Sunshine Act: The Intersection of Federal Law, Physicians, and Corporate Attorneys

Seth Bilazarian, MD

Disclosures

March 24, 2014

In This Article

Why You Should Care

So I was discussing this with my own group, and many of them asked this question: Why should I care about the Sunshine Act? The issue is that there will be postings of dollar amounts on the federally searchable database that say that you receive certain things of value -- whether those things are meals, books, or other kinds of things.

So if a patient asks you why you received X dollars in travel or research expenses from a medical drug or device manufacturer, how would you respond? How are you prepared to respond? Dinners that physicians attend, either locally or at a national meeting, will be listed as a dollar value, and the dollar value is actually quite high for a meal: $100 or $120, often.

Is it also a malpractice risk? For example, if you have an implanted device and then there is some kind of untoward effect... I think back to the times of stent thrombosis, putting in stents. If you are a speaker for a particular drug-eluting stent and then stent thrombosis occurred, would you be seen as a potential contributor to that, having not disclosed that relationship to the patient at the time of the implant?

The other issue is that a lot of physicians don't know about this. More than one half of the physicians reportedly don't know about the impact of the Sunshine Act.[4] This is, I think, going to be a significant issue in the coming months this year as this rolls out.

Certain states have taken a lead in this transparency area. In my state, Massachusetts, there has already been a transparency act in place for several years. Where the 2 laws overlap -- the federal and the state -- the one that is more stringent applies. If your state does not prohibit certain things and the federal law does prohibit it, then that is a problem. For instance, the Massachusetts law specifically excluded reprints, so if a representative gave me a journal article from a European journal that I don't subscribe to or have requested, that was specifically excluded as a thing of value -- but the federal law requires that manufacturers report that.

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