The Office of Management and Budget (OMB) received final regulations yesterday from the Centers for Medicare and Medicaid Services (CMS) to implement the Physician Payments Sunshine Act.
The Physician Payments Sunshine Act, officially titled as the "Transparency Reports and Reporting of Physician Ownership or Investment Interests", Section 6002 of the Patient Protection and Affordable Care Act (a.k.a., “Obamacare”), requires disclosure of all manner of payments between pharmaceutical and medical device manufacturers and health care professionals. Thanks to the Marketing Research Association’s (MRA) dogged campaign in 2008-2010, with some assistance from PMRG, respondent incentives were excluded from disclosure in the Sunshine Act.
Unfortunately, at the federal level, some researchers still appear to be bumping up against overly-conservative compliance departments within their industry clients – compliance departments that somehow still don’t comprehend that marketing research incentives are excluded from the transparency scheme.
As yet, the text of the final regulations are not public.
MRA will likely seek an advisory opinion from CMS to clarify the exclusion for respondent incentives, once the rules are approved by OMB and published in the federal register. This will help clarify the research exclusion beyond a shadow of a doubt for the aforementioned skeptical client company compliance departments.