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Rachel V. Rose, JD, MBA, advises clients on compliance and transactions in healthcare, cybersecurity, corporate and securities law, while representing plaintiffs in False Claims Act and Dodd-Frank whistleblower cases. She also teaches bioethics at Baylor College of Medicine in Houston. Rachel can be reached through her website, www.rvrose.com.
Compliance measures can assist healthcare industry participants avoid potential liability, whether civil or criminal, under the False Claims Act.
For healthcare industry participants, it is no secret that the False Claims Act remains the Government’s primary tool in fighting fraud perpetrated on a variety of government agencies, the federal fisc, and the taxpayers. Since 1986, recoveries under the civil False Claims Act are now in excess of $62 billion.
The first settlement by the U.S. Department of Justice involves a pharmaceutical company paying kickbacks in violations of the federal Anti-Kickback Statute (AKS), which led to a $12.6 million settlement. What’s notable about this particular situation is that a foundation was illegally used to cover federal beneficiaries’ copays for their own drugs from 2011 through 2014. Specifically, the government alleged that:
The key take-away is that “[p]harmaceutical companies cannot skirt the anti-kickback rules by disguising their inducements to federally-insured patients as charitable donations.” The AKS prohibits direct or indirect remuneration either in cash or in-kind in order to induce referrals or product utilization.
A second settlement involves a False Claims Act case brought by a physician against a hospital and a neurosurgery group for “bill[ing] Medicare for certain doubly and triply concurrent and overlapping surgeries, in violation of applicable regulations and reimbursement policies.” The Government “expect[s] health care providers participating in Medicare to bill for their services accurately and honestly [because] [p]roper billing ensures fair compensation and protects Medicare dollars that are much needed for patient care.” The government recovered $10 Million to resolve allegations and the defendants entered into a corporate integrity agreement, which lasts five years.
Overall, it is clear that healthcare fraud, in a variety of forms, is a priority for the DOJ, as well as other government agencies. Implementing fraud, waste, and abuse training, as well as other preventative compliance measures can assist healthcare industry participants avoid potential liability, whether civil or criminal, under the False Claims Act.