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Judicial Watch • Dhhs Provenge Docs 02242011

Dhhs Provenge Docs 02242011

Dhhs Provenge Docs 02242011

Page 1: Dhhs Provenge Docs 02242011

Category:General

Number of Pages:258

Date Created:February 24, 2011

Date Uploaded to the Library:February 20, 2014

Tags:02242011, Dhhs, provenge, Docs


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JR#2 000001 

From: Fltterman, Leslye (CMS/OCSQ) Sent: Tuesday, September 14, 2010 8:40 To: clockett@dendreon.com 
Cc: 	Jacques, Louis (CMS/OCSQ); Syrek Jensen, Tamara (CMS/OCSQ); Rollins, James (CMS/OCSQ); PASERCHIA, LORI (CMS/OCSQ); Pencek, Eileen (CMS/OCSQ); Ellis, Maria (CMS/()CSQ); Atkinson, Michelle (CMSIOCSQ) 
Subject: 	Request from Dendreon present the 11117 MEDCAC 
Dear Chris: 
Interested parties (including manufacturers) '"!1ay request presentation time submitting email along with their PowerPoint presentation the deadline which will stated the Federal Register Notice posted the end the month. The allotted time for any individual presenter will determined the number requests. Manufacturers not have special status the MEDCAC presentation process. Dendreon wishes submit written comments before the meeting will make them available the MEDCAC panelists. The MEDCAC questions will posted the end September the same day the Federal Register Notice published. Both documents may found the CMS CAG website the date the Federal Register notice published. 
Best regards, Les lye 
Leslye Fitterman, PhD. 
Centers for Medicare and Medicaid Services Office Clinical Standards and Quality Coverage and Analysis Group 
7500 Security Boulevard 
Cl-09-06 
Fax -410.-786-9286 Phone 410-786-1806 
IR#2 000002 

Louis 

From: Fitterman, Leslye (CMS/OCSQ) 
Sent: Monday, September 13, 201 3:29 

To: 	Jacques, Louis (CMS/OCSO); Rollins, James (CMSJOCSQ); PASERCHIA, LORI (CMSJOCSQ); Pencek, Eileen (CMS/OCSQ) 
Cc: Syrek Jensen, Tamara (CMS/OCSQ) 
Subject: RE: Specter Kerry provenge lkf 091310 lbj rev.doc 

Thank you. you have any revisions the Summary Statement requested OA? 
From: Jacques, LoulS (CMS/OCSQ) 
Sent: Monday, September 13, 2010 3:24 
To: Rolllns, James (CMS/OCSQ); Fitterman, Leslye (CMS/OCSQ); PASERCHIA, LORI (CMS/OCSQ); Pencek, Eileen (CMS/OCSQ) 
Cc: Syrek Jensen, Tamara (CMS/OCSQ) 
Subject: Specter Kerry provenge lkf 091310 lbj rev.doc 
IR#2 000003 

Louis 
From: Fitterman. Leslye (CMS/OCSQ) 
Sent: Monday, September 13, 2010 4:11 
To: Ashby, Lori (CMS/OCSQ) 

Cc: 	Jacques. Louis (CMSIOCSQ); Syrek Jensen, Tamara (CMS/OCSQ); Rollins, James (CMS/OCSQ); Pencek, Eileen (CMS/OCSQ) 
Subjec;t: 	Spector Kerry letter PROVENGE 
Attachments: 	Specter Kerry provenge 09131 lbj rev.doc; SUM-ADM Specter Kerry 091310 lbj.doc 
Lori: 
Attached please find the response letter and summary statement finalized Louis. 
Leslye 
IR#2 000004 

(Do noJ type date) 

The Honorable Arlen Specter and the Honorable John Kerry United States Senate 
Washington, 20510 
Dear Senators Specter and Kerry: 
Thank you for your letter the Administrator regarding the recently opened national coverage analysis (NCA), Autologous Cellular Immunotherapy Treatment Metastatic Prostate Cancer (CAG-00422N) ihat includes PROVENGE. 

Shortly after Dendreon was given FDA approval market PROVENGE was being covered case-by-case basis some local Medicare.administrative contractors. became aware differences coverage policy across contractors well questions about whether this cellular irnmunotherapy would most appropriately classified drug for Medicare purposes. had also received several inquiries ort this subject from members Congress their staffs. 
These factors contributed CMS' decision open the NCA, comprehensive review the clinical evidence that leads national coverage dtermination (NCD). This consistent with our published guidance document "Factors CMS Considers Opening National Coverage Determination," and with Section 1862(1) the Social Security Act governing Medicare's national and local coverage determination processes. Both documents support the use NCDs promote greater consistency coverage across 

Committee (MEDCAC) November 17, 2010 consider the currently available evidence this topic. While our analysis progressing, local contractors retain their statutory authority cover or.not cover PROVEN GE. within their jurisdictions. Upon publication the NCD they must all comply with the national policy. 
Based the statutory time frames expect that the proposed decision will published the CMS website March 30, 2011 and that the final decision will published later than days after the close the public comment period the proposed decision. appreciate your interest this issue. 

Sincerely, 
IR#2 000005 

IR#2000006 
From: Fitterman, Leslye (CMS/OCSQ) 
Sent: Monday, September 13, 2010 2:56 

To: Jacques, Louis (CMStOCSO): Syrek Jensen, Tamara (CMS/OCSQ) 
Cc: Rollins, James (CMSJOCSQ) 
Subject: Inquiry from Senators Specter and Keryy 

Attachments: 	cms-senators-spector-keny.gif; SUM-ADMIN Specter Kerry lkf 091310.doc; Specter Kerry provenge lkf 091310 lbj.doc 
Louis; 
Attached please find the letter sent Dr. Berwick, draftresponse and draft sum!Tlarv statement address the inquiry received from Senators Specter and Kerry. Jim has reviewed these and have incorporated his changes. 
Thanks, 
Leslye 
IR#2000007 

SllMMARV STATEMENT-ADMINISTRATOR'S CORRESPONDENCE 
NAME CORRESPONDENTS: 
Senator Arlen Specter and Senator John K.erry 

CONTAC.,.
PERSONS: 
Jam!$ Rollins Leslyc F'ittcrman 

IR#2 000008