The Sixth Circuit recently made some interesting findings related to the knowledge standard in the False Claims Act (“FCA”) and whether maximizing profits is evidence of fraud.

The knowledge standard in the FCA may create a disincentive for defendants to litigate cases brought by the government, especially considering the standard for liability can be met by the government demonstrating that the defendant acted with reckless disregard or in deliberate ignorance of the truth or falsity of the claim.   See 31 U.S.C. § 3729.  In light of this fairly low standard, it is no secret that some defendants decide it is less costly to settle a case, rather than engaging in protracted litigation with the government.  However, in one recent case the defendant, Renal Care Group, Inc. and its wholly-owned subsidiary, decided to fight back against allegations it defrauded the government of millions of dollars while providing dialysis treatments to Medicare beneficiaries suffering from end-stage renal disease.  Renal Care lost the first battle when the district court granted summary judgment in favor of the United States and awarded the government $82.6 million in damages and penalties.  On appeal, however, Renal Care secured a major victory when the court of appeals reversed the district court’s judgments on grounds that Renal Care did not act in reckless disregard under the FCA.

Without going into the specific facts alleged by the government, there are two important findings from this Sixth Circuit decision worth noting.  First, the Sixth Circuit determined that Renal Care did not act recklessly.  Per the Sixth Circuit, a defendant can be held liable under the FCA by showing that it acted with actual knowledge or constructive knowledge.  United States v. Renal Care Group, et al., No. 11-5779, slip op. at 17 (6th Cir. Oct. 5, 2012).  Constructive knowledge can be proven by demonstrating that the defendant acted in deliberate ignorance of, or with reckless disregard to, the truth or falsity.  One of the facts relied on by the court in reaching its decision on the knowledge requirement is that Renal Care sought legal counsel, who in turn sought clarification from CMS on what appears to be fairly ambiguous regulations.  The court focused on this fact, in addition to some others, in reaching its conclusion that Renal Care did not act recklessly. 

The Government Accountability Office (GAO) issued an interesting report in September that analyzed civil and criminal healthcare fraud cases.  The report is based on 2010 data from the various agencies in the federal government charged with investigating and pursuing healthcare fraud.  For purposes of this blog entry, I’m going to focus on some key numbers on the civil side. 

In 2010, the government investigated a total of 10,187 “subjects.”  Subjects included entities such as hospitals, medical clinics, and pharmacies, as well as individuals that provide services at these entities.

  • Of the 10,187 subjects investigated, 2,339 of the subjects were related to civil investigations, rather than criminal investigations.
  • Of the 2,339 civil investigations, nearly 20% of these were hospitals.  Medical centers or clinics made up another almost 18% of the total 2,339 civil investigations.
  • Of the total 2,339 civil investigations, the government actually pursued cases against 1,087.
  • Of the 1,087 civil cases the government pursued, the government either settled with, or won a judgment against, 55% of these subjects.
  • Of the 55% civil cases that either settled or resulted in a judgment for the government, 44% of these subjects were hospitals or medical facilities (medical practices or clinics).

These numbers are interesting because it shows that hospital or medical facilities make up over one third of all civil investigations and almost half of all settlements.  It is also interesting to look at the number of investigations that were based on qui tam filings.  A qui tam is a civil False Claims Act case brought by a private citizen, “relator” or “whistleblower,” on behalf of the government.  Once a case is filed, the Department of Justice and the Office of Inspector General are charged with investigating and making a determination about whether the government should pursue the case by becoming a party to the litigation.  In many cases, if the government believes the allegations have merit, the government will attempt to settle before actually litigating.

The Director of the Office of Civil Rights (“OCR”), Leon Rodriquez, has made clear that he “absolutely” plans to continue the office’s ongoing efforts to ramp up enforcement of HIPAA with resolution agreements, civil monetary penalties and other enforcement actions.  He has emphasized that privacy and security are issues that “really matter to me personally

Husch Blackwell welcomes Associate Wakaba Y. Tessier to the firm’s Healthcare group in St. Louis. Tessier has concentrated her practice in healthcare law since obtaining her J.D. in 2009, and prior to that worked in the healthcare industry for a pharmaceutical consulting firm.

Husch Blackwell’s Healthcare team continues to expand with Tessier as the fifth addition to the group this year. Emily Park joined the Jefferson City office in September upon receiving her J.D. from the University of Missouri School of Law. Kansas City Partner and former Health and Human Services Senior Counsel Brian Bewley, along with St. Louis Associate Kimela West, joined the firm in July. West had practiced at another firm in St. Louis where her clientele included a major health system with more than 20 hospitals, home health agencies and assisted living facilities. Initiating the hiring trend was Former Hospital Risk Management Director Tina Boschert, who joined the Kansas City office in May.

The American Health Lawyers Association (”AHLA”) noted today the following:  CMS Launches Initiative To Reduce Avoidable Hospitalizations Among Nursing Home Residents 

The Centers for Medicare & Medicaid Services (CMS) announced September 27 cooperative agreement awards to implement a new initiative aimed at reducing avoidable hospitalizations among nursing facility residents.

The awards to seven organizations—Alabama Quality

On September 25, 2012, two members of the Husch Blackwell Healthcare team, Brian Bewley and David Pursell, presented a webinar discussing:

  • An overview of Stark
  • Stark overpayment reporting requirements
  • Steps to take after discovering a potential Stark violation

As former Senior Counsel in the Office of Inspector General for Health and Human Services and

The Texas Health and Human Services Commission (HHSC) passed new and consolidated rules on October 14, 2012. According to the OIG’s counsel, the new rules increase the likelihood of litigation, increase revenue for the state, lower the State fiscal burden and increase the State’s ability to exercise a sanction on providers.
On December 1, 2011

The heads of both the Department of Justice (DOJ) and Department of Health and Human Services (HHS) sent a joint letter on Monday, September 24, to five hospital industry groups, including the American Hospital Association, threatening to prosecute providers that use electronic health records (EHR) to “game” the system and improperly obtain federal monies for