Trio Sentenced to Eight to 15 Years in Prison for Laundering Proceeds of Telephone Scam -
Following a jury trial, three individuals were convicted of a money laundering conspiracy and sentenced to eight, 10, and 15 years...more
Earlier this month, the US District Court for the District of Oregon issued a declaratory judgment invalidating a key component of the Oregon Drug Price Transparency Program.
The Oregon Drug Price Transparency Program was...more
The top legal issues in 2024 for the life sciences field reflect the complex and changing legal landscape that the industry is navigating, encompassing drug pricing, regulatory challenges, and broader societal and governance...more
2/22/2024
/ Affordable Care Act ,
Artificial Intelligence ,
Chevron Deference ,
Data Privacy ,
Data Security ,
Digital Health ,
Drug Pricing ,
Healthcare ,
Healthcare Reform ,
Innovative Technology ,
Intellectual Property Protection ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Reform ,
Regulatory Requirements ,
Startups ,
Technology
On January 30, a federal jury found six people guilty of federal civil rights offenses arising from their participation in a blockade of a reproductive health care clinic in Mount Juliet, Tennessee. The jury’s verdict is...more
Home Health Care Owner Sentenced to Nine Years in Prison for Medicare Fraud Scheme -
This week, the owner of a home health company was sentenced to nine years in prison for orchestrating a nearly $2.8 million scheme...more
2/5/2024
/ CARES Act ,
Coronavirus/COVID-19 ,
Email ,
Fraud ,
Healthcare Fraud ,
Home Health Care ,
Identity Theft ,
Income Taxes ,
IRS ,
Medicare Fraud ,
Money Laundering ,
Paycheck Protection Program (PPP) ,
Sentencing ,
Social Security ,
Tax Fraud ,
Wire Fraud ,
Witness Tampering
SCOTUS Declines to Hear False Claims Act Challenge -
On January 22, the US Supreme Court denied a petition to hear a challenge to a Fifth Circuit Court of Appeals decision that upheld scienter and False Claims Act (FCA)...more
1/29/2024
/ Confidential Information ,
Conspiracies ,
Denial of Certiorari ,
False Claims Act (FCA) ,
Insider Trading ,
Medicare Fraud ,
Misappropriation ,
Reimbursements ,
SCOTUS ,
Securities Fraud ,
Sentencing
On December 18, the US Food and Drug Administration (FDA) announced the availability of the Cosmetics Direct electronic submission portal and publication of final guidance for industry on cosmetic facility registration and...more
On December 14, the US Food and Drug Administration (FDA) issued new instructions for cosmetic companies to use when submitting mandatory serious adverse event reports to the agency.
As we reported last year, the...more
On November 8, the US Food and Drug Administration (FDA) announced its intent to delay enforcement of the requirements for cosmetic product facility registration and cosmetic product listing.
On November 8, the US Food and...more
Nevada Man Sentenced to 51 Months Imprisonment for Prize-Notification Fraud Scheme -
Earlier this week, a Nevada man was sentenced to 51 months in prison for perpetrating a prize-notification scheme that defrauded...more
Medical Marketer Convicted of $55 Million Fraud Scheme -
Late last week, a federal jury in the Northern District of Texas convicted Quintan Cockerell for his role in a $55 million fraud conspiracy involving TRICARE, a...more
11/6/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Criminal Convictions ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Health Care Programs (FHCP) ,
Fraud ,
Kickbacks ,
Medicaid ,
Medicaid Drug Rebate Program ,
Reimbursements ,
Settlement ,
TRICARE
On October 3, the US Food and Drug Administration (FDA) issued a proposed rule regarding the regulation of in vitro diagnostic products (IVDs). In this proposed rule, the FDA announced its intent to amend its regulations to...more
10/25/2023
/ Affordable Care Act ,
CLIA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Laboratory Developed Tests ,
Medical Devices ,
Medicare ,
Premarket Approval Applications ,
Proposed Legislation ,
Proposed Rules ,
Regulatory Oversight
Last Friday, the US Food and Drug Administration (FDA) announced its newly developed draft electronic submission portal — Cosmetics Direct — to facilitate submissions of cosmetic product facility registrations and product...more
Medical Supplier Agrees to Pay $29 Million for FCA Violations -
Earlier this month, the US Department of Justice (DOJ) and medical supplier Lincare Holdings Inc. reached an agreement to settle claims that Lincare violated...more
9/5/2023
/ Corporate Integrity Agreement ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Kickbacks ,
Medical Supplies ,
Medicare ,
OIG ,
Reimbursements ,
Settlement Agreements ,
Suppliers ,
Universal Health Services Inc v United States ex rel Escobar
DOJ Announced Results of Nationwide COVID-19 Fraud Enforcement -
On Wednesday, August 23, 2023, the US Department of Justice (DOJ) announced the results of a coordinated, nationwide enforcement action to combat COVID-19...more
8/28/2023
/ Beneficiaries ,
Coronavirus/COVID-19 ,
Cryptocurrency ,
Department of Justice (DOJ) ,
Enforcement ,
Fraud ,
Kickbacks ,
Medicare Fraud ,
Money Laundering ,
OIG ,
Public Health Emergency ,
Sanction Violations
Earlier this week, the US Food and Drug Administration (FDA) issued draft Q&A guidance entitled “Registration and Listing of Cosmetic Product Facilities and Products,” which clarifies the agency’s expectations regarding the...more
Supreme Court Justices Signal Skepticism of Qui Tam Constitutionality -
On Friday, June 16, the US Supreme Court ruled that the US Department of Justice (DOJ) has the authority to dismiss qui tam suits brought under the...more
Recent Filings Shed Light on DOJ’s View of Supreme Court’s Recent FCA Ruling -
On June 1, 2023, the US Supreme Court explained that an assessment of a defendant’s subjective beliefs — rather than what an objectively...more
6/19/2023
/ Chief Compliance Officers ,
Criminal Convictions ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Fraud ,
Healthcare Fraud ,
IRS ,
Medicare ,
Opioid ,
Pharmacies ,
Pharmacist ,
Scienter ,
SCOTUS ,
Tax Fraud ,
Wire Fraud
Anticipated Landmark Supreme Court Decision May Be Anything But On -
April 18, 2023, the US Supreme Court heard oral arguments in a set of highly anticipated cases regarding the scienter—or knowledge—provision of the False...more
4/24/2023
/ Appeals ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Fraud ,
Healthcare Fraud ,
Kickbacks ,
Oral Argument ,
Penalties ,
Pharmacy Benefit Manager (PBM) ,
Restitution ,
SCOTUS
Two Men Sentenced for $1.6 Million COVID-19 Fraud Scheme -
On Monday, April 10, two brothers were sentenced for their participation in a COVID-19 fraud scheme. The scheme involved fraudulent applications for $1.6 million...more
Supreme Court to Hear US Government in FCA Scienter Oral Argument -
On March 20, 2023, the US Supreme Court agreed to allow the federal government to participate in oral argument in the Supreme Court’s review of the...more
3/27/2023
/ Bribery ,
Deferred Prosecution Agreements ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Foreign Corrupt Practices Act (FCPA) ,
Generic Drugs ,
Insurance Fraud ,
Medicaid ,
Medicare ,
Oral Argument ,
Scienter ,
SCOTUS ,
Securities and Exchange Commission (SEC)
As those in the reproductive health space scramble to keep up with the ever-changing landscape of mifepristone (Mifeprex) access, it seems that every party must have their say.
The last three months have seen updates from...more
With the approval of the modified mifepristone Risk Evaluation and Mitigation Strategy (REMS), it has been a momentous few weeks in the reproductive health legal space.
Modification to the REMS for Mifepristone...more
Top Reasons for 2022’s Downward Trend in False Claims Act Recoveries -
Following the US Department of Justice’s (DOJ) release of statistics regarding FCA settlements and judgments for the 2022 fiscal year, Law360 spoke...more
2/20/2023
/ CARES Act ,
Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fees ,
Fraud and Abuse ,
Healthcare ,
Kickbacks ,
Medicare Advantage ,
Opioid ,
Private Equity ,
Proposed Amendments ,
Qui Tam ,
Settlement ,
Stark Law ,
Telehealth ,
Whistleblowers
On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023. Among the Act’s many provisions is the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which significantly expands the U.S....more