Looking back in time, the compliance field owes a lot to the healthcare industry. In the 1990s, there was a dramatic explosion in the industry in response to aggressive federal enforcement programs and increasing regulation. All of a sudden, compliance officers who sat in the backrooms of legal departments were “volunteered” to address proactive compliance. Federal regulators pushed the compliance function to assume a much...
Corporate compliance programs in the healthcare industry include many of the same elements that we are all familiar with – risk assessments, code of ethics, written policies and procedures, comprehensive training requirements, confidential reporting and investigation systems to address employee concerns, gifts, meals, grants, and medical education programs, and audit and review processes to maintain a continuous improvement program. Aside from this standard list of...
If you are a compliance officer for a healthcare provider (e.g. hospital, HMO, skilled nursing facility, hospice center), you must sometimes feel that no one understands or feels your pain. When you consider the number and extent of risks, it can be mind-boggling. I am sure there are times that compliance officers in the healthcare industry look wistfully or even with envy at a compliance...
The Supreme Court , in a unanimous decision, rejected a challenge by corporate pharmacy defendants, to the intent requirement in a Medicaid and Medicare over-billing False Claims Act case. Justice Clarence Thomas, who has established himself as the lead justice concerning False Claims Act cases, wrote the unanimous opinion. The defendants, SuperValu and Safeway, claimed that thier alleged overbilling did not meet the intent requirements...
The Justice Department continues to pile up healthcare enforcement actions — false claims, anti-kickback, and fraud. DOJ is on its way to a record year. In a recent enforcement action, Modernizing Medicine (“ModMed”), an electronic health record (“EHR”) vendor, agreed to pay $45 million for AKS and False Claims Act violations for receiving bribes in exchange for referrals and causing users to falsely report information...
We always focus on foreign bribery — the FCPA and corporate bribery of foreign officials. It is certainly a problem that undermines economic development and human rights. However, bribery and corruption is real and significant in the United States, from local to state to federal government officials, the news is filled with instances of bribery and corruption. Wherever there is money flowing, there is sure...
The Biden Administration warned the healthcare industry that it would aggressively prosecute fraud cases. The Justice Department is executing on that promise and doing so with great success. Week after week, we read about False Claims Act settlement with multi-million dollar penalties. We barely hear much about healthcare compliance innovation and strategies — the industry is clearly treading water when it comes to proactive compliance...
When it comes to the healthcare sector, the Justice Department and the HHS-Office of Inspector General have no shortage of investigations and targets for prosecution. The more resources made available to DOJ and HHS-OIG, the more money made for the federal government from medical care fraud. It is a very simple equation. It is like shooting fish in a barrel. BioReference and OPKO Health, Inc....
False Claims Act prosecutions continue against healthcare executives, physicians and professionals. Last year, DOJ recovered over $5.6 billion in FCA enforcement. DOJ expects total recoveries to increase in 2022. Over 95 percent of False Claims Act prosecutions involved healthcare fraud and kickbacks. Two Doctors and Eight Others Indicted for Healthcare Kickbacks In a recent prosecution in the Northern District of Texas, DOJ announced the indictment...
As for the Judiciary, the U.S. Supreme Court did not issue any relevant decisions nor grant certiorari in any notable FCA cases in FY21. To the contrary, they denied petitions to review appellate cases of potential significance (e.g., in June 2021 the Supreme Court declined to review a case from the Seventh Circuit regarding the government’s ability to move to dismiss over a relator’s objection)....
