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.

“We are pleased to be recognized as among the leading defense firms handling False Claims Act litigation,” said Brian Roark, who chairs the firm’s Healthcare Fraud Task Force. “We believe it speaks to the confidence clients have in our False Claims Act and government enforcement practices that we have been engaged to defend healthcare providers and government contractors in significant government investigations and litigation throughout the country.”

Since the Patient Protection and Affordable Care Act (PPACA) was signed into law in March 2010, there has been a significant proliferation of FCA litigation, particularly involving healthcare providers. During that time, Bass, Berry & Sims has represented clients in more than 50 FCA investigations and related FCA lawsuits in judicial districts across more than 25 states. These cases have resulted in some of the leading FCA appellate decisions, including key decisions by the U.S. Courts of Appeal in the Fourth, Sixth, Eighth and Ninth Circuits, and numerous district court opinions throughout the country in which the firm has successfully convinced district courts to dismiss FCA lawsuits against firm clients.

Continue Reading Bass, Berry & Sims Included Among Leading FCA Defense Firms

Please join us for the 7th Annual Healthcare Fraud Conference 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 are once again hosting the conference virtually.

We are excited about this year’s complimentary CLE program, which will provide 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 will 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 will be held on Wednesday, December 1 from 1:00 p.m. – 5:00 p.m. CT and Thursday, December 2 from 8:00 a.m. – 2:00 p.m. CT. To register, please click here.

Click here to view the agenda.

Continue Reading [Virtual Event] 7th Annual Healthcare Fraud Conference

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

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.

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

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?

One of the Department of Health and Human Services (HHS) Office of Inspector General’s (OIG’s) key compliance priorities is modernizing the agency’s program integrity and compliance information.

OIG has explained that its goals for this priority are to continue producing timely and useful resources and to make the resources it provides easier to access and use, to spur innovation and improve compliance programs.  On September 22, in furtherance of these goals, OIG posted a request for information (RFI) on its website.

OIG Seeks to Understand Value of Its Resources

Although all of the guidance available on OIG’s website remains “good guidance,” many of the resources have not been updated in decades.  In addition, advancements in technology now allow stakeholders to manage and operationalize data and information in previously unavailable ways.  Through the RFI, OIG seeks input from the healthcare industry and the public on a wide range of issues, including how stakeholders use OIG’s resources, as well as how to improve the value and timeliness of those resources.

Continue Reading OIG Publishes Wide-Ranging Request for Information

Please join us for the Compliance & Government Investigations Seminar hosted by Bass, Berry & Sims and FTI Consulting. Due to ongoing COVID-19 concerns, this event will be virtual only.

We are excited for this year’s complimentary CLE program, which will provide the same caliber of practical advice, insight into government developments, and thoughtful discussion from industry panelists you have come to expect from this seminar. This year’s topics include:

  • Inside Scoop: Top Issues In-House Counsel Currently Face
  • Update on International Trade Regulations and Enforcement
  • SEC Update: Key Enforcement and Regulatory Priorities
  • Running an Investigation
  • Antitrust Is Back: DOJ and FTC Signal Significant Increase in Antitrust Enforcement
  • Data Privacy Update
  • Healthcare Fraud Enforcement Updates
  • Hot Topics in Procurement Fraud in 2021 and Beyond
  • COVID-19 Funding Fallout: Preparation for Government Scrutiny

This year’s seminar will be held from 8:30 a.m.–3:45 p.m. CDT on Tuesday, September 28. To register, please click here.

Click here to view the agenda.

Continue Reading [Virtual Event] 8th Annual Compliance & Government Investigations Seminar

The U.S. Court of Appeals for the Seventh Circuit recently joined the ranks of every other circuit court of appeal to have considered the issue in holding that the False Claims Act (FCA) requires an objective scienter standard.  Under this standard, defendants who act under an incorrect interpretation of the relevant statute or regulation do not act “knowingly” under the FCA if both of the following are true:

  1. The interpretation was objectively reasonable.
  2. “Authoritative guidance” did not warn the defendant away from their interpretation.

Background on Objective Scienter Standard

The FCA imposes liability on those who “knowingly” submit false claims to the government. The term “knowingly” is statutorily defined to cover defendants who act with “actual knowledge,” “deliberate ignorance,” or “reckless disregard.”

In construing the scienter requirement of the Fair Credit Reporting Act (FCRA) in Safeco Insurance Co. of Am. v. Burr, which punishes “willful” violations, the Supreme Court analyzed the common-law definition of that term and noted that willfulness as a statutory condition of civil liability has generally been understood to cover both knowing and reckless violations of a standard.  The Court then held that a defendant interpreting an ambiguous statute or regulation did not act with “reckless disregard” where their interpretation was objectively reasonable and no authoritative guidance warned them away from their interpretation.

Continue Reading Seventh Circuit Holds FCA Requires Objective Scienter Standard

On July 26, Senator Chuck Grassley (R-IA) introduced a long-promised bill to amend the False Claims Act (FCA).  Not-so-creatively entitled the False Claims Act Amendments Act of 2021 (S.B. 2428), the proposed legislation is notably co-sponsored by a prominent—and bipartisan—group of senators.  The text of the bill, available here, would most importantly bring changes to the analysis of the FCA’s materiality element while also affecting the process through which defendants may obtain discovery from the government.

According to a press release issued by Senator Grassley, the legislation is mainly intended to “clarif[y] the current law following confusion and misinterpretation of the Supreme Court decision in United Health Services v. United States ex rel. Escobar.”  As we have previously covered at length (in blog posts dated June 23, 2016; March 20, 2020; April 8, 2020; and June 25, 2021) the U.S. Supreme Court’s 2016 decision in Escobar confirmed that the FCA’s materiality element is “rigorous” and “demanding,” and that it cannot be satisfied simply by showing that the government would have had the “option” to decline payment had it known the facts underlying an allegedly fraudulent claim.

Instead, Escobar focuses the materiality inquiry on the government’s actual or likely response to alleged fraud: if the government regularly pays similar claims with knowledge of the facts, that is “strong evidence” that the alleged misrepresentations are not material; on the other hand, if the government often denies payment under similar circumstances, that supports a finding of materiality.

In Senator Grassley’s view, however, Escobar has given way to “confusion” and “misinterpretation” that “has made it all too easy for fraudsters to argue that their obvious fraud was not material simply because the government continued payment.”   Consistent with that view, the proposed legislation appears calculated to make materiality-based dismissals—as well as other kinds of dismissals—more difficult for FCA defendants to obtain.  Whether it would succeed in that aim, however, is open to debate.

Continue Reading Changes Coming to the FCA?  Proposed Amendments Would Impact Materiality Analysis, Government Discovery, Among Other Issues