In This Issue:

- Judge Rules Against 340B Drug Authority

- FDA Approves Skin Infection Drug

- Implementation of the Affordable Care Act

- Other Federal Regulatory Initiatives

- Other Congressional and State Initiatives

- Other Health Care News

- Upcoming Hearings and Markups

- Excerpt from Judge Rules Against 340B Drug Authority:

A federal judge in the DC District Court ruled that the Department of Health and Human Services (HHS) does not have the authority to implement regulations related to provisions in the Affordable Care Act (ACA) to expand the 340B drug discount program to rural and cancer hospitals. The regulation would have allowed certain health care facilities to access 340B discounts on orphan drugs for non-orphan indications. Safety Net Hospitals for Pharmaceutical Access released a statement expressing its disappointment in the ruling. This may have significant implications for the much anticipated 340B “mega-rule” that is currently under review at the White House and was expected as soon as this month. Most analysts believe that the ruling is limited to the orphan drug issue because the ACA did not direct HRSA to make exceptions for orphan drugs. However, if the court ruling is interpreted to be broader, then Congress would have to step in via legislation to reign in possible overuse of the program.

Please see full update below for more information.

LOADING PDF: If there are any problems, click here to download the file.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Mintz Levin - Health Law & Policy Matters | Attorney Advertising

Written by:


Mintz Levin - Health Law & Policy Matters on:

Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.