Husch Blackwell’s False Claims Act team previously covered the results of a rare False Claims Act (FCA) trial in which a federal jury found that a surgical product distributor was liable for paying kickbacks to physicians. The federal judge overseeing that trial initially entered judgment against the distributor defendants for $487 million after trebling the government’s actual damages and then adding penalties for each kickback-tainted claim.

On February 8, 2024, however, that same federal judge amended the judgment over concerns that the statutory penalties were unconstitutionally excessive. This article highlights the issue and explains what those accused of violating the FCA can learn from this decision.Continue Reading Federal Court Reduces FCA Penalties by 82 Percent Because of Excessive Fines Clause Concerns

The Supreme Court’s unanimous decision in Universal Health Services, Inc. v. United States ex rel. Escobar, No. 15-7 (U.S. June 16, 2016) upholds the viability of the implied certification theory of False Claims Act liability. But it also makes cases arising from minor instances of noncompliance much harder to prove. The Court held that a knowing failure to disclose a violation of a material statutory, regulatory, or contractual requirement can create False Claims Act liability. The requirement need not be an express condition of payment, but it must be material to the government’s decision to pay.
Continue Reading New standard of proof for implied certification liability under FCA

A New York district court issued the first judicial opinion Monday, Aug. 3 on the Affordable Care Act’s “60-day rule,” which requires that a Medicare or Medicaid overpayment be reported and returned within 60 days of the date on which the overpayment was “identified.” The decision by Judge Edgardo Ramos provided a definition of what it means to “identify” an overpayment and thus begin the 60-day time period in which overpayments must be reported and returned. Given that the 60-day rule maintains that any person who knowingly fails to comply with this obligation within the 60-day timeframe has violated the False Claims Act (“FCA”), the potential implications of Judge Ramos’s decision are significant.
Continue Reading District court interprets ‘identification’ of overpayment under 60-day rule

Due diligence is often perceived as a mundane part of the mergers & acquisitions (M&A) process, but its importance in healthcare transactions is critical. Due diligence is one of the first steps of any transaction and involves a buyer undertaking an in-depth examination of the target to evaluate the business and uncover potential issues or liabilities. In the healthcare industry, diligence is especially important considering the heavy regulation of the industry, the unique areas of risk, and the significant liabilities that could be imposed upon a buyer if issues and liabilities are not identified before the transaction closes.
Continue Reading Unique Considerations in Healthcare M&A Part 1 – Due Diligence

The U.S. Department of Justice (DOJ) and the New York State Attorney General intervened in a federal False Claims Act (FCA) case on June 27, 2014, accusing Mount Sinai Health System of failing to report and return Medicaid overpayments within 60 days of identifying them. See U.S. ex rel Kane v. Healthfirst, Inc., et al., No. 11-2325 (S.D.N.Y). This case is one of the first examples of litigation involving “the 60-day repayment provision” under the Affordable Care Act (ACA).
Continue Reading DOJ intervenes in first False Claim Act case involving ACA ’60-day repayment provision’