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Judicial Watch • 1031 Fifth response letter

1031 Fifth response letter

1031 Fifth response letter

Page 1: 1031 Fifth response letter

Category:FOIA Response

Number of Pages:4

Date Created:May 2, 2011

Date Uploaded to the Library:October 16, 2014

Tags:1031, response, letter, HHS

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CA#S/ nters for Medicare Medicaid Services
7500 Security Boulevard, Mail Stop N2-20-16
Baltimore, Maryland 21244-1850
Office Strategic Operations and Regulatory Affairs/ Freedom Information Group fer to: Control Number 111520107025and PIN: DA9U
Via FedEx Overnight Mail
May 2011
Ms. Tegan Millspaw
Judicial Watch, Inc.
425 Third Street,S.W.
Washington, D.C. 20024
Dear Ms. Millspaw:
This letter our fifth and final response your November
Information Act (FOIA) U.S.C. 552),which yousent the Centers for Medicare
Medicaid Services (CMS). 2010request under the Freedom
Your request sought the following records: all records concerning
CMS national coverage analysis ofthe vaccine Provenge, including but not limited the
criteria being used analyze Provenge.
You further indicated withinyourrequest that you
would willing accept documents electronic format, andifnecessary, the rolling
production responsive records.
your request February date, our office has provided four interim responses 2011,February 23, 2011,March 23, 2011,and April 13, 2011
respectively, and released total of1,044pages records. Additionally, you may aware,
CMS published its March
30, 2011draftdecision memo recommending Medicare coverage
30, 2011 through April 29, 2011established public
Provenge our web site, and from March
comment period for that draftdecision. regret any delays that may have occurred responding your FOIA request. During this
final review ofthe responsive records for your request, was necessary for our office consult
with both the Agencyfor Healthcare Research and Quality (AHRQ) and withthe Office ofthe
General Counsel (OGC) regarding the disclosure ofrecords
had been either
provided created bythoseentities, provided those entities for the purpose
predecisional review.
Additionally, our search located records provided theDendreon
Corporation (Dendreon), which had been annotated being proprietaryand confidential
business nature.
Therefore, was necessary for our office contact Dendreon under the
predisclosure notification procedures Executive Order
12,600,to provide Dendreon
with the opportunity submit any concerns the company had regarding the disclosure oftheir
records underthe FOIA.
Ms. Tegan Millspaw, Judicial Watch 111520107025
For this fifth and final response, our office completed review additional 2009
reviewed, have ascertained that twenty (20) pages are outside the scope your request that the records did not reference the Provenge national coverage analysis, but
referenced the processing ofFOIA requests, and treatment and coverage for another
unrelated medical condition. Ninety (90) pages records were duplicate documents. remaining 1899 pages records include the remaining CMS records, the above referenced
AHRQ records, the Dendreon records, and all OGC records located, including the eight (8) pages
previously mentioned our April 13, 2011 letter. those 1899 pages, are releasing 1,529 pages full. are further releasing additional
265 pages with redactions under Exemptions U.S.C.
552(b)(5) (Exemption (b)(5)), and lJ.S.C. 552(b)(6) (Exemption (b)(6)). Finally, are withholding 105 pages full under
Exemption (b)(5). further itemization our disclosure determinations below:
Two hundred, nine (209) pages have been redacted under the deliberative process
privilege Exemption (b)(5);
Fifteen (15) pages have been redacted under both the deliberative process privilege
Exemption (b)(5) and the attorney-client privilege that Exemption;
Thirty-nine (39) pages have been redacted under Exemption (b)(6), protect the
personal privacy individuals;
Two (2) pages have been redacted under both Exemptions (b)(6) and (b)(5);
Sixty-five (65) pages have been fully withheld under the deliberative process
privilege Exemption (b)(5);
Forty (40) pages have been fully withhold under both the deliberative process privilege Exemption (b)(5) and the attorney-client privilege that Exemption.
Exemption {b){5): This Exemption protects inter-agency intra-agency memorandums
letters which would not available law party other than agency litigation with the
agency. Amongst the several bases upon which records may withheld under Exemption
(b)(5), the deliberative process privilege applies the materials withheld and redacted this
case. meet the fundamental requirements invoke the deliberative process privilege, the
9-ocuments must predecisional, i.e., antecedent the adoption agency policy and
inust deliberative, i.e., direct part the deliberative process that makes
recommendations expresses opinions legal policy matters.
The deliberative process privilege protects advice, recommendations, and opinions which are
pai;t the deliberative, consultative, decision-making process the agency. The general
purpose the deliberative process privilege Exemption (b)(5) prevent injury the
quality agency decisions, enc01,rrage open, frank discussions matters policy
een subordinates and superiors (thus preserving free and candid internal dialogue leading
agency decision making), and protect against public confusion that might result from closure reasons and rationales that were not fact ultimately the grounds for agencys
acfion. The records withheld under this Exemption contained unfinalized draft decision
memoranda and draft correspondence, intra-agency discussions and commentary concerning the
proposed content those draft memoranda and letters, and other matters upon which CMS
sought input from agency staff and deliberated prior final action.
Additionally, Exemption (b)(5) also encompasses the attorney-client privilege. This privilege
applies toconfidential communications between attorney and his client relating legal