News & Analysis as of

Self-Disclosure Requirements

Why Healthcare and Life Sciences Companies Need to Step Up Their Compliance Efforts in Advance of a U.S. Government Investigation

by Hogan Lovells on

In this hoganlovells.com interview, Hogan Lovells partner Gejaa Gobena discusses how the perception of compliance, remediation, and self-disclosure has evolved in the eyes of government prosecutors from how they factor at...more

Evaluating FCPA Pilot Program: The Data, The Trends

by Ropes & Gray LLP on

April 5 marked the one-year anniversary of the "Foreign Corrupt Practices Act Enforcement Plan and Guidance." Announced by the U.S. Department of Justice, Criminal Division's Fraud Section, the guidance outlined three...more

Compliance 2.0 and the Significance of HHS OIG’s 2017 Resource Guide: “Measuring Compliance Program Effectiveness”

by King & Spalding on

On March 27, 2017, in conjunction with the Health Care Compliance Association (“HCCA”) annual Compliance Institute (“CI”), the Department of Health and Human Services (“HHS”), Office of the Inspector General (“OIG”) released...more

Sally Yates’ was Already Famous for Changing the Focus of Compliance Investigations - The Yates Memorandum

by Ruder Ware on

By now the whole world knows about Sally Yates. We are likely to see a lot more of her as a central figure in Congressional investigations. For some of us who deal with compliance investigations, Sally Yates was famous long...more

Updated Status of the DOJ FCPA Pilot Program

The FCPA Pilot Program was introduced on April 5, 2016 as a one year experiment that sought to ‘motivate companies to voluntarily self-disclose FCPA-related misconduct, fully cooperate with the Fraud Section and …remediate...more

DOJ Announces Extension of FCPA Pilot Program

by Morgan Lewis on

The US Department of Justice plans to extend its FCPA Pilot Program, an initiative developed to encourage companies to self-report bribery violations and provide extensive cooperation in exchange for reduced penalties,...more

OIG Finalizes CMP Regulations, Largely as Proposed

by Baker Ober Health Law on

On December 7, 2016, the Department of Health and Human Services, Office of Inspector General (OIG) finalized [PDF] its proposal to update the civil monetary penalty (CMP) regulations – namely, incorporate new CMP authorities...more

Historic Risk Management Rules and Practices Go Live on March 1, 2017 in Leading Markets

by Seyfarth Shaw LLP on

For the first time in the history of derivatives, regulators in leading markets will require assets to collateralize many derivatives which are not settled in a regulated clearinghouse. It is not possible to overstate...more

The Bribery Act: To Disclose or Not To Disclose?

In this video interview, Barry Vitou (www.thebriberyact.com), Partner, Pinsent Masons, and head of their Global Corporate Crime Team, addresses: • His initial interest in global anti-corruption issues. • The role and...more

Provider Self-Disclosure Decisions – Voluntary Disclosure Process

by Ruder Ware on

The decision whether or not to voluntarily disclose non-compliance to the government can be very difficult. Not every case is clear. Clearly not every situation where there has been a billing error amounts to fraud or...more

When Leslie Caldwell Talks FCPA, You Should Listen

by Thomas Fox on

November begins the final push for the compliance conference season, which customarily ends with the ACI National FCPA Conference. During November and into early December, Department of Justice (DOJ) officials have...more

AAG Caldwell Touts Success of FCPA Enforcement and Pilot Program

by Michael Volkov on

In a speech last week, Criminal Division Assistant Attorney General Leslie Caldwell touted the success of the FCPA Pilot Program. AAG Caldwell outlined the success of the FCPA enforcement program, listing many of the...more

The City of Portland Issues Rules for “Ban the Box”

by Stoel Rives LLP on

We previously blogged about Portland, Oregon’s restrictive “ban the box” ordinance. The City of Portland recently issued administrative rules for its ordinance. The administrative rules are available here. The key...more

Declinations and Profits Disgorgement – It Was There All Along

by Thomas Fox on

Last week there were two declinations issued by Department of Justice (DOJ) for Foreign Corrupt Practices Act (FCPA) matters. The matters involved two Texas based, privately held companies. The first was HMT LLC (HMT) which...more

Summer Fraud and Abuse Roundup

by BakerHostetler on

Now that the kids are back in school and summer vacations are in the rearview mirror, it’s time to catch up on recent fraud and abuse developments. The federal government was busy this summer negotiating a pair of settlements...more

MDE Self-Disclosure Can Limit, Even Eliminate Risk of Environmental Penalties

by Ballard Spahr LLP on

Maryland entities that voluntarily discover and disclose environmental violations can still receive penalty reductions, or even complete forgiveness, under the rarely invoked Maryland Department of the Environment (MDE)...more

Commerce Guidance Supports Benefits of Voluntary Disclosures and Improved Compliance Programs

by Baker Donelson on

The U.S. Department of Commerce’s Bureau of Industry and Security (BIS) has issued a voluntary disclosure guidance for export violations. The guidance takes effect July 22 and its intent is to make Commerce’s enforcement more...more

Corporate Investigations and White Collar Defense - July 2016

“Official Acts”—What They Are… and Are Not - Why it matters: On June 27, 2016, the Supreme Court decided McDonnell v. U.S., holding that, for purposes of the federal public corruption statutes, an “official act”...more

AGG Food and Drug Newsletter - June 2016

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Guidance on Effective Self-Disclosure of FCPA Violations for Life Sciences Companies

by Arnall Golden Gregory LLP on

Every life sciences company with international operations should have a robust Foreign Corrupt Practices Act (FCPA) compliance program as part of its overall compliance strategy. On April 5, 2016, the Justice Department...more

OIG Updates Permissive Exclusion Criteria – Suggests Compliance Programs Are Expected

by Baker Ober Health Law on

On April 18th, the Office of Inspector General (OIG) issued updated guidance describing the factors it will consider in determining whether to exercise its permissive authority to exclude individuals and entities from federal...more

CMS Seeks Comment on Self-Disclosure Protocol Form

by King & Spalding on

On May 6, 2016, CMS published an information collection request notice regarding the existing Medicare self-referral disclosure protocol (SRDP). Specifically, CMS intends to streamline the current SRDP and revise the...more

Does the New FCPA Pilot Program Put the Odds in Disclosing Organizations’ Favor?

by Conduent on

“I volunteer as tribute” In The Hunger Games, Katniss Everdeen bravely uttered these words as she stepped forward to take the place of her sister in Panem’s annual fight to the death. While volunteering worked out for...more

May the Fourth Be With You – The Norwegian Sovereign Wealth Fund Awakens to Good Corporate Governance

by Thomas Fox on

May 4th is universally recognized (at least in the universe I inhabit) as Star Wars Day. According to Wikipedia, “May 4 is called Star Wars Day because of the popularity of a common pun spoken on this day. Since the phrase...more

The DOJ’s Self-Disclosure Program Is Not Even Half the Story

by Michael Volkov on

Lots of people are talking about the DOJ’s new self-disclosure pilot program, but it was only the last of three steps announced in the DOJ’s Fraud Section FCPA Enforcement Plan and Guidance. One of them has the potential to...more

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