The Feds are signaling that pharma firms must do much more self-policing regarding their marketing practices—including those involving meetings—or risk federal prosecution under anti-kickback regulations. Specifically, the government is targeting the provision of financial incentives to healthcare professionals to prescribe or recommend particular drugs, or to switch patients from one medicine to another. The Department of Health and Human Services (HHS) Inspector General Janet Rehnquist announced the release of the draft Compliance Program Guidance on Tuesday, October 1, during her address to the American Health Lawyers Association/Health Care Compliance Association Fraud & Compliance Forum, held in Washington, D.C. While her presentation was wide-ranging, a few passages from the draft guidance document seem especially relevant to medical conference organizers. First, “…pharmaceutical manufacturers may engage physicians to…speak at meetings. While there may be legitimate purposes to these arrangements, they pose a substantial risk of fraud and abuse; without appropriate safeguards, they can result in payments for referrals. Pharmaceutical manufacturers should ensure that they (and their sales agents) compensate health care professionals only for providing actual, reasonable, and necessary services and that the arrangements are not merely token arrangements created to disguise otherwise improper payments.” Second, “Pharmaceutical companies…engage in a number of other arrangements that offer benefits, directly or indirectly, to physicians or others in a position to make or influence referrals. These arrangements potentially implicate the anti-kickback statute. They include…sponsorship or other financing related to third-party educational conferences and meetings attended or taught by physicians or others in a position to generate or influence referrals.” And finally, “…The [Office of the Inspector General] recommends that pharmaceutical manufacturers at a minimum comply with the standards set by the PhRMA Code.” Watch for the December issue offor more detailed analysis.