On January 14, 2021, the U.S. Department of Justice (DOJ) reported its False Claims Act (FCA) statistics for fiscal year (FY) 2020. More than $2.2 billion was recovered from both settlements and judgments in 2020, the lowest...more
The Department of Justice (DOJ) announced on January 12, 2021, the first civil settlement to resolve allegations of fraud against the Paycheck Protection Program (PPP) of the Coronavirus Aid, Relief, and Economic Security...more
Earlier this summer, Ethan P. Davis, Principal Deputy Assistant Attorney General for the Civil Division of the U.S. Department of Justice (DOJ) delivered remarks addressing DOJ’s top priorities for enforcement actions related...more
8/28/2020
/ CARES Act ,
Controlled Substances Act ,
Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Enforcement Guidance ,
False Claims Act (FCA) ,
Fraud ,
Healthcare Fraud ,
Litigation Funding ,
Multidistrict Litigation ,
Paycheck Protection Program (PPP) ,
Qui Tam ,
Relators ,
SBA Lending Programs ,
The Granston Memo ,
Trump Administration
Through a January 9, 2020, press release, the Department of Justice (“DOJ”) reported more than $3 billion in total recoveries from settlements and judgments from fraud-related civil matters brought under the False Claims Act...more
1/13/2020
/ Department of Justice (DOJ) ,
Enforcement Actions ,
Failure to Comply ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Life Sciences ,
Medicare ,
Pharmaceutical Industry ,
Physician Medicare Reimbursements ,
Physicians ,
Qui Tam ,
Relators ,
Stark Law ,
Statistical Analysis
Yesterday, a final rule issued by the Centers for Medicare & Medicaid Services (CMS) establishing new enforcement initiatives aimed at removing and excluding previously sanctioned entities from Medicare, Medicaid, and the...more
11/5/2019
/ Affiliates ,
Bad Actors ,
Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Durable Medical Equipment ,
Enrollment ,
Health Care Providers ,
Healthcare Fraud ,
Healthcare Reform ,
Medicaid ,
Medicare ,
Revocation ,
Suppliers
The Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services Office of Inspector General (OIG) issued their long-awaited proposed rules in connection with the Regulatory Sprint to...more
The first 100 days of a new presidential administration serves as a traditional, if somewhat arbitrary, demarcation point. April 29, 2017, serves as the 100th day of the Trump administration, and we now have insight into how...more
On June 16, 2016, the Supreme Court of the United States rendered a unanimous decision in the highly anticipated False Claims Act (“FCA”) case of Universal Health Services, Inc. v. United States ex rel. Escobar.[1] In its...more
On April 18, 2016, the Office of Inspector General (“OIG”) of the Department of Health and Human Services issued a revised policy statement applicable to exclusions imposed under Section 1128(b)(7) of the Social Security Act...more
Section 6402(a) of the Affordable Care Act (“ACA”), which was enacted by Congress in 2010, requires a person who has received an overpayment to report and return the overpayment to the Secretary of Health and Human Services,...more
On September 9, 2015, the Department of Justice (“DOJ”) issued new guidance on individual accountability for corporate wrongdoing. In the memorandum and an accompanying speech by the Deputy Attorney General Sally Q. Yates,...more
9/29/2015
/ Attorney-Client Privilege ,
Board of Directors ,
C-Suite Executives ,
Chief Compliance Officers ,
Corporate Misconduct ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Government Investigations ,
Healthcare ,
New Guidance ,
Yates Memorandum
On August 3, 2015, in United States ex rel. Kane v. Healthfirst, Inc., et al., No. 1:11-cv-02325 (S.D.N.Y. Aug. 3, 2015), the United States District Court for the Southern District of New York issued the first reported...more
On April 20, 2015, the Office of the Inspector General of the U.S. Department of Health and Human Resources (“OIG”), in collaboration with the American Health Lawyers Association, the Association of Healthcare Internal...more
On December 3, 2014, the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule (CMS-6045-F) that updates various requirements for providers and suppliers wishing to enroll in the Medicare program. CMS issued...more
On Nov. 20, 2014, the U.S. Department of Justice (“DOJ”) announced settlements and judgments for False Claims Act (“FCA”) cases totaling $5.7 billion (compared to $3.8 billion in fiscal year 2013), $2.3 billion of which was...more
12/12/2014
/ Affordable Care Act ,
Anti-Kickback Statute ,
Anti-Retaliation Provisions ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Health Care Providers ,
Overpayment ,
Popular ,
Retaliation ,
Settlement ,
Whistleblowers
On July 22, 2014, the U.S. Court of Appeals for the D.C. Circuit and the U.S. Court of Appeals for the Fourth Circuit issued conflicting opinions on a key aspect of the Affordable Care Act ("ACA"). The cases are Halbig v....more
7/30/2014
/ Affordable Care Act ,
Appeals ,
Barack Obama ,
Employer Mandates ,
En Banc Review ,
Halbig v Burwell ,
Health Insurance ,
Health Insurance Exchanges ,
Healthcare Reform ,
King v Burwell ,
SCOTUS ,
Subsidiaries ,
Tax Credits
Especially in the District of Columbia Circuit, the home base for many fraud cases in which the government is opposed to health care providers and defense contractors, there had been considerable doubt that the...more
On March 31, 2014, in U.S. ex rel. Nathan v. Takeda Pharmaceuticals North America, the Supreme Court of the United States declined to review a decision by the U.S. Court of Appeals for the Fourth Circuit upholding a district...more
6/7/2014
/ Certiorari ,
Dismissals ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Medicare ,
Off-Label Use ,
Pharmaceutical Industry ,
Pleading Standards ,
Popular ,
Qui Tam ,
Rule 9(b) ,
SCOTUS ,
Split of Authority ,
Takeda Pharmaceuticals ,
Whistleblowers
On May 9, 2014, the Office of Inspector General ("OIG") of the Department of Health and Human Services published in the Federal Register a proposed rule amending the regulations relating to OIG's exclusion authority...more
On May 8, 2013, the U.S. Department of Health and Human Services' Office of Inspector General ("OIG") released an Updated Special Advisory Bulletin on the Effect of Exclusion from the Participation in Federal Health Care...more
In 1998, the Department of Health and Human Services' Office of Inspector General ("OIG") published the Self-Disclosure Protocol ("SDP"), which provides a mechanism through which health care providers may voluntarily report...more
On March 15, 2013, the U.S. Department of Health and Human Services’ Office of Inspector General (“OIG”) released the Updated OIG Guidelines for Evaluating State False Claims Acts (“2013 Guidelines”), which replaces the...more