Although this blog focuses mainly on the federal False Claims Act (FCA), other antifraud statutes feature in the qui tam relator and government enforcement toolkit. Key among them: the California Insurance Frauds Prevention Act (IFPA).
FCA Lawsuit Against Walgreens Dismissed Because Government Fails to Plead Materiality
On December 2, the U.S. District Court for the Western District of Virginia granted a motion to dismiss a False Claims Act (FCA) lawsuit brought by the United States and the Commonwealth of Virginia, which alleged that a Walgreens clinical pharmacy manager falsified hepatitis C drug prior authorization submissions to Virginia Medicaid. See United States v. Walgreen Co., 2021 WL 5760307 (W.D. Va. Dec. 3, 2021).
DOJ Releases 2021 FCA Civil Monetary Penalties Inflation Adjustment
On December 13, the Department of Justice (DOJ) published its Final Rule on the Civil Monetary Penalties Inflation Adjustment for 2021. Under the Bipartisan Budget Act of 2015, the DOJ annually adjusts for inflation civil monetary penalties provided by law that are within the jurisdiction of the DOJ, with respect to violations occurring after November 2, 2015.
Under the 2021 annual adjustment, the minimum False Claims Act penalty assessed per violation occurring after December 13, 2021, will be not less than $11,803 and not more than $23,607. This per violation statutory penalty is in addition to the statutory penalty of three times the amount of damages which the government sustains because of the violation. 31 U.S.C. 3729(a)(1). The below chart snippet from the final rule shows the increase in penalties due to inflation from 2016 to 2021.
If you have any questions related to the calculation of penalties under the False Claims Act, please contact the authors of this post.
Seventh Annual Healthcare Fraud Conference Highlights Key Risk Areas and Enforcement Developments for Healthcare Providers
Bass, Berry & Sims and the Tennessee Hospital Association hosted the Seventh Annual Healthcare Fraud Conference on December 1 and 2. The virtual conference featured more than 40 speakers and 500 attendees from over 40 states and the District of Columbia.
“The healthcare industry remains under intense scrutiny, making it more important than ever for providers to stay up to date on the latest developments concerning the FCA and fraud and abuse,” said Brian Roark, chair of the Bass, Berry & Sims Healthcare Fraud Task Force. “This conference examines those developments, provides practical solutions, and forecasts the most pressing issues ahead for healthcare providers.”
Topics Covered During Conference
Day 1 sessions covered conducting effective investigative interviews, navigating privilege issues in investigations, building effective compliance programs, navigating challenges posed by whistleblowers, understanding recent Stark Law and Anti-Kickback Statute developments, and False Claims Act self-disclosure considerations.
Day 2 kicked off with a review of the past year’s key healthcare fraud developments and looked at the future of the False Claims Act. Other sessions covered litigating healthcare fraud enforcement cases, provider relief fund audits and investigations, navigating contractor audits and administrative enforcement remedies, and hot topics in healthcare fraud. The day concluded with a 90-minute healthcare fraud hypothetical.
Click to access a recording of the conference. On-demand CLE is available for those that are interested.
Bass, Berry & Sims Included Among Leading FCA Defense Firms
Bass, Berry & Sims was recently recognized among leading False Claims Act (FCA) defense firms based on the number of FCA lawsuits in which the firm appeared on behalf of clients during the time period of 2016 through 2020. The third-party report was based on a review of federal court docket entries in FCA lawsuits throughout the country and listed firms based on the number of lawsuits and number of judicial districts in which the firms had appeared.
Continue Reading Bass, Berry & Sims Included Among Leading FCA Defense Firms
[Virtual Event] 7th Annual Healthcare Fraud Conference
The 7th Annual Healthcare Fraud Conference was hosted by Bass, Berry & Sims and the Tennessee Hospital Association. Because we are unable to provide an in-person forum due to ongoing concerns resulting from the COVID-19 pandemic, we once again hosted the conference virtually.
This year’s complimentary CLE program, provides the same caliber of practical advice, insight into significant fraud and abuse issues facing healthcare professionals, and thoughtful discussion from industry panelists for which this conference is known.
Topics include:
- Healthcare Fraud Year in Review
- Hot Topics in Healthcare Fraud: Today and Tomorrow
- The Future of the False Claims Act
- Provider Relief Fund Audits and Investigations
- Navigating Corporate Integrity Agreements and Administrative Remedies
- Litigating Healthcare Fraud Enforcement Cases
- Stark Law and Anti-Kickback Statute Enforcement Developments
- FCA Self-Disclosure Considerations
This year’s conference was held on Wednesday, December 1 and Thursday, December 2. To watch the conference on-demand, please click here.
Click here to view the agenda and presenters.
Continue Reading [Virtual Event] 7th Annual Healthcare Fraud Conference
DOJ Expands False Claims Act Reach into Cybersecurity
There is a new weapon in the Department of Justice’s (DOJ’s) already powerful False Claims Act (FCA) arsenal. In October 2021, the DOJ announced a new Civil Cyber-Fraud Initiative, under which it will pursue FCA liability against government contractors in the cybersecurity space. According to the announcement from Deputy Attorney General Lisa O. Monaco, the initiative seeks to “hold accountable entities or individuals that put U.S. information or systems at risk by knowingly providing deficient cybersecurity products or services, knowingly misrepresenting their cybersecurity protocols, or knowingly violating obligations to monitor and report cybersecurity incidents and breaches.”
Overview of the Civil Cyber-Fraud Initiative
The Civil Cyber-Fraud Initiative follows several significant cyberattacks, which are only becoming more prevalent. The new initiative is the first formal step DOJ has taken in combatting them by focusing on the preventative cybersecurity efforts of government contractors.
Continue Reading DOJ Expands False Claims Act Reach into Cybersecurity
[WEBINAR] Pfizer v. OIG – A Showdown: Prosecutions Involving Patient Assistance Programs
Pfizer lost a legal battle focused on the company’s financial assistance program against the Department of Health and Human Services Office of Inspector General (OIG) in the U.S. District Court for the Southern District of New York. The agency denied the pharmaceutical company’s request to vacate an OIG advisory opinion that effectively precludes the manufacturer from providing financial assistance directly to certain patients prescribed the manufacturer’s drug. The court also denied the manufacturer’s request for a declaratory judgment that the manufacturer’s contributions to an existing charity — which would use the funds to assist certain patients with their copayments for the manufacturer’s drug — do not violate the Anti-Kickback Statute.
Join us for a webinar on Tuesday, November 9 at 11:00 a.m. CT as we provide insight on the ruling and how the opinion’s wording may leave the door open to drugmakers to challenge unfavorable advisory opinions in the future. Click here to register.
During this webinar, we will cover the following topics:
- Overview of OIG’s historical guidance on patient financial assistance.
- DOJ’s enforcement actions against PAPs and manufacturer donors.
- OIG Advisory Opinions on direct patient assistance.
- Pfizer’s suit against HHS-OIG.
- Best practices when structuring patient assistance programs.
Who Should Attend?
- In-house legal counsel.
- Compliance officers.
- Privacy officers.
Accreditation
Tennessee CLE
This program has been approved for 1.5 hours general Tennessee CLE credit. Please provide your BPR number upon registration in order for Bass, Berry & Sims to report your participation to the Tennessee CLE Commission following the conference.
Other State CLE
Bass, Berry & Sims does not seek direct accreditation from states outside of Tennessee, but some states allow attorneys to earn credit through reciprocity or self-submission. Certificates of completion and other common supporting documents will be provided for use in jurisdictions outside of Tennessee.
Questions?
Submit questions for presenters upon registration or email them to Tara Swint.
Trio of False Claims Act Retaliation Rulings from September
The False Claims Act (FCA) prohibits employers from retaliating against whistleblowers who report FCA violations. 31 U.S.C. § 3730(h). To plead a claim under this anti-retaliation provision of the FCA, an employee must show the following three elements:
- The employee engaged in protected activity.
- The employer knew the employee engaged in protected activity.
- The employer took an adverse action against the employee as a result of the employee’s protected activity.
Courts state and apply these basic elements slightly differently, and this post examines three rulings from district courts across different circuits at the end of last month.
Vaughn v. Harris County Hospital District
On September 29, the District Court for the Southern District of Texas adopted the memorandum and recommendation of the magistrate judge denying the motion to dismiss a former employee’s retaliation claim, holding he satisfied his pleading requirements.
Continue Reading Trio of False Claims Act Retaliation Rulings from September
Reminder: When Are Communications with Corporate Counsel Privileged?
To foster open and honest communications with counsel, it is critically important that those communications are protected from disclosure by the attorney-client privilege. But, not every communication with counsel is privileged, and knowing when a communication with counsel is protected can sometimes prove difficult. Given an increasingly complex regulatory landscape, more and more attorneys—particularly in-house attorneys—are wearing dual hats as both lawyers and business advisors. As a lawyer, communications may be privileged; but if acting as a business advisor, communications may be subject to disclosure.
Since the corporate setting doesn’t lend itself to bifurcating legal and business communications, what happens when the lines are blurred or when a communication serves both purposes?
The “Primary Purpose” Test
Many courts, like the U.S. Courts of Appeal for the Second, Fifth, Sixth, and D.C. Circuits, require that for a communication to be protected by the attorney-client privilege, the “primary purpose” of the communication must be to give or receive legal advice. Attorney-client privilege does not apply to business, commercial, or tax advice. Under this method of analysis, courts look to the content of a communication to determine its predominant or primary purpose.
Continue Reading Reminder: When Are Communications with Corporate Counsel Privileged?