Sunflower Health Plan Diaphragmatic/Phrenic Nerve Stimulation (PDF) Form

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 I. It is the policy of health plans affiliated with Centene Corporation® that diaphragmatic/phrenic nerve stimulation with the Mark IV™ Breathing Pacemaker System is medically necessary when all of the following are met: A. Stimulation is used as an alternative to mechanical ventilation for an individual with severe, chronic respiratory failure due to one of the following: 1. Upper cervical spinal cord injury (at or above the C3 vertebral level); 2. Central alveolar hypoventilation disorder; B. Diaphragm movement with stimulation is visible under fluoroscopy; C. Intact and sufficient function in the phrenic nerve, lungs, and diaphragm; 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; 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. II. It is the policy of health plans affiliated with Centene Corporation that diaphragmatic/phrenic nerve stimulation with the NeuRX DPS™ RA/4 Respiratory Stimulation System is medically necessary when provided in accordance with the Humanitarian Device Exemption (HDE) specifications of the U.S Food and Drug Administration when all of the following are met: A. Stimulation is used as an alternative to mechanical ventilation for an individual with severe, chronic respiratory failure due to one of the following: 1. Amyotrophic lateral sclerosis (ALS); a. Age 21 years or older; b. Experiencing chronic hypoventilation but not progressed to forced vital capacity (FVC) less than 45% predicted; c. Diaphragm movement with stimulation is visible under fluoroscopy or by other radiographic techniques such as ultrasound; d. Intact and sufficient function in the phrenic nerve, lungs, and diaphragm. 2. Upper cervical spinal cord injury (at or above the C3 vertebral level); a. Age 18 years or older; Page 1 of 6 CLINICAL POLICY Diaphragmatic/Phrenic Nerve Stimulation 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 DPS RA/4 Respiratory Stimulation System (Synapse Biomedical, Inc.) United States Food and Drug Administration (FDA) approval for distribution of the NeuRx DPS™ RA/4 Respiratory Stimulation System (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 4 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.6 In 2011 the FDA approved the NeuRx DPS™ RA/4 Respiratory Stimulation 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.”7(p.1) Mark IV™ Breathing Pacemaker System (Avery Biomedical Device, Inc.) The Avery Breathing Pacemaker System (i.e., the Mark IV™ Avery Biomedical Device, Inc., Commack, NY) is the only other 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.”8 In 2019, the Spirit Diaphragm Pacing Transmitter received FDA premarket approval for the use of this system for patients who have functional luncgs and diaphragm muscle and who have an intact phrenic nerve.10,11 Coding Implications Page 2 of 6 CLINICAL POLICY Diaphragmatic/Phrenic Nerve Stimulation This clinical policy references Current Procedural Terminology (CPT®). CPT® is a registered trademark of the American Medical Association. All CPT codes and descriptions are copyrighted 2020, American Medical Association. All rights reserved. CPT codes and CPT descriptions are from the current manuals and those included herein are not intended to be all-inclusive and are included for informational purposes only. 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 64575 64580 64590 64595 Incision for implantation of neurostimulator electrode array; peripheral nerve, (excludes sacral nerve) Incision for implantation of neurostimulator electrode array; neuromuscular Insertion or replacement of peripheral or gastric neurostimulator pulse generator or receiver, direct or inductive coupling Revision or removal of peripheral or gastric neurostimulator pulse generator or receiver HCPCS ®* Codes C1778 C1816 L8680 L8681 L8682 L8683 L8689 L8695 L8696 Lead, neurostimulator (implantable) Receiver and/or transmitter, neurostimulator (implantable) Implantable neurostimulator electrode, each Patient programmer (external) for use with implantable programmable neurostimulator pulse generator, replacement only Implantable neurostimulator radiofrequency receiver [for phrenic nerve stimulator] Radiofrequency transmitter (external) for use with implantable neurostimulator radiofrequency receiver [for phrenic nerve stimulator] External recharging system for battery (internal) for use with implantable neurostimulator, replacement only External recharging system for battery (external) for use with implantable neurostimulator, replacement only Antenna (external) for use with implantable diaphragmatic/phrenic nerve stimulation device, replacement, each Reviews, Revisions, and Approvals Approved by MPC. No changes. (Original approval date 08/11) Approved by MPC. No changes. Approved by MPC. No changes. Approved by MPC. No changes. Approved by MPC. No changes. Integrated diaphragmatic pacing criteria from CP.MP.107 DME and Legacy WellCare Diaphragmatic Phrenic Nerve Stimulation HS-185 Revision Date 04/16 04/17 03/18 03/19 04/20 11/20 Approval Date 04/16 04/17 03/18 03/19 04/20 12/20 Page 3 of 6 CLINICAL POLICY Diaphragmatic/Phrenic Nerve Stimulation Reviews, Revisions, and Approvals policy. Removed ICD-10-PCS codes and replaced with ICD-10-CM codes. Seperated criteria by FDA approved device. Added medical necessity criteria for amyotrophic lateral sclerosis (ALS), additional verbiage changes made with no clinical significance. Specialist reviewed. Background and references reviewed and updated. Replaced “member” with “member/enrollee” in all instances. Annual review. References reviewed, updated, and reformatted. Changed “review date” in the header to “date of last revision” and “date” in the revision log header to “revision date.” Replaced investigational verbiage with “evidence is limited in supporting safety and efficacy.” Added CPT 64580 and 64590 and HCPCS L8680, L8682, L8683, L8695, and L8696. Updated code G83.89 to G83.9. Annual review. Criteria II.A.1.c. and Criteria II.A.2.b. updated to include “or by other radiographic techniques such as ultrasound” in addition to fluoroscopy. Background updated to include U.S. Food and Drug Administration premarket approval information regarding the Avery Spirit Diaphragm Pacing Transmitter. ICD-10 codes removed. References reviewed and updated. Reviewed by external specialist. Revision Date Approval Date 12/21 12/21 09/22 12/22 12/22