Topic8: Sunshine Act – Preparing KOLs for 2013

We are little over a year (Sept. 30, 2013) away from the date when Department of Health and Human Services (HHS) has committed to having the first round of Sunshine Act data made available to the public via the web.  Allow me to stipulate that we may have more time since the HHS has managed to miss every other deadline they have had with regards to the Sunshine Act.  And, allow me to stipulate that a fully Republican controlled government may actually repeal Obamacare and the Sunshine Act with it.

But, as we head into the 2013 planning season, I think it would be wise to assume this is actually going to happen and thus budget and plan accordingly.

Up to this point, we have discussed the Sunshine Act purely from an administrative point of view – how to collect this data and meet the immediate 2012 requirements.  But, in 2013 this information is going to be made public and we run the risk of losing the trust and support of the very KOLs that we have all invested so much time in developing.

It is critical that your company take a proactive stance on this situation:

• Reaching out to the KOLs for whom you will be reporting payments


• Educating them on the law and its reporting requirements


• Providing them with the same information provided to HHS and an explanation of that information


• Providing them with some context for this information and how to explain it to others


• Answering any questions they may have

I will discuss some approaches to this in hopes that it aids in your budget and planning efforts.

The first challenge to overcome in addressing this issue is intra-function coordination.  The data provided HHS includes payments from all company elements, including research, development, medical affairs and commercial.  Therefore, in addressing this to KOLs, a single cross-functional approach needs to be created.

I would suggest a meeting with the other relevant functions to address the corporate approach and name members to a task force.  MA is the logical leader for this given its role as straddling the worlds of products in and out of development.

Once this Task Force is formed, I would suggest the following approach:

1. Gather a list of those KOLs impacted by the reporting and prioritize if necessary based on KOLs with the biggest numbers


2. Work with each function reporting to develop standard explanations for the payments made


3. Develop general metrics such as average payments, ranges of payments, number of KOLs in each range, etc.


4. Develop individual KOL reports that contain the same information shared with HHS


5. Develop internal training with information about the Sunshine Act, the general metrics and how the company will explain it to others


6. Develop materials for KOLs that explain the Sunshine Act, the obligation to report, the expected approach by HHS to share the information, an explanation of the company’s payment types, some bullet points on how the information can be conveyed by the KOLs to others, and the general metrics and a FAQ


7. Assign KOLs impacted to specific MSLs with targets for discussions before September 2013


8. Train MSLs


9. Track the results

This should be a straight forward communication project, but it will be easy to put off as more urgent issues begin to crowd it out in 2013 so it will take consistent leadership to get it done.

What are your plans for supporting the rollout of HHS reporting of the Sunshine Act?  Leave your comments or questions (below) or email me directly (link on the right).