Maya Florence

Maya Florence

Skadden, Arps, Slate, Meagher & Flom LLP

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"In Escobar, Supreme Court Upholds False Claims Act’s Implied Certification Theory"

On June 16, 2016, the U.S. Supreme Court in Universal Health Services v. United States ex rel. Escobar unanimously upheld the implied certification theory of False Claims Act (FCA) liability. The Court ruled that a party can...more

6/17/2016 - Conditions of Payment False Claims Act (FCA) False Implied Certification Theory Federal Contractors Fraud Implied Certification Material Misrepresentation Materiality Medicaid Medicare Mental Health SCOTUS Universal Health Services Inc v United States ex rel Escobar Unlicensed Medical Providers

"New HHS OIG Criteria to Guide Resolution of Health Care Investigations"

The Office of Inspector General of the Department of Health and Human Services (OIG) has issued updated guidance on the use of its so-called permissive exclusion authority under Section 1128(b)(7) of the Social Security Act...more

4/22/2016 - Administrative Authority CMS DOJ Exclusion Orders False Claims Act (FCA) Federal Health Care Programs (FHCP) Fraud and Abuse HHS New Guidance OIG Risk Assessment Willful Misconduct

"One-Two Punch: Amarin Settlement Order and Vascular Solutions Acquittal Further Erode Off-Label Promotion Enforcement Regime"

In an apparent first, the U.S. Food and Drug Administration (FDA) has conceded that a pharmaceutical company may engage in truthful and nonmisleading speech promoting the off-label use of a prescription drug. This concession...more

3/9/2016 - Acquittals Amarin Criminal Conspiracy FDA Approval First Amendment Misbranding Off-Label Promotion Pharmaceutical Industry Popular Settlement

"Financial Relationships Likely to Be a Focus in Life Sciences Enforcement and Litigation"

For more than a decade, the Department of Justice (DOJ) has zealously pursued enforcement actions against the health care industry. Given the continued growth in government spending on health care and the billions of dollars...more

1/22/2016 - Caronia DOJ Enforcement Actions FDCA First Amendment Healthcare Fraud Inducements Life Sciences Off-Label Promotion Off-Label Use Pharmaceutical Industry Physicians Yates Memorandum

"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

9/29/2015 - Advertising Amarin Caronia Commercial Speech Corporate Counsel Criminal Prosecution DOJ Enforcement Actions False Advertising FDA FDCA First Amendment Health Care Providers Labeling Medical Devices Misleading Impressions Off-Label Promotion Pharmaceutical Industry Popular Product Labels Ripeness Warning Letters

"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

6/1/2015 - Criminal Prosecution False Claims Act (FCA) Federal Contractors First-to-File Health Care Providers KBR (formerly Kellogg Brown & Root) Qui Tam SCOTUS Statute of Limitations Wartime Suspension of Limitations Act

"FDA Guidance Limits Flexibility in Social Media Promotional Communications"

Three recently issued draft guidance documents (Draft Guidances) from the U.S. Food and Drug Administration (FDA or Agency) are designed to assist manufacturers in product communications via social media and other interactive...more

7/22/2014

OIG Releases Updated Provider Self-Disclosure Protocol

On April 17, 2013, the Office of the Inspector General (OIG) of the United States Department of Health and Human Services released an updated Provider Self-Disclosure Protocol (SDP). As self-described, OIG updated the SDP to...more

5/21/2013 - Disclosure Requirements Eligibility OIG Self-Disclosure Requirements Transparency

"Ranbaxy Resolves Criminal and Civil Charges Through Record Settlement"

Executive Summary - On May 13, 2013, generic drug manufacturer Ranbaxy USA Inc. (Ranbaxy), a subsidiary of Indian generic drug manufacturer Ranbaxy Laboratories Limited, pled guilty to seven felony charges as part of a...more

5/15/2013 - Civil Monetary Penalty Criminal Sanctions False Claims Act (FCA) FDA FDCA Penalties Settlement

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