[Federal Register Volume 70, Number 97 (Friday, May 20, 2005)]
[Notices]
[Pages 29313-29314]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-9642]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10151, CMS-10152, and CMS-R-220]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services, HHS.
    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: New Collection; Title of 
Information Collection: Data Collection for Medicare Beneficiaries 
Receiving Implantable Cardioverter-defibrillators for Primary 
Prevention of Sudden Cardiac Death; Form Nos.: CMS-10151 (OMB  
0938-NEW); Use: 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 
Investigational Device Exemption (IDE) clinical trial (see 42 CFR Sec.  
405.201), a trial under the CMS Clinical Trial Policy (see 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); Frequency: Other--as 
needed; Affected Public: Business or other for-profit, Individuals or 
Households, and Not-for-profit institutions; Number of Respondents: 
1217; Total Annual Responses: 50,000; Total Annual Hours: 4167.
    2. Type of Information Collection Request: New Collection; Title of 
Information Collection: Data Collection for Medicare Beneficiaries 
Receiving FDG Positron Emissions Tomography (PET) for Brain, Cervical, 
Ovarian, Pancreatic, Small Cell Lung and Testicular Cancers; Form Nos.: 
CMS-10152 (OMB  0938-NEW); 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; Frequency: Other--as 
needed; Affected Public: Business or other for-profit, Individuals or 
Households, and Not-for-profit institutions; Number of Respondents: 
2,000; Total Annual Responses: 50,000; Total Annual Hours: 4167.
    3. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: HIPAA Standard 
Unique Employer Identifier and Supporting Regulations in 45 CFR Parts 
160 and 162; Form Nos.: CMS-R-220 (OMB  0938-0874); Use: 
Section 1173b of Subtitle F of Title II of the Health Insurance 
Portability and Accountability Act of 1996 (P.L. 104-191) requires the 
Secretary of the Department of Health and Human Services to adopt 
standards for unique health identifiers for individuals, employers, 
health plans, and health care

[[Page 29314]]

providers. The use of this standard improves the Medicare and Medicaid 
programs, other Federal health programs and private health programs, by 
simplifying the administration of the system and enabling the efficient 
electronic transmission of certain health information; Frequency: 
Other--one-time; Affected Public: Business or other for-profit, Not-
for-profit institutions, Federal Government, and State, Local or Tribal 
Government; Number of Respondents: 2,550,000; Total Annual Responses: 
2,550,000; Total Annual Hours: 1.
    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/regulations/pra/, 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.
    Written comments and recommendations for the proposed information 
collections must be mailed within 60 days of this notice to the address 
below: CMS, Office of Strategic Operations and Regulatory Affairs, 
Division of Regulations Development, Attention: William N. Parham, III, 
PRA Analyst, Room C5-13-27, 7500 Security Boulevard, Baltimore, 
Maryland 21244-1850.

    Dated: May 2, 2005.
Michelle Shortt,
Acting Director, Regulations Development Group, Office of Strategic 
Operations and Regulatory Affairs.
[FR Doc. 05-9642 Filed 5-19-05; 8:45 am]
BILLING CODE 4120-01-P