Market Research’s Exception to DC Physician Payment Reporting Regulation
Friday, January 27, 2012
In August, the District of Columbia’s Board of Pharmacy approved revisions to its regulations to broadly exempt market research from D.C.’s physician payment reporting statute. Today, the approved final regulations were officially published and now have the force of law in D.C. The new regulations clear the way for pharmaceutical market research to return to D.C. and mark the successful conclusion of a long lobbying effort by CASRO.
Market Research Industry’s Exception to DC Physician
Payment Reporting Regulation Becomes Official
D.C.’s AccessRx Act of 2004 (the "Access Rx Act”) required pharmaceutical manufacturers and labelers to annually report all payments made in connection with marketing. While by its terms the AccessRx Act did not apply to payments made to health care practitioners as part of market research, D.C.’s Board of Pharmacy had explicitly extended the disclosure obligations to payments made in connection with market research surveys.
The regulations published today exempt payments made to health care practitioners for participation in market research from the reporting requirements of the AccessRX Act if: (i) the market research is conducted by an independent survey research organization; (ii) the pharmaceutical client does not know the identity of the practitioners who participate in the research; and (iii) the payments are determined and made directly by the survey research organization. The revisions apply to the next filing in July 2012, which means that the reporting obligation ceases effectively immediately.
Following Maine’s repeal of its physician payment reporting statute last summer, the only jurisdiction with a statute that broadly affects the research industry is Vermont, where such payments are now prohibited. So long as the identity of the physician respondent is blinded to the manufacturer, payments made to physicians as compensation for participation in market research are now not reportable under the federal Physician Payment Sunshine Act, D.C.’s AccessRx Act and under Minnesota’s similar statute. Massachusetts, which has considered repealing its own physician payment reporting statute several times, also exempts market research payments when the research is conducted in a double blind fashion.