In early March 2024 at the American Bar Association’s 39th National Institute on White Collar Crime, Deputy Attorney General (DAG) Lisa Monaco’s keynote remarks previewed the development of new and significant Department of...more
3/21/2024
/ American Bar Association (ABA) ,
CFTC ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Foreign Corrupt Practices Act (FCPA) ,
Healthcare ,
Securities and Exchange Commission (SEC) ,
Self-Reporting ,
Voluntary Disclosure ,
Whistleblower Awards ,
Whistleblower Protection Policies ,
Whistleblowers ,
White Collar Crimes
2023 was a very active one for Department of Justice (DOJ or the “Department”) guidance, and that guidance had one clear theme: DOJ wants companies to voluntarily self-disclose their misconduct. To incentivize...more
2/15/2024
/ Compliance ,
Cooperation ,
Corporate Crimes ,
Corporate Misconduct ,
Corruption ,
Department of Justice (DOJ) ,
Due Diligence ,
Enforcement ,
False Claims Act (FCA) ,
Safe Harbors ,
Self-Disclosure Requirements ,
Settlement ,
Voluntary Disclosure ,
White Collar Crimes
The Department of Justice and other federal enforcement agencies continued to hotly pursue individuals and entities involved in criminal telefraud schemes in 2022, as evidenced by the national coordinated law enforcement...more
2/13/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
DEA ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Billing ,
False Claims Act (FCA) ,
Fraud ,
OIG ,
Public Health Emergency ,
Telemedicine
Record Settlement in a Declined Case -
While defendants typically breathe a sigh of relief when the Department of Justice (DOJ) declines to intervene in a qui tam False Claims Act (FCA) case, a more favorable outcome is by...more
2/13/2023
/ Cyber Crimes ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Electronic Protected Health Information (ePHI) ,
False Claims Act (FCA) ,
Fraud ,
Health Care Providers ,
Long-Term Care ,
Private Equity Firms ,
Qui Tam ,
Settlement
Disclosing known or suspected fraud to regulators can have its benefits. As reported in a previous post, the Department of Justice (DOJ) issued policy guidance in 2019 on providing credit in False Claims Act (FCA)...more
Last week, the Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) issued Advisory Opinion No. 22-09 (AO 22-09), which addresses a proposed arrangement pursuant to which the operator of a...more
STATISTICAL TRENDS IN FALSE CLAIMS ACT LITIGATION -
FCA case activity for 2021 reveals seemingly contrary trends. For the federal fiscal year (FY) that ended September 30, 2021, the DOJ annual report on FCA enforcement...more
2/11/2022
/ Clinical Trials ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Kickbacks ,
Medical Devices ,
Medicare ,
Medicare Advantage ,
Nursing Homes ,
Pharmaceutical Industry ,
Pharmacies ,
Qui Tam ,
Telehealth
For the first time since April 2013, the Department of Health and Human Services’ Office of Inspector General (OIG) revised the Provider Self-Disclosure Protocol (SDP) on November 8, 2021. The SDP allows providers and other...more
11/11/2021
/ Civil Monetary Penalty ,
Corporate Integrity Agreement ,
Department of Justice (DOJ) ,
Disclosure Requirements ,
False Claims Act (FCA) ,
Health Care Violations ,
Healthcare Fraud ,
OIG ,
Provider Self-Disclosure Protocol ,
Reporting Requirements ,
Settlement ,
Whistleblowers
During a recent panel discussion hosted virtually by the American Bar Association, attorneys from the Department of Justice (DOJ) and certain U.S. Attorneys’ Offices known for health care fraud enforcement provided valuable...more
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
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
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
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
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
The Department of Justice (DOJ) recently announced that it has agreed to a $21.36 million settlement with compounding pharmacy Diabetic Care Rx LLC d/b/a Patient Care America (PCA), private equity firm Riordan, Lewis & Haden...more
9/23/2019
/ Amended Complaints ,
Anti-Kickback Statute ,
Department of Justice (DOJ) ,
Drug Compounding ,
False Claims Act (FCA) ,
False Implied Certification Theory ,
Fraud and Abuse ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Portfolio Companies ,
Private Equity Firms ,
TRICARE
On August 20, 2019, the United States exercised its authority under the False Claims Act (FCA) to seek dismissal of a relator’s qui tam suit because of the defendant’s burdensome discovery demands, in Polansky v. Executive...more
8/24/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Discovery ,
Dismissals ,
EHR ,
False Claims Act (FCA) ,
Health Care Providers ,
Qui Tam ,
Relators ,
The Granston Memo ,
Two-Midnight Rule
Last week, a U.S. district court judge in the Southern District of Florida upheld a magistrate judge’s decision to dismiss False Claims Act (FCA) allegations against a compounding pharmacy, its private equity firm owner, and...more
The Department of Justice (DOJ) recently announced a $1.99 million False Claims Act (FCA) settlement with GenomeDx Biosciences Corp. (“GenomeDx”), a laboratory headquartered in Vancouver, British Columbia with operations in...more
2/22/2019
/ Department of Justice (DOJ) ,
Failure to Comply ,
False Claims Act (FCA) ,
Health Care Providers ,
Local Coverage Determination (LCD) ,
Medical Necessity ,
Medicare ,
Physician Medicare Reimbursements ,
Physicians ,
Qui Tam ,
Relators
Last week the Department of Justice (DOJ) announced a $57 million settlement with electronic health record (EHR) software vendor Greenway Health LLC (Greenway). According to DOJ, Greenway violated the False Claims Act (FCA)...more
2/14/2019
/ Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
EHR ,
Electronic Health Record Incentives ,
False Claims Act (FCA) ,
Health Care Providers ,
Meaningful Use ,
Medicaid ,
Medicare ,
OIG ,
Settlement Agreements ,
Software ,
Third-Party Service Provider
In an Advisory Opinion posted earlier this week, the OIG gave the green light to a charitable pediatric clinic’s routine waiver of patient cost-sharing amounts. The OIG’s analysis hinged on several factors that, taken...more
1/21/2019
/ Advisory Opinions ,
Anti-Kickback Statute ,
Cost-Sharing ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Clinics ,
Healthcare Facilities ,
Low-Income Issues ,
Medicare ,
OIG ,
Pediatrics ,
Waivers
As in years past, the False Claims Act (FCA) remained a powerful health care enforcement tool in 2018, and FCA investigations and litigation persisted, fueled mainly by hundreds of lawsuits filed annually by relators,...more
1/16/2019
/ Anti-Kickback Statute ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Gilead Sciences Inc v United States ex rel Campie ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Petition for Writ of Certiorari ,
Solicitor General ,
Universal Health Services Inc v United States ex rel Escobar
The Department of Justice (DOJ) recently intervened in a False Claims Act (FCA) case that raises a variety of interesting allegations, including payment of kickbacks by a compounding pharmacy to contracted marketing companies...more
The waiver of copayments, coinsurance, and deductibles owed by patients treated by out-of-network laboratories and other providers is a hot topic in the health care industry. Despite the near absence of clear legal...more
Over the past year, significant regulatory changes began to take shape that will have lasting effects on the laboratory industry for years to come. After publishing draft guidance regarding the regulation of laboratory...more
12/31/2015
/ Aetna ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
CIGNA ,
CLIA ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Laboratory Developed Tests ,
OIG ,
PAMA ,
Stark Law
With Halloween looming, a discussion of skeletons that may be lurking in a health care provider’s closet is timely. Many of our previous posts, as well as the monthly Qui Tam Updates published by our Health Care Enforcement...more
10/29/2015
/ 60-Day Rule ,
Affordable Care Act ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Fair Market Value ,
False Claims Act (FCA) ,
Final Rules ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Overpayment ,
Physician Compensation Arrangements ,
Qui Tam ,
Relators ,
Safe Harbors ,
Settlement ,
Stark Law ,
Suppliers ,
Third-Party ,
Training