US Physician Payments Law Clarified At Last
US research associations MRA, PMRG and CASRO are celebrating success over regulations implementing the Physician Payments Sunshine Act, published late on Friday by the CMS. Following a five and a half year lobbying campaign, MR respondent payments are specifically excluded from reporting requirements.
The Act, which launches a centralized federal registry of payments to physicians from pharmaceutical and medical device manufacturers, was originally part of the Patient Protection and Affordable Care Act, aka 'Obamacare', of which the Senate version was signed into law in March 2010. The MRA won an exclusion for research incentives for doctors - but uncertainties remained over the definition of this exclusion and client compliance departments often refused to sanction projects. The new regulations and guidance are 'even more specific' and should put such concerns to rest.
The exclusion covered any 'payment or transfer of value' if 'made indirectly' to a doctor participating in a marketing research study where the pharmaceutical or medical device manufacturer 'is unaware of the identity' of the doctor receiving the payment. The new document gives MR as a specific example: 'an applicable manufacturer may hire a market research firm to conduct a double-blinded market research study, which includes paying physicians $50 for responding to a set of questions. The applicable manufacturer clearly intends a portion of the payment to be provided to physicians, but given that the reason for the third party's involvement is specifically to maintain the anonymity of the respondents and sponsor, we do not intend this to be considered a reportable indirect payment or other transfer of value.'
In additions to campaigning at the federal level, the MRA has helped secure good results for MR in the last few years in Massachusetts, Minnesota, DC, Maine, Colorado, Alaska, Maryland, New York, New Mexico, Arizona, Mississippi, Massachusetts, Illinois and Minnesota; and says 'marketing research is in a good position almost everywhere in the U.S. now.' West Virginia and Vermont are the two notable exceptions.
MRA's Director of Government Affairs Howard Fienberg told DRNO: 'We're thrilled that, after more than five years of MRA advocacy here in DC and around the country, marketing researchers are safe to conduct studies with doctors and the public can still benefit from this essential form of research.'
Web site: www.marketingresearch.org .