A quiet stretch over the holiday weekend. Two items today. A federal appeals court has weighed in on the Anti-Kickback Statute and the way HHS handles advisory opinion requests, and the DEA published a registration order worth a look if you hold a registration of your own.
A federal appeals court weighs in on the Anti-Kickback Statute and HHS advisory opinions
The D.C. Circuit has decided Vertex Pharmaceuticals v. HHS. The reading from Frier Levitt is that the court left the Anti-Kickback Statute’s reach broad while placing real limits on how HHS evaluates and processes advisory opinion requests. If that holds, a company weighing a patient support or copay assistance program has a somewhat more predictable path to a favorable opinion, and no less exposure under the statute itself. This is an appellate opinion, so anyone planning to rely on it should read the decision rather than a summary of it, including this one. Read more at Frier Levitt →
DEA publishes a decision and order against a physician registrant
The Drug Enforcement Administration published its decision and order in the matter of Stephen Bossenberry, M.D., in today’s Federal Register. An individual practitioner case rarely changes how a pharmacy operates day to day. These orders are still where the agency sets out its current thinking on registration sanctions, which makes them worth following for anyone who holds a DEA registration. Read more at the Federal Register →
This update is general information about developments in pharmacy law and regulation. It is not legal advice, it does not create an attorney-client relationship, and it should not be relied on as a substitute for advice about your own situation. Prior results do not guarantee a similar outcome. If you have a specific question about your pharmacy, call or write and we will talk about it properly.
Law Office of Bhavesh Desai | Bhavesh Desai, Pharm.D., Esq.
18085 Watson Way, Yorba Linda, CA 92886 | (909) 618-7299
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