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Compliance Disclosure Requirements False Claims Act (FCA)

Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory violations. ... more +
Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory violations.  In response to many corporate scandals evidencing rampant unethical business practices, many nations, including the United States, began passing strict regulatory frameworks aimed at curbing these abuses. Notable pieces of legislation in this area include the U.S. Foreign Corrupt Practices Act (FCPA), Sarbanes-Oxley (SOX), and the U.K. Bribery Act, to name a few. The foregoing statutes and the severe penalties often associated with them form the basis of many modern institutional compliance programs. less -
Robinson+Cole Health Law Diagnosis

Massachusetts Expands FCA Liability to Owners and Private Equity Investors

Under a new 2025 law, Massachusetts is one of the first in the nation to broaden its state False Claims Act (FCA) to require disclosures by investors and owners of health care entities. On January 8, 2025, Governor Maura...more

Bass, Berry & Sims PLC

Athira Pharma Inc. Agrees to Settle False Claims Act Allegations

Bass, Berry & Sims PLC on

On January 6, the Department of Justice (DOJ) announced that Athira Pharma Inc., a Washington-based biopharmaceutical company, agreed to pay over $4 million to settle allegations it violated the False Claims Act (FCA). The...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: November 2024

On the heels of a $7.6 million payment by Cleveland Clinic to settle allegations of False Claims Act (FCA) violations and unallowable sharing of passwords, Michael Lauer, NIH deputy director for extramural research, penned a...more

Gardner Law

Hiring Conflicts Result in FCA Violations

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A recent U.S. Department of Justice (DOJ) settlement highlights the importance of having (and following) a policy that prohibits conflicts of interest. In July 2024, the DOJ entered a nearly $1 million settlement with an...more

Holland & Hart LLP

OIG Issued Updated General Compliance Program Guidance for Healthcare Providers and Stakeholders

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On Monday, November 6, 2023, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) released its General Compliance Program Guidance (“GCPG”) for the general healthcare compliance community and...more

Venable LLP

OMB Pre-Releases Much-Anticipated Rewrite of the Uniform Guidance

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On December 26, 2013, the Office of Management and Budget (OMB) issued the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (commonly referred to as the "Uniform Guidance"). The...more

Alston & Bird

Incomplete Cybersecurity Compliance Disclosures May Support Fraud Claim Under the False Claims Act, Federal Court Holds

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At the heels of a recent Civil Cyber-Fraud Initiative related to cybersecurity practices and the False Claims Act (FCA), a cybersecurity-related FCA case has survived a motion for summary judgment, teeing up a trial to...more

Maynard Nexsen

Cooperation Credit in False Claims Act Defense and the Potential Impact of Reimbursement Analysis and Compliance

Maynard Nexsen on

While white collar and healthcare counsel have long known that one of the best strategies to reducing risk in defending a False Claims Act (FCA) case is cooperation and execution of compliance actions, the Department of...more

Holland & Knight LLP

DOJ Targets Executives and Individuals in Corporate Investigations

Holland & Knight LLP on

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

K&L Gates LLP

Are Public Companies Required to Disclose that the Government is Investigating Them?

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For many public companies, the first issue they have to confront after they receive a government subpoena or Civil Investigative Demand (“CID”) is whether to disclose publicly that they are under investigation. Curiously, the...more

Sheppard Mullin Richter & Hampton LLP

Court Broadens Confidentiality of Investigations - D.C. Circuit extends privilege in internal corporate probes, but inconsistent...

You are counsel to a government contractor that is conducting an internal investigation into possible fraud. Federal mandatory disclosure obligations require an investigation, as does the need to gather facts to seek legal...more

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