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Compliance In Focus
Posted by John Lehmann on Thu, Jan 31, 2013

5 Steps to Get Ready for the Sunshine Act

5 Steps to Get Ready for the Sunshine ActAs part of the Patient Protection and Affordable Act, the Sunshine Act requires medical device, pharmaceutical and similar companies to report any payment or other transfer of value to the Health and Human Services (HHS). While things aren’t yet set in stone, an article published on MedCityNews points to five steps companies can take to prepare for the Sunshine Act.

Listed below are the tips listed in the article, as well as excerpts from the author, Becky Holloway, which elaborate each preparation step:

  1. Map all upstream aggregate spend activity.
    Start by mapping upstream activities along the aggregate spend continuum. This includes everything from royalties and loaners to consulting fees and research.
  2. Get your contracts in order.
    Once everything is mapped, make sure everything can be managed in a central, automated contract repository. This will serve as the single source of truth for your data and will ensure accuracy.
  3. Communicate with your HCP/Os.
    To maintain strong relationships with healthcare providers, manufacturers need to think through and execute sensible communication plans. It’s also important to make sure that communication is a two-way street. Physicians will need a way to review aggregate spend data and report any issues if the data is inaccurate.
  4. Get a flexible solution in place.
    The last thing you want to do is spend a lot of money locking yourself into a system that will be costly and cumbersome to modify in the coming years.
  5. Prepare for the worst.
    I cannot emphasize this enough: over prepare. I think it is quite likely that there will be a high profile Sunshine Act case brought against a manufacturer in the coming years. Don’t be that company.

As they say, even with great preparation obstacles can still occur! The new act will likely require some adjustments on the industries part, but hopefully early preparation will allow a smooth transition to a post Sunshine Act climate. The act will definitely impact many companies that conduct clinical research and clinical trials, but the question remains- will this negatively impact physician’s willingness to participate in research?

Has your company taken any steps to prepare for the Sunshine Act? Please leave your suggestions below!

Photo Credit: Marcus Vegas

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Topics: Sunshine Act, Patient Protection and Affordable Care Act, Becky Hollaway

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