On March 15, 2023, the Centers for Medicare and Medicaid Services (CMS) issued initial program guidance related to implementation of the Medicare Drug Price Negotiation Program. CMS requested public comments on selected...more
On February 9, 2023, the Centers for Medicare and Medicaid Services (CMS) issued initial program guidance related to the implementation of the Prescription Drug Inflation Rebate Program. The rebate program was authorized...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’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
The US Department of Health and Human Services, Office of Inspector General has created an information portal and established a process to provide guidance on the application of the Anti-Kickback Statute and Beneficiary...more
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
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
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
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
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
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
Health care general counsel should review, and brief their internal clients on, the new Practical Guidance for Health Care Governing Boards on Compliance Oversight (Guidance), released on April 20, 2015. A joint effort by...more