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

-- [ Page 98 ] --

American Society for Gastrointestinal Endoscopy (ASGE): In a 2007 guideline on the role of endoscopy in the management of GERD, ASGE states that the endoluminal treatment of GERD is evolving and may have the potential to decrease the need for long-term antisecretory medications in selected patients (ASGE, 2007). However, most studies of endoluminal therapies for GERD have involved small numbers of PPI-dependent patients and have provided relatively Endoscopic Therapies For Gastroesophageal Reflux Disease (GERD) - Commercial Medical Management Guideline limited follow-up information, so the durability of these therapies remains in question. Additionally, both short and longterm safety issues surrounding the endoluminal devices continue to be a concern. The new endoscopic antireflux techniques represent a rapidly evolving area of GI endoscopy, but additional research is needed before they can be widely recommended. Appropriate patient selection and endoscopist experience should be carefully considered before pursuing these therapies. It is important that patients and practitioners alike be aware of the limitations in the evidence that exist with these devices at the present time.

Additional Medical Products Endoscopic Suturing Device® (ESD; Wilson-Cook Medical, Winston-Salem, NC), also called Sew-Right; Enteryx™ Procedure Kit (Boston Scientific Corp, Natick, MA); Gatekeeper™ Reflux Repair System (Medtronic Inc, Minneapolis, MN); Plexiglas (polymethylmethacrylate [PMMA]) (RGmbH & Co KG, Darmstadt, Germany); EsophyX™ System (EndoGastric Solutions Inc.) Additional Search Terms Acid regurgitation, antireflux surgery, bulking agents, chronic peptic esophagitis, ELGP, gastric emptying, Nissen fundoplication, reflux esophagitis References and Resources Resources American Gastroenterological Association (AGA). American Gastroenterological Association Medical Position Statement

on the Management of Gastroesophageal Reflux Disease. GASTROENTEROLOGY 2008;135:1383-1391. Available at:

http://download.journals.elsevierhealth.com/pdfs/journals/0016-5085/PIIS0016508508016065.pdf. Accessed January 2009.

American Society for Gastrointestinal Endoscopy (ASGE). Role of endoscopy in the management of GERD. 2007.

Available at: http://www.asge.org/searchnew.aspx?searchtext=EndoscopicAnti-RefluxProcedures. Accessed January 2009.

Chuttani R, Sud R, Sachdev G, et al. A novel endoscopic full-thickness plicator for the treatment of GERD: A pilot study.

Gastrointest Endosc. 2003;58(5):770-776.

Corley DA, Katz P, Wo JM, et al. Improvement of gastroesophageal reflux symptoms after radiofrequency energy: a randomized, sham-controlled trial. Gastroenterology. 2003;125(3):668-676.

DiBaise JK, Brand RE, Quigley EM. Endoluminal delivery of radiofrequency energy to the gastroesophageal junction in uncomplicated GERD: efficacy and potential mechanism of action. Am J Gastroenterol. 2002;97(4):833-842.

DiBaise JK, Oleynikov D. Endoluminal treatment of GERD - role in contemporary clinical practice. Medscape [Web site].

August 4, 2004. Available at: http://www.medscape.com/viewarticle/480380. Accessed January 2009.

Falk GW, Fennerty MB, Rothstein RI. AGA Institute technical review on the use of endoscopic therapy for gastroesophageal reflux disease. Gastroenterology. 2006;131(4):1315-1336.

Feretis C, Benakis P, Dimopoulos C, et al. Endoscopic implantation of Plexiglas (PMMA) microspheres for the treatment of GERD. Gastrointest Endosc. 2001;53(4):423-426.

Filipi CJ, Lehman GA, Rothstein RI, et al. Transoral, flexible endoscopic suturing for the treatment of GERD: a multicenter trial. Gastrointest Endosc. 2001;53(4):416-422.

Endoscopic Therapies For Gastroesophageal Reflux Disease (GERD) - Commercial Medical Management Guideline Fockens P, Bruno MJ, Gabbrielli A, et al. Endoscopic augmentation of the lower esophageal sphincter for treatment of gastroesophageal reflux disease: multicenter study of the Gatekeeper Reflux Repair System. Endoscopy. 2004;36(8):682Go MF, Dundon JM, Karlowicz DJ, et al. Delivery of radiofrequency energy to the lower esophageal sphincter improves symptoms of gastroesophageal reflux. Surgery. 2004 Oct;136(4):786-94.

Hayes, Inc. Directory Report. Endoscopic Therapies For Gastroesophageal Reflux Disease. Hayes Inc; Lansdale, PA:

October 2007. Update search October 2008.

Hayes, Inc. Search and Summary. Laparoscopic Surgery for the Treatment of Symptoms Associated with Gastroesophageal Reflux Disease (GERD). June 2008.

Hogan WJ, Shaker R. A critical review of endoscopic therapy for gastroesophageal reflux disease. Am J Med. 2003;115 Suppl 3A:201S-210S.

Hogan WJ. Endoscopic techniques for treatment of gastroesophageal reflux disease: a review of abstracts from digestive disease week 2003. Curr Gastroenterol Rep. 2004;6(3):196-201.

Houston H, Khaitan L, Holzman M, Richards WO. First year experience of patients undergoing the Stretta procedure.

Surg Endosc. 2003;17(3):401-404.

Mahmood Z, McMahon BP, Arfin Q, et al. Endocinch therapy for gastro-oesophageal reflux disease: a one year prospective follow up. Gut. 2003;52(1):34-39.

Montgomery M, HB, Ljungqvist O, Ahlman B, Thorell A. Twelve months' follow-up after treatment with the EndoCinch endoscopic technique for gastro-oesophageal reflux disease: a randomized, placebo-controlled study. Scand J Gastroenterol. 2006 Dec;41(12):1382-9.





Pleskow D, Rothstein R, Lo S, et al. Endoscopic full-thickness plication for the treatment of GERD: a multicenter trial.

Gastrointest Endosc. 2004;59(2):163-171.

Richards WO, Houston HL, Torquati A, et al. Paradigm shift in the management of gastroesophageal reflux disease. Ann Surg. 2003;237(5):638-649.

Rothstein R, Filipi C, Caca K, et al. Endoscopic full-thickness plication for the treatment of gastroesophageal reflux disease: A randomized, sham-controlled trial. Gastroenterology. 2006;131(3):704-712.

Schiefke I, Neumann S, Zabel-Langhennig A, et al. Use of an endoscopic suturing device (the "ESD") to treat patients with gastroesophageal reflux disease, after unsuccessful EndoCinch endoluminal gastroplication: another failure.

Endoscopy. 2005a. Amug; 37(8):700-5.

Schiefke I, Zabel-Langhennig A, Neumann S. et al. Long term failure of endoscopic gastroplication (EndoCinch). Gut.

2005b. Jun;54(6):752-8.

Schilling D, Kiesslich R, Galle PR, et al. Endoluminal therapy of GERD with a new endoscopic suturing device.

Gastrointest Endosc. 2005 Jul;62(1):37-43.

Endoscopic Therapies For Gastroesophageal Reflux Disease (GERD) - Commercial Medical Management Guideline Tam WCE, Schoeman MN, Zhang Q, et al. Delivery of radiofrequency energy to the lower oesophageal sphincter and gastric cardia inhibits transient lower oesophageal sphincter relaxations and gastro-oesophageal reflux in patients with reflux. Gut. 2003;52(4):479-485.

Tam WC, Holloway RH, Dent J, et al. Impact of endoscopic suturing of the gastroesophageal junction on lower esophageal sphincter function and gastroesophageal reflux in patients with reflux disease. Am J Gastroenterol.

2004;99(2):195-202.

Triadafilopoulos G, DiBaise JK, Nostrant TT, et al. Radiofrequency energy delivery to the gastroesophageal junction for the treatment of GERD. Gastrointest Endosc. 2001;53(4):407-415.

Triadafilopoulos G, DiBaise JK, Nostrant TT, et al. The Stretta procedure for the treatment of GERD: 6 and 12 month follow-up of the U.S. open label trial. Gastrointest Endosc. 2002;55(2):149-156.

Triadafilopoulos G. Clinical experience with the Stretta procedure. Gastrointest Endosc Clin N Am. 2003;13(1):147-155.

Triadafilopoulos G. Changes in GERD symptom scores correlate with improvement in esophageal acid exposure after the Stretta procedure. Surg Endosc. 2004;18:1038-1044.

Torquati A, Houston HL, Kaiser J, et al. Long-term follow-up study of the Stretta procedure for the treatment of gastroesophageal reflux disease. Surg Endosc. 2004;18:1475-1479.

Utley DS. The Stretta procedure: device, technique, and pre-clinical study data. Gastrointest Endosc Clin N Am.

2003;13(1):135-145.

–  –  –

Endoscopic Therapies For Gastroesophageal Reflux Disease (GERD) - 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.

CPT Codes:

43257 Upper gastrointestinal endoscopy including esophagus, stomach, and either the duodenum and/or jejunum as appropriate; with delivery of thermal energy to the muscle of lower esophageal sphincter and/or gastric cardia, for treatment of gastroesophageal reflux disease 43499 Unlisted procedure, esophagus 43999 Unlisted procedure, stomach ICD-9 Diagnosis Codes 530.11 Reflux esophagitis 530.81 Esophageal reflux 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 Endoscopic Therapies For Gastroesophageal Reflux Disease (GERD) - Commercial Medical Management Guideline TITLE: Epidural Steroid and Facet Injections for Spinal Pain Authorized By: Medical Management Guideline Committee

Adoption Date: 06/29/09 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.

ADOPTED FROM UNITEDHEALTHCARE FOR PACIFICARE USE

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 supersede these policies and are used to make coverage determinations. These Medical Policies are believed to be current as of the date noted.

–  –  –

Therapeutic facet joint injection is unproven for the treatment of chronic spinal pain due to inadequate clinical evidence of safety and/or efficacy in published, peer-reviewed medical literature. Clinical evidence is conflicting about the very existence of facet joint syndrome, and evidence from studies is inadequate regarding the superiority of periodic facet joint injections compared to placebo in relieving chronic spinal pain.

Facet joint injection, as a diagnostic procedure prior to radiofrequency ablation, is not recommended

in patients with:

• neurologic abnormalities

• more than one pain syndrome

• definitive clinical and/or imaging findings

• previous spinal surgery at the clinically suspected levels, or

• when the etiology of spinal pain is already known.

Epidural Steroid injections Epidural steroid injection is proven for the treatment of acute and sub-acute sciatica or radicular pain of the low back caused by disc herniation or degenerative changes in the vertebrae.

Epidural steroid injections have a clinically established role in the short-term management of low

back pain when the following criteria are met:

• Pain that is unresponsive to conservative treatment with oral medications, including when appropriate rest, non-steroidal anti-inflammatory drugs (NSAIDs), and physical therapy or exercise

• Pain that is associated with symptoms of nerve root irritation and/or low back pain due to disc extrusions and/or contained herniations.

Epidural steroid injection is unproven for all other indications of the lumbar spine. There is a lack of Epidural Steroid and Facet Injections for Spinal Pain- Commercial Medical Management Guideline evidence from randomized controlled trials indicating that epidural steriod injections effectively treat patients with lumbar pain not associated with sciatica or radicular pain.

** This policy does not apply to obstetrical epidural anesthesia utilized during labor and delivery. ** Additional Information Facet injection may be used as a diagnostic tool to locate the site to administer radiofrequency ablation (RFA).

Regulatory Requirements U.S. Food and Drug Administration (FDA): There are a number of injectable steroid formulations approved by the FDA, but none are specifically approved for epidural injection.



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