Medical Policy

 

Subject: Diaphragmatic/Phrenic Nerve Stimulation and Diaphragm Pacing Systems
Document #: MED.00100 Publish Date:    02/28/2018
Status: Revised Last Review Date:    01/25/2018

Description/Scope

This document addresses diaphragmatic/phrenic (D/P) nerve stimulation and diaphragm pacing systems with devices that have obtained clearance from the U.S. Food and Drug Administration (FDA), such as the NeuRx DPS RA/4 Respiratory Stimulation System (Synapse Biomedical, Inc., Oberlin, OH), which is an implantable electrical device that stimulates the diaphragm. Diaphragmatic/phrenic nerve stimulator devices and diaphragm pacing systems 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 for at least 4 continuous hours a day. A new diaphragmatic nerve stimulator, the Remedē® System (Respicardia®, Inc., Minneapolis, MN), has been cleared by the FDA for the treatment of moderate to severe central sleep apnea (CSA).

Position Statement

Medically Necessary:

I.  Diaphragmatic/Phrenic Stimulation

Diaphragmatic/phrenic nerve stimulation with an FDA-approved device is considered medically necessary as an alternative to invasive mechanical ventilation for individuals who are 18 years of age or older when ALL of the following criteria are met:

  1. The individual has ventilatory failure from stable, high spinal cord injury or ventilatory failure from central alveolar hypoventilation syndrome; and
  2. The individual cannot breathe spontaneously for 4 continuous hours or more without use of a mechanical ventilator; and
  3. Diaphragm movement with stimulation is visible under fluoroscopy; and
  4. 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 for at least 4 continuous hours a day; and
  5. Individual has normal chest anatomy, a normal level of consciousness, and has the ability to participate in and complete the training and rehabilitation associated with the use of the device; and
  6. Bilateral clinically acceptable phrenic nerve function is demonstrated with electromyography recordings and nerve conduction times.

II.  Diaphragmatic Stimulation

Diaphragm stimulation with an FDA approved diaphragm pacing system is considered medically necessary as an alternative to invasive mechanical ventilation in individuals who are 18 years of age or older when ALL of the following criteria are met:

  1. The individual has ventilatory failure from stable, high spinal cord injury or ventilatory failure from central alveolar hypoventilation syndrome or ventilatory failure from motor neuron disease, for example amyotrophic lateral sclerosis; and
  2. The individual cannot breathe spontaneously for 4 continuous hours or more without use of a mechanical ventilator; and
  3. Diaphragm movement with stimulation is visible under fluoroscopy; and
  4. Stimulation of the diaphragm directly results in sufficient muscle activity to accommodate independent breathing without the support of a ventilator for at least 4 continuous hours a day; and
  5. Individual has normal chest anatomy, a normal level of consciousness, and has the ability to participate in and complete the training and rehabilitation associated with the use of the device.

Not Medically Necessary:

Diaphragmatic/phrenic nerve stimulation devices and Diaphragm Pacing Systems are considered not medically necessary when:

Investigational and Not Medically Necessary:

Diaphragmatic/phrenic nerve stimulation and Diaphragm Pacing Systems are considered investigational and not medically necessary for all other indications including, but not limited to:

Rationale

Diaphragmatic/Phrenic Nerve Stimulators for Ventilator-Dependent Conditions

FDA clearance for distribution of the NeuRx DPS RA/4 Respiratory Stimulation System 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” (FDA, 2008).

The Avery Breathing Pacemaker System (that is, the Mark IV Avery Biomedical Device, Inc., Commack, NY) is the only other diaphragmatic/phrenic stimulator system cleared for use by the FDA in the United States for ventilator-dependent individuals. The pacemaker is classified as a Class III neurologic therapeutic device requiring premarket approval (PMA). 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” (FDA, 2003). Clinical trials that have studied the efficacy of this device have been very limited and included small numbers of subjects.

FDA clearance of the NeuRx device was primarily based on a prospective, nonrandomized, multicenter clinical trial that included 50 subjects throughout the U.S. and Canada (Onders, 2009). In the clinical trial, 98% of subjects with spinal cord injury were able to breathe normally for at least 4 hours following implantation of the device, while 50% have been able to completely eliminate their need for mechanical ventilation. The study inclusion criteria were:

Exclusion criteria were:

The study’s primary endpoint was to assess the ability of the NeuRx device to provide clinically acceptable tidal volume for at least 4 continuous hours of pacing. For a male subject, the tidal volume that is required to meet the basal metabolic requirement (VT-bmr) was defined as 7 ml/kg body weight. For a female subject, the VT-bmr was defined as 6 ml/kg body weight. The safety endpoint was to qualitatively assess the adverse event reports and compare these to a similar population. Secondary endpoints included reduction of dependence on mechanical ventilation and surgical implementation site independence. The study provided an average follow-up of 1.7 ± 1.4 years (median, 1.4; range 0.2-7.7). Overall, a total of 48 out of 50 subjects enrolled have been able to pace for longer than 4 consecutive hours while achieving tidal volumes greater than their basal metabolic requirements. At the end of the study period, 44 subjects were actively using the device. A total of 4 subjects died in the course of the study, and there were 11 incidents of aspiration and 3 incidents of upper airway obstruction that occurred in 3 subjects.

The length of the conditioning phase was variable. It ranged from 1 week for 18-20 year olds on mechanical ventilation for less than 1 year, to 14 weeks for 40-50 year olds on a ventilator for greater than 5 years. Use of the device for periods greater than 4 continuous hours a day occurred after a period of diaphragmatic conditioning that ranged from 1 week to several months. The study investigators concluded that this suggests that the use of the NeuRx DPS RA/4 Respiratory Stimulation System in individuals with high spinal cord injuries and stimulatable diaphragms may allow these subjects to be removed from the ventilator for at least 4 hours a day, provided that a mechanical ventilator is available at all times (as recommended in the labeling).

The most frequent adverse event attributable to this device was capnothorax. The capnothorax occurred as a consequence of the surgical implantation procedure. A total of 42% of the subjects enrolled in the clinical study experienced this complication in association with implantation of the electrodes in the diaphragm. While no subjects experienced compromised pulmonary gas exchange or hemodynamic instability as a result of the capnothorax, affected subjects required treatment with a chest tube, for up to 2 days in 1 individual, and an extended hospital stay of 5 days in 1 person. Synapse Biomedical Inc. has addressed this risk in the labeling and training procedure provided with this device. There have been few additional clinical studies of these devices, most of which were case series of small numbers with short-term outcomes data only.

In 2014, results of a retrospective review were published describing a multicenter, nonrandomized treatment protocol using a D/P system during the initial hospitalization phase following high (cervical) spinal cord injury. A total of 14 inpatient sites in the U.S. were included in this analysis, all of which used the same database for data collection, which included age, sex, mechanism and level of injury, date of injury, date of D/P system surgery, surgical findings, and outcomes. Twenty-nine subjects with an average age of 31.4 years (range, 17-65 years) were identified for this review; however, 7 subjects were subsequently disqualified due to pre-procedural findings from diaphragm motor point mapping that showed non-stimulatable diaphragms from either phrenic nerve damage or infarct. All subjects had experienced a traumatic high spinal cord injury with an elapsed time from injury to surgery of 40 days (range of 3-112 days). The post-procedure outcomes following laparoscopic D/P system implantation showed that 72.7% (16 of 22) were completely free of ventilator support in an average of 10.2 days (mean SE of 10.2 ± 13.1 days [range, 1-45 days]). The remaining 6 subjects who had undergone D/P system implantation experienced delayed weaning of 180 days (in 2 trial participants), and partial weaning was achieved in 3 subjects, reflecting a total success rate of 82%. It was possible to remove the D/P wires from 8 of the 22 implanted subjects due to complete respiratory recovery. The last subject needed transfer to a long-term acute care hospital and subsequently had life-prolonging measures withdrawn. The authors concluded that laparoscopic diaphragm motor point mapping early after traumatic cervical spinal cord injury can assist with diagnosing those with complete phrenic motor neuron loss or phrenic nerve injury for whom D/P system implantation is not indicated. Also, in those with intact phrenic nerve systems following injury, D/P system implantation can successfully wean them from ventilator support, although it is acknowledged that these individuals may have been successfully weaned from ventilator dependence over time during the course of their recovery without the use of DP (Posluszny, 2014).

On September 28, 2011, the FDA issued an approval under an HDE application for use of the NeuRx DPS Diaphragm Pacing System 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 (forced vital capacity) less than 45% predicted. For use only in patients 21 years of age or older.

This approval was based on results of a multicenter, prospective study of the NeuRx Diaphragm Pacing Stimulation (DPS) System of motor-point stimulation for conditioning the diaphragm of subjects with ALS which showed the probable benefit to health from use of the device outweighed the risks of injury or illness from its use (FDA/HDE; SSPB, 2011).

Diaphragmatic/Phrenic Nerve Stimulators for Central Sleep Apnea

Abraham and colleagues (2015) performed an industry-supported, prospective, multicenter, international, nonrandomized feasibility study to evaluate unilateral phrenic nerve stimulation to treat CSA. Eligible subjects (n=57) had apnea-hypopnea index (AHI) values of 20 or higher and at least 50% of their events were CSA as confirmed by polysomnography. The subjects were implanted with the Remedē System and evaluated after 1, 2, 3 and 6 months, with the primary endpoint of the study being AHI reduction by 50% after 3 months. The Remedē System was successfully implanted in 49 out of 57 subjects (86%); however, 10 subjects did not complete the study. A total of 26% of subjects had serious adverse events (AE) that were related to the procedure or the device and included lead repositioning problems, migraine, hematoma and atypical chest pain the first night of therapy. For the 47 subjects that completed 3 months of therapy, there was a mean reduction in AHI of 27.1 ± 17.7 episodes/h (55%, p<0.0001) and a mean reduction in the central apnea index of 23.4 ± 15.3 episodes/h (84%, p<0.0001). After 6 months, subjects reported improvement in sleepiness, and 56% reported a marked or moderate improvement in how they felt since starting the therapy. A total of 36 subjects with heart failure showed an average improvement of 10 points on the Minnesota Living with Heart Failure Questionnaire (95% confidence interval [CI], –16 to –4; p=0.0009) at 6 months. Limitations of the study included a small sample size, lack of a control arm, short follow-up duration, and potential for referral bias. The authors concluded that unilateral phrenic nerve stimulation appears to be safe and effective for CSA, but large, prospective, randomized, controlled trials are needed.

The FDA PMA of the Remedē System was based on an industry-supported, multicenter, prospective, randomized, controlled sham study that aimed to determine the safety and effectiveness for treating CSA (Costanzo, 2016). A total of 151 adult subjects were randomized to receive either medical management and the Remedē System (n=73), or medical management and an inactive sham Remedē System (n=78). The subjects in the study were an average of 65 years old and predominately Caucasian (95%) and male (89%). The primary endpoint was a 50% or greater reduction in AHI from baseline to 6 months, and the AHI was determined using polysomnography. Subjects were evaluated regularly until the end of the trial. After 6 months, the Remedē System was activated in the sham group. Effectiveness was based on modified intention-to-treat (ITT) data at 6 months (n=141). A significantly higher number of subjects in the active Remedē System group had a 50% or better reduction in AHI from baseline to 6 months post-procedure (p<0.0001). The success rate for the active Remedē System group was 51% compared to 11% in the sham group for a total difference of 41% (95% CI, 25% to 54%; p<0.0001). A total of 76% of subjects in the active Remedē System group reported improvement in quality of life. Safety results were based on ITT data for 12 months (n=151). There were 7 deaths but none were found to be related to the device or treatment. The number of subjects free from serious AEs was 91% (95% CI, 86% to 95%); however, 13 subjects had serious AEs including impending pocket erosion, implant site infection, lead dislodgement, concomitant device interaction, elevated transaminase, extra-respiratory stimulation, implant site hematoma, lead component failure, lead displacement, and non-cardiac chest pain. The number of subjects who experienced non-serious AEs was 48%. Implants were unsuccessful in 5 subjects, and the rate of explants was 5.3% (8/151). The authors concluded that transvenous neurostimulation could provide a treatment option for central sleep apnea. Limitations of the study included a low percentage of female subjects, potential referral bias, and a loss to follow-up.

The evidence, to date, is insufficient to demonstrate the safety and efficacy of this new implantable device, with 12 month safety outcomes data available from a single randomized controlled sham study. Large, randomized, controlled studies are needed to assess long-term outcomes.

Background/Overview

The NeuRx DPS RA/4 Respiratory Stimulation System is implanted through minimally invasive laparoscopic surgery and provides electrical stimulation to muscles and nerves that run through the diaphragm. This eliminates any direct contact with the phrenic nerve, allows all circuitry and electronics to remain outside the body, and provides direct, selective activation to each hemidiaphragm. According to manufacturer information, when stimulated by the NeuRx DPS, the diaphragm contracts, mimicking natural breathing and allowing air to fill the upper and lower parts of the lungs, rather than forcing air in with a mechanical ventilator. The device uses four electrodes implanted in the muscle of the diaphragm to electronically stimulate contraction; this stimulation allows the user to inhale. The DPS is lightweight and battery powered, eliminating the need for an external power source. Similar to the NeuRx DPS system, the Mark IV system is connected to the phrenic nerve by electrodes in the neck or chest area. The device consists of a surgically implanted receiver and electrodes which are connected to an external transmitter for transmitting the stimulating pulses across the skin to the implanted receiver.

The Remedē System was approved by the FDA on October 6, 2017 for the treatment of moderate to severe central sleep apnea in adult individuals. The manufacturer describes the device as:

An implantable pacemaker-like device that was designed for improving central sleep apnea (CSA) using Respidrive, a Respiratory Rhythm Management algorithm. The Remedē system delivers electrical pulses via a proprietary, novel transvenous implantable lead to one of the body’s two phrenic nerves. The Remedē system therapy is intended to stimulate the diaphragm to restore a more natural, less disrupted, breathing pattern.

Definitions

Alveolar Hypoventilation Syndrome: Insufficient ventilation leading to an increase in PaCO2 (that is, hypercapnia). Alveolar hypoventilation is caused by several disorders that are collectively referred to as hypoventilation syndromes. The term, central alveolar hypoventilation, is used to describe alveolar hypoventilation secondary to an underlying neurologic disease. Alveolar hypoventilation is a cause of hypoxemia. The presence of hypoxemia, along with hypercapnia, aggravates the clinical manifestations seen with hypoventilation syndromes.

Amyotrophic Lateral Sclerosis (ALS): A form of motor neuron disease that is caused by the progressive degeneration of upper and lower neurons in the spinal cord and brain that results in respiratory compromise and central alveolar hypoventilation syndrome due to muscle weakness and atrophy.

Capnothorax: A respiratory condition related to the implantation of device electrodes whereby air enters the pleural cavity. This condition is caused by the inflation of the abdomen with CO2 during laparoscopic surgical procedures.

Central Sleep Apnea (CSA): A type of sleep apnea that occurs when the brain periodically fails to communicate with the muscles that are necessary for breathing.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

CPT

 

64575

Incision for implantation of neurostimulator electrodes; peripheral nerve (excludes sacral nerve) [when specified as phrenic nerve stimulator]

64590

Insertion or replacement of peripheral or gastric neurostimulator pulse generator or receiver, direct or inductive coupling [when specified as phrenic nerve stimulator]

 

 

HCPCS

 

C1778

Lead, neurostimulator (implantable) [for phrenic nerve stimulator]

C1816

Receiver and/or transmitter, neurostimulator (implantable) [for phrenic nerve stimulator]

L8680

Implantable neurostimulator electrode, each [for phrenic nerve stimulator]

L8682

Implantable neurostimulator radiofrequency receiver [for phrenic nerve stimulator]

L8683

Radiofrequency transmitter (external) for use with implantable neurostimulator radiofrequency receiver [for phrenic nerve stimulator]

 

 

ICD-10 Procedure

 

0BHT0MZ-0BHT4MZ

Insertion of diaphragmatic pacemaker lead into diaphragm [by approach; includes codes 0BHT0MZ, 0BHT3MZ, 0BHT4MZ]

 

 

ICD-10 Diagnosis

 

G12.20-G12.29

Motor neuron disease

G47.35

Congenital central alveolar hypoventilation syndrome

G82.50-G82.54

Quadriplegia

G83.89

Other specified paralytic syndromes [respiratory]

J96.10-J96.12

Chronic respiratory failure

J96.20-J96.22

Acute and chronic respiratory failure

R06.81

Apnea, not elsewhere classified [respiratory muscle paralysis]

Z99.11

Dependence on respirator [ventilator] status

When services are Not Medically Necessary:
For the procedure codes listed above for the situations described in the Position Statement section as not medically necessary.

When services are Investigational and Not Medically Necessary:
For the procedure codes listed above when criteria are not met or for all other indications including the following diagnoses; or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

ICD-10 Diagnosis

 

 

All other diagnoses including the following:

J44.0-J44.9

Chronic obstructive pulmonary disease

R06.6

Hiccough

When services are also Investigational and Not Medically Necessary:

CPT

 

0424T

Insertion or replacement of neurostimulator system for treatment of central sleep apnea; complete system (transvenous placement of right or left stimulation lead, sensing lead, implantable pulse generator)

0425T

Insertion or replacement of neurostimulator system for treatment of central sleep apnea; sensing lead only

0426T

Insertion or replacement of neurostimulator system for treatment of central sleep apnea; stimulation lead only

0427T

Insertion or replacement of neurostimulator system for treatment of central sleep apnea; pulse generator only

0428T

Removal of neurostimulator system for treatment of central sleep apnea; pulse generator only

0429T

Removal of neurostimulator system for treatment of central sleep apnea; sensing lead only

0430T

Removal of neurostimulator system for treatment of central sleep apnea; stimulation lead only

0431T

Removal and replacement of neurostimulator system for treatment of central sleep apnea, pulse generator only

0432T

Repositioning of neurostimulator system for treatment of central sleep apnea; stimulation lead only

0433T

Repositioning of neurostimulator system for treatment of central sleep apnea; sensing lead only

0434T

Interrogation device evaluation implanted neurostimulator pulse generator system for central sleep apnea

0435T

Programming device evaluation of implanted neurostimulator pulse generator system for central sleep apnea; single session

0436T

Programming device evaluation of implanted neurostimulator pulse generator system for central sleep apnea; during sleep study

 

 

ICD-10 Diagnosis

 

 

All diagnoses

References

Peer Reviewed Publications:

  1. Abraham WT, Jagielski D, Oldenburg O, et al. Phrenic nerve stimulation for the treatment of central sleep apnea. JACC Heart Fail. 2015; 3(5):360-369.
  2. Ali A, Flageole H. Diaphragmatic pacing for the treatment of congenital central alveolar hypoventilation syndrome. J Pediatr Surg. 2008; 43(5):792-796.
  3. Alshekhlee A, Onders RP, Syed TU, et al. Phrenic nerve conduction studies in spinal cord injury: applications for diaphragmatic pacing. Muscle Nerve. 2008; 38(6):1546-1552.
  4. Costanzo MR, Ponikowski P, Javaheri S, et al. Transvenous neurostimulation for central sleep apnoea: a randomised controlled trial. Lancet. 2016; 388(10048):974-982.
  5. DiMarco AF, Onders RP, Ignagni A, et al. Phrenic nerve pacing via intramuscular diaphragm electrodes in tetraplegic subjects. Chest. 2005; 127(2):671-678.
  6. Elefteriades JA, Quin JA, Hogan JF, et al. Long-term follow-up of pacing of the conditioned diaphragm in quadriplegia. Pacing Clin Electrophysiol. 2002; 25(6):897-906.
  7. Garrido-Garcia H, Mazaira Alvarez J, Martin Escribano P, et al. Treatment of chronic ventilatory failure using a diaphragmatic pacemaker. Spinal Cord. 1998; 36(5):310-314.
  8. Gonzalez-Bermejo J, Morélot-Panzini C, Salachas F, et al. Diaphragm pacing improves sleep in patients with amyotrophic lateral sclerosis. Amyotroph Lateral Scler. 2012; 13(1):44-54.
  9. Hirschfeld S, Exner G, Luukkaala T, Baer GA. Mechanical ventilation or phrenic nerve stimulation for treatment of spinal cord injury-induced respiratory insufficiency. Spinal Cord. 2008; 46(11):738-742.
  10. Krieger LM, Krieger AJ. The intercostal to phrenic nerve transfer: an effective means of reanimating the diaphragm in patients with high cervical spine injury. Plastic and Recon Surg. 2000; 105(4):1255-1261.
  11. Mahajan KR, Bach JR, Saporito L, Perez N. Diaphragm pacing and noninvasive respiratory management of amyotrophic lateral sclerosis/motor neuron disease. Muscle Nerve. 2012; 46(6):851-855.
  12. Onders RP, Elmo MJ, Ignagni AR. Diaphragm pacing stimulation system for tetraplegia in individuals injured during childhood or adolescence. J Spinal Cord Med. 2007; 30 Suppl 1:S25-S29.
  13. Onders RP, Elmo M, Khansarinia S, et al. Complete worldwide operative experience in laparoscopic diaphragm pacing: results and difference in spinal cord injured patients and amyotrophic lateral sclerosis patients. Surg Endosc. 2009; 23(7):1433-1440.
  14. Onders RP, Khansarinia S, Weiser T, et al. Multicenter analysis of diaphragm pacing in tetraplegics with cardiac pacemakers: positive implications for ventilator weaning in intensive care units. Surgery. 2010; 148(4):893-897; discussion 897-898.
  15. Onders RP, Ponsky TA, Elmo M, et al. First reported experience with intramuscular diaphragm pacing in replacing positive pressure mechanical ventilators in children. J Pediatr Surg. 2011; 46(1):72-76.
  16. Posluszny JA Jr, Onders R, Kerwin AJ, et al. Multicenter review of diaphragm pacing in spinal cord injury: successful not only in weaning from ventilators but also in bridging to independent respiration. J Trauma Acute Care Surg. 2014; 76(2):303-309.
  17. Romero FJ, Gambarrutta C, Garcia-Forcada A, et al. Long-term evaluation of phrenic nerve pacing for respiratory failure due to high cervical spinal cord injury. Spinal Cord. 2012; 50(12):895-898.
  18. Shaul DB, Danielson PD, McComb JG, Keens TG. Thorascopic placement of phrenic nerve electrodes for diaphragmatic pacing in children. J Pediatr Surg. 2002; 37(7):974-978.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. American Thoracic Society (ATS) Clinical Policy Statement: Congenital central hypoventilation syndrome: genetic basis, diagnosis and management. September 2009. Available at: http://www.thoracic.org/statements/resources/pldd/congenital-central-hypoventilation-syndrome.pdf. Accessed on November 29, 2017.
  2. Centers for Medicare and Medicaid Services. National Coverage Determination for Phrenic Nerve Stimulators. NCD 160.19. Longstanding coverage determination; Effective date not posted. Available at: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=244&ncdver=1&bc=AAAAQAAAAAAA&. Accessed on November 29, 2017.
  3. Miller RG, Jackson CE, Kasarskis EJ, et al. Practice parameter update: The care of the patient with amyotrophic lateral sclerosis: drug, nutritional, and respiratory therapies (an evidence-based review). Report of the Quality Standards Subcommittee of the American Academy of Neurology (AAN). Neurology. 2009; 73(15):1218-1226.
  4. U.S. Food and Drug Administration (FDA). Part 882 Neurological devices. Sec. 882.5830. Implanted diaphragmatic/phrenic nerve stimulator. April 8, 1986. Revised April 1, 2017. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=882.5830. Accessed on November 29, 2017.
  5. U.S. Food and Drug Administration. Humanitarian Device Exemption Database. NeuRx DPS RA/4 Respiratory Stimulation System (Synapse Biomedical, Inc., Oberlin, OH). Summary of Safety and Probable Benefit. No. H070003. Rockville, MD: FDA. June 17, 2008. Available at: https://www.accessdata.fda.gov/‌scripts/cdrh/cfdocs/cfhde/hde.cfm?id=375540. Accessed on November 29, 2017.
  6. U.S. Food and Drug Administration (FDA). Humanitarian Device Exemption Database. NeuRx DPS Diaphragm Pacing System (Synapse Biomedical, Inc., Oberlin, OH). Summary of Safety and Probable Benefit. No. H100006. Rockville, MD: FDA. September 28, 2011. Available at: https://www.accessdata.fda.gov/‌scripts/cdrh/cfdocs/cfhde/hde.cfm?id=375558. Accessed on November 29, 2017.
  7. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH) Premarket Approvals for the Avery Breathing Pacemaker System Mark IV (Avery Biomedical Device, Inc., Commack, NY). Summary of Safety and Effectiveness. No. P860026. Rockville, MD: FDA. February 25, 1987; updated 2003. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma_template.cfm?id=p860026.   Accessed on November 29, 2017.
  8. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Premarket Notification Database. Remedē System (Respicardia, Inc., Minnetonka, MN). Summary of Safety and Effectiveness. No. P160039. Rockville, MD: FDA. October 6, 2017. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160039b.pdf. Accessed on November 29, 2017.
Websites for Additional Information
  1. National Institute of Neurological Disorders and Stroke. National Institute of Health (NIH). Amyotrophic Lateral Sclerosis (ALS) Fact Sheet. Last updated November 3, 2015. Available at: http://www.ninds.nih.gov/disorders/amyotrophiclateralsclerosis/detail_ALS.htm. Accessed on November 29 2017.
Index

Avery Mark IV Breathing Pacemaker System
Diaphragmatic Pacing
Electrophrenic Nerve Stimulator
NeuRx DPS
Remedē System
Respidrive, Respiratory Rhythm Management

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Document History

Status

Date

Action

Revised

01/25/2018

Medical Policy & Technology Assessment Committee (MPTAC) review. The document header wording updated from “Current Effective Date” to “Publish Date.” Added CSA to INV/NMN statement. Updated Description/Scope, Rationale, Background, Definitions and References sections.

 

10/01/2017

Updated Coding section with 10/01/2017 ICD-10-PCS procedure code changes; removed 0BHR0MZ, 0BHR3MZ, 0BHR4MZ, 0BHS0MZ, 0BHS3MZ, 0BHS4MZ deleted 09/30/17.

Revised

02/02/2016

MPTAC review. Minor typographical revisions made in the Position Statement section. Updated the References section.

Reviewed

02/04/2016

MPTAC review. References and Background sections were updated.

 

01/01/2016

Updated Coding section with 01/01/2016 CPT changes; removed ICD-9 codes.

Revised

02/05/2015

MPTAC review. The language of the medically necessary criteria for both DP stimulation devices and Diaphragm Pacing systems was clarified regarding the inability to breathe spontaneously for 4 consecutive hours or more per day without use of a mechanical ventilator. The Rationale and References sections were updated.

Reviewed

02/13/2014

MPTAC review. References were updated.

Revised

02/14/2013

MPTAC review. The title has been changed from: Diaphragmatic/Phrenic Nerve Stimulation to:  Diaphragmatic/Phrenic Nerve Stimulation and Diaphragm Pacing Systems. The medically necessary criteria have been reformatted for clarification with no change to the criteria. References and Coding sections were updated.

Revised

02/16/2012

MPTAC review. The position statements were expanded to add motor neuron disease, such as ALS, as medically necessary when criteria are met. The Rationale, Definitions, Coding and References were updated.

Reviewed

02/17/2011

MPTAC review. References were updated.

Reviewed

02/25/2010

MPTAC review. References and Coding were updated.

Revised

02/26/2009

MPTAC review. A position statement has been added to indicate that use of these devices for individuals with motor neuron diseases, such as amyotrophic lateral sclerosis (ALS), is considered not medically necessary. Updated Coding section.

New

11/20/2008

MPTAC review. Initial document development.

Pre-Merger Organizations

Last Review Date

Document Number

Title

Anthem, Inc.

 

 

No document

WellPoint, Inc.

07/14/2005

2.05.01

Electrophrenic Pacemaker