[Federal Register Volume 73, Number 173 (Friday, September 5, 2008)]
[Notices]
[Pages 51820-51821]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-20686]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

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


Agency Information Collection Activities: Proposed Collection; 
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) 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 functions; (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 CFR 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 at http://www.cms.hhs.gov/PaperworkReductionActof1995, or E-
mail your request, including your address, phone number, OMB number, 
and CMS document identifier, to [email protected], or call the 
Reports Clearance Office on (410) 786-1326.
    In commenting on the proposed information collections please 
reference

[[Page 51821]]

the document identifier or OMB control number. To be assured 
consideration, comments and recommendations must be submitted in one of 
the following ways by November 4, 2008:
    1. Electronically. You may submit your comments electronically to 
http://www.regulations.gov. Follow the instructions for ``Comment or 
Submission'' or ``More Search Options'' to find the information 
collection document(s) accepting comments.
    2. By regular mail. You may mail written comments to the following 
address:
CMS, Office of Strategic Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB Control Number ----------,
Room C4-26-05,
7500 Security Boulevard,
Baltimore, Maryland 21244-1850.

    Dated: August 29, 2008.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations 
and Regulatory Affairs.
[FR Doc. E8-20686 Filed 9-4-08; 8:45 am]
BILLING CODE 4120-01-P