CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Magnetic Esophageal Sphincter Augmentation to Treat Gastroesophageal Reflux

Governs coverage for laparoscopic implantation of a magnetic esophageal sphincter augmentation device (LINX) for treatment of gastroesophageal reflux disease (GERD); affects Medicare Advantage and Commercial plan members and providers submitting claims to Blue Cross Blue Shield of Rhode Island.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMagnetic Esophageal Sphincter Augmentation to Treat Gastroesophageal Reflux

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2017

Next Review DateN/A

Key ActionDo not submit claims for laparoscopic magnetic esophageal sphincter augmentation (CPT 43284); claims will be denied or are not covered under this policy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2017-01-01Effective date

2022-01-05Last updated

43284Not covered code

PMA 2012FDA reference

Coverage Criteria

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Coverage determination

Coverage stance differs by product:

Medicare Advantage stance: Magnetic esophageal sphincter augmentation to treat gastroesophageal reflux disease is not covered as the evidence is insufficient to determine the effects of the technology on health outcomes.

Commercial stance: Magnetic esophageal sphincter augmentation to treat gastroesophageal reflux disease is not medically necessary as the evidence is insufficient to determine the effects of the technology on health outcomes.

Benefits and covered services can differ between employer groups and individual contracts. Refer to the member's Evidence of Coverage or Subscriber Agreement for the specific benefit language that applies to the member when determining whether a service is covered or excluded under their plan.

For Commercial products, magnetic esophageal sphincter augmentation (LINX) for treatment of gastroesophageal reflux disease is considered not medically necessary. The policy finds the current evidence insufficient to determine the effects of this technology on health outcomes.

For members enrolled in Medicare Advantage Plans, magnetic esophageal sphincter augmentation for gastroesophageal reflux disease is not covered. The available evidence is judged insufficient to establish beneficial effects on health outcomes.

Provider Actions & Billing

Denial Risk

Prior authorization — not applicable; denial risk for CPT 43284

Prior authorization is not applicable for this procedure per the policy statement. However, claims for CPT code 43284 (laparoscopic placement of a sphincter augmentation device) are specifically identified as not covered / not medically necessary for applicable products and are subject to denial if submitted.

Affected code: 43284 — Laparoscopy, surgical, esophageal sphincter augmentation procedure (placement of magnetic band)

Note

Therapy context — patient population and clinical context

The device is intended for patients with gastroesophageal reflux disease (GERD) who continue to have symptoms despite maximum medical therapy (for example, proton pump inhibitors) and who seek an alternative to more invasive surgical options. The policy applies to the implantation (insertion) procedure only; removal is addressed under a related policy.

Documentation Required

Background

Gastroesophageal reflux disease (GERD) is the reflux of stomach acid into the esophagus that produces symptoms and/or mucosal injury. Clinical severity ranges from intermittent, medically managed heartburn to chronic or complicated disease that may require procedural or surgical intervention. The LINX magnetic sphincter augmentation system is a band of interlinked titanium beads with magnetic cores implanted around the gastroesophageal junction with the intent of augmenting the lower esophageal sphincter for patients whose symptoms persist despite maximal medical therapy.

Definitions

LINX Reflux Management System / Magnetic sphincter augmentation (MSA)

Device nameLINX Reflux Management System (magnetic sphincter augmentation)

CompositionSmall flexible band of 10 to 18 interlinked titanium beads with magnetic cores

PlacementPlaced laparoscopically around the esophagus at the gastroesophageal junction using standard laparoscopic techniques

Mechanism of actionMagnetic attraction between beads augments the lower esophageal sphincter to reduce reflux while allowing the ring to temporarily separate with swallowing

Removability and MRI considerationDevice can be removed laparoscopically if severe adverse events occur or if magnetic resonance imaging is needed

Maximum medical therapy

DefinitionTreatment including proton pump inhibitors (PPIs) at therapeutic doses aimed at controlling GERD symptoms prior to considering device implantation

Target patientsPatients who continue to have GERD symptoms despite maximum medical therapy (eg, PPIs)

FDA contextFDA-approved indication requires patients to have abnormal pH testing and persistent chronic GERD symptoms despite maximum therapy

Clinical purposeMaximize medical control of reflux symptoms and reserve device implantation for those not adequately controlled or unwilling to have long-term medication or fundoplication

OpenPayer

Magnetic Esophageal Sphincter Augmentation to Treat Gastroesophageal Reflux

Coverage Criteria

Coding

Provider Actions & Billing

Background

Definitions