Ellyn L. Sternfield

Ellyn L. Sternfield

Mintz Levin

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The Increasingly Murky World of 340B: What’s Next?

For the past 18 months, health care providers and the pharmaceutical industry have been hoping for some clarity regarding 340B Drug Discount Program operations. But things just keep getting murkier....more

9/3/2014 - Health Care Providers Healthcare HRSA OIG Orphan Drugs Pharmaceutical Pharmacies PHRMA Prescription Drugs Section 340B

HRSA “Interprets” Its Enjoined 340 Orphan Drug Rule into Effect

In January, I predicted that 2014 would be a game-changer for the 340B Drug Discount Program, in part because of HRSA’s announcement that, in June 2014, it would for the first time publish an omnibus rule governing 340B...more

6/19/2014 - 340B Drug Manufacturers FDA HRSA Orphan Drugs Pharmaceutical Prescription Drugs

Court Invalidates 340B Orphan Drug Rule

In a blow to government efforts to regulate the 340B Drug Discount Program, U.S. District Judge Rudolph Contreras has ruled that HRSA lacks regulatory authority to promulgate regulations expanding access to 340B discounts for...more

5/29/2014 - 340B HRSA Orphan Drugs Pharmaceutical Prescription Drugs

CMS Releases Physician Medicare Billing Data

The U.S. Department of Health and Human Services (HHS) announced on April 9th a “historic” release of Medicare payment data to provide consumers with “unprecedented transparency on the medical services physicians provide and...more

4/11/2014 - Billing CMS Healthcare HHS Medical Devices Medicare Pharmaceutical Sunshine Act

CMS Proposes Major Changes to Medicare Part C and Part D

On Jan. 10, the Centers for Medicare & Medicaid Services (CMS) published proposed rules labeled as ‘‘policy and technical’’ changes to the Medicare Advantage (Part C) and Medicare Prescription Drug Benefit (Part D) Programs....more

3/10/2014 - CMS Healthcare Medicare Medicare Part C Medicare Part D Pharmaceutical Prescription Drugs

CMS Proposes Major Rule Changes to Increase Payment Accuracy and Improve Program Integrity in Medicare Part C and Part D

On Jan. 10, the Centers for Medicare & Medicaid Services published proposed rules labeled as ‘‘policy and technical’’ changes to the Medicare Advantage (Part C) and Medicare Prescription Drug Benefit (Part D) Programs....more

3/10/2014 - CMS Healthcare Medicare Medicare Part C Medicare Part D Pharmaceutical Prescription Drugs

HHS-OIG Criticizes 340B Drug Discount Program

I recently posted that 2014 is expected to be a year of major developments in the 340B Drug Discount Program, with HRSA receiving enhanced funding, stepping up audit activity, and drafting regulations in response to criticism...more

2/11/2014 - Drug Manufacturers Healthcare HHS HRSA OIG Pharmaceutical Prescription Drugs

Grassley Turns His 340B Microscope on Manufacturers

For the first time, Senator Grassley has turned his scrutiny of the 340B Drug Pricing Program to pharmaceutical manufacturers. As we previously wrote, Senator Grassley has been among the most vocal of critics in...more

10/3/2013 - 340B Charles Grassley Drug Manufacturers Pharmaceutical Prescription Drugs

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

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

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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