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Judicial Watch • Dhhs Provenge Docs 02022011

Dhhs Provenge Docs 02022011

Dhhs Provenge Docs 02022011

Page 1: Dhhs Provenge Docs 02022011

Category:General

Number of Pages:15

Date Created:February 2, 2011

Date Uploaded to the Library:February 20, 2014

Tags:02022011, mzsnm, Dhhs, provenge, Docs


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From: Jacques, Louis (CMS/OCSQ) Sent: Monday, June 07, 2010 4:53 To: Stieber, Joan (CMS/CL) 
cc: Syrek Jensen, Tamara 
SUbject: RE: Privacy Release 
explanation matter (Provenge) 

From: Stieber, Joan (CMS/OL} 
Sent: Monday, June 07, 2010 3:58 
To: Jacques, Louis (CMS/CCSQ); Rollins, James (CMS/CCSQ) 
Cc: Syrek Jensen, Tamara (o-15/ 
SUbject: FW: Privacy Release from and explanation matter (Provenge) 
More Jnfo the question about coverage Provenge -please see note below re: speci case California underlying the Inquiry. alleges that the Medicare contractor approved first round the treatment but then removed approval for subsequent round. that's accurate, would the patient have any recourse? 
Your further thoughts this wquld appreciated. 
thanks -Joan 
1---- ,_,, ___, 
Thank you for your assistance and let know should discuss further, 
Mark 
under him. has been fighting prostate cancer since 2001. has been one 
fortunate folks one the first through treatment called Provenge. Provenge brand new treatment that seeks use the human tmmune system defeat prostate cancer. approved the FDA and its clinical trials showed efficacy extending the life prostate cancer patients. 
Mark, here 
facility called dlfflcult and somewhat palnful one which steel needles are arms and you are put chair where you have sit 
Inserted Into the veins both your 
perfectly still and not bend your arms for 
approximately four hours. During that time the blood taken out your body through one these steel needles, run through machine process called leukapheresis and then returned your body. The machine extracts the white blood cells from your body until they get suffictent quantity white blood cells. The blood cells are then packaged very sterile manner and sent off Dendreon Corporation. While Dendreon the white blood cells are cultured and sensitized primary protein that makes the devastating cells that constitute prostafe cancer. The theory and practice this, tested over long period time and approved the FDA, that these cells will then relnfused into your body, with the knowledge how recognize the cancer cells. Once the white blood cells are sensitized properly they can recognJze the cancer cells. And once your Immune system recognizes the cancer cells can work and kill them. 
Provenge had very good success its trials and the FDA has finally approved after many years. are all grateful that one the people able through this treatment. went for his first treatment May and had the blood taken. was sent Dendreon, which located back east. Unfortunately there are many things that can wrong along the way. Not the least there can some small amount contamination that enters into the system. There are number things cause the sample fail. his case the sample did unfortunately fail, and was scheduled for second leukapheresis. Usually the second one tremendously successful. Some men have had 

You can find.a more detailed explanation the process http://www.provenge.com/pdf/PROVENGEFAQs.pdf. 
The New Busy not the too busy. Combine all your e-mail accounts with Hotmail. 
Hotmail has tools for the New Busy. Search, chat and e-mail from your lnbox. Learn 

Louis 
From: Jacques, Louis (CMSJOCSQ) 
Monday, June 07, 2010 8:53 To: Rollins, James (CMS/OCSQ) Subject: Provenge 
Thinking may need open NCD this one. Let's chat later today. met with them quite awhile ago, don't remember who was the team from CAG; 
Louis Jacques, 
Director, Coverage Analysis Group Office Clinical Standards and Quality 

Centers for Medicare Medicaid Services 
Mailstop C1-09-05 
7500 Security Blvd 
Baltimore 21244 
(410) 
786-4612 

(410) 
786-9286 (FAX) 

From: Jacques, Louis (CMS/OCSQ) [mailto:Louis.Jacques@cms.hhs.gov] Sent: Monday, June 28, 2010 2:24 To: ARTHUR WRVEY 
Subject: RE: Availability 
How about tomorrow afternoon? 
.......
------------
From: ARTHUR.LURVEY@palmettogba.mm [mailto:ARTHUR.LURVEY@palmettogba.com] 
Sent: Monday, June 28, 2010 4:59 
To: Jacques, Louis (CMS/OCSQ) 
Subject: Availability 

You sent e-mail why was not the CMD meeting Baltimore. available for short phone call the 
next several days--just tell when. know you are concerned about Provenge and other matters---so avallable for 
your wisdom any this week. Next week travel Honolulu for our CAC sequences. 

Arthur Lurvey, MD, FACP, FACE 
Director, Medlcal Affairs P.almetto GBA 
P.O. Box 1476 
Augusta, Georgia 30903-1476 
Louis 
From:  Jacques, Louis (CMS/OCSQ)  
Sent:  Monday, June 14, 2010 4:40  
To:  Ashby, Lori (CMS/OCSQ}  
Subject:  Re: Provenge  
Long time ago  
Sent from Blackberry  

From: Ashby, Lori (CMS/OCSQ) To: Jacques, Louis (CMS/OCSQ) Cc: Anderson, Kelly (CMS/OCSQ) Sent: Mon Jun 1416:19:22 2010 Subject: Provenge 
Have met with Dendreon regarding Provenge? Kelly Anderson was asked this question reporter. 

From: Brown-Jones, Shanterrl (CMS/OCSQ) 
Sent: Wednesday, May 26, 2010 4:31 
To: Jacques, Louis (CMS/OCSQ)

Subject: RE: Question Medicare coverage Provenge 
Thanks Louis, will let Ellen know. 
 (Sf,flnflllc!tllltlf 
Coffespondence Liaison Specialist 
Office Clinical Standards and Quality Centers for Medicare Medicaid Services 

From: Jacques, Louis (CMS/OCSQ) Sent; Wednesday, May 26, 2010 4:26 
To: Brown-Jones, Shanterri (CMS/OCSQ); Syrek Jensen, Tamara (CMS/OCSQ) Cc: Ashby, Lori (CMS/OCSQ) 
Subjed:: RE: Question Medicare coverage Provenge 
There such provision that would change coverage. The 1861(t)(2)(B) com pendia not mandate coverage 
----"'---------

From: Brown-Jones, Shanterrl (CMS/OCSQ) 
Sent: Wednesday, May 26, 2010 4:25 
To: Syrek Jensen, Tamara (CMS/OCSQ) 

CC: Ashby, Lori (CMS/OCSQ); Jacques, Louis (CMS/OCSQ)Subject: RE: Question Medicare coverage Provenge Tamara, spoke with Ellen and she wanted ask you there was some kind special determination for cancer treatment that has been approved the FDA and would t"at change the coverage requirement? 
Thanks 

OfJJumtoni 6t3nnmc/"'1ttf 
Correspondence Liaison Specialist 
Office Clinical Standards and Quality 
Centers for Medicare Medicaid Services 

From: Syrek Jensen, Tamara (CMS/OCSQ) sent: Wednesday, May 26, 2010 4:02 To: Brown-Jones, Shanterri (CMS/OCSQ} 
Cc: Ashby, Lori (CMS/OCSQ); Jacques, Louis (CMS/OCSQ) Subject: RE: Question Medicare coverage Provenge 
Shanterri -there not open NCD LCD this issue. tamara
Tamara Syrek Jensen Deputy Director 
Coverage and Analysis Group 
Office Clinical Standards and Quality, CMS 
7500 Security Blvd. 
Baltimore, 21244 
(410) 786-3529
-- 
From: Brown-Jones, Shanterrl (CMS/OCSQ) 
sent: Wednesday, May 26, 2010 12:49 
To: Syrek Jensen, Tamara (CMS/OCSQ) 
Cc: Ashby, Lori (CMS/OCSQ) 

Subject: FW: Question Medicare coverage Provenge 
Importance: High Tamara, 

Kelly training this week and backing her up. Can you take look this questlon from the reporter coverage Provenge? 

Thanks 
OfJlt41ttmt. 68tmmc:Jt111tU 
Correspondence Liaison Specialist 
Office Clinical Standards and Quality 

Centers for Medicare Medicaid Services 
Email: 
Fax:410-786-6857 
From: Griffith, Ellen (CMS/OEA) 
sent: Wednesday, May 26, 2010 12:28 
To: Anderson, Kelly (CMS/OCSQ); Brown-Jones, Shanterri (CMS/OCSQ) Subject: FW: Question Mec:Ucare coverage Provenge 
Importance: High 
Don out. Can you help with this? 
Thanks, 
Ellen 
From: Angela Maas [mailto:amaas@alspub.com] Sent: Wednesday, May 26, 2010 12:04 
To: Griffith, Ellen (CMS/OEA) 
R#1 000010 

Subject: Question Medicare coverage Provenge Importance: High 
Ellen, hope this finds you well. I'm working article the recent approval prostate cancer therapy Provenge for SpuialhJ Phannacy News, and one sources health plan says they're waiting see what CMS does terms coverage the treatment. Could you give any information ..1n what CMS will far coverage Provenge? not, can you least tell when CMS may release its coverage information? 
I'm deadline, unfortunately, and wrapping the issue tomorrow. apologize for the lastminute question (this actually just came yesterday), but really appreciate any information you can give this. Thanks advance for your help! 
Best regards, 
Angela 
Angela Maas 
Managing Editor, Specialty Pharmacy News, Drug Benefit News 
Atlantic Information Services 
110017th St. NW, Ste. 3QO 
Washington, 20036 202.775.'9008 ext. 3054/Fax: 202.331.9542 

"'oulJ 
From: 
Sent: To: 
Subject: 
Absent :in5*Pcrc:t1-ons ttte. nnteary,_, lae:al cQotractors have discretion cover noneover tfi vat1e.us cQIJ!pt.irr.'l'tts f:Jf tJ.w::f"Nwstte ctGtalQleus immunotherapy program. 
-----Original Message---
Frot1: Berni.Ge Hecker ['11atlto:bernice.hecker@noridian.com] Sent: Fri 6/4/'2 12:4.1. To: Mf:DICARE-CfGSILlST.NDt.GOV 
Cc: J.acques., Louis (CMS/OCSQ},; Syrek Jensen, Tamara (CMS/OCSQ) Subject:
F/U New Tech call: P.rov.enge requested, had discussion with CAG regarding potential Provenge coverage with evidence development. Bottom-line: how can anyone cover anythin1 when are not yet sure what is? See below.  
The (Center for Medicare, forerly Cftlt1 -the Center for Medicare Management) the CMS authority benefit category determination,, i.e. whether not item service falls within the Medicare insurance benefit, and so, which one(s). The Provenge autologous inmunotherapy program comprises multiple discrete elements includins the collection the patient's blood, the processing the patient's cells and the subsequent infusion the processed cells back. into the patient. the current time, trying determine the preferred benefit category allocation for the elements Provenge. entirely unclear whether the elements would treated single bundled service not, how they should coded and priced yet. This being the case, seems that inform those seeking payment that neither nor CAG has authority pay this time and won't until decides what we are paying. Interested parties might directed CMS. 
Bernice Hecker MD, MHA, FACC Medicare,, Contractor Medical Director 
AK, IO,, OR, MN, Jur. (AZ, MT, ND, SD, UT, WY) 
Confidentiality Notice: This email message and any attachments are for the sole use the intended recipient(s) and may contain confidential and privileged information. Any unauthorized review, use, disclosure, distribution copying prohibited. you are not the intended recip!ent(s), please contact the sender replying this e-mail and destroy/delete all copies this e-mail message. 

From: Jacques, Louis (CMS/OCSQ) Sent: Tuesday, May 04, 201010:19 To: 'Paul.Deutsch@empirebtue.com' 
Cc: Syrek Jensen, Tamara (CMS/OCSQ); SAUVE, Marcel (CMS/OCSQ); Rollins, James 
(CMS/OCSQ) Subject: Re: Coverage for Provenge 
Paul 
They saw awhile ago. Aware their process. believe its coverable. Although vaccine Its not preventionWe'll look into 
Louis 
Sent from Blackberry 

From: DEUTSCH, PAUL  To: Jacques, LDuls (CMS/OCSQ) 
CC: COSTANTINO, GEORGE m>; CUnningham, carolyn  
Sent: Tue May 18:05:51 2010 
SUbject: C.OVerage for Provenge 
Louis, l).ave been discussing the new anti-prostate-cancer therapy, Provenge. 
The product described autologous vaccine, and manufactured harvesting patient antigen presenting cells, then incubating them with prostatic acid phosphatase and GM-CSF and then .returning the product the patient infusion. The purpose stimulate the host immune system into recognizing prostate cancer cells foreign. Th.is appears some form immunotherapy. there Medicare coverage for this? Would this considered under the drug/biologicals benefit(?? vaccine)? Since this requires the incorporation cells retrieved from patients, this biological immunotherapy? 
Thank you for looking this. 

Paul 
Paul Deutsch, 
Medical Director, MACJ-13 National Government Services, Inc Box 7108 
Indianapolis, 46206 7108 tel: 914-801-3567 
fax: 914-801-3600 
Please not i11clttde PHI e-mails this address. 
1R#1 000013 

From; 	Jacques, Louis (CMSIOCSQ) 
Sent: 	Wednesday, May 05, 2010 9:05 
To: 	DEUTSCH, PAUL 
Cc: 	COSTANTINO, GEORGE; Cunningham, Carolyn; Warren, John (CMS/CMM); Bassano, Amy (CMS/CMM); Rollins, James (CMS/OCSQ); Syrek Jensen, Tamara (CMSJOCSQ); SALIVE, Marcel (CMSIOCSQ); Rollins, James (CMS/OCSQ) 
Subject; 	RE: Coverage for Provenge 
P,GandC, 
Have CC's few CMSers this reply. 

Provenge made presentation here months ago and are familiar with their technology. may aqministered vaccine, but not preventive vaccination. believe coverable, but will defer CMM for benefit category discussion. 
Louis 
From: DEUTSCH, PAUL [mailto:Paul.Deut:sch@Empireblue.com] Sent: Tuesday, May 04, 2010 6:06 To: Jacques, LDuls B'. (CMS/OCSQ) Cc: COSTANTINO, GEORGE; cun nlngham, Q!rolyn SUbject: Coverage for Provenge Importance: Hlgn 
Louis, have been discussing the new anti-prostate-cancer therapy, Provenge. 
The product described autologous vaccine, and manufactured harvesting patient a.ntigen presenting cells, then incubating them with prostatic acid phosphatase and GM-CSF and then returning the product the patient infusion. The purpose stimulate the host immune system into recognizing prostate cancer cells foreign. This appears some form immunotherapy. 

[there Medicare coverage for this? Would this considered under the drug/biologicals benefit(?? vccine)? Since this requires the incorporation cells retrieved from patients, this biological itmunotherapy? 
T*1ank you for looking this. 
P Box 7108 
lnianapolis, 46206-7108 
R#1 000014 tel: 914-801-3567 fax: 914-801-3600 Please 11ot i11clude PHI e-1nails this address. 
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