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Audits Manufacturers

Gardner Law

Kickbacks and Consequences: Lessons from the Innovasis Settlement

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On May 29, 2024, the U.S. Department of Health and Human Services’ Office of Inspector General (HHS OIG) announced a $12 million settlement with Innovasis Inc., a medical device manufacturer, and two of its senior executives...more

Manatt, Phelps & Phillips, LLP

340B Hospitals Sue HRSA for Authorizing Audits of 340B Records

On July 24, two hospitals that participate in the Section 340B drug discount program—Oregon Health & Science University and Maine General Medical Center—filed separate lawsuits against the Health Resources and Services...more

Akin Gump Strauss Hauer & Feld LLP

2024 Guide to DOJ and HHS OIG Guidance on Effective Compliance Programs

The Department of Health & Human Services’ Office of Inspector General (HHS OIG) and U.S. Department of Justice (DOJ) have published important guidance and recommendations for pharmaceutical companies to develop and implement...more

Amundsen Davis LLC

PFAS: What Are They? Where Are They? And How Can Businesses Avoid the Litigation Associated with Them?

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“Per- and Polyfluoroalkyl Substances” (“PFAS”) are a group of approximately 15,000 chemicals found in thousands of products ranging from consumer products like food packaging, non-stick cooking materials, and cosmetics to...more

Foley & Lardner LLP

The Importance of Risk Audits for PFAS in the Automotive Industry

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The automotive industry continues to grow a record of sustainability, improving fuel efficiency and proliferating electric vehicles, and adopting eco-friendly manufacturing processes. Along with these important sustainability...more

King & Spalding

Major Shift in Best Price Proposed in Grab Bag of MDRP Reforms

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The title of CMS’s May 26 proposed rule, “Misclassification of Drugs, Program Administration and Program Integrity Updates Under the MDRP,” buries the lede. Amid twenty Medicaid Drug Rebate Program-related proposals—some...more

Wiley Rein LLP

[Webinar] 2023 Federal Infrastructure Series: Navigating the Federal Grant Compliance Landscape - May 16th, 12:00 pm - 1:00 pm EDT

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Please join us for the fourth episode of Wiley’s Federal Infrastructure Webinar series, a series of webinars that will bring together attorneys from across the firm to discuss current developments relating to the federal...more

McGlinchey Stafford

EPA Sets PFAS Enforcement Sights on Manufacturing Industry

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Perfluoroalkyl and polyfluoroalkyl substances (PFAS) are dominating the environmental health news cycles based on numerous studies which demonstrate their potential risks. The U.S. Environmental Protection Agency (EPA) is...more

Foley & Lardner LLP

Top Legal Issues Facing the Manufacturing Sector in 2022

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As the global economy faces the third year of the pandemic, manufacturers are no longer focused on figuring out when things will return to “normal.” Instead, they are applying lessons learned from the past few years to become...more

Arnall Golden Gregory LLP

There Is Never a Bad Time To Audit Your Supply Chain

In late December 2021, the United States banned imports of disposable gloves produced in Malaysia by manufacturer Brightway Holdings over allegations of forced labor....more

Foley & Lardner LLP

States Impose New Requirements for Dealer Warranty Reimbursement

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State legislatures across the country spent the first half of 2021 enacting laws that include several changes to warranty reimbursement obligations owed by suppliers to authorized dealers. Four states have new warranty...more

Williams Mullen

New Day at EPA

Williams Mullen on

Since the November presidential election, most trade journals have expressed the same or similar headlines: “The Joe Biden/Kamala Harris administration will elevate enforcement for violation of environmental rules and...more

Foley & Lardner LLP

Wait, Why Am I Picking Up Your Tab? Iowa Considers Requiring Equipment Repurchases Where the Dealer Initiates Termination

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Equipment manufacturers are generally well aware of the onerous and often expensive equipment repurchase obligations they incur when terminating or non-renewing a dealer. But at least these repurchase obligations make some...more

Arnall Golden Gregory LLP

Quality Agreements: An AGG Podcast Recap

A few weeks ago, AGG’s Food and Drug Practice Team launched its podcast series to discuss topics affecting the FDA-regulated industry. The series, called “I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues,”...more

Pillsbury Winthrop Shaw Pittman LLP

Not Too Late to Develop a Strong Strategy for 2020 CDR

The TSCA Chemical Data Reporting requirement is an important mechanism that helps EPA establish regulatory restrictions and enforcement initiatives. The next filing deadline is November 30, 2020 and requires the submission...more

Snell & Wilmer

President Trump Issues Executive Order to “Buy American” with Respect to “Essential Medicines”

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Amidst a flurry of policymaking from the White House last week, President Trump issued the Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States on August...more

BakerHostetler

FAQs: The Potential Risk of Audits and Enforcement of Misconduct Related to the Loans and Other Financial Benefits Programs...

BakerHostetler on

The CARES Act includes significant measures for individuals, employers, and businesses to handle and overcome the COVID-19 pandemic. The set of FAQs below is intended to address questions related to the potential risk of...more

Baker Donelson

HRSA Guidance Updates Suggest Tightening of 340B Covered Entity Repayment Rules

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Over the past several months, the Health Resources and Services Administration (HRSA) has issued a number of guidance updates related to the agency's expectations for health care providers participating in the 340B drug...more

Holland & Knight LLP

Healthcare Law Update: September 2017

Holland & Knight LLP on

OIG Advisory Opinions - Manufacturer's Free Replacement of Spoiled Pharmaceutical Products Authorized - On Aug. 25, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG)...more

Miles & Stockbridge P.C.

The Case for a Comprehensive 360° IP Strategy: Step 1 - Assessment

This article is the first entry in a multi-part series on the critical need for businesses to extract total value from their IP assets by developing and applying a comprehensive, consistent and efficient IP strategy. An...more

Stinson - Corporate & Securities Law Blog

Apple’s Conflict Minerals Smelters Nearly 100% Audited

Apple has filed its Form SD for the year ended December 31, 2015. It includes this disclosure: The combination of training, public reporting and a ticking clock drove the number from 82 smelters and refiners...more

Dorsey & Whitney LLP

US China Trade War–Developments in Trade, Trade Politics, Patents/IP, Antitrust and Securites

Dorsey & Whitney LLP on

On January 11thth, I put up my last post stating that because of its length, I have broken up the post into two parts. This February post includes a Trade, Customs and IP update with longer sections on Antitrust and...more

Faegre Drinker Biddle & Reath LLP

Indiana Department Of Revenue Adds Back Manufacturer’s Substantial Inter-Company Interest Expenses Claimed On Corporate Income Tax...

In a September 2014 ruling, a multi-national manufacturer with Indiana locations protested the Indiana Department of Revenue’s decision to add back interest expenses claimed on its corporate income tax returns. Manufacturer...more

Bradley Arant Boult Cummings LLP

Mississippi Legislature Passes Two Bills that Should Provide Greater Certainty to Businesses and Spur Economic Development

The Mississippi Legislature recently passed two bills that should provide greater certainty to businesses and spur economic development in the Magnolia State. House Bill 892, signed into law by Governor Phil Bryant on March...more

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