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Judicial Watch • 1031 Fourth Response

1031 Fourth Response

1031 Fourth Response

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Number of Pages:385

Date Created:April 12, 2011

Date Uploaded to the Library:October 16, 2014

Tags:1031, Fourth, response, HHS


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iRollins, James (CMS/OCSQ) 
IFrom:  Fitterman, Leslye (CMS/OCSQ)  
Sent:  Monday, August 09,20102:01  
To:  Rollins, James (CMS/OCSQ)  

Subject: RE: Provenge MEDCAC questions 080910 team Ibj If-doc Sure! 
From: Rollins, James (CMS/OCSQ) 
Sent: Monday, August 09, 2010 1:49 
To: Fitterman, Leslye (CMS/OCSQ); PASERCHIA, LORI (CMSjOCSQ); Pencek,Eileen (CMS/OCSQ) Subject: RE: Provenge MEDCAC questions 080910 team Ibj If. doc agreement with question but you might use example. There may other normograms available prognostic indicators for men the same group. should allow the MEDCA committee suggest other normogram they may familiar with (if there are other options use). Jarollins 
From: Fitterman, Leslye (CMS/OCSQ) 
Sent: Monday, August 09, 2010 1:30 
To: PASERCHIA, LORI (CMS/OCSQ)i Rollins, James (CMS/OCSQ)i Pencek, Eileen (CMS/OCSQ) 
Subject: Provenge MEDCAC questions 080910 team Ibj If.doc 

Please see changes made question and will verify with the FDA review dc)cuments. 

!.Rollins, James (CMS/OCSQ) 
Fitterman, Leslye (CMS/OCSQ)
From: 
Tuesday, August 10,20108:19 

Sent: 
Rollins, James (CMS/OCSQ); PASERCHIA, LORI A.' (CMS/OCSQ); Pencek, Eileen 
To: 
(CMS/OCSQ) 
FW: NCA Question 

Subject: 
FYI 
-----Original Message----From: Jacques, louis (CMS/OCSQ) 
Sent: Monday, August e9, 2e1e6:52 
To: Stieber, Joan (CMS/Ol); PASERCHIA, LORI (CMS/OCSQ); Fitterman, leslye (CMS/OCSQ) 

ICC: Saklas, Ariadne (CMS/Ol); Pettijohn, Juneous (CMS/Ol);: Syrek Jensen, Tamara (CMS/OCSQ); Ashby, Lori (CMS/OCSQ) Subject: RE: NCA Question 
Joan, 

Here's the boring story. were aware Provenge since Dendreon came see quite 
awhile ago. had plans NCD it. Shortly after its FDA approval, started 
get low level inquiry from the press whether Medicare would cover Provenge. Then saw 
some CMD questions whether Provenge was vaccine (it J"as touted vaccine for 
prostate cancer even though it's not vaccine the usual ~ense) and therefore not 
coverable Medicare. Then started see more questions!about whether was really 
drug and what benefit category might have. started looking into more, including 
chatting with about the benefit. Still did not want NCO. 

Then got Congressional from Sen Webb asking about spe~ific bennie. The MAC had 
stopped coverage because became unsure was coverable. following that inquiry became apparent that the MACs were going inconsistent about coverage (not unexpected 
given the small evidence base and that Provenge failed initial trials). this looked like would turn into chronic Hill issue like Avastin. figured that did not 
NCD we'd eventually asked one anyway, might w~ll just deal with now. 
Otherwise would only hiding behind theMACs and makingi them take the heat. MMA 731 
implies that NCDs should done when there Significant ~nconsistency local contractor 
coverage. 

So, suppose the most direct cause this NCO was the Hill. aside FDA just warned Dendreon about misleading advertising about Provenge. I'll the 
story. 

--~-~Original Message----
From: Stieber, Joan (CMS/Ol) 
Sent: Mon 8/9/2e1e 4:58 
To: Jacques, louis.B. (CMS/OCSQ); PASERCHIA, LORI (CMS/OCSQ); Fitterman, leslye (CMS/OCSQ) 
Cc: Saklas, Ariadne (CMS/Ol); Pettijohn, Juneous (CMS/Ol) 
Subject: RE: NCA Question 

Thanks louis. Are you saying you have FOIA request seeking explanation why you 
opened the NCA? 
And so, does that preclude our sharing any information with this Congressional inquirer (Rep. Inslee, D-WA)? would those separate m~tters? 
Also, the fact that have received FOIA request disclo~able? 
thanks --Joan 

From: Jacques, Louis (CMS/OCSQ) 
Sent: Monday, August 09, 2010 4:50 
To: Stieber, Joan (CMS/OL)j 'Leslye.Fitterman@cms.hhs.gov'j PASERCHIA, LORI (CMS/OCSQ) 
Cc: Saklas, Ariadne (CMS/OL)j Pettijohn, Juneous (CMS/OL) 
Subject: Re: NCA Question have foia 
Sent from Blackberry 
From: Stieber, Joan (CMS/OL) 

To: Jacques, Louis (CMS/OCSQ)j 'FITTERMAN, LESLYE (CMSjOCSQ)'j PASERCHIA, LORI 
(CMS/OCSQ) 
Cc: Saklas, Ariadne (CMS/OL)j Pettijohn, Juneous (CMS/OL): 
Sent: Mon Aug 16:44:31 2010 
Subject: FW:" NCA Question 

Louis, Leslye, Lori -OL received inquiry seeking more information "what spurred CMS 
open NCA [on Provenge]". there anything more you'd willing share about this, apart from what's already said the coverage website? -e.g~, the Tracking Sheet says: "eMS received informal inquiries 
for national coverage determination (NCO) for autologous cellular immunotherapy treatment prostate cancer. This interest arose upon the recent FDA "approval the Sipuleucel 
treatment regimen, marketed Provenge." 

thanks -Joan 

From: Saklas, Ariadne (CMS/OL) 
Sent: Monday, August 09, 2010 11:47 
To: Stieber, Joan (CMS/OL) 
Cc: Pettijohn, Juneous (CMS/OL) 
Subject: FW: NCA Question 

Dear Joan: think might have heard you mention something about this stand-up. Are you able speak and the staffer from Rep. Inslee's office about PROVENGE? Thanksl 
Sincerely, 
Ariadne Saklas Health Insurance Specialist Centers for Medicare and Medicaid Services 200 Independence Ave. Washington, D.C. 20201 
(202) 
690-8606 

(202) 
690-8168 Fax