2017 was slightly above average for new corporate integrity agreements (CIAs), with 46 entered into by the Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) and companies and individuals...more
3/26/2018
/ Charitable Organizations ,
Civil Monetary Penalty ,
Compliance ,
Corporate Integrity Agreement ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Health IT ,
Healthcare Fraud ,
Medical Devices ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
Settlement ,
Vendors
The Trump administration and Republican-led Congress spent substantial time and political capital in 2017 on efforts to repeal and replace the Affordable Care Act (ACA) and enact sweeping Medicaid reform. By the end of the...more
1/31/2018
/ Affordable Care Act ,
Block Grants ,
Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Deregulation ,
Enforcement Actions ,
Executive Orders ,
False Claims Act (FCA) ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Health Insurance ,
Healthcare Reform ,
Individual Mandate ,
Medicaid ,
Medical Devices ,
Medical Reimbursement Plans ,
Medicare ,
Opioid ,
Orphan Drugs ,
Political Parties ,
Popular ,
Stabilization Issues ,
Trump Administration ,
Universal Health Services Inc v United States ex rel Escobar
Panelists examined major enforcement actions from 2017 and identified key trends. Aggressive Enforcement With a Decrease in High-Dollar Settlements. Panelists noted that the Department of Justice (DOJ) continues its...more
12/5/2017
/ Anti-Kickback Statute ,
Corporate Integrity Agreement ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
Foreign Corrupt Practices Act (FCPA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
Materiality ,
Medical Devices ,
Off-Label Promotion ,
OIG ,
Patient Assistance Programs ,
Pharmaceutical Industry ,
Popular ,
Securities and Exchange Commission (SEC) ,
Universal Health Services Inc v United States ex rel Escobar
On September 22, 2017, Aegerion Pharmaceuticals resolved a wide-ranging probe by the Department of Justice (DOJ) regarding the company’s U.S. commercial activities relating to Juxtapid, a lipid-lowering agent for the...more
9/28/2017
/ Anti-Kickback Statute ,
Consent Decrees ,
Criminal Conspiracy ,
Criminal Investigations ,
Criminal Penalties ,
Deferred Prosecution Agreements ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Fraudulent Inducement ,
HIPAA Audits ,
HIPAA Breach ,
Medical Devices ,
Misdemeanors ,
Off-Label Promotion ,
Pharmaceutical Industry ,
Prescription Drugs ,
Promotional Items ,
Whistleblowers
2016 was a year of change for the Department of Health and Human Service's Office of Inspector General's (OIG) approach to corporate integrity agreements (CIA). The OIG began to use its new model CIA format and applied its...more
3/14/2017
/ Corporate Integrity Agreement ,
Corporate Misconduct ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Healthcare Fraud ,
Life Sciences ,
Medical Devices ,
New Guidance ,
OIG ,
Permissive Exclusion Authority ,
White Collar Crimes
While President Donald Trump made repeal of the Affordable Care Act (ACA) a centerpiece of his 2016 presidential campaign, he offered few details about how he would replace it or address other health care issues. More...more
2/4/2017
/ Administrative Appointments ,
Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Fraud Abuse and Waste ,
Health Insurance ,
Health Savings Accounts ,
Healthcare Fraud ,
Healthcare Reform ,
Innovation ,
Legislative Agendas ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Repeal ,
Tax Credits ,
Trump Administration
On the eve of a change in administration, the U.S. Food and Drug Administration (FDA or the Agency) released a flurry of documents regarding off-label communications and FDA’s ability to regulate such communications within...more
2/2/2017
/ Administrative Authority ,
Draft Guidance ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
First Amendment ,
Food and Drug Administration (FDA) ,
Free Speech ,
Life Sciences ,
Medical Devices ,
Off-Label Promotion ,
Pharmaceutical Industry
On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Act), one of the most important pieces of health care and life sciences legislation in several decades. The Act is intended to spur the rapid...more
12/14/2016
/ 21st Century Cures Initiative ,
Barack Obama ,
Cancer ,
Civil Monetary Penalty ,
Clinical Trials ,
Department of Health and Human Services (HHS) ,
Federal Funding ,
Food and Drug Administration (FDA) ,
HCEI ,
Health Information Technologies ,
Healthcare Fraud ,
Hospitals ,
Infectious Diseases ,
Innovation ,
Life Sciences ,
Medical Devices ,
Medical Research ,
Mental Health ,
National Institute of Health (NIH) ,
New Legislation ,
Opioid ,
Patient Privacy Rights ,
Pharmaceutical Industry ,
Prescription Drugs ,
Safe Harbors ,
Software Developers
On December 6, 2016, the Supreme Court of the United States ruled unanimously in State Farm Fire and Casualty Co. v. United States ex rel. Rigsby that violations of the False Claims Act’s (FCA) seal requirement do not require...more
On June 16, 2016, the U.S. Supreme Court in Universal Health Services, Inc. v. United States ex rel. Escobar1 (Escobar) unanimously upheld the implied certification theory of False Claims Act (FCA) liability and strengthened...more
11/7/2016
/ Appeals ,
Conditions of Payment ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
False Implied Certification Theory ,
Fraud ,
Government Knowledge Defense ,
Material Misrepresentation ,
Materiality ,
Motion to Dismiss ,
Pleading Standards ,
Qui Tam ,
Scienter ,
Summary Judgment ,
Universal Health Services Inc v United States ex rel Escobar
On October 5, 2016, Skadden hosted its Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies. The seminar focused on the current and developing challenges facing such companies and included...more
10/26/2016
/ Acquisitions ,
Biotechnology ,
Corporate Integrity Agreement ,
Corporate Misconduct ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement Actions ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Guilty Pleas ,
Indictments ,
Kickbacks ,
Life Sciences ,
Medical Devices ,
Mergers ,
OIG ,
Omissions ,
Personal Liability ,
Pharmaceutical Industry ,
Popular ,
Securities Fraud ,
Settlement ,
Yates Memorandum
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
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 ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Exclusion Orders ,
False Claims Act (FCA) ,
Federal Health Care Programs (FHCP) ,
Fraud and Abuse ,
New Guidance ,
OIG ,
Risk Assessment ,
Willful Misconduct
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
4/5/2016
/ Admissible Evidence ,
Class Action ,
Department of Justice (DOJ) ,
Fair Labor Standards Act (FLSA) ,
False Claims Act (FCA) ,
Health Care Providers ,
Relators ,
SCOTUS ,
Statistical Sampling ,
Tyson Foods v Bouaphakeo ,
Wage and Hour
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
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
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 ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
First Amendment ,
Healthcare Fraud ,
Inducements ,
Life Sciences ,
Off-Label Promotion ,
Off-Label Use ,
Pharmaceutical Industry ,
Physicians ,
Yates Memorandum
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
12/15/2015
/ Anti-Kickback Statute ,
Attorney General ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Health Care Providers ,
Healthcare Fraud ,
Medical Devices ,
Medicare Fraud Strike Force ,
Pharmaceutical Industry
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 ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Advertising ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Labeling ,
Medical Devices ,
Misleading Impressions ,
Off-Label Promotion ,
Pharmaceutical Industry ,
Popular ,
Product Labels ,
Ripeness ,
Warning Letters
On June 25, 2015, the U.S. Supreme Court announced its long-awaited decision in King v. Burwell. The Court concluded that statutory language in the Affordable Care Act (ACA) authorizing tax credits for consumers on “an...more
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
On April 20, 2015, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) published its “Practical Guidance for Health Care Governing Boards on Compliance Oversight” (the Guidance).1...more
A healthy market for M&A activity, particularly cross-border deals, and a strict regulatory environment are the big factors influencing the health and activities of life sciences companies. Skadden partners John T....more
1/27/2015
/ Cross-Border Transactions ,
Department of Justice (DOJ) ,
Food and Drug Administration (FDA) ,
Kickbacks ,
Life Sciences ,
Medical Devices ,
Off-Label Promotion ,
Pharmaceutical Industry ,
Popular ,
Qui Tam ,
Regulatory Standards ,
Strategic Enforcement Plan
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
On May 21, 2014, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a special advisory bulletin addressing independent charity patient assistance programs (PAPs) for federal health care...more