E8-20686. 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 § 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 [e-mail], or call the Reports Clearance Office on [phone].

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 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.