Magnetic Esophageal Sphincter Augmentation to Treat Gastroesophageal Reflux Disease

POLICY NUMBER

A.7.01.137

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 maximum medical therapy.

Gastroesophageal Reflux Disease

Gastroesophageal reflux disease (GERD) is defined as the 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.

In 2012, the LINX™ Reflux Management System (Ethicon; formerly Torax Medical) was approved by the U.S. Food and Drug Administration (FDA) through the premarket approval process for patients diagnosed with GERD, as defined by abnormal pH testing, and who continue to have chronic GERD symptoms despite maximal therapy for the treatment of reflux. The FDA initially required a 5-year follow-up of 100 patients from the investigational device exemption pivotal study to evaluate safety and efficacy of the device, which was completed in March 2016. In 2018, the manufacturer initiated a device recall due to a possible separation of the bead component with the adjacent wire link causing a potential discontinuous or open LINX device. This recall was terminated on November 4, 2020. FDA product code: LEI.

In March 2018, the FDA approved an update of the LINX® Reflux Management System precautions statement, stating that the use of the system "in patients with a hiatal hernia larger than 3 cm should include hiatal hernia repair to reduce the hernia to less than 3 cm and that the LINX Reflux Management System has not been evaluated in patients with an unrepaired hiatal hernia greater than 3 cm, add a hiatal hernia clinical data summary in the instructions for use, update the instructions for use section to highlight the recommendation to repair a hiatal hernia, if present, at the time of the LINX Reflux Management System implantation, and update the patient information booklet to align with the instructions for use and include 5 year clinical study results."

In February 2024, the FDA revised the labeling for the LINX® Reflux Management System. They removed a precautionary statement about Barrett's Esophagus (BE) from the instructions for use. However, the updated labeling now includes this guidance: "LINX has not been proven to effectively treat BE by causing regression or preventing progression to cancer. Patients with BE who use LINX to manage GERD symptoms should consult their physician about ongoing BE treatment, which may include continued use of proton pump inhibitors (PPIs)."

Related policies are –

POLICY

Magnetic esophageal sphincter augmentation to treat gastroesophageal reflux disease (GERD) is investigational.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

11/15/2012: Approved by Medical Policy Advisory Committee.

10/17/2013: Policy reviewed; no changes.

10/09/2014: Policy reviewed; no changes.

07/31/2015: Code Reference section updated for ICD-10.

11/05/2015: Policy reviewed. Policy statement unchanged. Investigative definition updated in policy guidelines section.

05/31/2016: Policy number A.7.01.137 added.

12/06/2016: Policy title changed from "Magnetic Esophageal Ring to Treat Gastroesophageal Reflux Disease (GERD)" to "Magnetic Esophageal Sphincter Augmentation to Treat Gastroesophageal Reflux Disease." Policy description updated. Policy statement updated to change "implantable magnetic esophageal ring" to "magnetic esophageal sphincter augmentation."

12/30/2016: Code Reference section updated to add new 2017 CPT codes 43284 and 43285.

01/09/2018: Policy description updated. Policy statement unchanged.

01/11/2019: Policy reviewed; no changes.

12/13/2019: Policy description revised to remove information regarding treatment. Policy statement unchanged.

01/19/2021: Policy description updated regarding devices. Policy statement unchanged.

02/01/2022: Policy description updated regarding devices. Policy statement unchanged.

01/23/2023: Policy description updated. Policy statement unchanged.

01/05/2024: Policy reviewed; no changes.

01/31/2025: Policy description updated regarding devices. Policy statement unchanged.

SOURCE(S)

Blue Cross Blue Shield Association policy # 7.01.137 

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

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