BlueCross and BlueShield of Montana Medical Policy/Codes
Phrenic Nerve Implant (Stimulator)
Chapter: Medicine: Treatments
Current Effective Date: September 24, 2013
Original Effective Date: September 24, 2013
Publish Date: June 24, 2013
Description

Hypoventilation is a state in which an abnormally low amount of air enters the lungs during respiration.  A phrenic nerve implant (stimulator) is an implanted device that provides electrical stimulation to the patient’s phrenic nerve to contract the diaphragm rhythmically and produce breathing in patients who have hypoventilation.  This device has been used successfully to treat hypoventilation caused by a variety of conditions, including respiratory paralysis resulting from lesions of the brain stem and cervical spinal cord and chronic pulmonary disease with ventilatory insufficiency.  The phrenic nerve stimulator is intended to be an alternative to management of patients with respiratory insufficiency who are dependent upon the usual therapy of intermittent or permanent use of a mechanical ventilator.  The integrity of the diaphragm and the phrenic nerves is required to provide adequate ventilation by electrical pulsing or stimulation.

Phrenic nerve implantation or stimulation is also known as:

  • Electrophrenic Respiration (REP)
  • Transvenous Electrophrenic Respiration (EPR) 
  • Electrophrenic Nerve Pacing (EPP)
  • Electrophrenic Pacemaker
  • Functional Electrical Stimulation (FES) of Phrenic Nerve
Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply.  If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Medically Necessary

BCBSMT may consider a phrenic nerve implant (stimulator) medically necessary for any of the following:

  • Respiratory paralysis resulting from lesions or injury to the brain stem and cervical spinal cord (C-3 or higher), such as quadriplegia or sleep apnea syndrome with central apnea;
  • Central alveolar hypoventilation syndrome;
  • Chronic pulmonary disease with ventilatory insufficiency.

NOTE:  Documentation must be submitted demonstrating that preoperative screening indicates the phrenic nerves, lungs, and diaphragm can sustain ventilation via electrical stimulation.

Not Medically Necessary

BCBSMT considers phrenic nerve implantation or stimulation not medically necessary:

  • When the patient can subsist independently of a mechanical respirator;
  • For temporary respiratory insufficiency;
  • If the patient has a nerve conduction disorder, e.g., tumor, vascular disease, diabetes mellitus, or multiple sclerosis;
  • If preoperative screening tests fail to demonstrate that the phrenic nerves, lungs, and/or diaphragm can sustain ventilation by electrical stimulation.

Investigational

BCBSMT considers phrenic nerve implantation or stimulation for treatment of hiccups experimental, investigational, and unproven.

Federal Mandate 

Federal mandate prohibits denial of any drug, device or biological product fully approved by the FDA as investigational for the Federal Employee Program (FEP). In these instances coverage of these FDA-approved technologies are reviewed on the basis of medical necessity alone.

Rationale

Since 1972, phrenic nerve stimulation has been an option for assisting the ventilation of patients with chronic paralytic respiratory insufficiency.  Garrido-Garcia, et al. conducted a study of patients with chronic ventilatory failure who were treated with phrenic nerve stimulation; they concluded that complete stable ventilation can be achieved using diaphragmatic pacing, and that it improves the prognosis and life quality of these patients.  Girsch, et al. conducted a similar study on children who had either central alveolar hypoventilation or total ventilatory insufficiency due to high cervical cord or brain stem lesion(s); they also concluded that, when chosen for the correct indications, phrenic nerve stimulation can increase the quality of life and should be preferred to positive pressure mechanical ventilation.

Implantation of a phrenic nerve stimulator is not without risks and adverse effects, and therefore should not be used for patients who can subsist independently of a mechanical respirator or who have temporary respiratory insufficiency. 

A search of peer-reviewed literature failed to reveal studies to support phrenic nerve stimulation as treatment of hiccups.

A literature search of online database and Medline database was performed through August 2008. No articles were identified that would change the coverage position of this medical policy.

Coding

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

ICD-9 Codes

34.85, 344.01, 344.02, 348.8

Procedural Codes: 64555, 64575, 64585, 64590, 64595, 95970, 95971, 95972, 95973
References
  1. Electrophrenic Pacemaker.  Chicago, Illinois: Blue Cross Blue Shield Association – Technology Evaluation Center Assessment Program (1989 November) 39599.0-39599.1.
  2. Talonen, P.P., Baer, G.A., et al.  Neurophysiological and technical considerations for the design of an implantable phrenic nerve stimulator.  Medical and Biological Engineering and Computing (1990 January) 28(1): 31-37.
  3. Bach, J.R. and K. O’Connor.  Electrophrenic Ventilation: a different perspective.  Journal of the American Paraplegia Society (1991 January) 14(1): 9-17.
  4. Brule, J.F., Leriche, B., et al.  Patients with high spinal cord injuries: evaluation of diaphragmatic function, indication of electrophrenic ventilation.  Agressologie (1993) 34 (Spec No 2): 90-92.
  5. Krieger, A.J., Gropper, M.R., et al.  Electrophrenic respiration after intercostal to phrenic nerve anastomosis in a patient with anterior spinal artery syndrome: technical case report.  Neurosurgery (1994 October) 35(4): 760-764.
  6. Staton, G., and R. Ingram.  Disorders of the Chest Wall.  Scientific American, Inc.   (1994 January) 1 - 12.
  7. Fritz, U., Braunn, U., et al.  Implantation of a phrenic stimulator in central respiratory paralysis.  Anesthetist (1995 December) 44(12): 880 - 883.
  8. Girsch, W., Koller, R., et al.  Vienna phrenic pacemaker—experience with diaphragm pacing in children.  European Journal of Pediatric Surgery (1996 June) 6(3):140-3.
  9. Garrido-Garcia, H., Mazaira Alvarez, J., et al.  Spinal Cord (1998 May) 36(5):310-4.
  10. Centers for Medicare and Medicaid Services – Phrenic Nerve Stimulator. Pub. No. 100-3, Manual Section No. 160.19.  Long-standing NCD, effective date not posted. http://www.cms.hhs.gov (Accessed April 26, 2006)
  11. Electrophrenic Pacemaker.  Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2005 January) Surgery 7.01.37.
History
June 2013  new 2013 BCBSMT medical policy.
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Phrenic Nerve Implant (Stimulator)