[Federal Register: May 20, 2005 (Volume 70, Number 97)]
[Notices]
[Page 29313-29314]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20my05-98]
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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 Paperwork@cms.hhs.gov, 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