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It has been almost a month since I returned from this year’s EMI program, and I am still telling anyone who will listen, what a great program it was, and what a good time I had! Perhaps my enthusiasm was the result of the temperatures in the high 70’s, or the beautiful (snow-free!) grounds and blooming flowers. More likely, it was the result of renewing old friendships and making new ones while participating in a terrific educational program and social event.
It has been over one year since the Internal Revenue Service (“IRS”) issued its final regulations explaining the scope and application of the medical device excise tax.
Early this year, a False Claims Act (“FCA”) whistleblower in a suit against the University of Texas Health Science Center filed a certiorari petition, asking the U.S. Supreme Court for guidance on whether and when a state entity such as a public university medical center can be held liable under the FCA.
Now that the ink is dry on the Idaho federal district court’s order requiring St. Luke’s Health System (“St. Luke’s”) to unwind its acquisition of Saltzer Medical Group (“Saltzer”) - a for-profit, physician-owned, multi-specialty group comprising approximately 44 physicians located in Nampa, Idaho - what does the decision mean for other providers?
The Department of Health and Human Services Office of Inspector General (“OIG”) recently released its Work Plan for Fiscal Year 2014 (the “Work Plan”), which contains numerous oversight and enforcement objectives of interest to drug manufacturers and related industry stakeholders.
Compounding is a process by which a pharmacist or a physician “combines, mixes, or alters ingredients to create a certain medication for a patient.”1 Historically, the Food and Drug Administration (“FDA”) held the position that compounding issues are a local matter for the pharmacy board, unless, in the FDA’s sole discretion, it decides that a particular pharmacy should be singled out for action.