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

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19 ALB. L.J. SCI. & TECH. 619 (2009)
Raul A. Tabora, Jr.

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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.