The U.S. FDA said in an April 27 letter to health care providers that the post-approval study for the Orbera intragastric balloon by Apollo Endosurgery Inc., of Austin, Texas, returned a hyperinflation rate of 2.3% (six out of 258 patients), and that the associated symptoms emerged between one and 23 weeks after inflation. Four of the six patients who experienced inflation required device removal, one of which was not associated with any symptoms. There were no reports of pancreatitis associated with the Orbera in this study. Clinicians are advised to monitor patients for symptoms “during the entire duration of treatment,” stating that pancreatitis is among the symptoms of hyperinflation. The data for the Reshape balloon included no instances of hyperinflation, although pancreatitis was seen in two of 159 patients (1.3%). While no deaths were reported in association with either device in either of these post-approval studies, 18 deaths worldwide have been reported since 2016, eight of which were reported in the U.S., five of which were reported with the Orbera device. Apollo Endosurgery ceased distribution of the Reshape in January 2019.
The U.S. Court of Appeals for the Federal Circuit affirmed a district court decision dismissing a motion for judgment as a matter of law filed by Ariosa Diagnostics and Roche Molecular Systems in their patent dispute with Illumina Inc. and Verinata Health Inc. The case revolves around the 7,955,794 patent for DNA assay optimization, and the outcome affirms Illumina’s previous $26.7 million win in a suit that commenced in 2014.
The Medicare Payment Advisory Commission (MedPAC) said in an April 22 letter to the Centers for Medicare and Medicaid Services that CMS should focus on changes to the Comprehensive Care for Joint Replacement (CJR) model that “could generate net savings for the Medicare program” instead of redistributing the entirety of the savings to participating providers. The CMS had recently announced an extension of the CJR program, which will have been in force for eight years at the conclusion of that extension. MedPAC said the evidence in support of this and other bundled payment programs as a method of reducing per-episode spending without harming quality of care “is already quite strong,” adding that this evidence also supports an expansion of the program nationally. The Commission also recommended that the working model be re-expanded to the 67 standard metropolitan statistical areas that were originally included in the scope of the program.