Life Science Compliance Update

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March 05, 2013

Physician Payment Sunshine Act: Survey Shows Physicians Still Unaware of Regulations

Doctor Unaware
According to a recent survey, some physicians actually know less about the Sunshine Act provision of the Patient Protection and Affordable Health Care Act now than they did one year ago.  More than half of the 1,025 physicians surveyed in January by global communications technology company MMIS Inc. and healthcare information services company Health Data Solutions said they didn’t know that the law requires pharmaceutical and medical device companies to track any payments or “transfers of value” to physicians and teaching hospitals as of August 1, 2013.  We reported last year on the same survey.  

Physicians did not know that the companies then will submit the data to the government, or that the Centers for Medicare and Medicaid Services (CMS) will begin publicly reporting the data as of March 2014.  This reflects a 5% decrease overall in familiarity with the law over last year’s survey results.  This is the third year the survey was conducted.  Other important findings from the survey include: 

  • Once physicians became aware of the Sunshine Act via the survey, 63% said the Sunshine Act’s requirements deeply concern them, in part because they do not trust companies to get the information right
  • 94% of physicians want to be able to review the payment data before it goes public, and to dispute any claims they think are wrong, something the final rules do allow—which is part of the 45-day review and correction period and the 15-day (newly added) dispute resolution period.
  • 43% said inaccurate reporting would adversely affect their interactions with industry, and
  • 21% said they would sever their relationship with a company that reported incorrect information. 

Many physicians reported having some sort of financial relationship with industry: 

  • Receiving samples (54%),
  • Receiving food and beverage in their workplace (57%),
  • Participating in an “industry-funded program” (48%),
  • Participating in speakers bureau programs (11%) and advisory board programs (10 %).  

Even though companies are prohibited from offering any entertainment or gifts that do not advance disease or treatment education under the voluntary Pharmaceutical Research and Manufacturers of America’s Code on Interactions with Healthcare Professionals—a practice that is also banned by law in several states—2% said they still accept free event tickets or gifts. 

The survey also included written physician comments and concerns; “these ranged from loss of privacy to the difficulties inherent in knowledge transfers regarding new medical therapies through industry education.” 

The survey did not specifically break out questions about accredited or certified continuing medical education, non-certified CME, and promotional activities.  However, it did ask respondents if they believed educational materials provided for patient education and industry support of conferences would fall under the Sunshine reporting rules.   

  • 39% thought that patient-education materials would have to be reported (the regulations exclude such materials), and
  • 75% thought that “conference funding” would also have to be reported (meals, travel and other educational materials that do not directly benefit patients may have to be reported if they qualify as indirect payments). 

“There are approximately 3,000 manufacturers of drugs and devices providing valuable education and resources to physicians that enhance patient care. Increasing transparency of the relationship between industry and our healthcare providers will undoubtedly encourage scrutiny by the public, physician peers and their institutions.” said CEO of MMIS, Michaeline Daboul. “Government, industry and physician organizations will need to increase communication in this new age of transparency, share data prior to public dissemination and provide a process for physicians and institutions to resolve disputes regarding incorrect or inaccurate information.” 

Daboul said that the survey results indicate that “there are some misunderstandings out there.  Physicians need to know that [accredited] CME will not be reported.”  She adds that, if physician associations and specialty societies don’t take up the mission to educate docs about the Sunshine Act requirements, CME providers may have to take on the job, because misunderstandings about what will be publicly report could have potential repercussions on providers, even accredited providers. story pointed to another survey that was conducted in the fall of 2012 by the CME Coalition, which showed that while 95 percent of the docs said CME was moderately to very important to their ability to keep up with the latest in patient treatments, three-quarters of them said that, if the Sunshine Act’s reporting requirements included accredited, commercially supported CME, it would have some effect on their decision to participate in certified CME activities produced with funding from industry grants. “Even though this is not the case, if they believe it is, they may well act accordingly,” the article noted.

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