The US Food and Drug Administration (FDA) has withdrawn its proposed rule on standardized testing methods for detecting and identifying asbestos in talc-containing cosmetics, almost exactly one year after publication....more
On November 21, the Centers for Medicare & Medicaid Services (CMS) issued a final rule announcing changes for Medicare payments for hospital outpatient services under the Hospital Outpatient Prospective Payment System...more
After issuing the Physician Fee Schedule (PFS) on October 31, the Centers for Medicare & Medicaid Services (CMS) has now published templates for manufacturers to utilize when complying with new requirements regarding the...more
On October 31, the Centers for Medicare & Medicaid Services (CMS) issued a final rule announcing changes for Medicare payments under the Physician Fee Schedule (PFS), effective on or after January 1, 2026....more
Brothers Convicted in $100 Million HIV Drug Fraud Scheme -
On October 29, a federal jury in Fort Lauderdale, Florida, convicted Maryland brothers Patrick and Charles Boyd of orchestrating a scheme to distribute roughly $100...more
11/4/2025
/ Constitutional Challenges ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Healthcare Fraud ,
HIV ,
Pharmaceutical Industry ,
Popular ,
Transgender ,
Whistleblowers ,
Wire Fraud
Private Equity Firm Not Liable for Alleged FCA Retaliation Claims by Former Employee of Portfolio Company -
The District Court for the District of Nebraska addressed whether a private equity owner could be liable as an...more
10/28/2025
/ Criminal Prosecution ,
Employer Liability Issues ,
Employment Litigation ,
False Claims Act (FCA) ,
Money Laundering ,
Popular ,
Portfolio Companies ,
Private Equity ,
Retaliation ,
Whistleblowers ,
White Collar Crimes
Earlier this month, the US Department of Health and Human Services (HHS) and US Food and Drug Administration (FDA) announced a nationwide crackdown on direct-to-consumer (DTC) drug advertisements....more
Last month, the US Food and Drug Administration (FDA) announced that it would begin daily publication of adverse event data for drugs and biologics via the FDA Adverse Event Reporting System (FAERS)....more
Last month, the US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) announced that they are requesting data and information to help develop a uniform definition of ultra-processed foods (UPFs) for...more
Texas Alleges That Eli Lilly Patient Assistance Programs Violates AKS -
The state of Texas and Health Choice Alliance, LLC filed a complaint alleging that pharmaceutical manufacturer Eli Lilly & Company, Inc. violated the...more
Regeneron Court Permits Government to Pursue False Certification Theory -
On August 4, the district court in the closely watched Regeneron case granted the government’s request to file a second partial summary judgment...more
On July 31, the US Department of Health and Human Services’ (HHS) Health Resources and Services Administration (HRSA) announced the availability of a new pilot program altering how pharmaceutical manufacturers can honor the...more
There are currently six states with active Prescription Drug Affordability Boards (PDABs) — Colorado, Maryland, Washington, Oregon, New Hampshire, and Minnesota....more
Key Insights for Pharma Manufacturers Regarding the AKS -
In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General...more
4/29/2025
/ Abbreviated New Drug Application (ANDA) ,
Anti-Kickback Statute ,
Compliance ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
New Regulations ,
Pharmaceutical Industry ,
Popular ,
Regulatory Requirements
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