The much-anticipated appellate showdown regarding the constitutionality of the whistleblower (or qui tam) provision of the federal False Claims Act (FCA) took place before a three-judge panel of the Eleventh Circuit Court of Appeals (Judge Elizabeth L. Branch, Judge Robert J. Luck, and Senior District Court Judge Federico A. Moreno, sitting by designation). The panel … Continue Reading
CMS currently treats skin substitutes as biologicals for the purposes of Medicare payment. ….. In the CY 2026 PFS final rule, CMS will pay for skin substitutes under the PFS as incident-to supplies, a change expected to reduce Medicare spending on these products by nearly 90% without compromising patient access or quality of care. We … Continue Reading
The Department of Justice (DOJ) released its annual False Claims Act (FCA) enforcement statistics on January 15, 2025, announcing that it had recovered in excess of $2.9 billion from FCA resolutions during Fiscal Year (FY) 2024 (ending September 30, 2024).… Continue Reading
As we anticipated in our October 17, 2024, blog, both the Government and the Relator have appealed the district court’s decision in U.S. ex rel. Zafirov v. Florida Medical Associates, LLC, et al. (Zafirov), the first case to hold that the qui tam provision of the federal False Claims Act violates the Appointments Clause of … Continue Reading
The latest Special Fraud Alert from the U.S. Department of Health and Human Services Office of Inspector General (OIG) warns about marketing schemes involving questionable payments and referrals among Medicare Advantage plans, health care professionals, and third-party marketers, such as agents and brokers. Issued on December 11, 2024, this new Special Fraud Alert focuses on … Continue Reading
For the first time ever, a judge has ruled that the qui tam provision of the False Claims Act (FCA), which whistleblowers have used to recover $52 billion on behalf of the government since 1986, is unconstitutional. … Continue Reading
How could alleged kickbacks threaten to render insolvent a publicly traded company with assets (taken from its latest SEC filing) in excess of $43 billion? The answer stems from a recent decision by the United States District Court for the District of Massachusetts. In its ruling denying the motion for summary judgment filed by defendants … Continue Reading
On June 27, 2023, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued its long-anticipated final rule amending the OIG’s civil monetary penalty (CMP) regulations as they relate to information blocking (CMP Final Rule or Rule). The CMP Final Rule was published in the Federal Register on July 3, 2023. … Continue Reading
For the second time this month, the United States Supreme Court addressed a circuit split involving the False Claims Act (FCA, 31 U.S.C. §§ 3729 – 3733). Earlier, in the SuperValu decision (discussed in a recent Health Law Rx Blog), the Court clarified that subjective intent is relevant in determining whether an objectively reasonable (but … Continue Reading
Yesterday, the United States Supreme Court held that a False Claims Act (FCA) defendant cannot rely on an objectively reasonable interpretation of a law, regulation, or rule to negate the scienter element of the FCA. In United States ex rel. Schutte v. SuperValu Inc., the Court emphasized the importance of a defendant’s subjective belief in … Continue Reading
There are multiple components to the risk defendants must consider when faced with going to trial for a matter involving the False Claims Act (FCA). Setting aside the incalculable impact that litigation can have on business operations, the statute itself anticipates repayment of the proven overpayment, treble damages, and exposure to a civil statutory penalty … Continue Reading
What does it mean to “knowingly” or “recklessly” violate the law when that law consists of highly complex and ever-changing regulations, which may be open to interpretation? The U.S. Supreme Court recently agreed to review that question in two consolidated cases from the Seventh Circuit: U.S. ex rel. Tracy Schutte, et al. v. SuperValu Inc., … Continue Reading
Two recent multi-million dollar False Claims Act (“FCA”) settlements demonstrate the vigor with which the Department of Justice (“DOJ”) is investigating and prosecuting allegedly fraudulent health care billing practices. These large settlements demonstrate how imperative it is that providers routinely review billing practices with the guidance of counsel.… Continue Reading
To facilitate the provision of care during the pandemic, the federal government and many state governments enacted changes that encouraged physicians and other nonphysician practitioners (collectively, Practitioners) to use telehealth services. While this new flexibility increased access to care, it also increased opportunities for fraud. On July 20, 2022, the U.S. Department of Health and … Continue Reading
Currently, providers have different risks of potential False Claims Act (“FCA”) liability depending on where they are geographically located due to the difference in the standards required by the U.S. Courts of Appeals regarding the level of specificity when relators (whistleblowers) plead FCA violations. The FCA imposes civil liability on any person requesting government funds … Continue Reading
For the first time since 2013, on November 8, 2021, the Department of Health and Human Services Office of Inspector General (“OIG”) updated its Health Care Fraud Self-Disclosure Protocol (“SDP”). The updated SDP makes several important revisions and clarifications that directly impact providers and suppliers who seek to self-disclose potential violations of healthcare fraud statutes … Continue Reading
The U.S. Department of Justice (“DOJ”) has settled six qui tam lawsuits brought in various jurisdictions by whistleblowers against a private equity firm and its portfolio healthcare companies. A group of diagnostic testing companies and the private equity firm, which held a minority investment interest in the parent, settled claims that they violated the False … Continue Reading
Novartis Pharmaceuticals Corporation (Novartis) has started July with significant settlements, putting two different fraud and abuse matters behind them. In what has been identified as the largest settlement of an Anti-Kickback Statute lawsuit brought by a whistleblower pursuant to the False Claims Act’s (FCA) qui tam provision, Novartis, a pharmaceutical company based in East Hanover, … Continue Reading
Many employers are now making plans to have their employees return to the workplace. Based on recent alerts from the FBI, part of preparing to protect workers from COVID-19 at work should include protecting the company from falling prey to fraudsters. To do that, employers should put in place procedures to carefully screen vendors from … Continue Reading
The Department of Justice announced on June 27, 2019 that David Brock Lovelace, the owner of DBL Management LLC, was found guilty by a federal jury in the U.S. District Court for the Middle District of Florida of conspiracy to pay healthcare kickbacks and structuring currency transactions to avoid reporting requirements. According to the evidence … Continue Reading
The Florida Legislature recently passed HB 369 (the Bill), which would tweak an important provision of the Florida Patient Brokering Act, Section 817.505 of the Florida Statutes (Patient Brokering Act). It seeks to clarify the exception to the Patient Brokering Act which incorporated by reference the criminal provisions of the federal Anti-Kickback Statute (42 U.S.C. … Continue Reading
Last month, in a unanimous decision, the U.S. Supreme Court ruled that the analysis of the applicable statute of limitations under the False Claims Act (FCA) as set forth in 31 U.S.C. § 3731 is the same regardless of whether the government intervenes in the action or not. While the decision is not likely to … Continue Reading
With an overwhelming amount of bi-partisan support, on May 7, 2019, Georgia enacted the Pharmacy Anti-Steering and Transparency Act, O.C.G.A. §26-4-119 (the GA Act). The GA Act goes into effect as of January 1, 2020. As healthcare providers are well aware, prohibitions against self-referrals are not new – federal and state laws prohibiting self-referrals by … Continue Reading
The Eleventh Circuit Court of Appeals, in its ruling in Cochise Consultancy Inc. v. U.S. ex rel. Hunt, created a 3-way circuit split regarding the determination of the applicable statute of limitations period in a False Claims Act (FCA) case. On March 19, the United States Supreme Court will hear oral argument on the matter, … Continue Reading
