Put Down That Doughnut! Four Tips for Not Getting Burned by the Sunshine Act

  • Chamberlin, Keith, MD, MBA, FASA
| Sep 02, 2014

Politicians are worried. Government is worried. Even your mother will be worried. Who is paying you off? Are you being influenced to prescribe something because a company gave you a gift? What research of yours has been tainted because the manufacturer of whatever it is you are researching paid you??

Transparency!! That is one of our new watchwords for everything both medical and financial. And the Sunshine Act mandates this transparency.

The Physician Payments Sunshine Act, also known as “Open Payments,” is a provision of the Affordable Care Act (42 USC §1320a-7h) that will create greater transparency among physicians, teaching hospitals, and drug and device manufacturers. It will do this by increasing public awareness of the financial relationships among these entities, by publishing reported data on a public, government-constructed website. Uh oh …

Truthfully, the concept behind the Sunshine Act is a good one — we need to make sure medical research is transparent and honest, and patients need to know their doctors are doing the best for them, without undue influence from drug companies or manufacturers of medical devices (pacemakers, spinal stimulators, pain pumps, central line kits, etc., etc.). And many physicians and administrators have great influence on what products or pharmaceuticals our facilities stock.

Tip 1: Know that anything of value you accept will be reported.

Yes, the government wants to know about those doughnuts. (Actually the trigger for reporting is anything of value greater than $10.)

All “applicable manufacturers” or group purchasing organizations (GPOs) are required to report payments or transfers of value they make to physicians and teaching hospitals. They report this information to the Centers for Medicare and Medicaid Services (CMS). These companies have been collecting data since Aug. 1, 2013, and they reported the collected data (through December 31) to CMS on March 31, 2014. The data about payments to you will be continuously collected on a yearly basis, and the website updated to reflect this data.

Now it gets even better: By Sept. 30, 2014, CMS will collect the data, aggregate it and publish it on a public website. There it is again: a government-constructed public website for health issues. I am certain the rollout will be a huge success.

Now, the Sunshine Act does not judge, make assumptions or draw conclusions from the data reported — it does not make anything illegal or legal. It simply permits the public to see how much money a physician or institution was paid, either in real dollars or any “transfer of value”: meals, trips, books, gifts (even promotional gadgets), consulting fees, travel expenses, grants, and on and on.

Tip 2: Review your data and make any necessary disputes before the Sept. 10 deadline.

What is the risk for anesthesiologists? First, residents are not part of this legislation, so they can rest easy. And likely most of the practicing anesthesiologists out there have nothing to worry about. Depending on how an educational event with dinner is structured/sponsored, the value of the dinner may need to be reported. However, if you do industry-funded research, have a consulting arrangement with an “applicable manufacturer” or, oh yes, are part of a teaching hospital, you should know what data is being reported about you. Initially you had until Aug. 31 to dispute any of the information. However, that deadline has now been extended until Sept. 10, 2014.

Tip 3: Download the Open Payments Mobile for Physicians app to find your data (or register online-- a two-step process).

How to review and if necessary dispute the information? Yes, another government-designed health website. You can register to find out what is being reported about you by going to the Open Payments Program Registration page. Registration is a 2-step (or '2-phase') process:

  1. Register in the CMS Enterprise Portal (to identify yourself), here’s the guide on how to do this.

  2. Register in the Open Payments System via the CME Enterprise Portal (to review/dispute data), here’s the guide on how to do this. 

This seems daunting, but relax, there is provided for you, on the Open Payments website, a detailed User Guide — it is over 300 pages long. I am in the process of registering and looking up my info. I have only been trying four days, but I will report back when I gain access … sometime next year.

There is another, much cooler way to check the reports about you. Yes, an app — for both the iPhone and Android operating systems. It is called Open Payments Mobile for Physicians, and is free and a quick download. I have it up and running, and there are no reported payments to me that I can find.

How do you dispute the information? Ah yes, another easy path. It turns out that CMS itself does not handle the disputes and you will actually NOT be able to dispute records on your own behalf. You will need to nominate an 'authorized representative' who will dispute records for you. That person, if s/he accepts your nomination, will also need to complete the two-step registration above, so be sure to give yourself and the other person plenty of time to complete these steps. Once a dispute is submitted, the company who submitted the payment will be notified, and then it is a personal issue between you and the company. 'Any data that is disputed, if not corrected by industry, will still be made public but will be marked as disputed.' It is complicated. Learn more about the review and dispute process.

Tip 4: Find out if you need to report anything.

So we know device manufacturers and drug companies need to report money spent on you and gifts given to you, but do you have to report money spent on others?

Let’s say you are a 25-physician group (or 50 or 100) and you give gifts of a substantial nature to surgeon’s offices, wine for surgeons themselves, let them use your vacation home, etc. Are you required to report those transfers of value? No. Holiday gift-giving as an individual remains safe. The law is relatively clear about who needs to report: “applicable manufacturers” who are based in the U.S. and engaged in the production, etc., etc., of any “drug, device, biological or medical supply” covered by Medicare or Medicaid [42 USC §1320a-7h(e)]. The law specifically excludes distributors and wholesalers, as long they do not hold title to any of the products they distribute.

But wait — what if you are member of a GPO? The law defines that as a group that “purchases, arranges for or negotiates the purchase of a . . . drug, device, biological, or medical supply for a group of individuals or entities, but not solely for the use of the entity itself” (42 CFR §403.902). Only you know if you are part of such a group.

So in the end what does this all mean? The Sunshine Act was created to “shine a light,” very publicly, on the financial relationship you have with a drug company or a device company. There is nothing illegal about a financial relationship — the government just wants the public to know if you are making decisions based on who pays you. We have seen potentially unethical relationships among doctors and the health industry (see Dr. Sibert’s article, “Today’s ‘Evidence-Based Medicine’ May Be Tomorrow’s Malpractice,” about ChloraPrep and Dr. Charles Denham). We should be held to a higher standard — after all, we are physicians. We are entrusted with the highest level of responsibility: the well-being of a human life.

That said, find out what is being posted about you. Work your way through the websites or download the app. As always: “Trust, but verify… .” Now, where are the doughnuts??

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