Medical Policy



Subject: Diaphragmatic/Phrenic Nerve Stimulation and Diaphragm Pacing Systems
Document #: MED.00100 Current Effective Date:    10/01/2017
Status: Revised Last Review Date:    02/02/2017

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.

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

U.S. Food and Drug Administration (FDA) clearance 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" (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. 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 individuals 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, a total of 44 subjects were actively using the device. Four 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 multi-center, 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 multi-center 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).  

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.  

A new device that is currently conducting its initial Phase II trial, in an effort to seek FDA clearance to market in the U.S. is the Remedē® System (Respircardia® , Inc., Minneapolis, MN) which, according to the manufacturer:

Is 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. 

The manufacturer sponsored, Phase II trial entitled, the Respicardia, Inc. Pivotal Trial of the Remedē System, has an estimated completion date of December 2017. At present, this device and its phrenic nerve stimulation technology has not been cleared to market in the U.S. by the FDA.

Definitions

Alveolar Hypoventilation Syndrome: Is defined as 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.

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. Ali A, Flageole H. Diaphragmatic pacing for the treatment of congenital central alveolar hypoventilation syndrome. J Pediatr Surg. 2008; 43(5):792-796.
  2. 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.
  3. DiMarco AF, Onders RP, Ignagni A, et al. Phrenic nerve pacing via intramuscular diaphragm electrodes in tetraplegic subjects. Chest. 2005; 127(2):671-678.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  10. 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.
  11. 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.
  12. 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.
  13. 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.
  14. 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.
  15. 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.
  16. 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 3, 2016.
  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 3, 2016.
  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. Respicardia, Inc. Pivotal Trial of the Remedē System. NLM Identifier: NCT01816776. Last updated September 9, 2015. Available at: https://clinicaltrials.gov/show/NCT01816776 . Accessed on November3, 2016.
  5. 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, 2012. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=882.5830. Accessed on November 3, 2016.
  6. U.S. Food and Drug Administration. Center for Devices and Radiological Health (CDRH) 510(k) Premarket Notification Database. NeuRx DPS RA/4 Respiratory Stimulation System (Synapse Biomedical, Inc., Oberlin, OH). Summary of Safety and Effectiveness. No. H070003. Rockville, MD: FDA. June 17, 2008. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=H070003. Accessed on November 3, 2016.
  7. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Premarket Notification Database.  NeuRx DPS Diaphragm Pacing System (Synapse Biomedical, Inc., Oberlin, OH).  Summary of Safety and Effectiveness. No. H100006. Rockville, MD: FDA. September 28, 2011. Available at:  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=H100006. Accessed on November 3, 2016.
  8. 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 3, 2016.
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 3 2016.
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
  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 Medical Policy & Technology Assessment Committee (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