Medical Group and Related Parties to Pay Over $62 Million to Resolve FCA Claims for False Diagnoses -
On March 26, the US Department of Justice (DOJ) announced that a California-based medical group and related parties...more
3/31/2025
/ California ,
Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Contractors ,
Health Care Providers ,
Healthcare Fraud ,
Imports ,
Medicare Advantage ,
Physicians ,
Settlement ,
Whistleblowers
Long Island Businessman Arrested in $22 Million Medicare Fraud Scheme -
A Long Island, New York, businessman was arrested on conspiracy, kickback, and money laundering charges stemming from an alleged scheme to defraud...more
In 2025, the retail and fashion industries are bracing for a transformative year, heavily influenced by the policies of the new Trump Administration. These policies promise rapid and significant changes, particularly in areas...more
2/20/2025
/ Americans with Disabilities Act (ADA) ,
Artificial Intelligence ,
CIPA ,
Class Action ,
Commercial Bankruptcy ,
Compliance ,
Data Privacy ,
E-Commerce ,
Environmental Social & Governance (ESG) ,
Executive Orders ,
Fashion Industry ,
Federal Trade Commission (FTC) ,
Form I-9 ,
Immigration ,
Independent Contractors ,
Influencers ,
International Trade ,
Mergers ,
Modernization of Cosmetics Regulation Act of 2022 (MoCRA) ,
NAD ,
PFAS ,
Private Attorneys General Act (PAGA) ,
Public Health ,
Retailers ,
Supply Chain ,
Tariffs ,
Terms of Use ,
Tracking Systems ,
Trump Administration ,
Workplace Investigations
In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on the use of artificial intelligence (AI) in the context of drugs, biologics,...more
1/22/2025
/ Artificial Intelligence ,
Biologics ,
Data Privacy ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Machine Learning ,
Medical Devices ,
New Guidance ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Requirements ,
Risk Assessment ,
Risk Management
Federal Government Urges Court of Appeals to Uphold Constitutionality of FCA Qui Tam Provisions -
In a brief filed earlier this week, the US federal government has urged the Eleventh Circuit Court of Appeals to uphold the...more
1/13/2025
/ Anti-Kickback Statute ,
Appeals ,
Appointments Clause ,
Article III ,
Constitutional Challenges ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Fraud ,
Health Care Providers ,
Healthcare Fraud ,
Medicare ,
Misrepresentation ,
National Institute of Health (NIH) ,
Pharmaceutical Industry ,
Qui Tam ,
SCOTUS ,
Settlement ,
Stark Law ,
Unconstitutional Condition ,
Whistleblowers
Second Circuit Partially Affirms Novartis’ Motion to Dismiss AKS Claims -
Last week, the Second Circuit Court of Appeals affirmed the district court’s ruling that dismissed allegations from a whistleblower who claimed that...more
1/6/2025
/ Anti-Kickback Statute ,
Appeals ,
Department of Justice (DOJ) ,
Digital Assets ,
False Claims Act (FCA) ,
False Statements ,
Foreign Agents Registration Act (FARA) ,
Fraud ,
Kickbacks ,
Medicaid ,
Medicare ,
Misleading Statements ,
Motion to Dismiss ,
New Regulations ,
Non-Fungible Tokens (NFTs) ,
Popular
Two years after the enactment of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the US Food and Drug Administration (FDA) has published the long-awaited proposed rule on talc-containing cosmetics....more
Earlier this month, the US Food and Drug Administration (FDA) issued new draft guidance regarding their accelerated approval pathway for new drugs and biologics, an expedited program designed to help address unmet medical...more
This past July, we reported on the Centers for Medicare & Medicaid Services (CMS) release of the 2025 proposed Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS) rules. CMS has now...more
11/22/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Final Rules ,
HOPPS ,
Inflation Reduction Act (IRA) ,
Infrastructure Investment and Jobs Act (IIJA) ,
Medicare Part D ,
Outpatient Prospective Payment System (OPPS) ,
Penalties ,
Physician Fee Schedule ,
Section 340B ,
Shareholders
US Supreme Court Declines to Consider AKS ‘Willfulness’ Question -
On October 7, the US Supreme Court denied a petition in which a whistleblower asked the Court to decide whether a “willful” act under the federal...more
10/14/2024
/ Anti-Kickback Statute ,
Bribery ,
Criminal Conspiracy ,
Denial of Certiorari ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Home Health Care ,
Kickbacks ,
Medicaid ,
Money Laundering ,
Popular ,
Scienter ,
SCOTUS ,
Telehealth ,
Whistleblowers
Florida Federal Judge Strikes Down FCA’s Qui Tam Provision as Unconstitutional -
On September 30, US District Judge Kathryn Kimball Mizelle of the Middle District of Florida held in a historic decision that the federal...more
10/7/2024
/ Anti-Kickback Statute ,
Appointments Clause ,
Criminal Convictions ,
Department of Health and Human Services (HHS) ,
False Claims Act (FCA) ,
False Statements ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Health Care Programs (FHCP) ,
Healthcare Fraud ,
Kickbacks ,
Medicaid ,
Medicare ,
Misrepresentation ,
OIG ,
Qui Tam ,
Sentencing ,
Settlement ,
Unconstitutional Condition
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