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

Seth Bilazarian, MD

Disclosures

March 24, 2014

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In This Article

When Physicians and Industry Collide

Seth Bilazarian, MD: Hi. I'm Seth Bilazarian, on theheart.org on Medscape.

I wanted to do a blog for some time on the Sunshine Act. It has been an act in development now for several months for me, and I have decided to call the blog post "The Intersection of Federal Law, Physicians, and Corporate Attorneys," on the basis of my experience in reviewing this.

The Sunshine Act, as I think most people are aware, is part of the ACA (Obamacare, or the Affordable Care Act). The design is that it is a transparency tool to provide patients and the public with information about financial interactions between physicians and industry. Congressional sponsors of the ACA reportedly have said that they expected this wouldn't stop, or chill, or call into question beneficial interactions between physicians and industry, but the main goal was to ensure transparency.

Physicians' interaction with industry has come into interest for the public and, therefore, legislative interest, because of the amount of it going on and through public reporting of certain aspects of the extent of the financial relations. Among US physicians, 94% had relationships with industry in 2007, 83% received gifts, and more than one quarter were paid for consulting or research participation.[1] As for physicians who participate in medical education or creating guidelines, there is a substantial number: 60% and 40%, respectively. One third of all continuing medical education (CME) offerings are commercially funded.[2] Thus, there is a fair amount of industry and physician or physician organization interaction, and this has been something that some people in the public have called into question.

The orthopedic surgeons seem to have taken the lead, unfortunately, in this and a high amount of payments. Average payments over $200,000 were reported in a Department of Justice settlement; the details are here on the slide, but I won't go into them.[3]

As I was thinking about this, I was trying to decide if I were a patient -- but certainly, as a physician who refers to other physicians -- what would I really want to know about industry relationships that is important? So I began to a series of questions, which I think are unanswerable but were worthy of consideration.

What level of monetary value do I really want to know about, either as a patient or as a referring physician? Do I want to know that a cardiac surgeon I referred to has gotten a slice of pizza for some new device that he uses -- or $100 in consulting fees, or $1000, or $10,000, or $100,000? At what level is that important?

Should it be disclosed before? Should I know, either as a referring physician or as a patient -- if I am sitting with a physician as a patient and I am about to have an implanted device, for instance -- should that be part of the consent process?

Should the type of the interaction that the physician has with industry guide the disclosure? If the physician is an inventor or an investor or speaker, are those different? I am not really sure.

Thinking more about this and the potential hazard for a physician, like me, who implants devices, pacemakers, and stents, I think that patients would be more interested in knowing these relations a priori, and that probably is a safeguard for long-term concerns. For me to disclose that I speak on behalf of this device or this drug, although it is cumbersome, may in the long run be very helpful if after the fact, there is some hazard and the Sunshine Act discloses 2 years hence that I had a relationship. It may raise red flags and concerns for a variety of other issues down the road.

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