05-9642. 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 § 405.201), a trial under the CMS Clinical Trial Policy (see 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); 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 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 [e-mail], or call the Reports Clearance Office on [phone].

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.