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«PacifiCare’s medical management guidelines represent the recommendation of the PacifiCare Medical Management Guideline (MMG) committee. They are ...»

-- [ Page 96 ] --

Daly JJ, Roenigk K, Holcomb J, et al. A randomized controlled trial of functional neuromuscular stimulation in chronic stroke subjects. Stroke. 2006 Jan;37(1):172-8.

Farr J, Mont MA, Garland D, et al. Pulsed electrical stimulation in patients with osteoarthritis of the knee: follow up in 288 patients who had failed non-operative therapy. Surg Technol Int. 2006;15:227-33.

Fitzgerald GK, Piva SR, Irrgang JJ. A modified neuromuscular electrical stimulation protocol for quadriceps strength training following anterior cruciate ligament reconstruction. J Orthop Sports Phys Ther. 2003 Sep;33(9):492-501.

Hayes, Inc. Medical Technology Directory. Functional Electrical Stimulation for Rehabilitation of Paralyzed Lower Limbs. Lansdale, PA: Hayes, Inc.; May 2003. Updated March 24, 2008.

Hayes, Inc. Medical Technology Directory. Neuromuscular Electrical Stimulation for Muscle Rehabilitation. Lansdale, PA: Hayes, Inc.; January 3, 2008. Updated January 3, 2009.

Klose KJ, Jacobs PL, Broton JG, et al. Evaluation of a training program for persons with SCI paraplegia using the Parastep 1 ambulation system: part 1. Ambulation performance and anthropometric measures. Arch Phys Med Rehabil.

1997;78:789-793.

Mont MA, Hungerford DS, Caldwell JR, et al. Pulsed electrical stimulation to defer TKA in patients with knee osteoarthritis. Orthopedics 2006;29(10):887-92.

Needham-Shropshire BM, Broton JG, Klose KJ, et al. Evaluation of a training program for persons with SCI paraplegia using the Parastep 1 ambulation system: part 3. Lack of effect on bone mineral density. Arch Phys Med Rehabil.

1997;78:799-803.

Ring H, Rosenthal N. Controlled study of neuroprosthetic functional electrical stimulation in sub-acute post-stroke rehabilitation. J Rehabil Med. 2005 Jan;37(1):32-6.

Wieler M, Stein RB, Ladouceur M, et al. Multicenter evaluation of electrical stimulation systems for walking. Arch Phys Med Rehabil. 1999;80:495-500.

Zizic TM, Hoffman KC, Holt PA, et al. The treatment of osteoarthritis of the knee with pulsed electrical stimulation. J Rheumatol. 1995;22(9):1757-1761.

History/Updates Electrical Stimulation for the Treatment of Pain and Muscle Rehabilitation - Commercial Medical Management Guideline

–  –  –

Contact Information For questions regarding this policy, send an email to the Medical Technology Interpretation Service at medical_drug_interpretation@uhc.com with the word "Medical" in the subject line.

Coding The Current Procedural Terminology (CPT) codes and HCPCS codes listed in this policy are for reference purposes only.

Listing of a service code in this policy does not imply that the service described by this code is a covered or non-covered health service. Coverage is determined by the benefit document.

HCPCS Codes:

E0745 Neuromuscular stimulator, electronic shock unit E0762 Transcutaneous electrical joint stimulation device system, includes all accessories E0764 Functional neuromuscular stimulation, transcutaneous stimulation of sequential muscle groups of ambulation Electrical Stimulation for the Treatment of Pain and Muscle Rehabilitation - Commercial Medical Management Guideline with computer control, used for walking by spinal cord injured, entire system, after completion of training program E0770 Functional electrical stimulator, transcutaneous stimulation of nerve and/or muscle groups, any type, complete system, not otherwise specified Coding Clarification Transcutaneous electrical joint stimulation devices (E0762) are noninvasive devices that deliver low-amplitude pulsed electrical stimulation.

This information is being distributed to you for personal reference. The information belongs to UnitedHealthcare and unauthorized copying, use and distribution are prohibited. This information is intended to serve only as a general reference resource regarding our Medical Policies and is not intended to address every aspect of a clinical situation.

Physicians and patients should not rely on these Medical Policies in making health care decisions. Physicians and patients must exercise their independent clinical discretion and judgment in determining care. The enrollee's specific benefit documents supercede these policies and are used to make coverage determinations. These Medical Policies are believed to be current as of the date noted.

Confidential and Proprietary, © UnitedHealthcare, Inc. 2009 Electrical Stimulation for the Treatment of Pain and Muscle Rehabilitation - Commercial Medical Management Guideline TITLE: Endoscopic Therapies For Gastroesophageal Reflux Disease (GERD) Authorized By: Medical Management Guideline Committee

Adoption Date: 09/16/09 Revision Date:

Disclaimer This medical management guideline represents the recommendation of the PacifiCare Medical Management Guideline (MMG) committee. It is based on the MMG committee's review of the available evidence as of the date of this medical management guideline.

This medical management guideline contains clinical practice and utilization criteria to assist professionals in PacifiCare’s medical management practice when making medical necessity determinations prior to, subsequent to, or concurrent with the provisions of health care services. This medical management guideline is intended to support consistent, appropriate medical necessity determinations, but it does not replace an individualized case-by-case review and medical necessity determination for each PacifiCare member.





Member benefit coverage and limitations may vary based on the member’s benefit plan.

This information is being distributed to you for personal reference. The information belongs to UnitedHealthcare and unauthorized copying, use and distribution are prohibited. This information is intended to serve only as a general reference resource regarding our Medical Policies and is not intended to address every aspect of a clinical situation. Physicians and patients should not rely on these Medical Policies in making health care decisions. Physicians and patients must exercise their independent clinical discretion and judgment in determining care. The enrollee's specific benefit documents supercede these policies and are used to make coverage determinations. These Medical Policies are believed to be current as of the date noted.

–  –  –

Description After evaluating relevant benefit document language (exclusions or limitations), refer to Coverage sections of this document to determine coverage.

This policy describes the use of minimally invasive, endoscopic treatments for patients with gastroesophageal reflux disease (GERD).

Endoscopic Therapies For Gastroesophageal Reflux Disease (GERD) - Commercial Medical Management Guideline Coverage All reviewers must first identify member eligibility, any federal or state regulatory requirements and the plan benefit coverage prior to use of this policy.

Coverage Rationale Endoscopic therapies for gastroesophageal reflux disease (GERD) are unproven.

Endoscopic therapies include:

1. Radiofrequency energy

• Stretta System

2. Endoscopic or plication suturing

• Bard EndoCinch Endoscopic Suturing System

• Endoscopic Suturing Device (ESD)

• Surgical Endoscopic Plication System (EPS)

3. Injection or implantation techniques

• Gatekeeper Reflux Repair System

• Plexiglas (polymethylmethacrylate [PMMA]) procedure There is insufficient evidence to conclude that endoscopic therapies for the treatment of GERD provide clinical benefits.

While some data suggest that some endoscopic therapies have acceptable safety profiles and may relieve symptoms, improve quality of life (QOL), and reduce antisecretory medication use in some patients with GERD, this evidence comes primarily from studies of small to moderate size that lack adequate control or comparison groups and provide only shortterm follow-up.

Specific manipulation of the endoscopic devices is a skill requiring extensive training and experience. Performance of these procedures requires a surgeon with the training and experience in endoscopic procedures, laparoscopic and/or open fundoplication, and the particular endoscopic system in use.

Regulatory Requirements U.S. Food and Drug Administration (FDA): Three endoscopic antireflux (endoluminal) procedures have received approval by the FDA for treatment of gastroesophageal reflux disease (GERD). Three, the Stretta System (Curon Medical Inc, Fremont, CA, formerly Conway Stuart Medical Inc, Sunnyvale, CA), the Bard EndoCinch Endoscopic Suturing System (Bard Endoscopic Technologies, Billerica, MA, a subsidiary of C.R. Bard Inc, Murray Hill, NJ), and the NDO Surgical Endoscopic Plication System (EPS; NDO Surgical Inc, Mansfield, MA) have been approved through the 510(k) (premarket notification) mechanism. Stretta was approved in April 2000 for radiofrequency thermal ablation treatment of GERD. Additional information available at: http://www.fda.gov/cdrh/pdf/k000245.pdf. Accessed January 2009.

Bard EndoCinch was approved in January 2001 for endoscopic suturing in the treatment of GERD. Additional information available at: http://www.fda.gov/cdrh/pdf/k003956.pdf. Accessed January 2009.

The plication system was approved in April 2003 for endoscopic suturing in the treatment of GERD in patients who

require and respond to pharmacological therapy. Additional information available at:

http://www.fda.gov/cdrh/pdf7/K072125.pdf. Accessed January 2009.

All three products are Class II devices (moderate risk) deemed substantially equivalent to other endoscopic devices utilizing other procedures.

Enteryx, initially approved in April 2003, was voluntarily withdrawn from the market on September 22, 2005. Gatekeeper, which was expected to gain FDA approval, was withdrawn in late 2005 before approval and is not expected to be Endoscopic Therapies For Gastroesophageal Reflux Disease (GERD) - Commercial Medical Management Guideline marketed.

Research Evidence Background Gastroesophageal reflux disease (GERD) affects more than 60 million people in the United States at least once per month with more than 15 million Americans experiencing symptoms such as heartburn, dysphagia, reflux or regurgitation on a daily basis. Persistent GERD may lead to esophageal damage or other serious conditions such as severe esophagitis, strictures, Barrett's metaplasia, and adenocarcinoma of the esophagus. Diagnosis of GERD is usually made on the basis of clinical presentation and response of symptoms to medications such as proton pump inhibitors (PPIs) that suppress stomach acid production. Other diagnostic tests, such as esophageal manometry, monitoring of esophageal pH, and barium radiology, are generally not used unless surgery is a consideration or confirmation of the diagnosis is complicated by other factors. For patients with severe or complicated GERD, an endoscopic examination may be performed for a complete evaluation of esophageal erosion.

Initial treatment of GERD usually involves over-the-counter (OTC) antacids and may include the use of OTC histamine-2receptor antagonists (H2RAs; also called H2 blockers). Lifestyle changes are also recommended. If these measures are ineffective or erosive esophagitis is present, higher-strength H2RAs or a proton pump inhibitor can be prescribed.

For some patients, medication alone does not alleviate symptoms and surgical treatment is necessary to treat the fundamental cause of GERD. These endoscopic, or endoluminal, therapies are designed to improve the function of the lower esophageal sphincter (LES), with the objective of eliminating symptoms, healing esophagitis, preventing recurrence of symptoms or progression of disease, and reducing the need for lifelong pharmacologic therapy. Currently, there are

three endoluminal approaches used to treat GERD (Hayes, 2007):

1. Radiofrequency energy - Stretta procedure which uses endoscopically placed needles to administer radiofrequency energy to the tissue surrounding the lower esophageal sphincter

2. Endoscopic or plication suturing - Bard EndoCinch and the Endoscopic Suturing Device (ESD), which places sutures proximal to the lower esophageal sphincter and the Endoscopic Plication System (EPS) which places a full-thickness transmural plication near the gastroesophageal junction under direct endoscopic visualization.

3. Injection or implantation techniques - Plexiglas (polymethylmethacrylate [PMMA]) procedure which involves injection of an inert polymer material into the submucosa of the proximal lower esophageal sphincter zone to provide bulking support to the sphincter and to and decrease transient relaxations of the lower esophageal sphincter (tLESRs).

Research Evidence Radiofrequency Energy Only one device is based on the technique of radiofrequency energy for GERD, the Stretta System. Monopolar radiofrequency devices use an active electrode and a dispersive electrode (grounding pad). Radiofrequency current flows from the active electrode to the adjacent tissue, causing heating of tissue water molecules. In the Stretta procedure, radiofrequency energy is delivered in a controlled fashion with constant tissue temperature monitoring to a selected target temperature of 85°to 65°tissue shrinkage (Hayes, 2007).



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