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Federal District Court Holds FCA’s Private Whistleblower Provisions Unconstitutional

On September 30, 2024, a federal district court judge held that the qui tam provisions of the False Claims Act (FCA) violate the Appointments Clause of Article II of the Constitution. U.S. ex rel. Zafirov v. Fla. Med....more

Acting U.S. Attorney Levy Forecasts False Claims Act COVID Cases Targeting Private Lenders Of CARES Act Loans That Failed In Their...

Acting U.S. Attorney Joshua Levy discussed the enforcement priorities for the Massachusetts U.S. Attorney’s Office (USAO) during a Q&A session on May 29, 2024, and made clear that the historical focus of the office remains...more

Rescheduling Madness: Key Takeaways from the Proposed Rule to Reschedule Marijuana under the CSA

Moving marijuana under the Controlled Substances Act (“CSA”) from Schedule I to Schedule III will bring celebrated changes to the beleaguered state-sanctioned cannabis industries currently operating in 37 states, but will...more

DOJ Releases COVID-19 Fraud Enforcement Task Force Report Touting Its Successes and Urging Lawmakers to Enact New Legislation

The government’s continued dedication of resources to investigating and prosecuting fraud against COVID-19 pandemic relief programs appears to have borne fruit according to the results of the COVID-19 Fraud Enforcement Task...more

Recent Bankruptcy Court Decision Leaves the Door Open to Bankruptcy Relief for Those in the Cannabis Industry

A Massachusetts Bankruptcy Court’s recent appellate decision in Blumsack v. Harrington (In re Blumsack) leaves the door open for those employed in the cannabis industry to seek bankruptcy relief where certain conditions are...more

Safeguarding Reproductive Rights

In a defining moment for reproductive rights in America, the Supreme Court’s decision in Dobbs v. Jackson Women's Health Organization (2022) marked a pivotal turning point. This ruling, revoking the constitutional right to...more

EnforceMintz — COVID-19 Fraud Enforcement Unlikely to Slow Down in 2024

The government continued to dedicate enormous resources to investigating and prosecuting fraud against COVID-19 pandemic relief programs in 2023. While we observed some civil False Claims Act settlements, criminal enforcement...more

Key Takeaways from the OIG’s New Comprehensive General Compliance Program Guidance

The Department of Health and Human Services’ Office of Inspector General (OIG) published a General Compliance Program Guidance (GCPG) on November 6, 2023, marking the first update to OIG’s compliance program guidance...more

Those Aren’t Doritos: FTC and FDA Send Warning Letters to Companies Marketing Delta-8 Infused Munchies

The Federal Trade Commission’s (FTC) recent press release marks a continuation in government action against manufacturers of products infused with delta-8 tetrahydrocannabinol (delta-8).  In May 2022, the U.S. Food and Drug...more

OIG Announces Long Overdue Modernization of its Compliance Program Guidance Documents

The Department of Health and Human Services’ Office of Inspector General (OIG) announced on April 24, 2023 that it will soon issue long overdue updates to its compliance program guidance documents (CPGs). First introduced in...more

Nevada proposes to add a whistleblower provision to existing cannabis law

Nevada lawmakers have proposed to take a page from the False Claims Act and add a whistleblower provision to existing cannabis law. Section 6 of Assembly Bill 413 (AB 413) would require Nevada’s Cannabis Compliance Board...more

FDA Modernizes Mammography Regulations, Provides Facilities with Eighteen-Month Compliance Deadline

On March 9, 2023, the Food and Drug Administration (FDA) published a final rule that updates the Mammography Quality Standards Act (MQSA) to reflect advances in mammography technology and, among other requirements,...more

AG Garland signals that Department of Justice's cannabis policy will be "very close" to Cole memorandum

In his March 1, 2023 testimony before the United States Senate, Attorney General Merrick Garland indicated that the Department of Justice's (DOJ) marijuana policy will harken back to 2013, when then-Attorney General James...more

Bankruptcy Court Finds Cannabis Employee Not Entitled to Chapter 13 Protection

A bankruptcy court’s recent denial of a debtor’s petition for bankruptcy relief on narrow grounds casts a long shadow on the viability of bankruptcy relief for those employed in the cannabis industry. Though confining the...more

CMS Proposed Rule for Refunding Overpayments Would Align With False Claims Act “Knowledge” Standard

The Centers for Medicare & Medicaid Services (CMS) proposed a rule late last year to harmonize the standard it would apply for providers to identify and refund overpayments with the “knowledge” standard under the False Claims...more

Serial Relator Brings Multiple Lawsuits Alleging False Claims Act Violations Premised on Paycheck Protection Program Fraud

A district court in the Southern District of New York recently unsealed a qui tam case brought by relator GNGH2, Inc., a for-profit company, against 15 entities that allegedly operated nursing homes in the Bronx, New York and...more

California Attorney General Probes Bias in Health Care Algorithms

A spurt of letters from California Attorney General Rob Bonta to leaders of hospitals and other health care facilities sent on August 31, 2022 signaled the kickoff of a government probe into bias in health care algorithms...more

Two Recent False Claims Act Settlements Highlight the Benefits of Self-Disclosure, Remediation, and Cooperation

Disclosing known or suspected fraud to regulators can have its benefits. As reported in a previous post, the Department of Justice (DOJ) issued policy guidance in 2019 on providing credit in False Claims Act (FCA)...more

FDA Expresses Displeasure with Consumer Products Containing Trendy Cannabis Ingredient Delta-8 THC

On May 4, 2022, the U.S. Food and Drug Administration (FDA) for the first time issued warning letters related to products containing delta-8 tetrahydrocannabinol (delta-8 THC). FDA has previously sent warning letters to...more

Health Care Enforcement Year In Review & 2022 Outlook

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

False Claims Act Settlements and Judgments Exceed $5.6 Billion in Fiscal Year 2021

The Department of Justice announced in a February 1, 2022 press release (Press Release) that it obtained more than $5.6 billion in settlements and judgments from civil cases involving fraud and false claims in the fiscal year...more

Co-Owner of Clinical Trial Company Pleads Guilty to Obstruction of Justice in Connection with Falsification of Clinical Trial Data

On January 12, 2022, the co-owner of a clinical research site in Miami, Florida pleaded guilty to one count of obstruction of justice after she knowingly lied to a United States Food and Drug Administration (FDA) investigator...more

Panel Discussion Among Government Lawyers Provides Key Insights into the Future of FCA Enforcement

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

FDA Releases Ambitious Action Plan for Further Reducing Children’s Exposure to Toxic Elements from Foods

The U.S. Food and Drug Administration (FDA), industry, policymakers, and consumers share a common goal of ensuring that the foods and beverages Americans eat and drink are safe, and the law has long prohibited the...more

FDA’s Biologics Inspections in the (Negative) Limelight: Will Congress or Executive Leadership Take Action?

In an unexpected twist to a troubling situation that began over two years ago, U.S. Special Counsel Henry Kerner penned a letter to President Biden on March 31, 2021 questioning the Food and Drug Administration’s (FDA’s)...more

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