Donna Lee Yesner

Donna Lee Yesner

Morgan Lewis

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Medical Device Manufacturer Settles Trade Agreements Act Suit

A whistleblower alleged that the manufacturer knowingly violated the Trade Agreements Act’s country of origin requirement. Government contractors must agree that the products they sell to the U.S. government under...more

9/12/2014 - Corporate Counsel Country of Origin Federal Contractors Healthcare Manufacturers Medical Devices Trade Agreements Trade Agreements Act Whistleblowers

HHS OIG Reports Findings on 340B Contract Pharmacy Program

Program often fails to pass through savings to uninsured patients and creates risk of diversion and duplicate discounts. As a condition of payment for covered outpatient drugs by Medicaid, manufacturers must enter into...more

2/18/2014 - 340B HHS OIG Pharmaceutical Pharmacies Prescription Drugs

HRSA Publishes Orphan Drug Rule for 340B Program

Rule requires most manufacturers to change government pricing methodologies, calculations, and systems. On July 23, the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human...more

7/25/2013 - 340B Affordable Care Act Drug Manufacturers Healthcare HHS HRSA New Regulations Pharmaceutical Prescription Drugs Public Health Service Act

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