Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Gastroesophageal Reflux Disease

Treatment: Magnetic collar around the swallowing tube (esophagus) and upper stomach; LINX Reflux Management System; code 43284

The insurer denied coverage for magnetic collar around the swallowing tube (esophagus) and upper stomach; LINX Reflux Management System; code 43284.

The denial is overturned.

According to the documentation submitted this is the case of a patient who presented to the doctor's office via a telehealth visit. The provider noted the patient has been diagnosed with laryngopharyngeal reflux (LPR)/gastroesophageal reflux disease (GERD). The patient has suffered with symptoms of GERD since childhood. The patient has constant throat clearing and runny nose, obstructive sleep apnea (OSA) and dental breakdown. The patient has not had any specific testing beyond Ear, Nose and Throat (ENT) evaluation and the provider opinion was that he has GERD. The patient is interested in the LINX procedure. The plan was esophagogastroduodenoscopy (EGD)/Bravo, Barium swallow and follow up.

The EGD was done and showed normal upper third of esophagus, middle third and lower third of esophagus. The gastroesophageal flap valve was classified as Hill Grade III; Bravo capsule was deployed. Demeester score was 1.5 and the interpretation was that this was a normal pH study with virtually no esophageal acid exposure.

The patient was seen again, and results were reviewed. The EGD was normal. Barium swallow was normal and esophageal motility study (EMS) was normal. The provider noted that they do not think the patient has surgical GERD, if the patient has GERD at all. The provider noted that some of the symptoms suggest a swallowing mechanism issue. The provider noted that LINX placement without objective evidence of acid reflux would not be covered.

A follow up visit via telehealth noted that the patient had objectively confirmed GERD with primary LPR symptoms. The patient had used proton pump inhibitors (PPIs) with limited improvement. The patient had been seeing an ENT who diagnosed GERD and LPR and the patient had been following all of the ENT strategies for managing these symptoms, including double dose PPI. The provider now feels the patient is a candidate for the LINX procedure.

Thus, this patient has reflux and an elevated Demeester score and as such is a good candidate for LINX.  In addition, Louie (2023) noted that initial guidance provided by the manufacturer also suggested that patients should have: No hiatal hernia >3 centimeters (cm) or a paraoesophageal hernia; No esophagitis worse than Los Angeles (LA) class A or B; adequate esophageal motility; body mass index (BMI) <35; no Barrett esophagus and no prior esophageal or gastric surgery." Thus, given these references, the patient is a suitable candidate for esophageal sphincter augmentation device. It also should be recognized that the adverse risks are not increased over standard treatment services as this procedure is less invasive than the standard fundoplication. Thus, the LINX is a very good option for this patient.

The LINX Reflux Management System; code 43284 has been shown to be an effective treatment modality. Based upon these findings the health care plan did not act reasonably and with sound medical judgment. Denial for the procedure in this case is therefore reversed.

Based on the above, the insurer's denial must be reversed. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for a magnetic collar around the swallowing tube (esophagus) and upper stomach; LINX Reflux Management System; code 43284 is substantiated.