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Joint Promotional Programs With Physicians Raise Compliance Risks

Enforcement in Life Sciences Series: Key Cases in 2020 Reflect Emerging DOJ Focus for Pharmaceutical and Medical Device Makers - Recent settlements between the U.S. Department of Justice (DOJ) and a range of...more

DOJ Introduces Novel Theories of Liability and Requires Unprecedented Controls in Speaker Program Settlement

Enforcement in Life Sciences Series: Key Cases in 2020 Reflect Emerging DOJ Focus for Pharmaceutical and Medical Device Makers - About the Enforcement in Life Sciences Series - Recent settlements between the U.S....more

HHS-OIG Year in Review: Despite Challenges Posed by the Pandemic, 2020 Saw an Uptick in Enforcement Action

Despite the challenges posed by the COVID-19 public health emergency in 2020, the Office of Inspector General, U.S. Department of Health and Human Services (HHS-OIG) entered into the highest number of corporate integrity...more

HHS-OIG Signals Increasing Skepticism of Speaker Programs, Identifies Practices That Raise Compliance Red Flags

On November 16, 2020, the Office of the Inspector General of the Department of Health and Human Services (HHS-OIG) issued a Special Fraud Alert regarding the inherent fraud and abuse risks associated with...more

HHS-OIG Year in Review: Pharma and Medical Device CIAs Increase, Include Novel Provisions

Corporate integrity agreements (CIAs) continued to be an important tool for the Office of Inspector General, U.S. Department of Health and Human Services (HHS-OIG) in 2019. Notably, pharmaceutical and device manufacturers saw...more

Sweeping Changes Proposed to Safe Harbors for Drug Discounts to Health Plans

The Department of Health and Human Services (HHS) has published a proposed rule that would make sweeping changes to the discount and rebate arrangements between drug manufacturers on the one hand and Medicare Part D plans and...more

The 10 Most Important Changes in the New and Improved AdvaMed Code of Ethics

At the close of 2018, the Advanced Medical Technology Association (AdvaMed) released an updated version of its Code of Ethics governing medical technology manufacturers in their interactions with health care professionals...more

Skadden's 2019 Insights: Trump Policy Actions Could Reshape Health Care and Life Sciences Landscape

In 2018, President Donald Trump and numerous executive branch agencies announced proposals that, if implemented, will reshape the landscape for virtually every sector of the health care industry. Many of these proposals are...more

"Supreme Court Permits Use of Statistical 'Representational Evidence': Implications for the FCA"

On March 22, 2016, the U.S. Supreme Court issued a decision in the Fair Labor Standards Act (FLSA) class action Tyson Foods, Inc. v. Bouaphakeo. In an opinion authored by Justice Anthony Kennedy, the majority held that class...more

Recent Corporate Integrity Agreements Highlight HHS OIG’s Compliance Program Priorities

Corporate Integrity Agreements (CIAs) are among the most important tools in the U.S. Department of Health and Human Services Office of Inspector General’s (OIG) toolbox for promoting compliance in the health care industry....more

"Key Takeaways: Fifth Annual Pharmaceutical and Medical Device Seminar"

On November 17, 2015, a group of Skadden attorneys and corporate counsel joined representatives from more than 20 life sciences companies to discuss U.S. enforcement issues companies throughout the industry face. The key...more

"The Future of Government Regulation, Enforcement of Off-Label Promotion"

Three years ago, in United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that the Federal Food, Drug and Cosmetic Act (FDCA) neither prohibits nor criminalizes truthful, nonmisleading speech that...more

"Supreme Court Decision in FCA Case Both a Win, Setback for Health Care Providers"

On May 26, 2015, the U.S. Supreme Court issued a rare unanimous decision in a False Claims Act (FCA) case that cuts both ways for the health care industry. In an opinion authored by Justice Samuel Alito, the Court held in...more

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