Archives: Anti-Kickback Statute

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DOJ Settlement with Home Health Providers Underscores Strategic Considerations for Self-Disclosure

Eventually, any health care organization with an effective compliance program is very likely to discover an issue that raises potential liability and requires disclosure to a government entity. While we largely discuss False Claims Act (FCA) litigation and defense issues on this blog, a complementary issue is how to address matters that raise potential liability … Continue Reading

Recent Developments on the Fair Market Value Front – Part 1

Over the last several months, a handful of federal court decisions—including two rulings this summer on challenges to the admissibility of proposed expert testimony—serve as reminders of the importance of (and parameters around) fair market value (FMV) issues in the context of the Anti-Kickback Statute (AKS) and the False Claims Act (FCA). First, a quick … Continue Reading

False Claims Act Settlement with eClinicalWorks Raises Questions for Electronic Health Record Software Vendors

On May 31, 2017, the US Department of Justice announced a Settlement Agreement under which eClinicalWorks, a vendor of electronic health record software, agreed to pay $155 million and enter into a five-year Corporate Integrity Agreement to resolve allegations that it caused its customers to submit false claims for Medicare and Medicaid meaningful use payments … Continue Reading

A Hospital’s Deserving Stark and AKS Victory—But At What Cost?

This April, providers cheered when a federal district court in the Middle District of Florida found insufficient evidence to support a relator’s theory that a hospital had provided free parking to physicians, in violation of the Stark Law and Anti-Kickback Statute (AKS). In the Report and Recommendation for United States ex rel. Bingham v. BayCare … Continue Reading

New OIG Rules Change Patient Incentive Program Landscape: Where Are the Limits Now?

With health care becoming more consumer-driven, health care providers and health plans are wrestling with how to incentivize patients to participate in health promotion programs and treatment plans. As payments are increasingly being tied to quality outcomes, a provider’s ability to engage and improve patients’ access to care may both improve patient outcomes and increase … Continue Reading

OIG Revises Safe Harbors under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements

On December 7, 2016, the Office of Inspector General of the US Department of Health and Human Services published a final rule containing revisions to both the federal Anti-Kickback Statute safe harbors and the beneficiary inducement prohibition in the civil monetary penalty rules. Effective January 6, 2017, the Final Rule modifies certain existing safe harbors … Continue Reading

‘Tis the Season for Giving: OIG Updates Policy on Gifts of Nominal Value to Medicare and Medicaid Beneficiaries

On December 7, 2016, the Office of the Inspector General (OIG) of the US Department of Health and Human Services (HHS) issued a policy statement increasing its thresholds for gifts that are considered “nominal” for purposes of the patient inducement provisions of the civil monetary penalties law (section 1128A(a)(5) of the Social Security Act) (CMP … Continue Reading

Predictions on False Claims Act Enforcement in the Trump Administration

While there are a number of executive policies that will be affected by the presidential election, there are several reasons to expect modest change in the government’s approach to False Claims Act (FCA) actions. The most significant reason for this expectation is that the vast majority of FCA cases are filed by relators on behalf … Continue Reading

Fifth Circuit Upholds Omnicare Decision for Lack of Supporting Evidence of Kickback Violation

On October 28, 2016 in an unpublished opinion, the Fifth Circuit Court of Appeals affirmed the decision of the US District Court for the Southern District of Texas that granted summary judgment to Omnicare, Inc. in a qui tam action. We discussed the decision of the district court here. The relator alleged, among other claims, … Continue Reading

Old Dog, New Tricks: Fraud and Abuse in the Age of Payment Reform

The good, reassuring news about that “old dog” fraud and abuse as it enters an age of payment reform is that criminal liability for fraud still requires a specific intent to defraud the federal health care programs, anti-kickback liability still requires actual knowledge of at least the wrongfulness, if not the illegality, of the financial … Continue Reading

Corporate Outsiders – on the Wrong Side of the Circuit Split on Rule 9(b)

A district court in the Middle District of Florida issued a new decision that will continue to make it challenging for corporate outsiders to successfully pursue a declined qui tam complaint – at least in the Eleventh Circuit. In U.S. ex rel. Chase v. Lifepath Hospice, Inc., et al., No. 10-cv-1061, 2016 WL 5239863 (M.D. … Continue Reading

District Court Dismisses FCA Claims Based on Fraudulent Off-Label Promotion for Lack of Particularity

On May 23, 2016, the US District Court for the District of Massachusetts dismissed several of the claims in a False Claims Act (FCA) whistleblower suit against Medtronic, Inc. and its wholly-owned subsidiary Medtronic MiniMed, Inc. (Medtronic) related to its insulin pumps and integrated diabetes management systems. In United States ex rel. Witkin v. Medtronic, … Continue Reading

OIG Issues New Exclusion and CIA Guidance

On April 18, 2016, Inspector General Daniel R. Levinson announced the publication of updated guidance on how the Office of Inspector General (OIG) makes decisions about using its permissive exclusion authority and requiring integrity obligations when presented with a False Claims Act (FCA) settlement. This document is noteworthy not only to defendants in FCA cases … Continue Reading

OIG Continues to Refine Guidance on Patient Assistance Programs

The past three months have seen a flurry of advisory opinion activity from the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG). The majority of this activity focuses on patient assistance programs (PAPs) as donors and organizations continue to have questions about OIG’s most recent PAP guidance. While none of … Continue Reading

Claims Against Individuals Fail in Northern District of Illinois

On December 15, 2015, the U.S. District Court for the Northern District of Illinois dismissed Relator’s claims against two individual defendants in United States ex rel. Sibley v. A Plus Physicians Billing Service, Inc., No. 13C 7733, 2015 WL 8780548 (N. D. Ill. Dec. 15, 2015). The court granted the individuals’ (Laurie Gentile and Eric … Continue Reading

Circumstantial Evidence Stretched Beyond Its Limits in Proving Kickback and Fraud-on-DrugDex Theories

Two decisions from the US District Court for the Southern District of Texas limit the extent to which relators can stretch the use of circumstantial evidence to support a False Claims Act case based on an anti-kickback or off-label marketing theory. In two separate decisions on December 10 and December 14 in US ex rel. … Continue Reading

Warner Chilcott Pleads Guilty to Health Care Fraud Charges and Pays $125 Million; Several Company Executives Face Individual Liability

On October 29, 2015, the United States announced a $125 million settlement with a subsidiary of pharmaceutical manufacturer Warner Chilcott to resolve a sealed qui tam in United States ex rel. Alexander, et al. v. Warner Chilcott plc, et al., Civil Action No. 11-CA-1121 (D. Mass.). The global settlement consisted of $22.9 million in criminal … Continue Reading

DOJ Pursues Both Sides of an Alleged Kickback Arrangement Under the FCA

As many health lawyers know, the government usually only pursues the person or entity that offers or pays allegedly improper remuneration, even though the federal Anti-Kickback Statute (AKS) also applies to those to solicit or receive it.  This uneven enforcement pattern occurs for a variety of reasons — the alleged payor is the focus of … Continue Reading

Huge Stark Law Hospital Settlements and Physician Culpability – The New Normal Post-Tuomey?

After the federal government’s victory against Tuomey Hospital, we have seen an increasing number of large False Claims Act (FCA) settlements with hospitals involving Stark Law allegations. Despite the intricacies of Stark Law compliance, the U.S. Department of Justice (DOJ) has not shown much leniency in its treatment of these cases, as shown by two … Continue Reading

Recent Advisory Opinion Shows OIG’s Growing Acceptance of Financial Integration Among Related Entities

On July 20, the Office of Inspector General of the Department of Health and Human Services (OIG) posted a new Advisory Opinion (the Opinion) addressing a health system’s restructured arrangement to lease employees, and provide other operational and management services, to a related psychiatric hospital (the Arrangement). The Opinion is a notable departure from other … Continue Reading

Omnicare Decision Demonstrates that Relators Cannot Rely on Ambiguous Evidence of Intent to Survive Summary Judgment, and Should Exercise Caution

On September 3, the U.S. District Court for the Southern District of Texas granted summary judgment in favor of Omnicare in United States ex rel. Ruscher v. Omnicare, Inc., and in doing so, made clear that in order to get to a jury, relators must come forth with evidence of intent that is more than … Continue Reading

Can Satisfying A Regulatory Requirement Now Equate To Providing Illegal Remuneration?

Defending False Claims Act litigation is often a costly budget item. The disposal of weak cases by the government through the intervention decision making process has always been a critical safety valve for non-culpable defendants. Two of the more concerning trends in False Claims Act litigation, however, are (1) the increasing likelihood of relators pursuing … Continue Reading

Overview of Recent Stark Law Developments

There has been a flurry of judicial and administrative activity regarding the Stark Law in recent weeks, bringing both promises of reprieve for the health care industry in complying with the technicalities of the law, and reminders of the need for executive vigilance when evaluating and approving transactions with referring physicians. On July 15, 2015, … Continue Reading

Recent Appellate Developments in “Implied Certification”

We have previously written several articles regarding the circuit courts’ application of the so-called “implied certification” theory of liability under the False Claims Act (FCA). That theory is the subject of a petition for certiorari in the case of United States v. Triple Canopy, on which we have previously reported. Under the implied certification theory, … Continue Reading
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