Tuesday, November 13, 2018

CPT 43284, 438285 - sphincter augmentation device - GERD


Coding Code Description CPT

43284 Laparoscopy, surgical, esophageal sphincter augmentation procedure, placement of  sphincter  augmentation device (ie,magnetic band), including cruroplasty when performed

43285 Removal of esophageal sphincter augmentation device

GERD

gastroesophageal reflux disease  — is a  long - term medical condition. It’s a digestive  problem that affects the ring of muscles between the esophagus (the tube that carries swallowed food to the stomach) and the stomach. When food is swallowed, the muscles at the end of the esophagus open so food can pass into the stomach. The muscles then close to prevent acid from backing up into the esophagus. In GERD, however, the ring of muscles is too weak. GERD is usually treated with changes to lifestyle and diet. A number of other treatments have been studied.

One technique calls for placing a ring of magnetic beads around the base of the esophagus, just above the stomach. The ring opens to allow swallowed food into the stomach and then immediately tightens . This technique is investigational (unproven). More and longer studies are needed to find out how well such devices work.

Note:
The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The  rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy  informs them about  when a  service may be covered.


Description


A laparoscopically implanted ring composed of interlinked titanium beads with magnetic cores has been developed for the treatment of gastroesophageal reflux disease (GERD). The device is placed around the esophagus at the level of the gastroesophageal junction and is being evaluated in patients who have GERD symptoms, despite maximal medical therapy.

Background

Gastroesophageal Reflux Disease


Gastroesophageal reflux disease (GERD) is defined as reflux of stomach acid into the esophagus that causes symptoms and/or mucosal injury.  GERD is a common medical disorder, with  estimates of 10% to 20% prevalence in developed countries. The severity of GERD varies widely.  Many patients have mild, intermittent symptoms that do not require treatment or only require occasional use of acid blocker medications. Other patients have chronic, severe GERD that can  lead to complications such as Barrett esophagus and esophageal cancer.

Treatment

For patients with severe disease, chronic treatment with acid blockers is one option. For some  patients, medications are not adequate to control symptoms; other patients prefer to avoid the use of indefinite, possibly lifelong medications. Surgical treatments are available for these  patients, primarily a Nissen fundoplication performed either laparoscopically or by open surgery.  A number of less invasive procedures are also being evaluated as an intermediate option between medical therapy and surgery

The LINX Reflux Management System is composed of a small flexible band of 10 to 18 interlinked titanium beads with magnetic cores. Using standard  laparoscopic techniques,the band is placed around the esophagus at the level of the gastroesophageal junction. The magnetic attraction between the beads is intended to augment the lower esophageal sphincter to prevent gastric reflux into the esophagus, without compressing the esophageal wall. It is proposed that swallowing food or liquids creates sufficient pressure to overcome the magnetic bond between the beads, allowing the beads to separate and temporarily increase the size of the ring. The target population is patients who have GERD symptoms despite maximum medical therapy (eg,proton pump inhibitors) but who
do not want to risk having the adverse effects of a surgical procedure like Nissen fundoplication. Adverse events of the LINX Reflux Management System may include dysphagia or odynophagia. The device can be removed by a laparoscopic procedure if severe adverse events occur or if magnetic resonance imaging is needed for another condition.

Summary of Evidence
For individuals who have GERD who receive MSA, the evidence includes prospective and retrospective observational comparative studies, 2 single -arm inter ventional trials, and a number of single-arm observational studies.Relevant outcomes are symptoms, change in disease status,  medication use, and treatment -related morbidity. In the 2 single - arm, uncontrolled  manufacturer - sponsored studies  submitted to the U.S. Food and Drug Administration for device   approval,  subjects showed improvements in GERD-HRQL scores and reduced proton pump inhibitor use. Similarly, observational comparative studies, most often comparing MSA with laparoscopic Nissen fundoplication, generally have shown that GERD-HRQL scores do not differ significantly between fundoplication and MSA, and patients can reduce proton pump inhibitor use after MSA. However, the comparative studies are retrospective and nonrandomized, may be affected by  selection bias, and the subjective outcome measures used in these studies (eg, the  GERD - HRQL scores) may be biased. A randomized trial is in progress ( NCT02505945); it will compare treatment with the MSA and treatment with double-dose proton pump inhibitors. Randomized comparisons of MSA with laparoscopic Nissen fundoplication are also needed to evaluate the relative risk-benefit of these 2 procedures. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements

Society of American Gastrointestinal and Endoscopic Surgeons In 2013, the Society of American Gastrointestinal and Endoscopic Surgeons  published guidelines

on the safety and effectiveness of the LINX Reflux Management System.The Society indicated that safety analyses of the LINX system suggested the procedure is associated with few serious adverse events and no reported mortality, and that currently available data demonstrated a reasonable assurance as to the efficacy of the system. The guidelines concluded that direct comparative studies between the LINX procedure and Nissen fundoplication would be needed.

But based on the available evidence, the LINX device should be an option available to patients and providers for the management of medically refractory gastroesophageal reflux disease.

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