REIMBURSEMENT GUIDE

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Effective January 1, 2007, the following coding considerations are available to providers performing the Plicator procedure. This information has been released by the American Medical Association (AMA), the Centers for Medicare and Medicaid Services (CMS), as well as shared by healthcare providers and professional coders familiar with the Plicator procedure. While NDO Surgical Inc. believes this information to be reliable, the actual selection of codes remains the responsibility of the provider. Because individual insurers may have different requirements, and this information is subject to change without notice, providers are encouraged to contact their payers with questions.¹

INDICATIONS FOR USE

The Endoscopic Plication System was cleared by the U.S. Food and Drug Administration (FDA) on October 23, 2003 (K032820) “for the treatment of the symptoms of chronic gastroesophageal reflux disease (GERD) in patients who require and respond to pharmacological therapy.”

The Plication System consists of a reusable endoscopic instrument that delivers a transmural suture at the gastroesophageal (GE) junction to restructure the gastric cardia, creating an improved barrier to GE reflux.

CLINICAL LEVEL OF EVIDENCE

The Plicator procedure is a minimally invasive outpatient alternative for patients who suffer with refractory GERD, are unable to tolerate a daily regimen of high dose PPIs, and/or are contraindicated for surgery. Supported by numerous peer-reviewed articles, including a multi-center, randomized, patient-blinded sham-controlled trial and 36-month post-treatment follow up, the Plicator procedure offers sustained superior clinical results. In appropriately selected GERD patients, the Plicator procedure improves GERD symptom and quality of life scores, while reducing and often eliminating the need for anti-secretory medications. In the treatment algorithm of “therapeutic escalation” for symptomatic GERD patients, the Plicator procedure is a high quality, low-cost alternative.

Noteworthy publications to review include:

• Pleskow, D. et al, “Endoscopic Full-Thickness Plication for the Treatment of GERD: Long-Term Multicenter Results,” Surgical Endoscopy 2007; 21:439-444.
• Rothstein R. et al, “Endoscopic Full-Thickness Plication for the Treatment of Gerd: A Randomized, Sham-Controlled Trial,” Gasteroenterology 2006; 131:704-712.
• Pleskow, D. et al, “Endoscopic Full-Thickness Plication for the Treatment of GERD: 12-month follow-up for the North American Open-Label Trial,” Gastrointestinal Endoscopy, 2005, Vol. 61, No. 6, pp.643-649.
• Haber G. et al, “The Plicator Procedure for the Treatment of GERD: 12-Month Multicenter Results,” Gastrointestinal Endoscopy, 2005, Vol. 61, No. 5, Abstract 17.
• Lin E. et al, “Objective Improvements Following Full-Thickness Gastric Cardia Plication for Complicated GERD,” SAGES 2005, Abstract S040.
• Torquati A. and Richards W. “Endoluminal GERD Treatments: Critical Appraisal of Current Lieterature with Evidenced-Based Medicine Instruments,” Surgical Endoscopy, 2007, Vol. 21, pp.697-706.

CODING CONSIDERATIONS

Coding is at the discretion of the physician based upon the clinical condition of the patient, the nature of the physician’s findings and the procedural steps dictated in the patient’s medical record. When an unlisted procedure? is reported, the service or procedure should be described in detail that includes an adequate definition and description of the nature, extent, and need for the procedure. Additionally, the time, effort, and an explanation of why the device used was necessary to provide the service should be presented. Additional items may include complexity of symptoms, diagnosis, pertinent findings, diagnostic & therapeutic procedures, concurrent problems and follow-up care.

*Must be reported for Medicare hospital outpatient procedure – some private payers may recognize these codes
**T Status indicator – Significant procedure; multiple procedure reduction applies
***APC National average rates are indicated

Reimbursement Support: info@thereimbursementgroup.com

866-658-GERD(4373)

Procedure coding should be based upon medical necessity and procedures and supplies provided to the patient. Coding and reimbursement Information is provided for educational purposes and does not assure coverage of the specific item or service in a given case. NDO Surgical makes no guarantee of coverage or reimbursement of fees. Contact your local Medicare Fiscal Intermediary, Carrier or CMS for specific information as payment rates listed are subject to change. To the extent that you submit cost information to Medicare, Medicaid or any other reimbursement program to support claims for services or items, you are obligated to accurately report the actual price paid for such items, including any subsequent adjustments.

Current Procedural Terminology numeric codes, descriptions, and modifiers are trademark and Copyright AMA. Plicator is a registered trademark of NDO Surgical, Inc. All rights reserved.1 This information is shared for educational purposes only.
2 AMA. CPT 2007. AMA Press, 2007.
3 Medicare Program: Changes to the hospital outpatient prospective payment system CY 2007. Federal Register, 11/24/06.