Ellyn L. Sternfield

Ellyn L. Sternfield

Mintz Levin

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The 340B Mega-Reg is Dead

With all due credit to the Coroner from the Wizard of Oz, like the Wicked Witch of the East crushed by Dorothy’s house, the 340B Drug Discount Program mega-reg is “not only merely dead, it’s really most sincerely dead.” And...more

11/19/2014 - HHS HRSA Prescription Drugs Proposed Regulation Section 340B

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 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

2014 May Be a Game-Changer for the 340B Drug Discount Program

The year 2014 looks to be a year of major developments for the 340B Drug Discount Program. We have seen (1) a first in terms of the Health Resources and Services Administration (HRSA) imposing sanctions on audited entities,...more

1/30/2014 - Discounts Federal Budget HRSA Manufacturers Orphan Drugs 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

Hospitals Fight Back to Defend 340B Program Operations

Adhering to the axiom that the best defense is a good offense, SNHPA (Safety Net Hospitals for Pharmaceutical Access), an organization of close to 1000 hospitals participating in the 340B Drug Pricing Program, is attempting...more

7/11/2013 - 340B GAO Healthcare Healthcare Professionals Hospitals Patients Prescription Drugs SNHPA

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

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

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