ASCO is a comprehensive network of 28,000 oncologists in U.S.
This is not just 28,000 votes. When it comes to cancer, the collective voice of 28,000 oncologists is authoritative.
And, what the head of ASCO (speaking on behalf of the entire 28,000 members) was saying in his comment is that CMS will be breaking the law to not provide coverage for Provenge, citing specific statues.
It went beyond even that, saying that CMS to even contemplate examining whether to provide coverage is making the local contractors have second thoughts about reimbursement now which is having a real impact on real people right now.
What this does is, it provides a legal basis for someone who couldn't get Provenge (because of this confusion) to sue CMS for breaking the law and shortening their life.
Can you imagine the political firestorm that would result from that, especially right now with the heightened sensitivities about Obamacare?
I believe CMS will have to clarify soon whether they are really going to examine whether to refuse coverage for on-label use of Provenge.
If they come out and says so, I think that could result in lawsuits right away.
If they end up denying coverage at the end of this process, that would open up the possibility of class action lawsuits with thousands of terminal prostate cancer victims involved, claiming wrongful deaths resulting from illegal refusal to reimburse.
It would be massive. I just can't see the scenario unfolding that way.
Exactly, ASCO interest OVERLAPS with the DNDN interest. It is an OVERLAP, not an outright endorsement of Provenge, just that CMS should not restrict it as an approved cancer therapy. That is all I was saying. I never said it wouldn't be helpful.
To me the letter reads like a bald warning to CMS. (I’m not a lawyer but I used to run a government contracting office that disbursed about $1.5 B a year.)
The letter specifically references federal law more than once to point out the foolishness of CMS doing a review of Provenge.
It wasn't stated in so many words, but "between the lines" it strongly suggests the basis for legal action, if the situation is not corrected soon.
Whoever is going to take that legal action may be in question, but the basis for it is clearly stated. If I were CMS, I'd take that to heart and do something.
However, we should recognize that bureaucrats spend your tax money to defend their actions, so, short of being embarrassed, there is little incentive for them to do anything that looks like they bowed to public or outside pressure (or common sense).
Bottom line is this letter is a big plus for DNDN. Buy and hold.
I have respect for your opinion having read it many times before. I think that the real motivation of the letter is ASCO concern of CMS second guessing (if you will) FDA approved therapies. They are not PROMOTING Provenge at all. They are NOT saying it works and giving study results to prove that assertion. They do reference the law. But, if this were another newly approved therapy from a different company, they would have done the SAME thing. That is MY point.