Bay Area’s uBiome the Focus of an FBI Investigation into Billing Practices
According to the Wall Street Journal, the Federal Bureau of Investigation visited the offices of uBiome last week. An unnamed source told the Journal that the law enforcement agency search was related to uBiome's billing practices. However, what those concerns are have not been shared publicly, the Journal said. Not only is the FBI looking into uBiome’s billing practices, but the Journal also reported that the California Department of Insurance is also looking at the Bay Area-based company’s billing practices as well. Some uBiome patients told The Wall Street Journal they spoke to California authorities about matters including the role of doctors who ordered the tests.
Among the complainants is Damian Moskovitz, a uBiome consumer. The Journal noted that Moskovitz filed a complaint about the doctors with the Medical Board of California and also filed a complaint about his uBiome experience with the California Department of Insurance. Moskovitz said he was interested in using the tests to monitor chronic health problems. According to the report, Moskovitz said he filled out a uBiome checklist regarding gastrointestinal symptoms he was experiencing. The Journal said doctors who reviewed his responses approved the uBiome tests without having contacted him, before doing so. Moskovitz said his health-insurance information was requested, the Journal reported.
Citing an unnamed official with the California insurance industry, the Journal stated that some of the tests that uBiome sells were billed to patients with private Medicare plans. Billing government plans for tests that are not deemed medically necessary may violate federal laws, the Journal said.
uBiome said it "does not have any control over physician billing. Any improper billing by physicians, if it occurred, is not related to uBiome's billing practices,” the Journal said. A uBiome spokesperson told BioSpace that the company is “cooperating fully with federal authorities on this matter. We look forward to continuing to serve the needs of healthcare providers and patients.”
uBiome, which was founded in 2012, uses advanced technology to analyze human microbiome. The company has four primary consumer products, SmartGut, SmartJane, Explorer and Explorer Plus. Explorer is a consumer product that helps people understand the role that food and lifestyle can play in gut wellness
SmartGut is a stool test that identifies microbes in the gut for patients with chronic gut conditions such as IBD, IBS, Crohn’s Disease and ulcerative colitis. SmartJane is a women’s health test that genotypes all 19 clinically relevant strains of HPV, identifies four common sexually transmitted diseases (chlamydia, gonorrhea, syphilis, and mycoplasma genitalium), and surveys more than 20 vaginal microbes associated with bacterial vaginosis and other conditions.
In March, uBiome and L’Oréal entered into a partnership to continue longtime research into skin microbiome. The two companies intend to conduct new research on the skin's bacterial ecosystem. The partnership came several months after uBiome announced it had cut 10 percent of its staff as the company underwent a realignment to expand its focus in therapeutics. In September 2018, uBiome secured $83 million in a Series C financing round. The Series C financing was earmarked for the shift toward the focus on patients with chronic gut conditions such as IBD, IBS, Crohn’s Disease and ulcerative colitis.