommodate independent breathing without the support of a ventilator.

I.E: Normal chest anatomy, a normal level of consciousness, and the ability to participate in and complete the training and rehabilitation associated with the use of the device.

Criteria II — NeuRx RA/4 Diaphragm Pacing System

Covered when ALL of the following are met for NeuRx RA/4 (per HDE/approved indications):

II.A.1

II.A.1.a: Age 21 years or older.
II.A.1.b: Experiencing chronic hypoventilation but not progressed to forced vital capacity (FVC) less than 45% predicted.FVC >= 45% predicted
II.A.1.c: Diaphragm movement with stimulation is visible under fluoroscopy or by other radiographic techniques such as ultrasound.
II.A.1.d: Intact and sufficient function in the phrenic nerve, lungs, and diaphragm.

Criteria III — Insufficient Evidence / Not Supported Indications

Not covered / insufficient evidence:

III: There is insufficient evidence to support the safety and efficacy of diaphragmatic/phrenic nerve stimulation for other conditions, including but not limited to central sleep apnea (e.g., Remedé System).

There is insufficient evidence to support the safety and effectiveness of diaphragmatic/phrenic nerve stimulation for conditions other than the device- and diagnosis-specific indications described in this policy. Examples of unsupported uses include treatment of central sleep apnea, including applications of the Remedé System, where published data do not demonstrate clear long-term safety and clinical benefit. Requests for coverage for indications outside those explicitly listed in this policy risk denial due to lack of evidence of clinical benefit.

Coverage is provided only in accordance with the member’s benefit terms. Decisions are subject to the terms, conditions, exclusions and limitations of the member’s coverage documents (for example, evidence of coverage or certificate of coverage). For Medicaid members, applicable state Medicaid provisions take precedence where conflicts exist. This policy is a guide to medical necessity and does not guarantee payment; providers must follow applicable Health Plan administrative policies and contractual requirements when submitting claims.

Any indication outside the specific device- and diagnosis-based FDA-approved or HDE indications described in this policy is considered unsupported by the current evidence and is not covered. Examples include use of diaphragmatic/phrenic nerve stimulation for disorders such as central sleep apnea (e.g., Remedé System), for which the available data are insufficient to establish safety and effectiveness.

Coding and Clinical Thresholds

Referenced CPT CodesCPT

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

Referenced HCPCS CodesHCPCS

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

1–10 of 13

1/2

inv-09: Minimum daily ventilator independence — key clinical threshold (>=4 hours/day)

Minimum ventilator-free durationStimulation must allow breathing without mechanical ventilator support for at least 4 continuous hours per day.

Context of useSpecified as a required threshold for NeuRx RA/4 when used for upper cervical spinal cord injury and for other device-specific indications where noted.

Documentation requirementClinical documentation must demonstrate the patient can achieve ≥4 continuous hours/day of independent breathing as part of authorization and evaluation.

inv-10: ALS FVC threshold — key clinical threshold (FVC not less than 45% predicted)

ALS FVC requirementFor NeuRx RA/4 in ALS patients: forced vital capacity (FVC) must not be less than 45% of predicted.

Provider Requirements, Prior Authorization, and Claims

Prior Authorization

Prior authorization required; list of affected codes

Prior authorization is required per plan rules for requests involving implantation or use of diaphragmatic/phrenic nerve stimulation devices. Submit clinical documentation supporting medical necessity consistent with the policy criteria.

Affected CPT codes: 64575, 64580, 64590, 64595
Affected HCPCS/Codes: C1778, C1816, L8680–L8696 (including L8685–L8688)

Prior Authorization

Prior authorization expectations and regulatory review

Prior authorization requests must follow Health Plan administrative policies and any applicable regulatory determinations; review Medicare NCDs/LCDs for Medicare members before applying policy criteria.

Ensure consistency with applicable Medicare NCDs, LCDs, and Coverage Articles prior to applying criteria for Medicare members
Health Plan-level administrative policies and procedures govern prior authorization processes

Background and Device Information

Diaphragm or phrenic nerve stimulation (diaphragm pacing) uses electrical stimulation of the phrenic nerve or diaphragm muscle to produce rhythmic diaphragm contractions intended to support or replace mechanical ventilation. These systems are intended to reduce or eliminate ventilator dependence in patients with chronic ventilatory insufficiency due to diaphragm paralysis or severe paresis, for example after high cervical spinal cord injury or in selected patients with neuromuscular disease. Different commercially available systems have distinct regulatory statuses and labeled indications; coverage in this policy is limited to those device–diagnosis combinations meeting the specific criteria described herein.

Definitions and Regulatory Terms

inv-20: Definition — Diaphragm pacing / diaphragmatic/phrenic nerve stimulation (short key/value)

DefinitionElectrical stimulation of the phrenic nerve or diaphragm to produce rhythmic diaphragm contractions that support or replace mechanical ventilation.

PurposeUsed to reduce or eliminate need for ventilator support in patients with chronic ventilatory insufficiency due to diaphragm paralysis or severe paresis.

TechniquesStimulation may be delivered via implanted electrodes (intramuscular or perineural) connected to implanted or external stimulators.

inv-21: Definition — Humanitarian Device Exemption (HDE) and its relevance to NeuRx RA/4

HDE explainedA Humanitarian Device Exemption (HDE) is an FDA regulatory pathway allowing distribution of devices for rare conditions with limited evidence; NeuRx RA/4 was initially granted FDA distribution under an HDE (June 17, 2008) and later received device approvals for additional indications.

Policy Summary

PayerPartners Health Management

PolicyDiaphragmatic/Phrenic Nerve Stimulation

Policy CodePolicy CP.MP.203

Change TypeDevice expansioncoding and background updates

Effective Date

Next Review Date

SourceLink

On This Page

II.A.2

II.A.2.a: Age 18 years or older.
II.A.2.b: Diaphragm movement with stimulation is visible under fluoroscopy or by other radiographic techniques such as ultrasound.
II.A.2.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.>= 4 hours/day
II.A.2.d: Intact and sufficient function in the phrenic nerve, lungs, and diaphragm.

II.General: NeuRx RA/4 coverage follows FDA HDE specifications where applicable.

PopulationApplies to ALS patients considered for NeuRx RA/4 under the FDA HDE/approved indications.

Clinical implicationPatients with FVC <45% predicted are excluded from the NeuRx ALS indication per policy criteria.

Step Therapy

Step therapy not specified; coverage contingent on meeting criteria

No step therapy requirements are specified in this policy; coverage is conditioned on meeting the device‑ and diagnosis‑specific medical necessity criteria described in the policy.

Coverage for NeuRx RA/4 and Mark IV/Spirit devices requires meeting all listed criteria (device- and diagnosis-specific)
No sequential trials or step edits are defined in this policy

Note

Provider action: follow plan authorization and submission procedures

Providers must request authorization and submit required clinical documentation as specified by the Health Plan; follow plan procedures for prior authorization submission and claims filing.

Providers are bound by contract terms when submitting claims and requests
State Medicaid provisions take precedence for Medicaid members when conflicts exist

Documentation Required

Required clinical documentation to support authorization

Submit documentation demonstrating the applicable covered diagnosis, evidence of diaphragm movement with stimulation, intact phrenic nerve/lung/diaphragm function, and ability to achieve sufficient independent breathing (including ≥4 continuous hours/day where specified).

Diagnosis documentation: upper cervical spinal cord injury (at or above C3), central alveolar hypoventilation, or ALS as applicable
Radiographic confirmation of diaphragm movement with stimulation (fluoroscopy or ultrasound)
Evidence of intact and sufficient phrenic nerve, lung, and diaphragm function
For NeuRx RA/4 spinal cord injury indication: documentation that stimulation will allow breathing without ventilator for at least 4 continuous hours/day
For NeuRx ALS indication: age and FVC documentation (ALS: age ≥21; FVC not less than 45% predicted)

Billing Rule

Claims and contract requirements

Providers must follow Health Plan administrative policies and contractual terms when submitting claims; plan documents govern coverage and payment decisions.

Claims are subject to the terms, conditions, exclusions and limitations of the member's coverage documents
For Medicaid members, state Medicaid provisions take precedence if conflicts exist

Denial Risk

Denial risk when policy criteria are not met

Requests that do not meet the policy's medical necessity criteria risk denial. Common denial triggers include absence of a covered diagnosis, lack of radiographic evidence of diaphragm movement with stimulation, insufficient phrenic nerve/lung/diaphragm function, or inability to complete required training.

Device used for indications outside those listed (e.g., central sleep apnea) — insufficient evidence
No visible diaphragm movement with stimulation on fluoroscopy or other radiographic technique
Insufficient phrenic nerve, lung, or diaphragm function to support independent breathing
Inability to participate in or complete the training and rehabilitation associated with device use

Note

Coverage conditioned on member benefit terms and legal requirements

Coverage and benefit administration are subject to the member's plan terms, conditions, exclusions, and limitations; applicable state and federal requirements may affect coverage determinations.

Coverage is not guaranteed and is dependent on the member's coverage documents (evidence of coverage, policy, contract)
State Medicaid rules override this policy where conflicts exist

Relevance to NeuRx RA/4NeuRx RA/4 received FDA clearance under an HDE for use in certain high spinal cord injury patients and subsequently an HDE approval for use in ALS patients; HDE-specified indications and conditions of use are reflected in coverage criteria.

Regulatory noteHDE approvals may include post-approval tracking or manufacturer obligations as conditions of distribution noted by the FDA summaries.

inv-22: Definition — Diaphragm pacing / phrenic nerve stimulation device category summary

Device categoryImplantable or external systems that stimulate the phrenic nerve or diaphragm to provide ventilatory support (diaphragm pacing/phrenic nerve stimulation).

ExamplesSystems include Avery/Mark IV and Spirit Diaphragm Pacing Systems (implanted receivers/electrodes) and NeuRx RA/4 (intramuscular diaphragm electrodes with external stimulator).

Key device featuresMay use implanted leads/electrodes connected to implanted receivers/transmitters or intramuscular electrodes connected to external stimulators; indications and regulatory status vary by system.

Indication variabilityFDA-reviewed systems have different approved indications (e.g., Avery systems for chronic ventilatory support and NeuRx RA/4 under HDE for select spinal cord injury and ALS indications).