Harry...,
if somewhere in their policy statements they indicate that they have the ability to decide the effectiveness and value of a drug to their policy holders and whether they will cover it.
Again, another good point, and please note the following opinion from a different atty: "The general statute under Federal law that covers this is the ERISA statute. Under ERISA plans have the ability to craft their coverage in a manner to exclude certain drugs or type of drugs. A typical provision is that the plan will not cover "experimental" or "investigational" drugs. It would depend in the end on how the provision is defined in the plan documents. However, it seems utterly arbitary and capricious (which is the standard of review the court will use, it will have to find that plans interpretation is arbitrary and capricious before it will over turn the plan's discretaionayr powre to exclude) for a plan to deny coverage for a drug that (1) shows great efficacy, (2) for a condition with nothing else even close in treatment efficacy, and (3) which has been approved by the FDA, not just once, but twice.
I believe this can be lititaged and that the patient doing the litigation will win this case, and obtain an injunction forbidding the plan not to cover Tysabri.
In the end, again, it is contractual, and there is nothing absolutely forbidding the terms experimental and investigational to be defined more broadly, and to give the plan more discretion to exclude even FDA drugs, but I doubt this is the case, and therefore, coverage will be provided even if it takes litigation by a patient.
Further, it is my memory, as I have not worked with ERISA for about a decade, that if the patient sues, gets the injunction to stop the plan from denying coverage for Tysabri, that the plan will owe the patient his or her attorney's fees as well. Therefore, given the Plan an incentive not to arbitrarily and capriciously withhold coverage, say for a drug that is absolutely FDA approved and effective, in fact more effective than anything out there, because not only will the Plan lose, they will also have to pay attorney's fees for their attorneys and for the patient's attorneys as well. Still, they will be stubborn as they may find advantage in delaying coverage and happily eat the attorney's fees."
I detest litigation, but sometimes its good to have the law on the patient's side for a change! Yaaaaaaaaaaay!
Lauren