In this installment of the Healthcare Enforcement Roundup we cover new and longstanding issues impacting the healthcare enforcement landscape. First, we explore the impact of the Coronavirus (COVID-19) on the healthcare...more
7/27/2020
/ 1135 Waivers ,
Compliance ,
Continuing Legal Education ,
Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
e ,
False Claims Act (FCA) ,
Guidance Update ,
Health Care Providers ,
Hospitals ,
Objective Falsity ,
Physicians ,
Split of Authority ,
Stark Law ,
Whistleblowers
As the largest corporate relief package in US history, the CARES Act likely will produce an unparalleled number of government investigations in the months and years to come. Companies that receive assistance should be...more
While the United States and governments around the world have pushed forward COVID-19 relief packages and Chinese manufacturers have restarted production, supply chain and manufacturing disruptions continue to grow. At times,...more
Organizations of all sizes are entering, performing and sometimes seeking to avoid contract obligations in connection with the COVID-19 pandemic. This webinar will provide an overview of the potential impact that COVID-19 has...more
4/7/2020
/ Best Practices ,
Breach of Contract ,
Contract Disputes ,
Contract Drafting ,
Contract Negotiations ,
Contract Termination ,
Contract Terms ,
Coronavirus/COVID-19 ,
Force Majeure Clause ,
Performance Standards ,
Webinars
On March 11, 2020, the Second Circuit heard arguments in United States v. Chi Ping Patrick Ho, a case testing the reach of the Foreign Corrupt Practices Act (FCPA) much like the 2018 case United States v. Hoskins. And, once...more
As the US federal government dedicates trillions of dollars toward containing and treating Coronavirus (COVID-19) and stimulating the national economy, it is also waiving many federal health program requirements to allow...more
In light of the novel Coronavirus (COVID-19) pandemic, many businesses are confronting circumstances that may excuse or delay their obligations to perform under existing contracts due to the occurrence of a force majeure...more
A recent US District Court for the District of Connecticut decision reveals the practical limits of the Foreign Corrupt Practices Act (FCPA) in cases involving foreign nationals, foreign conduct and complex multinational...more
In this installment of the Healthcare Enforcement Quarterly Roundup we cover several topics that have persisted over the past few years and identify new issues that will shape the scope of enforcement efforts in 2020. In this...more
2/7/2020
/ Administrative Procedure Act ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Compounding ,
Drug Distribution ,
Enforcement Actions ,
Enforcement Guidance ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Insurance ,
Healthcare Fraud ,
Healthcare Reform ,
Kickbacks ,
Medicare ,
Opioid ,
Overpayment ,
Pain Management ,
Pharmacies ,
Prescription Drugs ,
Private Equity ,
Regulatory Violations ,
Rulemaking Process ,
Settlement Negotiations ,
Stark Law
The final quarter of 2019 brought forward new guidance and proposed rules with major implications for healthcare companies, enforcement developments in healthcare private equity investing and opioid litigation matters, among...more
1/28/2020
/ Anti-Kickback Statute ,
Continuing Legal Education ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Health Insurance ,
Healthcare Facilities ,
Healthcare Fraud ,
Hospitals ,
Investors ,
Medical Necessity ,
Medicare ,
Medicare Advantage Organizations (MAOs) ,
New Guidance ,
Opioid ,
Pharmaceutical Industry ,
Physicians ,
Private Equity ,
Proposed Rules ,
Stark Law ,
Webinars
On January 21 and 22, 2020, we will be hosting our 8th McDermott International Seminars in Osaka and Tokyo respectively. These seminars will focus on cross-border M&A, GDPR, intellectual property, global enforcements and...more
12/20/2019
/ Acquisitions ,
Cross-Border Transactions ,
Data Privacy ,
Data Security ,
Emerging Technology Companies ,
Enforcement Actions ,
Events ,
Foreign Corporations ,
Foreign Investment ,
General Data Protection Regulation (GDPR) ,
Intellectual Property Protection ,
Merger Controls ,
Mergers
A few days before Thanksgiving, the news media published an internal memo by the Office of General Counsel (OGC) at the US Department of Health and Human Services (Department) to officials at the Centers for Medicare and...more
12/6/2019
/ Administrative Procedure Act ,
Azar v Allina Health Services ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Local Coverage Determination (LCD) ,
Medicare ,
Medicare Part C ,
New Guidance ,
Notice and Comment ,
OGC ,
Overpayment ,
Provider Payments ,
Rulemaking Process ,
SCOTUS ,
Social Security Act
The US Sentencing Guidelines permit reductions of criminal penalties based on a business organization’s inability to pay criminal fines, but were unclear about how it would make such determinations. An October 8 memorandum...more
12/3/2019
/ Corporate Crimes ,
Corporate Criminal Fines ,
Corporate Misconduct ,
Criminal Penalties ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Failure To Pay ,
Federal Sentencing Guidelines ,
Memorandum of Guidance ,
Penalty Reductions ,
White Collar Crimes
EU COMPETITION LAW AND ARTIFICIAL INTELLIGENCE -
Artificial Intelligence (AI) and big data are playing an increasingly important role in the economy. Competition law will have to evolve if it is to reconcile the positive...more
11/15/2019
/ Abuse of Dominance ,
Artificial Intelligence ,
Bribery ,
CFIUS ,
Collusion ,
Competition ,
Digital Marketplace ,
EU ,
European Commission ,
FIRRMA ,
Foreign Corrupt Practices Act (FCPA) ,
General Data Protection Regulation (GDPR) ,
Interim Measures ,
Manufacturers ,
Personal Data ,
Real Estate Transactions ,
Resale Price Maintenance (RPM)
The Second Circuit’s decision in United States v. Ng Lap Seng is a win for the government, because it reinforces the broad reach and scope of the Justice Department’s enforcement of the FCPA. When adopting and implementing an...more
8/21/2019
/ Anti-Corruption ,
Appeals ,
Bribery ,
Corporate Counsel ,
Corruption ,
Criminal Convictions ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Foreign Corrupt Practices Act (FCPA) ,
Foreign Official ,
Official Act ,
White Collar Crimes
In this second installment of the Healthcare Enforcement Quarterly Roundup for 2019, we cover several topics that have persisted over the past few years and identify new issues that will shape the scope of enforcement efforts...more
8/16/2019
/ Acquisitions ,
Centers for Medicare & Medicaid Services (CMS) ,
DEA ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Fraud ,
Home Health Agencies ,
Mergers ,
New Guidance ,
New Rules ,
OCR ,
OIG ,
Opioid ,
Pharmaceutical Industry
Frequent regulatory and policy changes, increasing government scrutiny and private whistleblower activity pose greater risks to health care organizations more than ever before. McDermott’s Q2 Health Care Enforcement Roundup...more
7/30/2019
/ Compliance ,
Continuing Legal Education ,
Cooperation ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement ,
Enforcement Actions ,
False Claims Act (FCA) ,
Freedom of Religion ,
Health Care Providers ,
Home Health Agencies ,
Home Health Care ,
Hospitals ,
Opioid ,
Opt-Outs ,
Physicians ,
Stark Law ,
Statute of Limitations ,
Telemedicine ,
Webinars ,
Whistleblowers
What Happened:
• Last week, the Antitrust Division reported that it has changed its Justice Manual to state that it will consider antitrust compliance at the charging stage in criminal antitrust investigations, instead of...more
7/17/2019
/ Antitrust Division ,
Antitrust Investigations ,
Antitrust Violations ,
Best Practices ,
Cartels ,
Chief Compliance Officers ,
Compliance ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Justice Manual ,
New Guidance ,
White Collar Crimes
FCPA UPDATES FOR GLOBAL COMPANIES -
In recent months, the US Department of Justice (DOJ) has issued important guidance for global companies on corporate compliance programs and the Foreign Corrupt Practices Act (FCPA)...more
7/2/2019
/ CFIUS ,
Chief Compliance Officers ,
Corporate Fines ,
Corporate Misconduct ,
Data Protection ,
Data Protection Authority ,
Department of Justice (DOJ) ,
Foreign Corporations ,
Foreign Corrupt Practices Act (FCPA) ,
Foreign Direct Investment ,
Foreign Investment ,
General Data Protection Regulation (GDPR) ,
Google ,
National Security ,
New Guidance ,
Securities and Exchange Commission (SEC) ,
Self-Disclosure Requirements
Boards and management should make use of recent expanded guidance from the US Department of Justice to ensure that their compliance programs are considered “effective” if and when an investigation arises. Companies should...more
Introduction -
In this first installment of the Health Care Enforcement Quarterly Roundup for 2019, we continue to monitor trends we identified in 2018 and introduce new enforcement efforts that are expected to persist in...more
4/26/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
EHR ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Contractors ,
Health Care Providers ,
OIG ,
Opioid ,
Prescription Drugs ,
Qui Tam ,
Statute of Limitations ,
Telemedicine ,
The Granston Memo
Assistant Attorney General Brian Benczkowski’s remarks provide important guidance for management and boards, and underscore the US Department of Justice’s commitment to prosecuting individuals for corporate misconduct....more
3/14/2019
/ Acquisitions ,
Cooperation ,
Corporate Executives ,
Corporate Misconduct ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
FCPA Corporate Enforcement Policy (CEP) ,
Foreign Corrupt Practices Act (FCPA) ,
Mergers ,
Remediation ,
Self-Disclosure Requirements ,
Voluntary Disclosure ,
White Collar Crimes
This latest installment of the Health Care Enforcement Quarterly Roundup reflects on trends that persisted in 2018 and those emerging trends that will carry us into 2019 and beyond. Leading off with the US Department of...more
1/29/2019
/ Anti-Kickback Statute ,
Corporate Investigations ,
Criminal Investigations ,
Department of Justice (DOJ) ,
Dismissals ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Individual Accountability ,
Materiality ,
Opioid ,
Pain Management ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Qui Tam ,
REMS ,
RICO ,
Settlement ,
Universal Health Services Inc v United States ex rel Escobar ,
Yates Memorandum
Data Inspections in China: Increased Supervision and Compliance -
Data protection inspections have become more frequent for companies with operations in China. Many companies are struggling for guidance on how to...more
How to Prepare for and Prevent Data Falsification Issues -
In September 2015, news broke that Volkswagen had manipulated software on its diesel engine vehicles to avoid emissions requirements, a disclosure that led to the...more