Join us for the next webinar in our Enforcement Outlook series, which will focus on the latest trends and hot topics surrounding the False Claims Act (FCA). Members of our White-Collar Practice Group will dive into how the...more
McDermott’s Healthcare Litigation, Compliance and Investigations Forum is back when you need it the most.
Heightened regulatory scrutiny and enforcement activity pose legal, financial and reputational risks for healthcare...more
10/10/2023
/ Administrative Procedure Act ,
Anti-Kickback Statute ,
Antitrust Provisions ,
Attorney-Client Privilege ,
Chief Compliance Officers ,
Compliance ,
Continuing Legal Education ,
Enforcement Actions ,
Events ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Facilities ,
Investigations ,
Life Sciences ,
Physicians ,
Regulatory Requirements ,
Restrictive Covenants
Two separate lawsuits alleging False Claims Act (FCA) violations by retail drug pharmacies made their way to the Supreme Court of the United States this term. The lawsuits decided whether the pharmacies could defeat these...more
6/14/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
False Claims Act (FCA) ,
Fraud ,
Healthcare ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Reasonable Interpretations ,
Safeco ,
Scienter ,
SCOTUS ,
US ex rel Thomas Proctor v Safeway Inc ,
US ex rel Tracy Schutte et al v SuperValu Inc et al
The Anti-Kickback Statute (AKS) is a criminal statute that, in broad strokes, bars the payment or receipt of “remuneration” in exchange for referrals. It has become one of the most lucrative theories of civil liability under...more
The healthcare enforcement landscape is shifting quickly. This issue of McDermott’s Healthcare Enforcement Quarterly examines emerging trends and key issues for organizations that may become subject to enforcement scrutiny,...more
4/14/2022
/ Appeals ,
Biden Administration ,
Centers for Disease Control and Prevention (CDC) ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Medicare ,
OIG ,
Regulatory Oversight ,
Substance Abuse ,
Telehealth ,
Trump Administration
Stay current on the healthcare enforcement issues impacting your business’ compliance strategies. In this installment of the Healthcare Enforcement Roundup, we address:
• Key areas of enforcement scrutiny in 2021,...more
4/2/2021
/ 1135 Waivers ,
Biden Administration ,
Coronavirus/COVID-19 ,
Criminal Prosecution ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Enforcement Guidance ,
Executive Orders ,
False Claims Act (FCA) ,
Healthcare Fraud ,
OIG ,
Private Equity ,
Regulatory Oversight ,
Revocation ,
Telehealth ,
Telemedicine
The large volume of relief funding distributed by the government in connection with the COVID-19 pandemic will be the source of enforcement and regulatory scrutiny for years to come. During this webinar – the first in a...more
4/1/2021
/ Biden Administration ,
Continuing Legal Education ,
Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
Dismissals ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Materiality ,
Objective Falsity ,
Provider Relief Fund ,
Relief Measures ,
Telehealth ,
Webinars
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
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
The US Court of Appeals for the Third Circuit endorsed two controversial interpretations of the Stark Law’s “volume or value” standard, known as the correlation theory and the practice “loss” theory in U.S. ex rel. J. William...more
10/3/2019
/ Appeals ,
Compensation Agreements ,
Dismissal With Prejudice ,
False Claims Act (FCA) ,
Health Care Providers ,
Hospitals ,
Medical Centers ,
Motion to Dismiss ,
Patient Referrals ,
Petition For Rehearing ,
Physician Compensation Arrangements ,
Physician Medicare Reimbursements ,
Physicians ,
Pleading Standards ,
Relators ,
Reversal ,
Rule 9(b) ,
Stark Law ,
Statutory Interpretation ,
Statutory Violations
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
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
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
In a January 10, 2019, decision, the US District Court for the District of Arizona granted summary judgment to Defendants because Relators failed to raise a genuine issue of material fact on the issue of “knowledge” under the...more
Following our inaugural installment of the Health Care Enforcement Quarterly Roundup, we are pleased to be back this quarter with another overview of key enforcement trends in the health care industry. In this issue, we...more
Over the past 18 months, we have closely monitored the Trump administration’s approach to health care enforcement issues, with a particular focus on whether prosecution of the False Claims Act (FCA) remains a priority under...more
In a two-page memorandum, the US Department of Justice (DOJ) announced a broad policy statement prohibiting the use of agency guidance documents as the basis for proving legal violations in civil enforcement actions,...more
2/16/2018
/ Administrative Procedure Act ,
Attorney General ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Enforcement Guidance ,
Executive Branch ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medicare ,
Memorandum of Guidance ,
Rulemaking Process
The law is uncertain. One example of this uncertainty is how the “Yates Memo” is to be applied in civil cases—in particular, what constitutes “cooperation” and how cooperation may benefit a company under investigation for...more