The U.S. Court of Appeals for the Third Circuit recently issued a False Claims Act (FCA) decision calling into question productivity-based physician compensation structures under the Stark Law, in reliance on a controversial interpretation of the Stark Law’s “volume or value” standard.

The case, U.S. ex rel. Bookwalter v. UPMC, involved employment arrangements between the University of Pittsburgh Medical Center’s (UPMC) subsidiary physician practice entities and neurosurgeons who performed procedures at UPMC’s affiliated hospitals.  The decision is significant for hospitals and health systems in that the Third Circuit’s holding is contrary to guidance promulgated by the Centers for Medicare & Medicaid (CMS) and appears to call into question a common compensation methodology used by health systems to compensate physicians.

Continue Reading Third Circuit Holds Allegations of Improper Compensation Methodologies under the Stark Law Survive Motion to Dismiss

Earlier this month, the Eleventh Circuit Court partially affirmed a lower court’s decision in United States vs. Aseracare, stating that disagreements between doctors related to a patient’s prognosis does not qualify as hospice fraud under the False Claims Act (FCA).

Earlier in the year, I discussed the case with with Hospice News stating, “Settlements involving allegations about medical necessity of hospice services continued to dominate enforcement actions this last year. Hospice organizations should be particularly mindful of the patients they are accepting and ensure that the appropriate documentation is retained.” The publication repurposed the quote for the September 2019 article.

The full article, “Court: Difference of Opinion is Not Hospice Fraud,” was published by Hospice News on September 11, 2019, and is available online.

On July 19, 2019, Myriad Genetics disclosed a $9.1 million settlement agreement to resolve a False Claims Act (FCA) qui tam lawsuit alleging that it engaged in a scheme to fraudulently bill Medicare for certain hereditary cancer tests.

Notably, the qui tam relator in the case was not a Myriad corporate insider, but rather a medical director for Palmetto GBA, the Medicare Administrative Contractor (MAC) responsible for overseeing the program through which Myriad’s tests are covered by Medicare.  In this way, the settlement illustrates the often overlooked risk that individuals other than conventional corporate whistleblowers—including even government employees or employees of government administrative contractors—may serve as FCA relators.

Continue Reading Myriad Genetics Settlement Illustrates FCA Risks Posed by Government and Other Non-Traditional Relators

On July 5, 2019, the D.C. Circuit Court of Appeals affirmed dismissal of a qui tam lawsuit against several chemical manufacturers that set forth a unusual theory of liability: the relator alleged that the manufacturers violated the False Claims Act (FCA) by failing to self-report information about the dangers of their chemicals under the Environmental Protection Agency’s (EPA) voluntary Compliance Audit Program.

According to the relator, the manufacturers should have self-disclosed certain information to the EPA, who in turn would have assessed civil penalties under the Toxic Substances Control Act.  By failing to do so, the relator alleged that the defendant manufacturers concealed their obligations to transfer property (the risk information) and money (the unassessed penalties) to the government.

Continue Reading Failure to Voluntarily Self-Report is a “Non-starter” under the FCA

In addition to the United States Department of Justice’s recently issued guidelines related to cooperation in FCA enforcement actions, the Department of Justice (DOJ)’s Criminal Division recently revised its guidance pertaining to assessment of corporate compliance programs.  The revised guidance will inform DOJ’s approach to criminal investigations, charging decisions, plea agreements, and sentencing in cases involving alleged corporate noncompliance or wrongdoing.

DOJ previously published guidance on its evaluation of corporate compliance programs in 2017.  As with the previous version, the revised guidance eschews a “rigid formula” for assessing compliance programs.

Continue Reading DOJ Asks “Fundamental Questions” of Corporate Compliance Programs

The Medicare Advantage program, which allows private insurance companies to offer and administer Medicare benefits, continues to be an area of sharp scrutiny for False Claims Act (FCA) enforcement despite some significant recent setbacks in pursuing FCA liability against Medicare Advantage Plans (MA Plans or Plans).  In 2018, several district court decisions raised obstacles to the pursuit of FCA liability against MA Plans, and those decisions have continued to affect FCA enforcement efforts in the first half of 2019.  Despite those setbacks, however, the prevalence of government enforcement actions involving Medicare Advantage illustrates that it remains an area of focus for the Department of Justice (DOJ).

The Focus on Medicare Advantage

Unlike traditional fee-for-service Medicare, MA Plans are compensated on a monthly basis through a fixed payment for each member.  The amount of the monthly payment – known as a capitation payment – is determined for each payment year through a process called “risk adjustment” and is based on each individual member’s demographic information and data reflecting the member’s medical condition, as documented during the 12 months preceding the payment year.  A member’s condition and medical diagnoses must be supported by a valid medical record.

Continue Reading Medicare Advantage: Recent Developments in FCA Enforcement

I recently provided comments for an article in Hospice News detailing the False Claims Act case against hospice provider, Heartland Hospice, that also details the government’s focus within this broader long-term care industry. The qui tam case against Heartland recently was dismissed with prejudice by a federal judge.

“Overall, qui tam cases continue to be filed in increasingly high numbers year over year,” I stated in the article. “We continue to see an increase in both civil and criminal investigations involving hospice providers.  Hospice fraud continues to feature prominently in [U.S. Department of Health and Human Services Office of the Inspector General’s] Work Plan.”

The full article, “Court Dismisses Fraud Case Against Heartland Hospice,” was published by Hospice News on June 27, 2019, and is available online.

For a detailed overview about healthcare fraud, please download Bass, Berry & Sims’ Healthcare Fraud and Abuse Review, an in-depth and comprehensive review of enforcement settlements, court decisions and developments affecting the healthcare industry.

We wrote an article examining recent enforcement actions by the government within the long-term care industry for McKnight’s Long-Term Care News. In the article, we point out that “recent cases reinforce the notion that long-term care providers should pay particular attention to the government’s efforts to police arrangements and business practices that implicate the federal Anti-Kickback Statute and similar regulatory prohibitions.”

We also provide some best practices for long-term care providers to potentially lower the risk of fraud, including:

  1. Careful evaluation of any arrangements that involve payment that could be viewed as a kickback or referral
  2. Continual monitoring of enforcement actions by the government to stay up-to-date on risk areas.

The full article, “Providers Facing Heightened Kickback Scrutiny,” was published by McKnight’s Long-Term Care News on June 5, 2019, and is available online.

The U.S. Department of Justice (DOJ) routinely encourages the subjects of False Claims Act (FCA) enforcement actions to make voluntary disclosures and fully cooperate with the government on the premise that cooperation leads to reduced liability. The DOJ recently issued guidance on the types of activities that will earn “cooperation credit.” But how much is cooperation worth, in terms of actual dollars? According to recent data and an analysis by Seton Hall Law School Professor Jacob T. Elberg, perhaps not much.

Discretion over Damages Multiplier Incentivizes Cooperation

The government’s basis for incentivizing cooperation lies primarily in its discretion in seeking damages and penalties allowable under the FCA. A defendant can be liable under the FCA for three times the amount of damages the government sustains, plus a civil penalty for each false claim. But such severe damages and penalties are not required, particularly where the government and a defendant negotiate a settlement to resolve FCA allegations without a court judgment or any finding of liability.

Continue Reading Mixed Messages: DOJ Releases New FCA Cooperation Guidelines, while Study Questions Whether Cooperation Actually Garners Credit

In two recent decisions, federal district courts in the Eastern District of Pennsylvania and the Southern District of Illinois, respectively, considered the Government’s motions to dismiss False Claims Act (FCA) lawsuits against pharmaceutical companies and marketing consultants alleging violations of the Anti-Kickback Statute (AKS) related to patient assistance programs.  As discussed in our previous post, the two lawsuits were among 11 similar qui tam actions filed by corporate relators described by the Department of Justice (DOJ) as “shell companies,” and which DOJ sought to preemptively dismiss based on its view that the claims lacked merit and that litigation of the actions would waste “scarce government resources.”

In the Pennsylvania case, U.S. ex rel. Harris v. EMD Serono, Inc., the court granted DOJ’s motion to dismiss over the relators’ objection.  In the Illinois case, U.S. ex rel. CIMZNHCA, LLC v. UCB, Inc., the court denied DOJ’s motion, declining to dismiss the case.  Although reaching different dispositions, both courts parted ways with a prior decision of the U.S. Court of Appeals for the D.C. Circuit by holding that the Government does not possess “unfettered” discretion to dismiss FCA actions.  Instead, the courts joined two other circuits in requiring the Government to demonstrate that its decision to dismiss an FCA action has “a rational relationship to a government interest.”

The circuit split highlighted by the decisions in EMD Serono and UCB is one of increasing importance in light of indications that the Government may be more aggressive in seeking preemptive dismissals of qui tam actions following the January 2018 Granston Memo.

Continue Reading District Courts Hold that DOJ Lacks “Unfettered” Discretion to Preemptively Dismiss <em>Qui Tam</em> Actions

From the Bass, Berry & Sims Blog Network
From the Bass, Berry & Sims Blog Network

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