Episode 371 -- DOJ's New Corporate Enforcement Program
Everything Compliance: Episode 154, The Law Firms in Trouble Edition
Compliance Tip of the Day: Measuring Compliance Training Effectiveness
SBR-Author’s Podcast: The Unseen Life of an Undercover Agent: A Conversation with Charlie Spillers
Daily Compliance News: May 19, 2025, The Definition of Corruption Edition
10 For 10: Top Compliance Stories For the Week Ending May 17, 2025
Daily Compliance News: May 15, 2025, The Downfall in Davos Edition
Daily Compliance News: May 14, 2025, The Widened Whistleblower Program Edition
Everything Compliance: Episode 153, The CW 25 Edition
The JustPod: A Discussion with Defense Counsel Rocco Cipparone and Angie Levy on January 6 Prosecutions
Compliance into the Weeds: USRA Declination Case Study - Self-Disclosure Best Practices
False Claims Act Insights - Trump DOJ Sharpens Its Focus on Healthcare Fraud
Daily Compliance News: May 1, 2025, The 100 Days of Corruption Edition
Podcast - Every Case Is a New World
Episode 366 -- DOJ Issues Data Security Program Requirements
Episode 365 -- Four Sanctions Cases Everyone Should Know
False Claims Act Insights - DOJ’s Reliance on FCA to Pursue Covid-Related Fraud
Compliance into the Weeds: The Uncertain Future of Compliance Monitors under the Trump Administration
The Presumption of Innocence Podcast: Episode 59 - Enforcement Priorities of the Second Trump Administration: DOJ Focus
10 For 10: Top Compliance Stories For the Week Ending April 12, 2025
The health care regulatory space realized significant regulatory and enforcement developments in 2024 that are influencing how providers and industry stakeholders approach various compliance measures and enforcement...more
Pfizer Settles Its Subsidiary’s Kickback Allegations for Nearly $60 Million - Pfizer Inc. agreed to pay over $59,746,277 to resolve allegations that its wholly owned subsidiary, Biohaven Pharmaceutical Holding Company...more
As government scrutiny and enforcement targeting the Medicare Advantage (Medicare Part C) program continued in 2024, the industry’s response to agency actions escalated. Last year also resulted in the first sizable Part D...more
Welcome to the Fall 2024 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and compliance...more
Whistleblower Watch is a critical resource for in-house counsel and compliance professionals. Each quarter, Cozen O’Connor summarizes the most notable False Claims Act (FCA) enforcement actions, settlements, and legal trends,...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. ...more
From an agency guidance and regulatory developments perspective, 2022 was fairly quiet until the latter part of the year. Consistent with past practice, the Office of Inspector General for the Department of Health and Human...more
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
On December 27, 2022, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule which, in part, seeks to amend the existing regulations for Medicare Parts A, B, C, and D regarding the standard for when an...more
On October 5, 2022, the Office of Inspector General (“OIG”) posted Advisory Opinion No. 22-19 (the “Opinion”), which limits the ability of pharmaceutical manufacturers to offer cost-sharing subsidies to Medicare Part D (“Part...more
On September 15, 2022, the Department of Justice (DOJ) announced a $7.9 million settlement with generic manufacturer Akorn Operating Company LLC (Akorn) to resolve allegations that Akorn caused the submission of...more
On May 28, 2021, OIG released its Semiannual Report to Congress (the Report). The Report describes OIG’s work during the 6-month semiannual reporting period of October 1, 2020, through March 31, 2021 (the Semiannual Reporting...more
Court Rules Prescription Drug Event and Enrollee Encounter Data Are 'Claims for Payment' Under the False Claims Act - US District Judge Noel L. Hillman approved a whistleblower’s request to file a Fourth Amended Complaint...more
The Biden Administration wasted no time in implementing some of the new President’s campaign promises relating to health insurance and the Affordable Care Act (“ACA”). First, on February 10 the Department of Justice filed a...more
On Tuesday, September 1, 2020, the Drug Enforcement Agency (“DEA”) proposed 2021 aggregate production quotas (APQs) for controlled substances in schedules I and II of the Controlled Substances Act (“CSA”) and an Assessment of...more
In 2019, U.S. Department of Justice (DOJ) enforcement activity targeting drug and device manufacturers jumped sharply over the prior year, reflecting an increased focus on fraud and abuse in the life sciences sector. More...more
Omnicare and CVS Face Fraudulent Billing Lawsuit - On Tuesday, the US Attorney’s Office for the Southern District of New York announced a False Claims Act lawsuit against Omnicare, Inc. and its parent company, CVS Health...more
In his 2016 presidential campaign, Donald Trump frequently expressed populist themes, rhetorically criticizing “big business” and “special interests,” and signaled an activist antitrust agenda with his comment in October 2016...more
Concluding one of the longest merger reviews in history, on September 4, Judge Richard Leon, District Judge for the District of Columbia, issued his final ruling in United States v. CVS Health, approving the proposed...more
On June 4 – 5, 2019, Judge Richard J. Leon of the U.S. District Court for the District of Columbia held an extraordinary and unprecedented evidentiary hearing to decide whether to enter the proposed Final Judgment in U.S. v....more
The District of Columbia District Court has again deferred its decision regarding whether to approve the merger between CVS Health and Aetna, a $69 billion transaction that was first announced back in December 2017. ...more
The United States Department of Justice Antitrust Division announced on October 10, 2018, that it was conditionally approving the CVS/Aetna merger, a $69 billion transaction that combines the nation’s largest retail pharmacy...more
Outlook for This Week in the Nation's Capital - Congress Returns. Clark Hill hopes that everyone had a safe and happy Labor Day weekend. ...more
States may be starting to take aim at prescription automatic refill programs. Automatic refill programs have been proven to increase patient adherence, especially among patients with chronic conditions. However, these...more
Another Shutdown? Congress needs to pass another short-term spending bill by Friday in order to keep the government open, but some House Republicans are against the plan for a fifth continuing resolution that would fund the...more