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Compliance In Focus
Posted by Brandy Smith on Tue, Feb 5, 2013

Finally! Regulation Rules Released: Sunshine Act

It’s been a long time coming but at last the “rules”- the Physician Payment Sunshine Act is final.Finally! Regulation Rules Released These are intended to give the public easier access to information on healthcare providers and their financial ties to companies in order to decrease any underlying or potential bias. How will this be accomplished?

According to an article posted on TheHill, “The rules will require drug, device and biologic manufacturers to annually report to Centers for Medicare and Medicaid Services (CMS) the payments and gifts they make to physicians and teaching hospitals. CMS, in turn, will create an online database that makes the disclosures easily accessible to the public.”

What exactly needs to be disclosed? Section 1128G of the Act includes nature of payment categories, including:

  • Consulting fees
  • Gift
  • Entertainment
  • Food
  • Charitable contribution
  • Royalty or license
  • Current or prospective ownership o investment interest
  • Grant

The goal of this disclosure is to not only increase transparency, but also equip patients with the knowledge of financial interests creating better informed patients. Without doubt this will change the industry significantly but it remains to be seen just how much. Many companies that conduct clinical research and clinical trials will be impacted, but will this negatively impact physician’s willingness to participate in research?

What are the consequences if the rules aren’t followed? An article points out that “Section 402.105 of the Sunshine Act establishes that CMS or the Office of the Inspector General (OIG) may impose fines of up to $10,000 (but not less than $1,000) per failure to report, with those penalties not to exceed $150,000 per annual submission report.” Is this fine enough to force the formality of reporting payments?

With the release of the long awaited rules we’re anxious to hear your thoughts. Do you think this will provide increased transparency and a better informed public? Or will industry be weighed down by rules and regulations? Share your thoughts below.

Photo Credit: Marcio Cabral de Moura

Regulations Revelations

Topics: Sunshine Act, Healthcare Providers, Regulations


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