In 2021, we provided an overview of multiple federal lawsuits challenging the US Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) enforcement of the 340B Drug Pricing...more
Precision Lens Pays $12 Million to Resolve FCA and AKS Violations -
Late last week, Precision Lens and the estate of its former principal agreed to pay $12 million to resolve allegations regarding violations of the False...more
8/5/2024
/ Anti-Kickback Statute ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Fraud ,
Healthcare ,
Insurance Fraud ,
Kickbacks ,
Medicare ,
Reimbursements ,
Settlement ,
Stark Law ,
Telemarketing ,
Whistleblowers
Federal Court Dismisses $680 Million FCA Suit -
On July 23, a Maryland federal judge, Ellen L. Hollander, dismissed a $680 million False Claims Act (FCA) suit that was previously revived by the US Supreme Court. The suit...more
Pharma’s favorite summer pastime is back again: reviewing the Centers for Medicare & Medicaid Services (CMS) release of the 2025 proposed Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS)...more
7/18/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Food and Drug Administration (FDA) ,
Hospitals ,
Medicaid ,
Medicaid Drug Rebate Program ,
Medicare Part B ,
Medicare Part D ,
Outpatient Prospective Payment System (OPPS) ,
Pharmaceutical Industry ,
Physician Fee Schedule ,
Proposed Rules ,
Reimbursements ,
Section 340B ,
Shareholders
A recent US Supreme Court decision, which grabbed headlines because it involved an abortion-related drug, with potential repercussions in litigation far-removed from health care due to the decision hinging on “standing,”...more
As we have reported at length, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) imposed extensive new requirements related to cosmetic products marketed in the United States. As compliance deadlines for these new...more
6/24/2024
/ Compliance ,
Cosmetics ,
Fashion Industry ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Modernization of Cosmetics Regulation Act of 2022 (MoCRA) ,
PFAS ,
Product Labels ,
Product Packaging ,
Product Recalls ,
Registration Requirement
Companies subject to the requirements of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) should take note that the deadline to register cosmetic facilities and list cosmetic products is fast approaching on July...more
District Court Declines to Stay Case Pending Resolution of FCA Causation Standard Issue Before Court of Appeals -
Earlier this week, a Massachusetts federal judge denied a motion to stay proceedings filed by Medtronic,...more
6/10/2024
/ Anti-Kickback Statute ,
Appeals ,
Causation ,
Criminal Convictions ,
Cryptocurrency ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Healthcare Fraud ,
Mail Fraud ,
Ponzi Scheme
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