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AMERICAN SOCIETY OF GENERAL SURGEONS
                            P.O. Box 4834, Englewood, Colorado 80155 • Phone: 800-998-8322 • (303) 771-5948
                                       Fax: (303) 771-2550 • Internet: http://www.theasgs.org




                       OFFICERS
                                         Date: April 1, 2011
                          President
           Guy Nicastri, MD, FACS
                     Pawtucket, RI       TO: Medical Directors
                   President Elect
          Karl LeBlanc, MD, FACS         FROM: Guy Nicastri, M.D., ASGS President
                  Baton Rouge, LA
              Secretary Treasurer        RE: Coverage of Transoral Fundoplication
             Harold Kent MD,FACS
                     Brunswick, GA
                                         The ASGS represents the scientific, educational, socioeconomic, ethical,
         Immediate Past President
         Robert Sewell, MD, FACS
                                         and professional interests of General Surgeon Specialists. With over 3,000
                    Southlake, TX        members, we are the only national organization that represents exclusively
         BOARD OF TRUSTEES
                                         practicing general surgeons. We are dedicated to maintaining the highest
                                         standards of practice for the specialty of General Surgery and the highest
    Reginald C. W. Bell, MD, FACS
                        Denver, CO       quality of care for those patients who require surgery. As a result, we seek
     Michael S. Bouton, MD, FACS
                                         to serve as a knowledgeable resource for patients and payers in matters
                      Houston, TX        related to new technology used in General Surgery.
        Ronald Clement, MD, FACS
                  New London, CT         The introduction of new technology is a constant in modern medicine.
         Philip Z. Israel, MD, FACS      While the U.S. Food and Drug Administration (FDA) provides regulatory
                        Marietta, GA     clearance on safety and effectiveness, practicing general surgeons require
         Ronald Kaleya, MD, FACS         scientific evidence on net health outcomes before offering new procedures
                         Bronx, NY       to their patients. In addition, to meet the clinical expectations of practicing
        Jarrod Kaufman, MD, FACS         general surgeons, new technology must stay consistent with fundamental
                      Freehold, NJ       surgical principles. If not, it quickly becomes apparent that the new
         George McGee, MD, FACS          technology will be ineffective.
                   Hattesburg, MS
         John T. Moore, MD, FACS         In the surgical treatment of gastroesophageal reflux disease (GERD), the
                       Denver, CO
                                         ASGS believes that transoral fundoplication adheres to fundamental
Edwin W. Shearburn, III, MD, FACS        surgical principles. We also believe that there is a sufficient body of peer-
                    Sellersville, PA
                                         reviewed literature that establishes transoral fundoplication as reasonable
                        Governor,        and medically necessary for a subset of patients who are candidates for
     American College of Surgeons
       Jay A. Gregory, MD, FACS
                                         surgical fundoplication; specifically, patients who either can not obtain
                   Muskogee, OK          satisfactory relief from standard PPI therapy or who wish to avoid a
        EXECUTIVE DIRECTOR               lifetime of dependence on such medications, and present with a 2
               Carol A. Goddard          centimeter or smaller hiatal hernia.
                     Denver, CO
                                         The ASGS has developed the attached position statement in support of
                                         transoral fundoplication as an educational tool for payers. As you update
                                         your 2011 medical policy on the surgical treatment of GERD, we
                                         encourage you to include transoral fundoplication as an acceptable
                                         technique used by trained General Surgeons to create a surgical
                                         fundoplication.

                                         The ASGS is committed to providing a forum for discussion with U.S.
                                         payers on issues
                                         that impact General Surgery Specialists and their patients. We are
American Society of General Surgeons (ASGS) Position Statement
                            Transoral Fundoplication


The ASGS supports the use of transoral fundoplication by trained General Surgeons for
the treatment of symptomatic chronic gastroesophageal reflux disease (GERD) in
patients who fail to achieve satisfactory response to a standard dose of Proton Pump
Inhibitor (PPI) therapy or for those who wish to avoid the need for a lifetime of
medication dependence. The purpose of surgical fundoplication is to reconstruct the
biomechanics and physiology of the esophagogastric junction in order to prevent
stomach contents from refluxing into the patient’s esophagus. The General Surgeon
has a choice on how to achieve a surgical fundoplication – open incisional, laparoscopic
or transoral. Transoral fundoplication adheres to the same fundamental surgical
principles, which have guided surgical care of GERD for more than 50 years.
Specifically, a trained General Surgeon can create a full thickness esophagogastric
fundoplication to correct an incompetent lower esophageal sphincter with a transoral
approach.

During transoral fundoplication, a General Surgeon constructs an anterior partial
fundoplication of 270-300 degrees by attaching the fundus to the anterior and left lateral
wall of the distal esophagus slightly above the esophagogastric junction through
fullthickness plications using multiple fasteners around the gastroesophageal junction. In
clinical studies, the transoral fundoplication procedure has been shown to offer
comparable results to traditional open and laparoscopic approaches. Transoral
fundoplication is also indicated to narrow the gastroesophageal junction and reduce
hiatal hernia < 2cm in patients with chronic GERD.

The ASGS continues to supports the adoption of this procedure by trained General
Surgeons as a less invasive alternative to more conventional surgical techniques.
However, ASGS believes that in patients who are candidates for fundoplication, the
preferred surgical technique for creating the fundoplication should be left to the
discretion of the General Surgeon and should be based on the surgeon’s independent
medical judgment and the individual patient’s clinical circumstances.
The ASGS position on transoral fundoplication is based in part upon the following peer-
reviewed.
Supporting Publications:

-Barnes WE, Hoddinott KM, et al. Transoral incisionless fundoplication offers high
patient satisfaction and relief of therapy-resistant typical and atypical symptoms of
GERD in community practice. Surgical Innov 2011 Feb;[Epub ahead of print].

-Bell RCW, Freeman KD. Clinical pH-metric outcomes of transoral esophagogastric
fundoplication for the treatment of gastroesophageal reflux disease. Surgical
Endoscopy. 2010 December 8;[Epub ahead of print].

-Cadiere G-B, Van Sante N, et al. Two-year results of a feasibility study on Antireflux
Transoral incisionless fundoplication (TIF) using EsophyX. Surgical Endoscopy. 2009;
23 (5): 957-64.


	
  

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Coverage of transoral fundoplication

  • 1. AMERICAN SOCIETY OF GENERAL SURGEONS P.O. Box 4834, Englewood, Colorado 80155 • Phone: 800-998-8322 • (303) 771-5948 Fax: (303) 771-2550 • Internet: http://www.theasgs.org OFFICERS Date: April 1, 2011 President Guy Nicastri, MD, FACS Pawtucket, RI TO: Medical Directors President Elect Karl LeBlanc, MD, FACS FROM: Guy Nicastri, M.D., ASGS President Baton Rouge, LA Secretary Treasurer RE: Coverage of Transoral Fundoplication Harold Kent MD,FACS Brunswick, GA The ASGS represents the scientific, educational, socioeconomic, ethical, Immediate Past President Robert Sewell, MD, FACS and professional interests of General Surgeon Specialists. With over 3,000 Southlake, TX members, we are the only national organization that represents exclusively BOARD OF TRUSTEES practicing general surgeons. We are dedicated to maintaining the highest standards of practice for the specialty of General Surgery and the highest Reginald C. W. Bell, MD, FACS Denver, CO quality of care for those patients who require surgery. As a result, we seek Michael S. Bouton, MD, FACS to serve as a knowledgeable resource for patients and payers in matters Houston, TX related to new technology used in General Surgery. Ronald Clement, MD, FACS New London, CT The introduction of new technology is a constant in modern medicine. Philip Z. Israel, MD, FACS While the U.S. Food and Drug Administration (FDA) provides regulatory Marietta, GA clearance on safety and effectiveness, practicing general surgeons require Ronald Kaleya, MD, FACS scientific evidence on net health outcomes before offering new procedures Bronx, NY to their patients. In addition, to meet the clinical expectations of practicing Jarrod Kaufman, MD, FACS general surgeons, new technology must stay consistent with fundamental Freehold, NJ surgical principles. If not, it quickly becomes apparent that the new George McGee, MD, FACS technology will be ineffective. Hattesburg, MS John T. Moore, MD, FACS In the surgical treatment of gastroesophageal reflux disease (GERD), the Denver, CO ASGS believes that transoral fundoplication adheres to fundamental Edwin W. Shearburn, III, MD, FACS surgical principles. We also believe that there is a sufficient body of peer- Sellersville, PA reviewed literature that establishes transoral fundoplication as reasonable Governor, and medically necessary for a subset of patients who are candidates for American College of Surgeons Jay A. Gregory, MD, FACS surgical fundoplication; specifically, patients who either can not obtain Muskogee, OK satisfactory relief from standard PPI therapy or who wish to avoid a EXECUTIVE DIRECTOR lifetime of dependence on such medications, and present with a 2 Carol A. Goddard centimeter or smaller hiatal hernia. Denver, CO The ASGS has developed the attached position statement in support of transoral fundoplication as an educational tool for payers. As you update your 2011 medical policy on the surgical treatment of GERD, we encourage you to include transoral fundoplication as an acceptable technique used by trained General Surgeons to create a surgical fundoplication. The ASGS is committed to providing a forum for discussion with U.S. payers on issues that impact General Surgery Specialists and their patients. We are
  • 2. American Society of General Surgeons (ASGS) Position Statement Transoral Fundoplication The ASGS supports the use of transoral fundoplication by trained General Surgeons for the treatment of symptomatic chronic gastroesophageal reflux disease (GERD) in patients who fail to achieve satisfactory response to a standard dose of Proton Pump Inhibitor (PPI) therapy or for those who wish to avoid the need for a lifetime of medication dependence. The purpose of surgical fundoplication is to reconstruct the biomechanics and physiology of the esophagogastric junction in order to prevent stomach contents from refluxing into the patient’s esophagus. The General Surgeon has a choice on how to achieve a surgical fundoplication – open incisional, laparoscopic or transoral. Transoral fundoplication adheres to the same fundamental surgical principles, which have guided surgical care of GERD for more than 50 years. Specifically, a trained General Surgeon can create a full thickness esophagogastric fundoplication to correct an incompetent lower esophageal sphincter with a transoral approach. During transoral fundoplication, a General Surgeon constructs an anterior partial fundoplication of 270-300 degrees by attaching the fundus to the anterior and left lateral wall of the distal esophagus slightly above the esophagogastric junction through fullthickness plications using multiple fasteners around the gastroesophageal junction. In clinical studies, the transoral fundoplication procedure has been shown to offer comparable results to traditional open and laparoscopic approaches. Transoral fundoplication is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia < 2cm in patients with chronic GERD. The ASGS continues to supports the adoption of this procedure by trained General Surgeons as a less invasive alternative to more conventional surgical techniques. However, ASGS believes that in patients who are candidates for fundoplication, the preferred surgical technique for creating the fundoplication should be left to the discretion of the General Surgeon and should be based on the surgeon’s independent medical judgment and the individual patient’s clinical circumstances. The ASGS position on transoral fundoplication is based in part upon the following peer- reviewed.
  • 3. Supporting Publications: -Barnes WE, Hoddinott KM, et al. Transoral incisionless fundoplication offers high patient satisfaction and relief of therapy-resistant typical and atypical symptoms of GERD in community practice. Surgical Innov 2011 Feb;[Epub ahead of print]. -Bell RCW, Freeman KD. Clinical pH-metric outcomes of transoral esophagogastric fundoplication for the treatment of gastroesophageal reflux disease. Surgical Endoscopy. 2010 December 8;[Epub ahead of print]. -Cadiere G-B, Van Sante N, et al. Two-year results of a feasibility study on Antireflux Transoral incisionless fundoplication (TIF) using EsophyX. Surgical Endoscopy. 2009; 23 (5): 957-64.