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  • Litigation Aspects of Off-Label Use: Quality of Care, Generally Accepted Medical Practices & Emergence of Cost Containment

    With my prior experience at the New York State Department of Social Services–we regulated the Medicaid program that is now undertaken by the State Department of Health–I think I may be the only advocate of more regulation in this area, or more restraints of some sort, as we’ll get into shortly. Let’s start off with a graph. This graph shows essentially the growth in prescription drug reimbursement by all sectors, by the insurance companies, the Medicaid program, and Medicare over the course of the last several decades. I think it provides an indication of why there has been so much concern with regard to prescription drugs in general, and specifically with regard to off-label uses of these drugs.