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
Since May 2023, federal legislators have introduced a broad array of bills designed to address the rapid promulgation of artificial intelligence (AI) technologies. In that time, over 50 bills have been introduced, the vast...more
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
Artificial intelligence (AI) is a phrase that we hear in many different areas of our e-data and discovery practice. But, as it relates to e-discovery, AI is not necessarily a new development...more
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
Last week the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) issued Advisory Opinion 23-06 (AO), which advised that a proposed arrangement between certain laboratories for the purchase...more
10/4/2023
/ Advisory Opinions ,
Billing ,
Carve Out Provisions ,
Clinical Laboratories ,
Competition ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
OIG ,
Physicians ,
Risk Management
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
The head of the Food and Drug Administration (FDA), Dr. Robert Califf, announced on August 30, 2022 that, in addition to an extensive review of opioid regulations, the agency is launching a framework aimed at preventing...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
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
A few weeks ago, we posted about a publication by the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) of responses to certain frequently asked questions (FAQs) received from the health...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 many of our readers know, as a result of the public health emergency caused by COVID-19, effective March 1, 2020, the U.S. Department of Health and Human Services (“HHS”) issued blanket waivers of its authority under...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
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
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