News & Analysis as of

False Claims Act (FCA) Regulatory Standards

Skadden, Arps, Slate, Meagher & Flom LLP

DOJ Enters First Intervention in Cybersecurity Qui Tam

The U.S. government’s recent complaint in a relator-filed case under the False Claims Act (FCA): - Marks the first FCA suit in which the Department of Justice (DOJ) has intervened since launching its ongoing Civil...more

Goodwin

Horizon Scan for Private Investment Funds - May 2024

Goodwin on

Welcome to the second edition of our Horizon Scan for 2024: key recent and expected funds, regulatory, and tax developments to look out for. As before, we focus on the most important developments and changes that we expect to...more

Bass, Berry & Sims PLC

The United States Intervenes in its First False Claims Act Cybersecurity Case

Bass, Berry & Sims PLC on

The United States notified the U.S. District Court for the Northern District of Georgia that it plans to intervene in a False Claims Act case filed against Georgia Tech Research Corporation (Georgia Tech) by its Associate...more

Mintz

EnforceMintz — 2023 Brings Uptick in Cybersecurity Enforcement, Insight Into Potential Risks

Mintz on

After the Department of Justice (“DOJ”) announced its Civil Cyber-Fraud Initiative in October 2021, many in the False Claims Act (“FCA”) bar expected an onslaught of enforcement actions and qui tam cases. The initiative...more

Proskauer - Health Care Law Brief

Recent FCA and AKS Litigation Highlights Use of Different Standards in Different Circuits

In an important decision limiting the reach of the Federal Anti-Kickback Statute (42 U.S.C. 1320a-7b(b)) (“AKS”) and its application to violations of the False Claims Act (31 U.S.C. 3729, et seq.) (“FCA”), the U.S. Court of...more

Latham & Watkins LLP

FCA’s 2022/23 Business Plan: Key Highlights

Latham & Watkins LLP on

As the FCA’s remit continues to grow, the regulator pledges flexibility in the face of global financial and geopolitical headwinds. On 7 April 2022, the FCA released its new Business Plan as part of a package including...more

Jones Day

Fourth Circuit Limits Who Can Act "Knowingly" Under False Claims Act

Jones Day on

Health care industry participants frequently operate under nuanced legal frameworks that apply to the receipt of government funds. A breach of these regulations can open the door to draconian liability under the FCA even when...more

Polsinelli

Senate to Consider Pared Down, But Still Unfavorable, Amendments to FCA

Polsinelli on

As we wrote on July 28, 2021, Senator Chuck Grassley has sponsored a bill (S. 2428) that would amend the False Claims Act (FCA) in several significant ways that are unfavorable to defendants. On October 28, 2021, the Senate...more

Jones Day

DOJ Rescinds Limits on the Use of Agencies' Guidance Documents in Civil Enforcement Actions

Jones Day on

A recent action by the Department of Justice ("DOJ") rescinds two prior policies (commonly referred to as the Brand Memo and the Sessions Memo) that had established limits on the federal government's use of agency guidance...more

Akerman LLP - Health Law Rx

Caveat Emptor: Private Equity Firms Are Increasingly Vulnerable to Qui Tam Lawsuits

The U.S. Department of Justice (“DOJ”) has settled six qui tam lawsuits brought in various jurisdictions by whistleblowers against a private equity firm and its portfolio healthcare companies. ...more

Carlton Fields

Recent Cases Indicate Viability of False Claims Act Liability Connected to Federal Cybersecurity Standards

Carlton Fields on

Government contractors are no strangers to the numerous quality standards and assurances required by the government. Over the past several years, cybersecurity in federal contracting has emerged as yet another standard to...more

Hogan Lovells

HUD and DOJ Signal Easing of FCA Enforcement in FHA Residential Mortgage Lending Through Interagency Memorandum

Hogan Lovells on

On October 28, 2019 the U.S. Department of Housing and Urban Development (HUD) and the U.S. Department of Justice (DOJ) released a Memorandum of Understanding (MOU) announcing their joint approach to False Claims Act (FCA)...more

WilmerHale

False Claims Act: 2018 Year-in-Review

WilmerHale on

Federal False Claims Act (FCA) recoveries in fiscal year 2018 amounted to $2.88 billion, down by roughly $600 million from the prior year and dropping below $3 billion for the first time in eight years. Healthcare cases,...more

Bricker Graydon LLP

DOJ conference remarks provide insight into government priorities related to health care

Bricker Graydon LLP on

National conferences tend to bring out a number of government employees willing to give a peek behind the curtain and insight into how the government thinks and what is on the horizon in terms of government priorities....more

K2 Integrity

Private Equity Is Booming. So Are the Regulatory Headaches.

K2 Integrity on

This may be private equity’s golden age, a time when firms are raising record sums and are poised to pour that capital—more than a trillion dollars, by some accounts—into investments across a host of industries. Originally...more

Akerman LLP - Health Law Rx

New Consequences for Unpaid Medicare Overpayments

For years, CMS has had the authority to refuse to enroll new Medicare providers if they or their owners have an unpaid Medicare overpayment, but CMS was not exercising this authority. Now, it appears that CMS is going to...more

Bradley Arant Boult Cummings LLP

Designing Clinical Studies To Avoid Regulatory Scrutiny

Practical advice following the Primex Clinical Laboratories settlement - Earlier this year, the Department of Justice (DOJ) announced a $3.5 million settlement against Primex Clinical Laboratories, a California laboratory...more

Robinson+Cole Health Law Diagnosis

“Brand Memo” from the U.S. Department of Justice: Reading Between the Lines

On January 25, 2018, Associate Attorney General Rachel Brand issued a memo on behalf of the U.S. Department of Justice (DOJ) prohibiting certain DOJ uses of federal agency guidance documents in affirmative civil enforcement...more

Troutman Pepper

Value-Based Contracting for Prescription Drugs and Medical Devices: An Innovative Solution Impaired by Outdated Regulations

Troutman Pepper on

Often lost in the cacophony of headlines surrounding rising health care costs is the promise that value-based contracting offers as a possible solution. In contrast to the traditional fee-for-service model, value-based...more

Hogan Lovells

New E.O. Reinforces President Trump's "Buy American" Agenda

Hogan Lovells on

On April 18, 2016, President Donald Trump signed the executive order “Buy American and Hire American” aimed at maximizing the federal government’s use of goods, products, and materials produced in the United States. The E.O....more

Brownstein Hyatt Farber Schreck

Independent Hospitals Innovating, Finding New Partnerships in Response to Market Pressures

Standard & Poor’s (S&P) Rating Services recently warned the health care sector was at “a tipping point where negative forces have started to outweigh many providers’ ability to implement sufficient countermeasures.” S&P noted...more

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