The 40 HAIs in 2016 included the healthcare sector and included medical and clinical practices (13), elderly and home care (13), hospitals and healthcare systems (6), medical device manufacturers (3), distributors and suppliers (2), dental practices (2) and pharmacies (1).4 In particular, despite at least four significant doj comparisons with pharmaceutical manufacturers in 2016, none resulted in a new or modified CIA (although one with B. Braun Medical, Inc. included CIA-like compliance obligations in a non-criminal prosecution agreement). The comparison with Byram resolves the same requests for catalog funding, as well as allegations that Byram received numerous bribes in 2012 and 2013 from Hollister and three other manufacturers of stoma and continuation care products, namely Coloplast Corp., Montreal Ostomy and Safe N`Simple, in exchange for Byram`s consent to conduct advertising campaigns and send patients to the manufacturers` products. The comparison with Byram also resolves allegations from the U.S. and the State of California that Byram filed falsely inflated claims against California`s Medi Cal program, which is contrary to California`s Billing Limit Cap Executive Order, Cal. Code Regs., tit. 22, § 51008.1, which limits the amount a supplier can charge for certain products. The United States and the State of California assert that Byram, when Byram charges Medi-Cal for Coloplast urology products sold by Byram to Medi Cal beneficiaries, knowingly failed to account for the significant discounts that Byram knew at the time of billing for the Medi-Cal program, it was significantly reducing the prices it paid for the products. As part of the False Claims Act transaction, Byram also entered into a corporate integrity agreement with the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG). The agreement also provides for penalties for late submissions, errors and omissions, and compliance violations.
In 2007, the companies reportedly reached an agreement where Hollister Byram would pay the costs of cash incentives granted to its sales reps for any new order of Hollister rings and barrier strips. In 2012, the companies reportedly struck another deal under which Hollister paid cash incentives for Vice President Byram, who led the highest annual revenue growth for Hollister catheters. And from 2009 to 2014, Hollister was paying US$200,000 a year to “catalog financing” to incentivize Byram`s recommendation on its products, according to the settlement agreement. The company entered into a five-year corporate integrity agreement as part of the transaction. Recently, ResMed Corp. agreed to pay more than US$37.5 million to remedy alleged violations of the False Claims Act for paying bribes to durable medical equipment (EMR) suppliers, sleep labs and other healthcare providers, which is contrary to anti-kickback status. They also entered into a corporate integrity agreement. All agreements must be tracked through a centralized contract tracking system and a distribution reporting system that includes an authorization process for all contracts. The agreement settles five complaints filed by whistleblowers under the provisions of qui Tam of the False Claims Act. These whistleblowers will together receive an estimated $6.2 million share in the transaction. The published settlement agreements described allegations of misconduct over a period from 2007 to 2014.
In this case, it was alleged that Hollister bribed Byram to promote his medical devices, which is contrary to the ban on bribes to Medicare and Medicaid. Benjamin C. Mizer, head of the DOJ`s civilian unit, said in a statement: Dean W. Milligan arrived in Byram in 2017. He has extensive experience in the fields of healthcare, distribution, finance and the revenue cycle, with a proven track record. Nick joined Byram in 2007. An experienced leader in health information systems, Nick`s daily goal is to advance technology to support business growth while facilitating healthcare for our clients. . . .