Donna Lee Yesner

Donna Lee Yesner

Morgan Lewis

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Latest Publications


The CMS Final Covered Outpatient Drug Rule Addresses Many Industry Concerns

The rule implementing the Medicaid Drug Rebate Program is less burdensome and costly than what was originally proposed. In 2010, the Affordable Care Act (ACA) directed the US Centers for Medicare and Medicaid Services...more

2/3/2016 - Affordable Care Act CMS Final Rules Manufacturers Medicaid Pharmaceutical Industry Prescription Drugs Rebates

Trade Agreements Act Compliance Activity Increasing at VA

Companies should include internal TAA compliance reviews in their overall manufacturing compliance programs. Every manufacturer of medical devices and pharmaceuticals that offers a product for sale to the federal...more

4/21/2015 - Country of Origin Federal Supply Schedule (FSS) Manufacturers Medical Devices Pharmaceutical Industry Supply Chain Supply Contracts Trade Agreements Act Veterans Administration

No More FSS Tracking Customer Compliance, What’s the Catch?

GSA issues a proposed rule aiming to lower pricing under GSA contracts and impose new data reporting obligations on contractors. On March 4, the U.S. General Services Administration (GSA) issued a proposed rule that...more

3/13/2015 - Data-Sharing Federal Contractors GSA Reporting Requirements

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 - HHS OIG Pharmaceutical Industry Pharmacies Prescription Drugs Section 340B

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 - Affordable Care Act Healthcare HHS HRSA New Regulations Pharmaceutical Industry Prescription Drugs Public Health Service Act Section 340B

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