This report reviews notable areas for government enforcement actions during 2023 that were discussed in our monthly Healthcare Regulatory Check-Up reports. In the past year, we saw the relevant federal government enforcement...more
2/29/2024
/ Anti-Kickback Statute ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
OIG ,
Stark Law
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for November 2023. We discuss several US Department of Health and Human Services (HHS) agency actions, including the new General...more
1/15/2024
/ Ambulatory Surgery Centers ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Disclosure Requirements ,
Enforcement Actions ,
False Claims Act (FCA) ,
Final Rules ,
Fraud and Abuse ,
Healthcare Facilities ,
Healthcare Fraud ,
Healthcare Reform ,
Hospitals ,
No Surprises Act (NSA) ,
Outpatient Prospective Payment System (OPPS) ,
Payment Systems ,
Regulatory Reform ,
Skilled Nursing Facility
On November 6, 2023, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) published the General Compliance Program Guidance (GCPG) as a revised reference guide for the healthcare compliance...more
11/16/2023
/ Anti-Kickback Statute ,
Compliance ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Healthcare Fraud ,
OIG ,
Patients ,
Stark Law
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for June 2023. We discuss several civil enforcement actions involving false claims, the Anti-Kickback Statute (AKS) and...more
7/31/2023
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Justice (DOJ) ,
Emerging Technologies ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Health Information Technologies ,
Healthcare ,
Healthcare Fraud ,
Medicare ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Securities and Exchange Commission (SEC) ,
Telehealth ,
Telemedicine
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for April 2023. We discuss several criminal and civil enforcement actions related to the Anti-Kickback Statute (AKS) and the...more
6/8/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Testing ,
False Claims Act (FCA) ,
Fraud ,
Kickbacks ,
Medicaid ,
Medical Debt ,
OIG ,
Self-Disclosure Requirements ,
Settlement ,
Stark Law ,
TRICARE
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for March 2023. We discuss several criminal and civil enforcement actions that involve Anti-Kickback Statute (AKS) and...more
5/3/2023
/ Coronavirus/COVID-19 ,
Criminal Convictions ,
Criminal Prosecution ,
Department of Defense (DOD) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Durable Medical Equipment ,
Enforcement Actions ,
False Claims Act (FCA) ,
False Statements ,
Florida ,
Fraud ,
Health Care Providers ,
Healthcare Fraud ,
Hospitals ,
Kickbacks ,
OIG ,
Physicians ,
Remand ,
Settlement ,
Voluntary Disclosure ,
Whistleblowers
After a rare False Claims Act (FCA) trial—especially one premised on violations of the Anti-Kickback Statute (AKS)—a federal jury in Minnesota returned a $43 million verdict against Precision Lens, a distributor of medical...more
3/30/2023
/ Anti-Kickback Statute ,
Appeals ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Kickbacks ,
Medical Devices ,
Medicare ,
OIG ,
Physicians ,
Settlement
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity and developments occurring in January 2023, including several criminal and civil enforcement actions related to the federal...more
3/9/2023
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Fraud ,
Health Care Providers ,
Hospitals ,
Manufacturers ,
Medical Devices ,
Non-Compete Agreements ,
Pharmaceutical Industry ,
Physicians ,
Proposed Regulation ,
Regulatory Agenda ,
Self-Referral ,
Stark Law
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity between August 21 and September 20, 2022, including a guilty plea from a telemedicine physician who wrote prescriptions for...more
10/7/2022
/ Advisory Opinions ,
Anti-Kickback Statute ,
Antitrust Violations ,
Biotechnology ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Hospitals ,
Medicare ,
Medicare Shared Savings Program ,
Nurses ,
OIG ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Price Transparency ,
Technology ,
Telehealth ,
TRICARE
This special inaugural issue of McDermott’s Healthcare Regulatory Check-Up highlights noticeable enforcement activity, OIG regulatory developments, CMS regulatory developments and other key developments for healthcare...more
5/27/2022
/ Advisory Opinions ,
Anti-Kickback Statute ,
Co-payments ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
False Claims Act (FCA) ,
Health Care Providers ,
Manufacturers ,
Medicaid Drug Rebate Program ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
Stark Law
The US Department of Justice recently intervened in an qui tam alleging false and fraudulent claims involving the acquisition of physician practice locations by a health system and subsequent management of the health system’s...more
4/19/2022
/ Anti-Kickback Statute ,
Asset Purchase Agreements ,
Department of Justice (DOJ) ,
Drug Pricing ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Hospitals ,
Medicare ,
Physicians ,
Professional Services Contract ,
Qui Tam ,
Reimbursements ,
Reversal ,
Section 340B
Healthcare enforcement saw an uptick in 2021 and in the first quarter of 2022 as the Department of Justice and other agencies ramped up their investigations following the COVID-19 slowdowns. This uptick in enforcement,...more
4/4/2022
/ Centers for Disease Control and Prevention (CDC) ,
Continuing Legal Education ,
Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Facilities ,
Healthcare Fraud ,
Opioid ,
Physicians ,
Risk Mitigation ,
Webinars
On November 8, 2021, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued an update to the Health Care Fraud Self-Disclosure Protocol (SDP). This update revises and renames the...more
In its November 16, 2020, Special Fraud Alert, the HHS Office of Inspector General drew attention to potential fraud and abuse risks of speaker programs hosted by pharmaceutical companies and medical device manufacturers....more
11/18/2020
/ AdvaMed ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Health Care Providers ,
Healthcare Fraud ,
Inspector General ,
Manufacturing Facilities ,
Medical Devices ,
New Guidance ,
OIG ,
Pharmaceutical Industry ,
PHRMA ,
Risk Factors ,
Speaker Programs
The US Department of Justice and the US Department of Health and Human Services Office of Inspector General recently announced a significant healthcare fraud takedown involving $4.5 billion in allegedly false and fraudulent...more
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
The first half of 2020 set the tone for an unprecedented year for the healthcare industries. In light of the COVID-19 pandemic, healthcare organizations are navigating uncharted compliance waters while continuing to face...more
7/14/2020
/ 1135 Waivers ,
Compliance ,
Continuing Legal Education ,
Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Guidance Update ,
Health Care Providers ,
Objective Falsity ,
Physicians ,
Split of Authority ,
Stark Law ,
Webinars ,
Whistleblowers
The US Department of Justice’s (DOJ) revised compliance program document “The Evaluation of Corporate Compliance Programs,” released June 1, 2020, helps organizations understand how DOJ evaluates compliance programs for...more
On June 1, 2020, the Criminal Division of the Department of Justice (DOJ) issued updates to its “Evaluation of Corporate Compliance Program” guidance. This update reflects the agency’s evolving views on compliance program...more
Hospitals and health systems are facing consumer demand for innovation, the need to expand and enhance streams of revenue and the push for improved quality, all while navigating changing regulations, federal enforcement,...more
2/6/2020
/ Antitrust Litigation ,
Centers for Medicare & Medicaid Services (CMS) ,
CMIA ,
Cyber Attacks ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Federal Trade Commission (FTC) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Hospitals ,
Medicare ,
No-Poaching ,
OCR ,
Popular ,
Ransomware
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
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
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
DOJ recently announced the release of formal guidance on how civil attorneys can award “cooperation credit” to defendants who cooperate with DOJ during a False Claims Act investigation. This formal policy provides some new...more
6/21/2019
/ Chief Compliance Officers ,
Cooperation ,
Corporate Misconduct ,
Defense Strategies ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Good Faith ,
Government Investigations ,
New Guidance ,
Scienter ,
Self-Disclosure Requirements