Primacea Blog

Primacea's founders describe the problems and pathways for physicians to manage their industry relationships under the bright lights of the Sunshine Act in a March 2013 Endovascular Today cover story.

"From inventing a new device to providing expertise on how it might be improved or best used, physicians interact with industry in a variety of ways, often receiving paid compensation for their time and work or being provided with meals or travel expenses. While ordinarily understood to be of value by many within the field, public and political scrutiny has increased in recent years, and legislation now dictates that all financial ties be disclosed publicly, online."

The interview describes the background of the Sunshine Act, how it grew to 76,000 words of regulations, and the reporting responsibilities around financial exchanges between industry and physicians.

It emphasizes the need for physicians to take responsibility for their own compliance. Every payment that physicians receive, directly or indirectly, will be reported on a publicly searchable website. Unless a physician has the tools to accurately record and track these relationships, he or she could find that they are ill-prepared in the event that questions arise about the work they do. Industry and hospitals will spend hundreds of millions of dollars annually to comply with the Act. Unfortunately, none of these expenditures will necessarily protect a physician.

CMS finalized the rules for Sunshine reporting of payments to physicians which will be published in the Federal Register on February 8, 2013. The 287 pages detail how payments must be recorded starting August 1, 2013 and reported to CMS by March 31, 2014. 

The final rules include significant modifications based on extensive feedback received from responders. (Our comments can be downloaded at Primacea comments on CMS-5060-P.)

Subsequent posts will analyze details of the now-final Sunshine rules.

The entire document can be found at Sunshine Rules - CMS. 

According to a study published in the Archives of Internal Medicine, only 14% of physicians provided consulting services to industry in 2009, down from 28% in 2004. The study speculates as to potential causes of the decline: press coverage of physician-industry relationships, changing medical school and hospital policies, increased public reporting of consulting relationships, and/or reduced spending by pharmaceutical and medical device companies.

Two years ago, The New York Times told the stories of leading academic scientists, including a cardiologist, a psychologist and an oncologist, who decided to no longer accept paid engagements with industry. One physician explained his decision as "responding to societal pressure." He noted that he is less willing to collaborate on treatments now that receives no pay for spending weekends on advisory boards, and he concluded "I resent the fact that I had to make this decision."

Several physicians told Primacea of similar feelings: all missed contributing their ideas and experiences to the process of advancing medicine. So why did they reduce or stop consulting? Overwhelmed by changing laws and rules, many concluded that continuing industry engagement wasn't worth the risk to their careers and reputations. Others feared being the next subject of an investigation or newspaper article. One even declined to accept royalties legitimately earned on a breakthrough invention.

Concerned physicians acknowledge that a number of physicians were improperly retained and compensated at times in the past. To the extent that the reduction in physician consulting is due to industry eliminating such inappropriate hiring, these recent changes are positive. However, to the extent that these changes primarily reduce productive physician-industry interactions, more appropriate regulations need to be developed.

Conversations with leading physicians lead me to conclude that the vast majority of the decline in physician-industry interaction can be traced to two concerns: public suspicion about physician motives in working with industry and personal fear about conforming to complex and changing legal, regulatory and institutional requirements. More research is required to better understand this issue from the perspective of physicians.

We must reverse the decline in collaborations between physicians and medical companies. Three things must happen so that physicians may continue their critical role in advancing patient care (as has been acknowledged by physician and industry leaders and is nearly universally accepted). First, the value of such collaborations must be more broadly appreciated. Second, a consensus must be formed as to what constitutes appropriate interactions. Third, processes for certifying ethical collaborations must be instituted.