The year 2023 was historic from a Stark Law enforcement perspective, as we witnessed a resurgence of False Claims Act (FCA) enforcement actions predicated on Stark Law violations. This increase was capped off in December 2023...more
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
12/19/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Department of Health and Human Services (HHS) ,
Digital Health ,
False Claims Act (FCA) ,
Healthcare ,
Incentives ,
Investors ,
Medicare ,
OIG ,
Private Investment Funds ,
REIT ,
Shareholders ,
Transparency
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
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
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
On September 24, 2021, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a request for information (RFI) to advance its guidance modernization initiative. The RFI seeks industry...more
12/9/2021
/ Advisory Opinions ,
Audits ,
Comment Period ,
Compliance ,
Corporate Integrity Agreement ,
Department of Health and Human Services (HHS) ,
Fraud Alerts ,
List of Excluded Individuals/Entities (LEIE) ,
OIG ,
Regulatory Oversight ,
Request For Information ,
Resource Management
One of the few constants in the evolving government enforcement landscape is a focus on life sciences companies and their interactions and financial relationships with providers. In this final installment of our three-part...more
6/3/2021
/ Artificial Intelligence ,
Compliance ,
Coronavirus/COVID-19 ,
Digital Health ,
Enforcement ,
Health Care Providers ,
Influencers ,
Life Sciences ,
Patients ,
Product Placement ,
Social Media ,
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
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
As healthcare moves increasingly from fee-for-service model to one focused on outcomes and value-based payments, the traditional fraud and abuse laws, such as the Anti-Kickback Statute and the Stark Law, pose obstacles to...more
5/28/2020
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Compliance ,
Coronavirus/COVID-19 ,
Fee-for-Service ,
Health Care Providers ,
Healthcare Fraud ,
New Rules ,
OIG ,
Physicians ,
Policy Statement ,
Proposed Rules ,
Self-Referral ,
Stark Law ,
Telemedicine ,
Value-Based Care ,
Waivers
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
Earlier this year, DOJ and OIG independently issued guides focused on evaluating compliance program effectiveness. The guides approach the topic from different perspectives but cover overlapping themes and work well in...more
On April 18, 2016, Inspector General Daniel R. Levinson announced the publication of updated guidance on how the Office of Inspector General (OIG) makes decisions about using its permissive exclusion authority and requiring...more
4/29/2016
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Corporate Integrity Agreement ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Fraud ,
Health Care Providers ,
Medicare ,
New Guidance ,
OIG ,
Permissive Exclusion Authority ,
Stark Law