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Transparency Anti-Kickback Statute

Gardner Law

Why Compliance Audits Are Non-Negotiable

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In today’s heightened enforcement environment, compliance auditing isn’t just a best practice—it’s a necessity. Federal and state laws and industry guidance, including the Office of Inspector General (OIG) Compliance Program...more

Gardner Law

OIG’s Perspective on Discount and Refund Programs

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The U.S. Department of Health and Human Services Office of Inspector General (HHS OIG) recently issued Advisory Opinion No. 24-04, which primarily addressed a Refund Program offered by a U.S. pharmaceutical company affiliate....more

Gardner Law

Anti-Fraud & Sunshine Update

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Staying up-to-date with fraud enforcement trends and recent cases and settlements can sometimes be viewed as a “Glass Half Empty” perspective, focusing on negative aspects of the industry and the perceived threat of...more

Mintz - Health Care Viewpoints

Senate Democrats Pass Long-Awaited Drug Pricing Reforms in Budget Reconciliation Bill

On August 7, 2022, after extensive deliberation, Senate Democrats passed their long-awaited reconciliation bill, the Inflation Reduction Act of 2022 (the Reconciliation Bill). In addition to climate and tax provisions, the...more

ArentFox Schiff

Physician Ownership in Medical Device Company Will Not Trigger Anti-Kickback Statute Enforcement Action, OIG Concludes in Advisory...

ArentFox Schiff on

Physician-owned companies that generate revenue from the sale of medical devices ordered by their physician owners have in recent years been the target of federal fraud and abuse enforcement actions. OIG Advisory Opinion...more

Skadden, Arps, Slate, Meagher & Flom LLP

Skadden's 2020 Insights

Despite political and economic uncertainties, markets and deal activity were resilient in 2019, and strong fundamentals remain in place heading into 2020. Companies continue to face a challenging litigation and enforcement...more

McGuireWoods Consulting

Washington Healthcare Update - November 2019 #4

McGuireWoods Consulting on

This week in Washington: The House and Senate are out for Thanksgiving recess this week. Congress - Hearings/Markups - House Committee on the Judiciary: “The Patent Trial and Appeal Board and the Appointments Clause:...more

Sheppard Mullin Richter & Hampton LLP

HHS Proposes Rule to Eliminate Safe Harbor for PBM Drug Rebates

On February 6, 2019, the Office of the Inspector General of the U.S. Department of Health and Human Services (the “OIG”) published in the Federal Register a proposed rule (the “Proposed Rule”) that, if made final in its...more

Skadden, Arps, Slate, Meagher & Flom LLP

A Dialogue With Corporate Counsel: Skadden’s Eighth Annual Pharmaceutical and Medical Device Seminar

On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more

WilmerHale

Foreign Corrupt Practices Act Alert

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Busy Q1 Yields Several Significant FCPA Resolutions - Overview - On February 19, during the US Securities and Exchange Commission’s (SEC) annual “SEC Speaks” conference, Kara Brockmeyer, Chief of the SEC’s FCPA...more

K&L Gates LLP

Australian Anti-Corruption Proposal to Mandate Disclosure of Offshore Mining and Resources Payments to Governments

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Australia has taken a significant step in supporting a global movement for accountability and transparency in the mining and extractives industries. On 28 October 2014, Greens leader Christine Milne introduced the...more

Bracewell LLP

The Transparency Initiative: Are You Ready?

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The UK is set to become the first EU member state to transpose the most recent EU directives on accounting and transparency rules in an effort to satisfy growing demands for a European-wide strategy to fight corruption in...more

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