Like most industries, the health care sector is grappling with the uses of artificial intelligence (AI) and what AI means for the future. At the same time, many health care companies already have integrated algorithms and AI...more
2/13/2024
/ Algorithms ,
Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Justice (DOJ) ,
Enforcement ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Technology ,
Healthcare ,
Medicare Advantage ,
Natural Language Processing ,
Popular ,
Qui Tam ,
Whistleblowers
After the Department of Justice (“DOJ”) announced its Civil Cyber-Fraud Initiative in October 2021, many in the False Claims Act (“FCA”) bar expected an onslaught of enforcement actions and qui tam cases. The initiative...more
2/12/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
Department of Defense (DOD) ,
Department of Justice (DOJ) ,
Disclosure Requirements ,
Enforcement ,
False Claims Act (FCA) ,
Federal Acquisition Regulations (FAR) ,
Fraud ,
Regulatory Standards ,
Risk Assessment ,
Securities and Exchange Commission (SEC) ,
Settlement
Government enforcement activities focused on tele-fraudsters remained active in 2023, but did not break substantial new ground. Several significant criminal resolutions last year involved allegations that were similar to each...more
Over the last year, a few important questions related to False Claims Act (FCA) cases have garnered significant attention. Two of those questions ultimately made their way to the Supreme Court. In one case, which has already...more
As many of our readers are likely aware, last week the Supreme Court agreed to hear a second False Claims Act (FCA) issue this term. Having previously accepted and heard argument on a case concerning the government’s...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
On January 21, 2022, the First Circuit adopted a deferential standard that gives the government broad authority to dismiss False Claims Act (FCA) suits brought by private citizens (or relators) on behalf of the government...more
Last week, a bipartisan group of Senators led by Senator Chuck Grassley (R-Iowa) introduced two pieces of proposed legislation, one of which would amend the False Claims Act (FCA) and the other of which would amend the...more
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
As our readers know, we have long been closely watching False Claims Act (FCA) cases across the country alleging the submission of false claims based on the lack of medical necessity, particularly as a possible circuit split...more
Last Friday, the Department of Justice (DOJ) announced another increase to civil monetary penalties assessed under the False Claims Act (FCA), among other statutes.
DOJ made these adjustments to account for inflation, in...more
The Ninth Circuit Court of Appeals recently allowed a False Claims Act (FCA) case based on an alleged lack of medical necessity to proceed, rejecting the lower court's decision that subjective medical opinions about the...more
As many of our readers know, the AseraCare case was closely watched over the last several years because of its significance to efforts by the Department of Justice (DOJ) to allege that submission of claims for services...more
On Monday, the U.S. Court of Appeals for the Eleventh Circuit issued its long-awaited and closely watched decision in United States v. AseraCare Inc.. The court ruled that a claim cannot be deemed false under the False Claims...more
9/12/2019
/ Defense Strategies ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Hospice ,
Medical Necessity ,
Motion for Summary Judgment ,
Physicians ,
Qui Tam ,
Relators ,
Remand ,
Sua Sponte
Over the last two years, much of the healthcare world has been watching the government’s prosecution of Insys Therapeutics for its sales and marketing practices related to its Subsys spray. Subsys is powerful and highly...more
6/26/2019
/ Chapter 11 ,
Commercial Bankruptcy ,
Corporate Integrity Agreement ,
Deferred Prosecution Agreements ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Executive Compensation ,
False Claims Act (FCA) ,
Guilty Pleas ,
Healthcare ,
Kickbacks ,
OIG ,
Qui Tam ,
Racketeering
As part of our ongoing discussion of the Polukoff False Claims Act (FCA) qui tam case (involving allegations that certain heart procedures performed by a cardiologist, and billed for by two hospital defendants, were not...more
5/10/2019
/ Appeals ,
Appointments Clause ,
Article II ,
Constitutional Challenges ,
False Claims Act (FCA) ,
FRCP 9(b) ,
Motion to Dismiss ,
Petition for Writ of Certiorari ,
Pleading Standards ,
Qui Tam ,
Relators ,
Reversal
WHAT’S INSIDE -
Who Decides How Bankruptcy Laws Are Applied?
PROMESA: An Experiment Doomed to Fail -
The Role of Alter Ego in Restructuring -
SPECIAL FRAUD SECTION -
Don’t Depend on a Handshake -
Health...more
4/25/2019
/ Department of Justice (DOJ) ,
False Claims Act (FCA) ,
FRCP 9(b) ,
Government Investigations ,
Health Care Providers ,
Healthcare Fraud ,
Medicaid ,
Medicare ,
Motion to Dismiss ,
Petition for Writ of Certiorari ,
Qui Tam ,
Relators
As many of our readers know, we have been closely following the Polukoff False Claims Act (FCA) qui tam case, which is based on allegations that certain heart procedures performed by a cardiologist were not medically...more
2/8/2019
/ Appointments Clause ,
Article II ,
Denial of Rehearing ,
Failure to Comply ,
False Claims Act (FCA) ,
FRCP 9(b) ,
Health Care Providers ,
Healthcare Fraud ,
Medicare ,
Petition for Writ of Certiorari ,
Split of Authority ,
Whistleblowers
Nearly one year ago, on January 25, 2018, the Department of Justice’s (DOJ) Regulatory Reform Task Force issued a memorandum entitled “Limiting Use of Agency Guidance Documents In Affirmative Civil Enforcement Cases.” Many...more
1/8/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Controlled Substances Act ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Enforcement Guidance ,
False Claims Act (FCA) ,
Litigation Strategies ,
OIG ,
Opioid ,
Physicians ,
Regulatory Requirements
In a three-sentence order issued on October 29th, the Tenth Circuit Court of Appeals declined to grant a Request for Rehearing in the closely watched Polukoff case. One of the questions raised in the Request was whether, by...more
Last week, the U.S. Attorney’s Office for the District of Massachusetts announced that it had entered into an agreement with a Massachusetts-based medical device manufacturer to settle allegations that the Company had...more
The U.S. Court of Appeals for the Fifth Circuit recently decided a case that could have a substantial impact on False Claims Act (“FCA”) jurisprudence with respect to the element of “materiality.” In U.S. ex rel. Joshua...more
11/30/2017
/ Attorney's Fees ,
Department of Justice (DOJ) ,
Department of Transportation (DOT) ,
Disclosure Requirements ,
False Claims Act (FCA) ,
False-Certification of Conformance ,
Federal Highway Administration ,
Federal Rule 12(b)(6) ,
Material Misstatements ,
Materiality ,
Qui Tam ,
Reimbursements ,
Universal Health Services Inc v United States ex rel Escobar ,
Whistleblowers ,
Writ of Mandamus
Earlier this week, the Office of Inspector General for the Department of Health and Human Services (“OIG”) posted its fiscal year (“FY”) 2016 data about Medicaid Fraud Control Units (“MFCUs”) across the country....more
Last month, the U.S. District Court for the District of Utah joined the AseraCare court and others in finding that a relator cannot successfully allege violations of the False Claims Act (“FCA”) based on a purported lack of...more
Last month, we reported on a Massachusetts federal court jury’s decision to acquit the former CEO of Warner Chilcott in one of the first prosecutions of a health care executive following the Department of Justice’s (“DOJ”)...more
7/27/2016
/ Acquittals ,
CEOs ,
Corporate Executives ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Felonies ,
Food and Drug Administration (FDA) ,
Fraud ,
Health Care Providers ,
Medical Devices ,
Misdemeanors ,
Off-Label Promotion ,
Personal Liability ,
Yates Memorandum