Healthcare/Fraud & Abuse – Predictions for 2010

I offer three predictions. First, it is clear that the emphasis on investigating alleged off-label promotion for pharmaceuticals will continue at the Federal level, bolstered by the increased cooperation between the Department of Justice and the Food and Drug Administration. On the state level, Attorneys General will turn increasingly to the use of the very broad consumer protection legislation that exists in virtually all states as a platform for their own investigations and settlements in this arena.

Second, healthcare reform will bring increased scrutiny by payors, and those that manage their pharmaceutical benefits, on activities by industry that could be viewed as weakening a payors ability to control costs through the effective use of their formulary – such as manufacturer co-pay reduction coupons, vouchers and the use of samples.

And third, the drumbeat for transparency with respect to anything of value provided to health care professionals as well as health care institutions (whether meals, consulting fees or research agreements) will go on and will require industry to redouble efforts to assure compliance with best practices in their relationships with players in the health care industry and to create company wide systems to track such expenditures.