In our annual report, we examine health care enforcement trends, predict how health care enforcement may evolve, and offer practical guidance about what these trends and predictions mean for health care providers, payors, and...more
2023 was a busy year across several federal agencies in terms of issuing compliance guidance for corporations, including health care companies. For example, the Department of Justice (DOJ) issued significant compliance...more
2/15/2024
/ American Bar Association (ABA) ,
Clawbacks ,
Compensation ,
Compliance ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
New Guidance ,
OIG ,
Risk Management ,
White Collar Crimes
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
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
From an agency guidance and regulatory developments perspective, 2022 was fairly quiet until the latter part of the year. Consistent with past practice, the Office of Inspector General for the Department of Health and Human...more
2/13/2023
/ Advisory Opinions ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Medicare Part A ,
Medicare Part B ,
Medicare Part C ,
Medicare Part D ,
OIG ,
Overpayment ,
Policies and Procedures ,
Regulatory Requirements ,
Self-Disclosure Requirements
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
For the last few years, we have been closely monitoring and reporting on COVID-19 related fraud enforcement efforts by federal agencies. We detailed those findings in our Health Care Enforcement 2020 Year in Review & 2021...more
4/29/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Defense (DOD) ,
Department of Justice (DOJ) ,
Department of Labor (DOL) ,
Department of the Interior ,
Enforcement Actions ,
Enforcement Authority ,
FBI ,
Food and Drug Administration (FDA) ,
Fraud ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Medical Billing Codes ,
Medicare ,
OIG ,
Provider Relief Fund ,
Telemedicine ,
USPS
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
In its first exercise of a newly granted authority, the Federal Trade Commission (FTC or the Commission) on April 15, 2021 charged a St. Louis-based chiropractor and his company (the Defendants) with violating the COVID-19...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
On March 16th, Attorney General William Barr issued a memorandum to all United States Attorneys directing each U.S. Attorney’s Office (USAO) to “prioritize the detection, investigation, and prosecution of all criminal conduct...more
4/7/2020
/ Anti-Kickback Statute ,
Conspiracies ,
Coronavirus/COVID-19 ,
Criminal Investigations ,
Department of Justice (DOJ) ,
Enforcement Programs ,
Genetic Testing ,
Healthcare ,
Healthcare Fraud ,
Illegal Profits ,
Kickbacks ,
Public Health ,
U.S. Attorney ,
Virus Testing
In the midst of the upheaval caused by social distancing and related efforts to minimize and contain COVID-19-related risks, we have been monitoring steps taken by the Department of Justice (DOJ), the U.S. Attorneys’ Offices...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
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
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
As we predicted in our year-end post on civil and criminal enforcement trends, 2018 is already off to strong start in opioid-related enforcement against individual providers and associated practices. Earlier this month, the...more
2/20/2018
/ Controlled Substances Act ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Health Care Providers ,
Healthcare Fraud ,
Medicare ,
Opioid ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians
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
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
On May 6th, we posted about the possibility that the Department of Justice (“DOJ”) might dramatically increase False Claims Act (“FCA”) penalties after the Railroad Retirement Board (“RRB”) nearly doubled the per-claim...more