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

Seth Bilazarian, MD

Disclosures

March 24, 2014

In This Article

Review and Corrections

Corrections allegedly are going to be allowed. Physicians will be allowed to appeal to a vendor, but on the basis of my experience (which I will share in a second), dealing with the vendors has been very concerning. They seem to be very hesitant, so they are under no obligation to change anything -- even if you are very concerned that they have misrepresented it, mislabeled it, or ascribed it to you when it really shouldn't have been to you but to your institution.[6] A physician can request that it be recategorized, but it appears to me that the industry is so concerned about potentially draconian financial penalties from the federal government that they may just say, "Tough for you, doctor. That is the way it is. We are not going to change it."

One way you can try to at least follow this as it goes forward is to follow postings. There is a mobile app called Open Payments Mobile for physicians, where you can see what kind of physician payments have been ascribed to you. Of course, the public will be able to use that as well.

We can potentially work with manufacturers and group purchasing organizations before the data are reported to try to make sure they are clear before they are reported. Once data are reported, making changes will be problematic. There is allegedly a 45-day review and dispute window each spring after the data are reported to the Centers for Medicare & Medicaid Services (CMS), before they are reported to the public, for us to review and potentially make changes.

My personal experience is that this is really being rolled out aggressively. As I mentioned, at ACC I am asked to provide my NPI number. The Cardiovascular Research Foundation (CRF) has a meeting before ACC in which they have asked for my NPI number. Presumably, CRF has industry sponsorship for their event, and I don't know whether I will be ascribed a value for that CME meeting [Editor's Note: CME is excluded from the Sunshine Act disclosure requirements]. For the first time at the last American Heart Association (AHA) meeting, I was asked to submit my NPI number for the investigator's dinner meeting where the ENGAGE-AF data were presented (I am an investigator for the ENGAGE-AF trial). So these are going to be significant issues going forward.

I tried to ask on the ground here with my industry representatives what this was all about and how they were handling it, and I wanted to get a sense of what was happening here. I asked them by email, specifically how you are going to handle the Sunshine Act?

I asked the representatives from drug and device manufacturers for most of the branded things, NOACs, statins, antiplatelet therapies, pacer manufacturers, and statin manufacturers. I asked them very specific questions. and what I asked them specifically is in this email here. I asked 7 questions, including:

  • How are you going to assign values for a journal article?

  • How are you going to assign medical education materials, such as posters or brochures?

  • How are you going to handle samples?

  • How are you going to handle lunch in the office or dinner outside the office?

I also asked, how are you going to handle issues of national meetings? I asked these questions of them and asked for their official company response. I didn't want them to just tell me how they were going to handle it locally, but how it was going to be handled officially.

I was really shocked and disappointed. It was uniform that the device manufacturers gave very disappointing responses. They wouldn't answer my questions.

Going forward, I am concerned, given the HealthCare.gov experience with regard to how it has caused problems for our patients enrolling in it and insurance companies. How will this be handled when we have these data posted on a Website?

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