Other than market research and "feeling out" insurance companies, do you know of any medicare regulations that control what a new drug price can be?
For Medicare Part D, there are no pricing restrictions. The 2003 law that created Part D explicitly forbids such restrictions, and the healthcare reform law that just went into effect does not alter this.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”