[Federal Register: November 14, 2008 (Volume 73, Number 221)]
[Notices]               
[Page 67520]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14no08-92]                         


[[Page 67520]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10151 and CMS-10152]

 
Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

AGENCY: Centers for Medicare & Medicaid Services.
    In compliance with the requirement of section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid 
Services (CMS), Department of Health and Human Services, is publishing 
the following summary of proposed collections for public comment. 
Interested persons are invited to send comments regarding this burden 
estimate or any other aspect of this collection of information, 
including any of the following subjects: (1) The necessity and utility 
of the proposed information collection for the proper performance of 
the Agency's function; (2) the accuracy of the estimated burden; (3) 
ways to enhance the quality, utility, and clarity of the information to 
be collected; and (4) the use of automated collection techniques or 
other forms of information technology to minimize the information 
collection burden.
    1. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Data Collection 
for Medicare Beneficiaries Receiving Implantable Cardioverter-
defibrillator for Primary Prevention of Sudden Cardiac Death; Use: The 
Centers for Medicare and Medicaid Services (CMS) provides coverage for 
implantable cardioverter-defibrillators (ICDs) for secondary prevention 
of sudden cardiac death based on extensive evidence showing that use of 
ICDs among patients with a certain set of physiologic conditions are 
effective. Accordingly, CMS considers coverage for ICDs reasonable and 
necessary under Section 1862 (a)(1)(A) of the Social Security Act. 
However, evidence for use of ICDs for primary prevention of sudden 
cardiac death is less compelling for certain patients.
    To encourage responsible and appropriate use of ICDs, CMS issued a 
Decision Memo for Implantable Defibrillators on January 27, 2005, 
indicating that ICDs will be covered for primary prevention of sudden 
cardiac death if the beneficiary is enrolled in either an FDA-approved 
category B IDE clinical trial (42 DFR Sec.  405.201), a trial under the 
CMS Clinical Trial Policy (NCD Manual Sec.  310.1) or a qualifying 
prospective data collection system (either a practical clinical trial 
or prospective systematic data collection, which is sometimes referred 
to as a registry). Form Number: CMS-10151 (OMB 0938-0967); 
Frequency: Reporting--Quarterly; Affected Public: Business or other 
for-profit and not-for-profit institutions; Number of Respondents: 
1,217; Total Annual Responses: 50,000; Total Annual Hours: 12,500.
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Data collection 
for Medicare Beneficiaries Receiving FDG Positron Emission Tomography 
(PET) for Brain, Cervical, Ovarian, Pancreatic, Small Cell Lung, and 
All Other Cancers; Use: In the Decision Memo CAG-00181N issued 
on January 27, 2005, CMS determined that the evidence is sufficient to 
conclude that for Medicare beneficiaries receiving FDG positron 
emission tomography (PET) for brain, cervical, ovarian, pancreatic, 
small cell lung, and testicular cancers is reasonable and necessary 
only when the provider is participating in and patients are enrolled in 
a systematic data collection project. CMS will consider prospective 
data collection systems to be qualified if they provide assurance that 
specific hypotheses are addressed and they collect appropriate data 
elements. The data collection should include baseline patient 
characteristics; indications for the PET scan; PET scan type and 
characteristics; FDG PET results; results of all other imaging studies; 
facility and provider characteristics; cancer type, grade, and stage; 
long-term patient outcomes; disease management changes; and anti-cancer 
treatment received. Form Number: CMS-10152 (OMB 0938-0968); 
Frequency: Reporting--On occasion; Affected Public: Business or other 
for-profit and not-for-profit institutions; Number of Respondents: 
2,000; Total Annual Responses: 50,000; Total Annual Hours: 4,167.
    To obtain copies of the supporting statement and any related forms 
for the proposed paperwork collections referenced above, access CMS Web 
Site address at http://www.cms.hhs.gov/PaperworkReductionActof1995, or 
E-mail your request, including your address, phone number, OMB number, 
and CMS document identifier, to Paperwork@cms.hhs.gov, or call the 
Reports Clearance Office on (410) 786-1326.
    To be assured consideration, comments and recommendations for the 
proposed information collections must be received by the OMB desk 
officer at the address below, no later than 5 p.m. on December 15, 
2008: OMB, Office of Information and Regulatory Affairs, Attention: CMS 
Desk Officer, New Executive Office Building, Room 10235, Washington, DC 
20503, Fax Number: (202) 395-6974.

    Dated: November 6, 2008.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations 
and Regulatory Affairs.
 [FR Doc. E8-27061 Filed 11-13-08; 8:45 am]

BILLING CODE 4120-01-P