The Office of Inspector General (OIG) has announced that it is expanding the topics it considers for new Frequently Asked Questions (FAQs) submitted by healthcare stakeholders. OIG will now answer general questions about the Federal anti-kickback statute (AKS), questions related
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Pharmaceutical Suppliers Beware: Expect Increased Scrutiny of Average Wholesale Pricing Methodology and Marketing “The Spread”
A Texas federal court recently denied a pharmaceutical supplier’s motion to dismiss claims brought by a whistleblower under the federal False Claims Act (FCA) alleging violations of the Anti-Kickback Statute (AKS) and manipulation of Average Wholesale Pricing (AWP) rules. The
Distributor of Ophthalmic Surgical Products Found Guilty of Paying Kickbacks and Violating the False Claims Act: May Be Liable For Up To $848 Million in Civil Damages and Penalties
On February 28, 2023, a federal jury in the District of Minnesota found the Cameron-Ehlen Group, d/b/a Precision Lens, and its founder and owner Paul Ehlen (the “Defendants”) guilty of paying kickbacks to ophthalmic surgeons in violation of the False
CMS Streamlines Stark Law Self-Disclosures
The Centers for Medicare & Medicaid Services recently announced updates to the voluntary self-referral disclosure protocol for reporting and resolving technical violations under the physician self-referral law commonly known as the Stark Law.
Read on for details about these updates,
Medicare Accelerated Payment Fraud Leads to Criminal Conviction
Government investigators focus on pandemic-related fraud has culminated in a recent criminal conviction As announced by the Department of Justice (DOJ), on Friday, January 13, 2023, a federal jury convicted a Colorado physician of theft for misappropriating almost $250,000
DOJ’s False Claims Act Statistics Show Declining Recoveries, Increasing Enforcement
The U.S. Department of Justice recently announced it recovered over $2.2 billion under the False Claims Act in fiscal year 2022 — the lowest annual recovery since 2008. Despite declining recoveries, the number of new matters suggests that investigation activity
SCOTUS to Decide if False Claims Act Reaches Defendants Offering Reasonable Interpretation of Vague Requirement
On Jan. 13, the U.S. Supreme Court granted a writ of certiorari to petitioners in two False Claims Act cases to determine whether the law’s knowledge requirement reaches defendants who can offer an “objectively reasonable” interpretation of an ambiguous legal
Pharmaceutical Manufacturer Agrees to $900M False Claims Act Settlement to Resolve Kickback Claims
On July 20, Biogen Inc. agreed to pay $900 million to settle claims the company violated the False Claims Act by allegedly paying improper consulting and speaker fees and providing lavish meals and entertainment to medical providers to induce them
Supreme Court to Review When DOJ May Dismiss Relator Suits
Last month, the Supreme Court granted certiorari in United States ex rel. Polansky v. Executive Health Resources, Inc., a case presenting the question whether the federal government forfeits the authority to dismiss False Claims Act (FCA) suits brought in its
