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Pharma Compliance Info Compliance Officers as Chief Data Analyst US Sunshine Act

Compliance Officers as Chief Data Analyst

March 18, 2016 by Thomas Sullivan.
With the US Sunshine reporting data fast approaching March 31, compliance teams are heads down in getting the spend records collected, audited and ready for final reporting. The frenzy of systems issues (both internal and CMS), personnel challenges and vendor management makes the race to the finish line a close call for most compliance team. How does one take a break to analyze the data before it goes in for submission? What are the risks for submitting data in the public domain without a pre-audit and analytical review?

After conversations with a variety of compliance teams, we narrowed down the risks to three broad categories:Pharma Compliance Info Compliance Officers as Chief Data Analyst US Sunshine Act

  1. Incomplete Spend Report
    1. Missing spend transactions
  2. Incorrect Spend report
    1. Spend amounts are incorrect
    2. Improper classification of spend
  3. Suspect Spend
    1. False Claim / Fraud
    2. Questionable spend (excessive for a category)
    3. Unethical spend

As evidenced by the case of Insys Therapeutics and Olympus, the risks of getting trapped for any of the above issues go beyond just the penalties imposed by CMS. The fines are many fold and the reputational risk many multiples of the dollar amount at stake.

To read this article by Thomas Sullivan

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