[Federal Register Volume 78, Number 77 (Monday, April 22, 2013)]
[Notices]
[Pages 23768-23769]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-09413]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers CMS-10151]
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: Reinstatement with
change of a previously approved collection; Title of Information
Collection: Data Collection
[[Page 23769]]
for Medicare Beneficiaries Receiving Implantable Cardioverter-
Defibrillators for Primary Prevention of Sudden Cardiac Death; 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 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: Occasionally; Affected Public: Private Sector; Business or
other for-profits, Not-for-profit institutions; Number of Respondents:
1,702; Total Annual Responses: 82; Total Annual Hours: 139,356. (For
policy questions regarding this collection contact JoAnna Baldwin at
410-786-7205. For all other issues call 410-786-1326.)
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 Email 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 the document identifier or OMB control number. To be assured
consideration, comments and recommendations must be submitted in one of
the following ways by June 21, 2013:
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: April 17, 2013.
Martique Jones,
Deputy Director, Regulations Development Group, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2013-09413 Filed 4-19-13; 8:45 am]
BILLING CODE 4120-01-P