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Ellyn L. Sternfield

Ellyn L. Sternfield

Mintz Levin


Latest Publications

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Five Takeaways from the OIG’s Special Advisory Bulletin on Exclusion

This week the Office of Inspector General for the Department of Health and Human Services (“OIG”) issued an updated Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs, an...more

5/13/2013 - Exclusions False Claims Act Federal Funding Healthcare Liability OIG Penalties

CMS Proposes to Increase Awards for Non-Qui Tam Whistleblowers

CMS wants to change the way that it rewards non-qui tam whistleblowers who report alleged fraudulent or unlawful conduct related to Medicare or Medicaid. Using an IRS program as a model, CMS recently proposed rule changes to...more

5/1/2013 - CMS IRS Proposed Regulation Qui Tam Whistleblowers

Grassley Questions Hospital 340B Program Profits

In a March 2013 article, I wrote about members of Congress calling for increased oversight of the 340B drug discount program and, in particular, hospital use of 340B drugs. This week, Senator Charles Grassley of Iowa...more

4/5/2013 - 340B Charles Grassley Healthcare Hospitals Medicare Pharmaceutical Prescription Drugs

Sixth Circuit Rules No FCA Liability Based on Violation of Medicare Requirements

On April 1st, the Sixth Circuit reversed an $11.1 million dollar summary judgment finding entered against MedQuest Associates, a diagnostic testing company. In its opinion, the Sixth Circuit found that violation of two...more

4/4/2013 - False Claims Act Healthcare Medicare MedQuest

OIG Report Critical of P&T Committee Oversight

In a newly issued Report, the OIG has expressed concern regarding CMS’s lack of oversight of P&T Committee conflicts of interest. As the entities responsible for making Medicare Part D formulary decisions, P&T Committees...more

3/12/2013 - CMS Conflicts of Interest Medicare OIG P&T Committees

Big Changes Are Happening With the 340B Drug Program

Things are drastically changing for covered entities under the 340B program. In the last 18 months several factors have led the Health Resources and Services Administration (HRSA) to ramp up its oversight and auditing of...more

3/6/2013 - 340B Affordable Care Act GAO HRSA Prescription Drugs

FDA Will Not Appeal Second Circuit Decision in U.S. v. Caronia

After the Second Circuit’s split decision in U.S. v. Caronia, holding that truthful off-label marketing is protected under the First Amendment and thus cannot be prosecuted under the misbranding provisions of the Food Drug...more

1/30/2013 - Caronia FDA FDCA First Amendment Misbranding Off-Label Promotion Pharmaceutical Prescription Drugs

Merck Compelled to Disclose Documents; Confidentiality and Privilege Waived with Prior Disclosure to Government

A court has ruled that Merck’s production of documents to the government under a confidentiality agreement during the Vioxx investigation waived any confidentiality or privilege; documents that Merck had previously disclosed...more

12/19/2012 - Attorney-Client Privilege Confidentiality Agreements ERISA Merck Privilege Waivers Vioxx Work Product Privilege

Off Label Marketing – First Amendment Challenge Ruling

The U.S. Court of Appeals for the 2nd Circuit upheld a First Amendment challenge to the federal prosecution of pharmaceutical salesperson Alfred Caronia for off-label marketing, http://www.ca2.uscourts.gov/decisions. Given...more

12/6/2012 - Commercial Speech FDA FDCA Free Speech Marketing Off-Label Promotion Off-Label Use Pharmaceutical

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