DOJ Continues Historic Level of Criminal and Civil Enforcement Against COVID-19 Fraud -
On Friday, March 26, 2021, the Department of Justice (DOJ) announced an update on its efforts to combat COVID-19 related fraud. ...more
In this final post of our blog series on the substantial changes to the regulations implementing the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law), we cover change to (i)...more
On January 19, 2021, significant changes to the regulations implementing the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law) went into effect. The sweeping changes come...more
As you know, we have been parsing through the HHS rules that finalize important changes to the Anti-Kickback Statute (AKS) and Physician Self-Referral Law (Stark Law) regulations. To recap, our team provided an overview of...more
While health care entities often want to provide free or discounted items or services to patients (e.g., free transportation, co-payment waivers, free supplies), these free or discounted items or services pose risk under both...more
On November 20, 2020, the Department of Health & Human Services (HHS) finalized significant changes to the regulations implementing the Anti-Kickback Statute (AKS), the Physician Self-Referral Law (commonly known as the Stark...more
11/24/2020
/ Anti-Kickback Statute ,
Beneficiary Inducement ,
Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
DMEPOS ,
Final Rules ,
OIG ,
Safe Harbors ,
Stark Law ,
Value-Based Care
On Wednesday, August 26th, the Centers for Medicare & Medicaid Services (CMS) issued a notice extending the deadline to finalize significant proposed changes to the Physician Self-Referral Law (commonly known as the Stark...more
Comments made by Department of Justice (DOJ) attorneys during a recent webinar provided insight into the government’s civil enforcement priorities related to the coronavirus pandemic. In particular, government attorneys...more
8/19/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud ,
Government Investigations ,
Loan Forgiveness ,
Main Street Lending Programs ,
Paycheck Protection Program (PPP) ,
SBA ,
Telemedicine
United States Attorney Andrew E. Lelling recently announced that the U.S. Attorney’s Office (USAO) for the District of Massachusetts entered into a Memorandum of Understanding (MOU) with Special Inspector General Brian D....more
Leading up to a webinar on July 15, 2020, we are publishing a blog series covering the risks of enforcement against companies that received COVID-19 relief funds under the CARES Act and strategies for mitigating these risks....more
7/6/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Infectious Diseases ,
Natural Disasters ,
OIG ,
Paycheck Protection Program (PPP) ,
Qui Tam ,
Relators ,
Whistleblower Protection Policies ,
Whistleblowers
Since the early days of the pandemic, Mintz’s COVID-19 Compliance & Enforcement Defense Task Force has closely monitored and advised clients on the evolving COVID-19 relief programs, including those created by the Coronavirus...more
6/23/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
FCC ,
Federal Reserve ,
Health Care Providers ,
Main Street Lending Programs ,
Paycheck Protection Program (PPP) ,
Paycheck Protection Program Flexibility Act of 2020 (PPPFA) ,
Relief Measures ,
SBA ,
Small Business Loans
The Department of Justice (DOJ) has announced its first criminal securities fraud prosecution related to COVID-19, and it involves health care fraud as well. Mark Schena, president of Arrayit Corporation, a publicly traded...more
6/12/2020
/ Bribery ,
Coronavirus/COVID-19 ,
Criminal Conspiracy ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Guilty Pleas ,
Health Care Providers ,
Healthcare Fraud ,
Kickbacks ,
Medicare ,
Public Health Emergency ,
Securities Fraud
In an effort to address the need to increase the availability of COVID-19 testing, the Centers for Medicare & Medicaid Services (CMS) has issued guidance notifying pharmacies and other Medicare-enrolled suppliers that they...more
Today the Small Business Administration (SBA) issued additional guidance with respect to the “necessity” certification required under the CARES Act in connection with the Paycheck Protection Program (PPP).
The relevant...more
In Part Five of our Roadmap Series, we take a closer look at COVID-19 screening and testing, including best practices and legal implications, as potential tools to maintain a safe workplace.
Can We Screen Our Employees...more
In an effort to increase access to COVID-19 testing for Medicare and Medicaid beneficiaries, the Centers for Medicare & Medicaid Services (CMS) has issued a second round of regulatory waivers that includes relaxed Medicare...more
On Friday, the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) issued responses to a series of frequently asked questions (FAQs), in an effort to provide some level of regulatory...more
As authorized by Section 1135 of the Social Security Act, the Centers for Medicare & Medicaid Services (CMS) has announced that it will extend temporary Medicare billing privileges to physicians and non-physician...more
Two weeks ago, on March 9, the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) sent warning letters to seven companies that allegedly made false or deceptive claims about their products’ ability to...more
The Office of Inspector General for the U.S. Department of Health and Human Services (OIG) recently issued a favorable Advisory Opinion regarding a proposal by a pharmaceutical manufacturer (Requestor) to provide financial...more
2/3/2020
/ Advisory Opinions ,
Anti-Kickback Statute ,
Beneficiary Inducement ,
CMP Law ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Manufacturers ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
REMS ,
Travel Expenses
As discussed in our article recently published by Law360, 2019 brought yet another year of robust health care enforcement activity, and the False Claims Act (FCA) remains the government’s most powerful civil health care...more
As reported previously, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently published two proposed rules that seek to implement wholesale changes to the Anti-Kickback Statute (AKS) and...more
12/19/2019
/ ACOs ,
Advisory Opinions ,
Anti-Kickback Statute ,
Beneficiary Inducement ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Healthcare Reform ,
Home Health Care ,
OIG ,
Proposed Rules ,
Public Comment ,
Safe Harbors ,
Stark Law ,
Telehealth ,
Value-Based Care
As we previously reported, the Department of Health & Human Services (HHS) recently issued two proposed rules intended to reduce the regulatory burden associated with the Anti-Kickback Statute (AKS) and the Physician...more
11/22/2019
/ Anti-Kickback Statute ,
Beneficiary Inducement ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Homeland Security (DHS) ,
Health Care Providers ,
Healthcare Reform ,
Physician Compensation Arrangements ,
Physicians ,
Safe Harbors ,
Stark Law
This post is the fourth installment of our blog series on significant, proposed changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law) recently announced by the...more
This post is the third installment of our blog series on recent proposed rules from the Department of Health & Human Services (HHS) that, if finalized, would implement major changes to the Anti-Kickback Statute (AKS) and the...more
10/23/2019
/ Anti-Kickback Statute ,
Beneficiary Inducement ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Healthcare Reform ,
OIG ,
Personal Services ,
Proposed Rules ,
Regulatory Requirements ,
Safe Harbors ,
Stark Law ,
Value-Based Care ,
Warranties