March 2014

On March 12, 2014, the Food and Drug Administration (FDA) shut down the plant of cheese manufacturer, Roos Foods, after an investigation linked a listeria outbreak to the manufacturer’s Mexican cheeses.

In February, the FDA recalled various types of Mexican

The FDA issues Warning Letters to provide individuals and companies with an opportunity to take voluntary and prompt corrective actions for violations of regulatory significance that may otherwise lead to enforcement.  A Warning Letter is the FDA’s principal means of

On March 4, 2014, the Obama Administration released its Fiscal Year 2015 proposed budget, which includes significant changes to federal health care spending and certain Medicare program requirements.  Described below are certain proposals of significance to the healthcare sector.

Inpatient

The Centers for Medicare & Medicaid Services (“CMS”) has requested comments on the burdens of collecting information under the Self-Referral Disclosure Protocol (“SRDP”).

The SRDP, released by CMS in September 2010 and revised in May 2011, gives providers a way

On Wednesday, March 5th, the Department of Health and Human Services Office of Inspector General (“OIG”) released a report stating that an investigation into 10 states’ Medicaid agencies found that there were many security vulnerabilities that could result in patients’

On March 12th, the FDA published a letter it had sent last month to Switzerland-based drug maker IBSA Institut Biochimique SA regarding the false and misleading nature of a Facebook page for the company’s drug, Tirosint.

Specifically, the FDA’s Office