Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Chronic Gastroesophageal Reflux.
Treatment: Linx (a sphincter augmentation device) system and full hospital admission (procedure code 43284).
The insurer denied coverage for Linx system and full hospital admission (procedure code 43284).
The denial is overturned

The patient has a medical history of asthma, premature ventricular contractions, and gastroesophageal reflux disease (GERD) which. He initially presented to the surgeon's office after an upper endoscopy and biopsy demonstrated mild esophageal erosion. He continued to have reflux symptoms despite being on proton pump inhibitors. The patient returned to the surgery office with a desire to pursue surgical options for his persistent GERD symptoms. He underwent an esophageal motility study that showed ineffective esophageal motility. Ambulatory pH monitoring performed demonstrated reflux with a DeMeester score of 45.5. The surgeon discussed the surgical options for reflux and the LINX system with the patient in detail. 

The scientific evidence in peer-reviewed literature does support a result of improvement in health outcome. Chen et al performed a meta-analysis of four databases comparing Linx to Nissen fundoplication. A total of 4 trials included 624 patients, 325 of whom underwent Nissen fundoplication and 299 patients had the Linx procedure. They noted that operating times were significantly shorter with the Linx procedure, and patients undergoing Linx experienced less gas and bloating compared to patients who had the laparoscopic Nissen fundoplication (LNF).

The Linx system (CPT 43284) was approved by the Food and Drug Administration (FDA) as a premarket-approved (PMA) device. Feasibility and pivotal clinical trials approved by the FDA to establish safety and efficacy were published in the New England Journal of Medicine. Linx is indicated for patients diagnosed with gastroesophageal reflux disease as defined by abnormal pH (potential of hydrogen) testing and who wish to pursue alternative options to continuous acid suppression therapy. Based on recent clinical evidence, the FDA has also updated the Indication for Use precaution to establish the effectiveness of Linx in patients with a hiatal hernia > 3 cm (centimeters). 

This patient is a good candidate for the Linx and full hospital admission. He has a long history of GERD which has been confirmed by abnormal pH testing. He also has persistent symptoms despite daily proton pump inhibitor (PPI) use. The Linx system and full hospital admission is the best available treatment for this patient at this time. Linx has been shown to produce equivalent efficacy to the laparoscopic Nissen fundoplication, which is a more invasive procedure requiring increased dissection of the tissues, increased operating time, and permanent alteration of the gastric fundus anatomy. There are no increased adverse risks associated with Linx compared to the laparoscopic Nissen fundoplication. 

In summary, the Linx system and hospital admission are likely to be more beneficial than the standard laparoscopic Nissen fundoplication. Linx is a fundic-sparing laparoscopic surgical treatment for GERD that reconstructs the lower esophageal sphincter in a non-invasive way that preserves normal anatomy. A potential sequela of a fundoplication is the inability to vomit or vent the stomach, which can lead to additional concerns such as the gas-bloat syndrome and excessive nausea. Almost all Linx patients retain the ability to belch and vomit. This patient has GERD as demonstrated by abnormal pH testing. He has persistent symptoms despite being on long-term PPI therapy. LINX has been demonstrated in the peer-reviewed literature to be a safe and effective treatment option that offers several distinct advantages over the traditional laparoscopic Nissen fundoplication. 

The Linx procedure is likely to be more beneficial than any other standard health service and the adverse risk are not increased over other standard services/treatments.

The carrier's denial of Linx system and full hospital admission (procedure code 43284) should be overturned.