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Date Printed: June 26, 2017: 11:40 AM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. 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.

02-61000-33

Original Effective Date: 06/15/04

Reviewed: 01/24/13

Revised: 01/20/17

Subject: Diaphragmatic-Phrenic Nerve Stimulation (i.e., Electrophrenic Pacemaker)

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates    
           

DESCRIPTION:

Electrophrenic pacing, also known as diaphragmatic/phrenic nerve stimulation or breathing pacemaker, is intended as an alternative to mechanical ventilation in selected individuals with ventilatory insufficiency (or failure) who have retained adequate function in their phrenic nerves and diaphragm. The D/P nerve stimulator is an implanted device that acts as a pacemaker by providing regular electrical pulses to stimulate the phrenic nerves. Stimulation of the nerves then causes the diaphragm to contract, which produces negative pressure in the chest, allowing air to enter the lungs. The equipment needed to receive D/P nerve stimulation treatment is small enough to be worn in a pocketed belt or vest, and allows considerable freedom for individuals who may be ambulatory or confined to a wheelchair. The stimulator consists of an externally worn transmitter and implanted receiver with electrodes. The receiver and electrodes for these devices may be placed either by open thoracotomy or laparoscopically.

Electrophrenic pacemakers are contraindicated in the following situations:

POSITION STATEMENT:

The use of an electrophrenic pacemaker meets the definition of medical necessity for individuals with permanent, severe hypoventilation related to one of the following conditions:

Electrophrenic pacemakers meet the definition of medical necessity when used as an alternative to invasive mechanical ventilation in individuals with motor neuron disease, for example amyotrophic lateral sclerosis (ALS), when ALL of the following criteria are met:

The use of electrophrenic pacemakers does not meet the definition of medical necessity when:

The use of an electrophrenic pacemaker is considered experimental or investigational, as there is insufficient clinical evidence to support the effectiveness of this therapy for all other applications, and specifically for the following:

BILLING/CODING INFORMATION:

There is no specific code describing electrophrenic pacemaker devices.

The following CPT codes are commonly used for implantation and revision or removal of these devices:

CPT Coding

64585

Revision or removal of peripheral neurostimulator electrode array

64590

Incision or replacement of peripheral or gastric neurostimulator pulse generator or receiver, direct or inductive coupling

64595

Revision or removal of peripheral or gastric neurostimulator pulse generator or receiver

HCPCS Coding

L8696

Antenna (external) for use with implantable diaphragmatic/phrenic nerve stimulation device, replacement, each

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

The following National Coverage Determination (NCD) was reviewed on the last guideline reviewed date: Phrenic Nerve Stimulator, (160.19) located at cms.gov.

DEFINITIONS:

Alveolar ventilation: the volume of gas (air) expired from the alveoli to the outside of the body per minute.

Amyotrophic lateral sclerosis (ALS): a debilitating disease with varied etiology characterized by rapidly progressive weakness, muscle atrophy, muscle spasticity, difficulty speaking (dysarthria), difficulty swallowing (dysphagia), and difficulty breathing (dyspnea); also known as Lou Gehrig’s disease.

Diaphragm: the thin muscle below the lungs and heart that separates the chest from the abdomen.

Hypoventilation: a state in which an abnormally low amount of air enters the lungs.

Phrenic nerve: is mainly the motor nerve of the diaphragm.

Quadriplegia: paralysis of all four limbs (i.e., arms, legs).

RELATED GUIDELINES:

Percutaneous Electric Nerve Stimulation (PENS), 02-61000-03

OTHER:

Other terms for describing these devices:

Diaphragm pacer
Electrophrenic pacemaker
Phrenic nerve pacer
Phrenic nerve stimulator

REFERENCES:

  1. American Thoracic Society/European Respiratory Society. ATS/ERS Statement on Respiratory Muscle Testing. Am J Respir Crit Care Med; Vol 166, pp 518-624, (2002).
  2. Avery Laboratories Inc., Commack NY website, (accessed 06/01/06).
  3. Blue Cross Blue Shield Association Medical Policy 7.01.37, Electrophrenic Pacemaker, (03/07/06).
  4. Centers for Medicare and Medicaid Services (CMS); National Coverage Determination (NCD), Publication 100-3, Section 160.19, (accessed at CMS website 05/12/09).
  5. Clinical Trials.gov. Humanitarian Device Exemption (HDE) Post-Approval Study (PAS) of NeuRx Diaphragm Pacing System (DPS) for Amyotrophic Lateral Sclerosis (ALS). NCT01605006. Accessed 12/20/12.
  6. Clinical Trials.gov. Motor-Point Stimulation for Conditioning the Diaphragm of Patients with Amyotrophic Lateral Sclerosis (ALS). NCT00420719. Accessed 12/20/12.
  7. DiMarco AF, Onders, RP, Kowalski, KE, et al: Dept. of Physiology, Case Western Reserve University and MetroHealth Medical Center, Cleveland Ohio. “Phrenic nerve pacing in a tetraplegic patient via intramuscular diaphragm electrodes”. Am J Respir Crit Care Med 2002 Dec 15; 166(12 Pt 1): 1604-6.
  8. HAYES Medical Technology Directory, “Diaphragmatic/Phrenic Nerve Stimulation” (DIAP0202.02), (12/03; updated 12/18/07).
  9. Miller RG, Jackson CE, Kasarskis EJ, England JD, Forshew D, Johnston W, Kalra S, Katz JS, Mitsumoto H, Rosenfeld J, Shoesmith C, Strong MJ, Woolley SC, Quality Standards Subcommittee of the American Academy of Neurology. 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. Neurology 2009 Oct 13;73(15):1218-26.
  10. National Guideline Clearinghouse. 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 (2009).
  11. Onders RP, Aiyar H, Mortimer JT. “Characterization of the human diaphragm muscle with respect to the phrenic nerve motor points for diaphragmatic pacing”. Am Surg. 2004 Mar; 70(3): 241-7.
  12. Onders RP, Aiyar H, Mortimer JT: Dept. of Surg, University Hospitals of Cleveland and Case Western Reserve University Ohio. “Characterization of the human diaphragm muscle with respect to the phrenic nerve motor points for diaphragmatic pacing”. Am Surg. 2004 Mar; 70(3): 241-7.
  13. Shaul DB, Danielson, PD, McComb JG, Keens TG: Dept of Surgery, Childrens Hospital Los Angeles and Keck School of Medicine, University of Southern CA, Los Angeles CA. “Thoracoscopic placement of phrenic nerve electrodes for diaphragmatic pacing in children”. J Pediatr Surg. 2002 Jul; 37(7): 974-8.
  14. St. Anthony’s ICD-9 Code Book, (current edition).
  15. Stedman’s Concise Medical Dictionary, (4th edition).
  16. U.S. Food and Drug Administration (FDA). Title 21 – Food and Drugs, Chapter 1 – Food and Drug Administration Department of Health and Human Services, Subchapter H – Medical Devices, Part 882 – Neurological Devices. Accessed 0610/08.
  17. U.S. Food and Drug Administration (FDA) NeuRx DPS™ RA/4 Respiratory Stimulation System; Humanitarian Device Exemption (HDE) approval, September 2011.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Practice & Coverage Committee on 01/24/13.

GUIDELINE UPDATE INFORMATION:

06/15/04

New Medical Coverage Guideline.

06/15/05

Scheduled review; no change in coverage statement.

07/15/06

Scheduled review: no change in coverage statement; added coding information.

07/15/07

Scheduled review; reformatted guideline; updated references.

07/15/08

Reviewed; position statement revised to include indications not considered medically necessary; updated references.

06/15/09

Scheduled review; no change in position statement; references updated.

10/01/09

HCPCS 4th quarter update; deleted ICD-9 diagnosis code 348.8 was removed from the guideline.

01/01/11

Revision; related ICD-10 codes added.

01/01/12

Annual HCPCS coding update: removed 64577.

02/15/13

Revision of position statement regarding covered indications; references updated.

05/11/14

Revision: Program Exceptions section updated.

01/01/15

Annual coding update: added L8696

11/01/15

Revision: ICD-9 Codes deleted.

10/01/16

Revision; billing/coding information section updated.

01/20/17

Revised 64585, 64590 and 64595 code descriptor.

Date Printed: June 26, 2017: 11:40 AM