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Compliance In Focus
Posted by John Lehmann on Fri, Apr 19, 2013

Meeting the Requirements of the Sunshine Act

The Physician Payment Sunshine Act was published to the federal register as part of the PatientMeeting the Requirements of the Sunshine Act Protection and Affordable Act on 08 February 2013.  The Sunshine Act became officially became effective 09 April 2013 (60 days after being published).  In preparation for this event, we have posted several previous blogs to help prepare the research community and raise awareness.

Drug, device, biologic, and medical supply manufacturers covered by Medicare, Medicaid, or the Children’s Health Insurance Program (CHIP) are now required to report payments as well as physician ownership or investment interests annually to the secretary of the Department of Health and Human Services (DHHS). 

In turn, the secretary of DHHS will make the information reported available publicly via website, thus greatly enhancing the transparency of financial interest held by investigators.  The compliance date for the rule requires that data collection will begin on 01 August 2013 and must be reported by 31 March 2014, with no retroactive reporting required.

This information should readily be available to manufacturers who keep strong accounting records, but will nonetheless take some effort to compile and summarize each year.  Some fear that the bigger issue is that the Sunshine Act will influence a physician’s willingness to continue to work with manufacturers knowing that their financial “laundry” will be aired publicly. 

  • If this is the case, patients could potentially be negatively affected if good physician’s take a step back from current research, teaching, or consulting roles. 
  • Conversely, patient’s stand to benefit from more transparency which is believed to heighten the ethical bar for physicians involved. 

Which do you think is more likely to happen?  We’d love to hear your opinion.  We would also love to hear from manufacturers regarding how you view this new requirement and how you plan to accomplish it.

Photo Credit: Tamara van Molken

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Topics: Sunshine Act, Patient Protection and Affordable Care Act, DHHS

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