Whether or not the Sunshine Act will improve or diminish the practice of medicine in the United States remains to be seen. But it will not eliminate the role of bias in the medical field or the pharmaceutical industry. Earlier this year, the Department of Health and Human Services ruled that the so-called “Physician Payments Sunshine Act” (Section 6002 of The Patient Protection and Affordable Care Act), will go into effect. The goal of this Sunshine Act is to introduce more transparency into the financial relationships between drug, device, and biologic manufacturers and the physicians who advise, consult, and work with them. Any payment or gift greater in value than $10 given to any physician must be submitted to the Secretary of Health and Human Services, and be posted on a publicly-available website, or prompt a fine of as much as $10,000 per gift, which will be the responsibility of the company. Data will be collected by the Centers for Medicare and Medicaid Services (CMS) beginning August 1, and all 2013 data is due by March 31, 2014. The CMS will begin making these data public by September 30, 2014.
Ostensibly, this Sunshine Act has been created to limit the amount of physician bias in the modern healthcare system, something with which Dan Ariely is intimately acquainted. As a burn patient, he was at the mercy of forces beyond his control, and as he found, often beyond rationality itself. Now, as a noted behavioral economist and psychologist, he’s published widely on the irrationality of human behavior. In his blog, Ariely comments frequently on his research into irrationality and the effects of cognitive bias in the world around us.
In this video from TED, Ariely speaks about how physicians (and other researchers) can be motivated by their own biases to persuade their patients to follow a specific course of treatment.
For companies like Cadence Research and Consulting, the impact of the Act depends on the specifics of the project through which physicians are engaged. Guidance from CMS indicates that market research is exempted from reporting requirements due to the fact that a manufacturer is not paying physicians directly, and that the identity of the manufacturer is necessarily kept hidden from the physician. However, money spent on physician travel, food, and lodging for “promotional” activities like advisory board meetings or investigator meetings should already be recorded. For these items, Cadence proactively maintains a master list of these expenses for each physician that can be tailored to each individual client’s needs. In many cases, clients already provide us with individual reporting spreadsheets that can be completed and submitted with meeting deliverables and close-out files.
Of course, whether or not the Sunshine Act will improve or diminish the practice of medicine in the United States remains to be seen. But it will not eliminate the role of bias in the medical field or the pharmaceutical industry. As Dan Ariely notes, “It’s just a fact of human life: we are compelled to reciprocate favors, and an ingrained inability to disregard what’s in our financial interest.”