False Claims Act (FCA) Compliance

News & Analysis as of

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...more

Foreign Corrupt Practices Act Alert

Busy Q1 Yields Several Significant FCPA Resolutions - Overview - On February 19, during the US Securities and Exchange Commission’s (SEC) annual “SEC Speaks” conference, Kara Brockmeyer, Chief of the SEC’s FCPA...more

Compliance Lessons from the Olympus Corporate Integrity Agreement – Part I

The recent Olympus Corporation and related entities (collectively ‘Olympus’) enforcement action demonstrated a company seemingly dedicated to lying, cheating and stealing its way across the globe in search of almighty dollar....more

Olympus Settles FCPA Charges with DOJ

The Department of Justice resolved another FCPA investigation centered on payments made to health officials. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, Tokyo, Japan, and Olympus...more

Olympus: A Culture of Bribery and Kickbacks

When compliance officers read about a major Justice Department settlement action, we can all hear the collective sigh of relief – “Thank goodness, that did not happen here in my company.”...more

What Must the Government Prove to Establish that a Defendant Recklessly Interpreted a Statute or Regulation in Violation of the...

If you read one thing... - Learn what evidence the government or the relator must establish to prove that the defendant “recklessly” interpreted a statute or regulation in violation of the FCA. - Understand...more

Health Care Enforcement in 2016: A Look Back on 2015 and Forecasting the Year Ahead

2015 was a year of transition for the U.S. Department of Justice (“DOJ”), with the installation of a new Attorney General, Deputy Attorney General, and several other high-level officials. In January 2015, Andrew Weissmann...more

Health Care E-Note - November 2015

With medical device related acquisitions at all-time highs, and regulatory interest intense from the Federal Trade Commission, the Food and Drug Administration, the Securities and Exchange Commission, and the Office of...more

Principal Deputy Assistant Attorney General Mizer on Yates Memo: “No Partial Credit for Cooperation that Doesn’t Include...

Principal Deputy Assistant Attorney General Benjamin C. Mizer’s remarks at the 16th Pharmaceutical Compliance Congress and Best Practices Forum highlighted the Department of Justice’s “renewed commitment to ensuring that...more

Construction Law Advisory - October 2015

The Massachusetts Attorney General is taking action to ensure that general contractors working on public construction are complying with state requirements to use DBE/MBE subcontractors. In August 2015, the Attorney...more

Justice Department Recovers Nearly $6 Billion From False Claims Act Cases in 2014

The U.S. Department of Justice (DOJ) obtained a record $5.69 billion in settlements and judgments from civil cases involving fraud and false claims against the government in fiscal year 2014. This marks the first time the DOJ...more

Recent Cases Involving 60-Day Overpayment Rule Should Put Healthcare Providers on Alert

Two recent federal court cases show that the federal government intends to vigorously enforce the so-called “60-day Rule” for the return of overpayments enacted as part of the Affordable Care Act (the “ACA”) even though the...more

DOJ Sets Its Sights on Directors and Officers

Whether publicly traded or privately held, corporate boards have been put on notice – the Department of Justice (Justice or DOJ) is after you! On September 9th, DOJ issued a memo entitled: Individual Accountability for...more

Health Update - September 2015

Latest Healthcare False Claims Act Roundup and Top 3 Best Practices to Reduce Exposure - As the legal landscape in healthcare becomes increasingly complex, healthcare companies that receive federal program funds face...more

DOJ Targets Executives and Individuals in Corporate Investigations

Responding to criticism stemming from a lack of individual prosecutions as a result of the financial crisis, Deputy Attorney General Sally Yates has issued a new guidance memorandum establishing six new steps for federal...more

Practices, Optics and Implications: A Cautionary Tale from the North Broward Hospital District Settlement

The $69.5 million settlement by North Broward Hospital District in Fort Lauderdale, Florida to resolve False Claims Act allegations paints a cautionary tale of the importance of hospital practices and optics in connection...more

Prosecuting Doctors for Medicare Fraud

Federal prosecutors have turned their attention to physicians for Medicare fraud prosecution. Physicians who participate in the Medicare program have to be aware of the significant risks of Medicare fraud....more

Highway 61 Revisited-Tombstone Blues and Corporate Integrity Agreements

I conclude my tribute to my favorite Bob Dylan album, Highway 61 Revisited with a look at the most surreal song on the disc, Tombstone Blues. I want to use it to contrast the most excellent article that appears today as a...more

Corporate Investigations & White Collar Defense - September 2015

No Dog Days of August for the SEC—A Recap of a Busy Month - Why it matters: Who says there is a government slowdown in August? Not for the SEC. August 2015 turned out to be very busy indeed for the agency, which...more

When the Government Comes Knocking

This article will provide an outline of some of the most significant points for hospitals to use when confronted with a formal government investigation under the Criminal or Civil False Claims Act. As noted below, you should...more

Kane and the “60-Day Rule”: The Unforgiving World of Medicare and Medicaid Overpayments

The Southern District of New York has spoken on one of the first issues to confront those seeking compliance with the new “60-day rule” under the Affordable Care Act (ACA), and it does not bode well for defendant hospitals...more

FCA 60-Day Repayment Provision Runs from Discovery of Potential Overpayment

The U.S. District Court for the Southern District of New York issued the first decision directly addressing when an overpayment is “identified” for purposes of starting the 60-day repayment clock under the federal False...more

DOJ Hires Compliance Counsel to Aid in Charging Decisions

In today’s robust enforcement climate, most companies have taken at least the first steps towards establishing a formal corporate compliance program. The mere existence of such a program, however, will not by itself protect a...more

In Closely Watched Case, Federal Court Upholds the Government’s Position on Provider Mandate to Report and Return Medicare and...

The Patient Protection and Affordable Care Act (“PPACA”), signed into law on March 23, 2010, included a provision (the “Report and Refund Mandate”), broadly requiring health care providers, suppliers, Part D plans and managed...more

SDNY Issues Groundbreaking Decision On False Claims Act Sixty-Day Rule

Medicare and Medicaid providers have an obligation to refund overpayments from federal health care programs. The False Claims Act (“FCA”) imposes liability for any person who “knowingly conceals or knowingly and improperly...more

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