The U.S. Department of Justice (DOJ) and the Department of Health and Human Services Office of Inspector General (HHS-OIG) unveiled a coordinated voluntary self-disclosure policy that allows healthcare companies to obtain the benefits of both agencies’ disclosure programs through a single submission, marking a significant change in how companies report potential criminal healthcare fraud.
DOJ Fraud Division Directive 26-12: Implications for Corporate Fraud Enforcement
On October 1, 2026, Assistant Attorney General Colin M. McDonald issued Directive 26-12, titled “Corporate Enforcement in the Fight Against Fraud.” It directs prosecutors in the National Fraud Enforcement Division (Fraud Division) to pursue healthcare, government, tax, and trade fraud using an “all-tools approach.” The directive also reminds prosecutors to give credit to companies that disclose misconduct, cooperate, and remediate.
New False Claims Act Settlement Highlights Importance of Voluntary Self-Disclosures and Due Diligence
According to an April 1 Department of Justice (DOJ) press release, DRI Relays Inc. (DRI), a subsidiary of TE Connectivity Corporation (TEC) and manufacturer of electrical relays and sockets used on military platforms, agreed to pay $15.7 million to settle allegations that it violated the False Claims Act (FCA).
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Innovasis Settlement Implications
We recently co-authored an article published by Law360 detailing what the $12 million settlement of the U.S. Department of Justice’s (DOJ) case against medical device maker Innovasis Inc. may mean for other Anti-Kickback Statute (AKS) cases.
The Tale of an AKS Self-Disclosure
Last week, the Department of Justice (DOJ) announced a $12 million settlement with spinal device manufacturer, Innovasis Inc. (Innovasis) and senior executives Brent Felix and Garth Felix related to allegations that they violated the False Claims Act (FCA) by paying kickbacks to surgeons to induce their use of its spinal devices.
False Claims Act Settlements to Know from Q1 2024
Despite the recent downward trend in DOJ healthcare industry settlements, the first quarter of 2024 saw many noteworthy False Claims Act (FCA) and civil healthcare fraud settlements related to alleged kickbacks, medically unnecessary services and equipment, pharmaceutical issues and Controlled Substances Act violations.
CMS Publishes New Data on Self-Referral Disclosure Protocol Settlements
The Centers for Medicare & Medicaid Services (CMS) recently published updated data regarding settlements made under the Voluntary Self-Referral Disclosure Protocol (SRDP), an important mechanism through which providers may disclose actual or potential violations of the federal physician self-referral prohibition commonly known as the Stark Law.
False Claims Act Fundamentals: Self-Disclosures
When healthcare providers and other government contractors are subject to scrutiny for bills submitted to the government, it is often the result of a whistleblower complaint filed under the qui tam provisions of the False Claims Act.
Register Now | 8th Annual Nashville Healthcare Fraud Conference
Please join us for the 8th Annual Nashville Healthcare Fraud Conference hosted by Bass, Berry & Sims and the Tennessee Hospital Association. Eligible for more than seven hours of CLE credit (including ethics), this complimentary program will take place on December 8th in Nashville (full day). The conference will be broadcast virtually the mornings of December 15th and 16th.
Watch On-Demand | How to Submit a Stark Law Self-Disclosure Webinar
Watch the recording of our latest webinar, in which our panel of national healthcare fraud and abuse attorneys will discuss how to disclose a Stark Law violation to CMS.