Benjamin Zegarelli

Benjamin Zegarelli

Epstein Becker Green

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OIG Warns Pharmaceutical Manufacturers of Improper Part D Beneficiary Coupon Use

On September 19, 2014, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) released a study showing that pharmaceutical manufacturer safeguards to prevent Medicare Part D (“Part D”)...more

10/6/2014 - Drug Manufacturers Medicare Medicare Part D OIG Pharmaceutical Pharmacies Prescription Drugs

FDA Takes a Bold Step Toward Laboratory Developed Test Regulation: How Labs and IVD Manufacturers Should Prepare for the Future

On July 31, 2014, the U.S. Food and Drug Administration ("FDA") announced plans to regulate laboratory developed tests ("LDTs"). In this Client Alert, we explore FDA's proposed regulatory framework for LDTs and discuss some...more

9/9/2014 - Clinical Laboratories FDA Laboratory Developed Tests Manufacturers Medical Devices Regulatory Standards

More of the Same: Recently Released FDA Social Media Guidance for the Life Sciences Industry

On June 17, 2014, the U.S. Food and Drug Administration ("FDA") continued to outline its expectations for pharmaceutical and medical device manufacturer use of social media platforms to promote manufacturers' products in two...more

6/25/2014 - Advertising Biotechnology FDA Healthcare Life Sciences Medical Devices Pharmaceutical Popular Social Media

CMS Requests Comments on the Dispute Resolution Process Associated with the Physician Payment Sunshine Act

On May 5, 2014, the Centers for Medicare & Medicaid Services ("CMS") announced an opportunity to submit comments on the dispute resolution and correction procedures proposed in the final rule on the Open Payments reporting...more

5/9/2014 - Affordable Care Act CMS GPOs Hospitals Physician Medicare Reimbursements Physicians Public Comment Section 6002 Sunshine Act

Recent FDA Social Media Marketing Enforcement Actions and the Likely Impact of Social Media Promotion Guidance

In recent years, guidance by the U.S. Food and Drug Administration ("FDA" or "Agency") for industry on the use of social media has continued to evolve in incremental steps, but the pharmaceutical and medical device industries...more

3/27/2014 - Enforcement Actions FDA Marketing Prescription Drugs Social Media

Eighth Circuit Adopts Novel False Claims Act Fraud-in-the-Inducement Theory Long Espoused by Government

On October 15, 2013, a divided three-judge panel of the United States Court of Appeals for the Eighth Circuit rendered a federal False Claims Act ("FCA") judgment against Bayer Healthcare Pharmaceuticals ("Bayer"), based on a...more

11/12/2013 - DOD False Claims Act Fraud Fraudulent Inducement Prescription Drugs Qui Tam

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