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The important thing areas of potential risk below the Federal Anti-Kickback statute additionally arise from pharmaceutical producer relationships with three teams: purchasers, physicians or different health care professionals, and sales brokers. Actions that pose potential danger embody reductions and different phrases of sale provided to purchasers, product conversion, consulting and advisory funds. The pharmaceutical producers and their staff and brokers should be aware of the constraints the Anti-Kickback statute places on the advertising and promoting of merchandise paid for by federal and state health care applications. To that end, the draft guidance recommends pharmaceutical manufacturers ensure that such actions match squarely within one of the protected harbors underneath the Anti-Kickback statute. The Division of Well being and Human Providers has promulgated secure harbor regulations that shield sure specified arrangements from prosecution below the Anti-Kickback Statute.