Open Payments: Research Payments Distorted by Including Value of the Medicines and Devices

 

The Open Payments program, an element of the Affordable Care Act (the “Sunshine Act”), has required the healthcare industry to adhere to a complex transparency program since its implementation in 2014. The Act is an attempt to track payments and transfers of value between life sciences manufacturers and healthcare professionals, and requires any payments and transfers of value to be reported publicly on the Open Payments website. Many have been concerned that such a requirement has the potential to do more harm than good, especially since the reliability of the data has been called into question.

According to the Wall Street Journal, a group from Johns Hopkins University argues that the required reported information creates a “distorted” image of the money that doctors might receive, because for the research template it does not break out a specific value to medicines that pharmaceutical companies provide for clinical trials. “Donated drugs are intended for use by patients and do not provide direct monetary value to physician-investigators. The Open Payment rules for research cloud this critical distinction. One may presume that the public may have difficulty distinguishing between donated drugs for research and transfers of financial value to physicians.”

Given that there is such great concern about the perceived image of a physician being listed on the website as receiving industry money just for receiving medicine samples to pass on to patients, or for speaking and/or attending an industry conference or training session, there are questions as to whether physicians will abandon decades of constructive activity with the pharmaceutical industry, and vice versa. 

A 2014 survey of physicians conducted by MedPanel, however, has found that the impact of the Open Payments Website has not been as dramatic as previously feared. Nearly half of the 461 physicians surveyed said they had not visited the Open Payments website, and over half of the physicians said they were not even very familiar with Open Payments itself. For those who did find the time to visit the site, their motivation typically stemmed from general curiosity about what was being reported about them and their concerns about the accuracy of the reported information.

Of the surveyed physicians who had visited the Open Payments website, about half of them found inaccuracies in the reported data, with thirty percent indicating that payments by manufacturers had been attributed to them that they were not aware of. Additionally, fourteen percent of the surveyed physicians who visited the site said that payments they know they received were not reported.

Advanced Health Media did their own solicitation of views on Open Payments as part of its 2015 Third Annual Industry Conference. One of their panels, Real-Life Perspectives, included five physicians who were active in promotional meetings and training activities. More than one of those five physician panelists had viewed the Open Payments website only because they needed to prepare for participating in the panel. All panelists also indicated that none of their patients had ever asked them about data on the Open Payments website, but if asked, at least one would tell his or her patient that the reason he or she is on the website is because they speak at events. Though certain patients and the government may be concerned about conflicts of interest with healthcare providers speaking and participating in industry-promotional programs, the content provides a cutting-edge learning source for physicians.

In addition to the solicitation of views by Advanced Health Media, they also examined promotional programs conducted by some of their compliance technology and services clients throughout the Open Payments implementation period. They found that the total volume of annual meetings decreased by twenty percent from 2011 to 2013, prior to the Open Payments implementation, but there was a thirty percent increase in the volume of annual meetings from 2013 to 2014, including the period immediately after the Open Payments program was in full swing.

In the 2014 MedPanel survey, seventy-six percent of physicians reported that their level of paid participation in promotional programs remained largely unchanged after Open Payments going into effect. As stated by an Advanced Health Media panelist, “People come out to hear good speakers. We need to continue to have good speakers who actually see patients and have clinical experience.”

While it doesn’t seem as though Open Payments has materially altered the way physicians interact with life sciences companies, cost pressures will likely eventually force some level of changes to how healthcare providers and pharmaceutical manufacturers deliver and consume education. 

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