Scott Gottlieb, M.D., a practicing physician, has served in various capacities at the Food and Drug Administration, including senior adviser for medical technology; director of medical policy development; and, most recently, deputy commissioner for medical and scientific affairs. Dr. Gottlieb has also served as a senior policy adviser at the Centers for Medicare & Medicaid Services.
Click here to read Scott’s Medical Innovation blog.
To understand how the Centers for Medicare and Medicaid Services (CMS) approaches its responsibilities regarding the coding, coverage, and payment of medical services--and uses these autorities to pursue its policy prerogatives--consider the circumstances surrounding the pharmaceutical company Sepracor and its drug Xopenex.
We need to consider new models for funding the delivery of curative treatments if we are going to encourage the development of such technologies and enable their efficient adoption. Only by changing our economic constructs are we going to realize the full public health benefit of the curative treatments in development.
A year ago, the Food and Drug Administration quietly posted a public notice that it wanted to hire an independent lab to test a generic drug that it had already approved. FDA wanted to make sure the drug was safe and effective.
In 2001, progressives led the fight against restrictive health plan networks and drug formularies that were being introduced by managed care as a way to tamp down on costs. In 2010 they embraced these schemes as a Faustian bargain with insurers.