Fines Possible if Manufacturers Don't Validate Sunshine Act Data

To avoid fines and "reputational risks," group purchasing organizations and drug and device manufacturers must validate the accuracy of their spending before submitting it to CMS pursuant of the Sunshine Payment Act, according to a Bloomberg BNA report.

Companies can face civil monetary penalties from $1,000 to $10,000 per transaction for failure to accurately and punctually report data to CMS, and they can face civil monetary penalties from $10,000 to $100,000 for a knowing failure to accurately and punctually report data, according to the report.

Additionally, the Department of Justice, HHS, the OIG and the Securities and Exchange Commission can all access submitted spending data, heightening the risk that inaccurate submissions can initiate government investigations, according to the report.

Here are four steps to help reduce data submission errors.

  1. Analyze the source system data and ensure the data are accurate.
  2. Identify base causes for any spending data errors.
  3. Then implement procedures to correct the errors.
  4. Increase employee education and ensure employees know the causes of spending data errors as well as consequences for inaccurate data submissions.

More Articles on the Sunshine Act:

Sunshine Act Review, Dispute Period Begins
2 Ways the Sunshine Act Proposal Affects the Device Industry
Sunshine Act's CME Exclusion Eliminated Under Proposed Rule

 

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