Although incentives for U.S. physicians to participate in marketing research studies sponsored by pharmaceutical and medical device manufacturers are allowed in certain circumstances by the Physician Payments Sunshine Act (passed as part of the Affordable Care Act, aka Obamacare, in 2010), the launch of the database tracking and publicizing payments to physicians last year certainly presents a potential impediment to physician respondent cooperation.
So MedPanel ran a study late last year using their medical practitioner online panel to see what respondents thought about the Open Payments database, the Sunshine Act, and the impact on research participation. Four hundred and sixty-one physicians participated even though there was (amusingly) no respondent incentive involved.
Some of the results were unsurprising: only 37 percent of respondents claimed they completely understood the regulations; and 70 percent of the 46 percent of respondents who had visited the Open Payments website did so to check what was reported about them on it.
However, given all the confusion MRA and our members have encountered among pharmaceutical and medical device manufacturers’ compliance departments, and the confusion evinced by the respondents to this study, we were surprised that only 21 percent of these physicians reported that their participation in such marketing research studies has declined since passage of the Sunshine Act. MedPanel concluded that these physicians’ “concern about the propriety of receiving payments from manufacturers is likely a contributing factor to these physicians’ lower level of participation.”
We can't yet predict whether this response rate impact will improve (or worsen) as physicians, manufacturers and the public get more used to the Sunshine Act.
The MedPanel study has been one of the only investigations of the impact of the Sunshine Act on physician participation in marketing research since an MRA-sponsored study conducted prior to the Sunshine Act’s passage, and we are grateful to MedPanel for conducting and sharing it.
MRA encourages review of our industry 1-pager on the Sunshine Act (designed to be handed to corporate compliance departments), our compliance FAQs, a joint FAQ developed with CASRO and PMRG, an overview of related laws at the state level, and a model form for a physician's acknowledgement of participation in marketing research. We continue to keep track of physician incentives issues at the state and federal level (and monitoring our colleagues’ travails abroad, such as with the Loi Bertrand in France) and take action to advocate for and defend survey, opinion and marketing research whenever possible.
This information is not intended and should not be construed as or substituted for legal advice. It is provided for informational purposes only. It is advisable to consult with private counsel on the precise scope and interpretation of any laws/regulation/legislation and their impact on your particular business.