[Federal Register Volume 74, Number 11 (Friday, January 16, 2009)]
[Notices]
[Page 3051]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-685]



[[Page 3051]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-8003, CMS-10185 and CMS-10164]


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: Home and 
Community Based Waiver Requests and Supporting Regulations in 42 CFR 
440.180 and 441.300-310; Use: Under a Secretarial waiver, States may 
offer a wide array of home and community-based services to individuals 
who would otherwise require institutionalization. States requesting a 
waiver must provide certain assurances, documentation and cost and 
utilization estimates which are reviewed, approved and maintained for 
the purpose of identifying/verifying States' compliance with such 
statutory and regulatory requirements. CMS has recently revised this 
data collection tool, as well as the methodology by which the data is 
collected. Form Number: CMS-8003 (OMB  0938-0449); Frequency: 
Annually; Affected Public: State, Local or Tribal Governments; Number 
of Respondents: 49; Total Annual Responses: 71; Total Annual Hours: 
9,059.
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medicare Part D 
Reporting Requirements and Supporting Regulations under 42 CFR 423.505; 
Form Number: CMS-10185 (OMB  0938-0992); Use: Title I, Part 
423, Sec.  423.514 describes CMS' regulatory authority to establish 
requirements for Part D sponsors. It is noted that each Part D plan 
sponsor must have an effective procedure to develop, compile, evaluate, 
and report to CMS, its enrollees, and the general public, at the times 
and in the manner that CMS requires, statistics in the following areas: 
(1) The cost of its operations; (2) The availability of utilization of 
its services; (3) The availability, accessibility; and acceptability of 
its services; (4) Information demonstrating that the Part D plan 
sponsor has a fiscally sound operation; and (5) other matters that CMS 
may require. Subsection 423.505 of the Medicare Prescription Drug 
Modernization and Modernization Act establishes as a contract provision 
that Part D Sponsors must comply with the reporting requirements for 
submitting drug claims and related information to CMS. Data collected 
via Medicare Part D Reporting Requirements will be an integral resource 
for oversight, monitoring, compliance and auditing activities necessary 
to ensure quality provision of the Medicare Prescription Drug Benefit 
to beneficiaries. Refer to the ``Crosswalk of Changes between the 
CY2009 and CY2010 Part D Reporting Requirements'' document to view a 
list of current changes. Frequency: Reporting--yearly, quarterly and 
semi-annually; Affected Public: Business or other for-profit; Number of 
Respondents: 4,526; Total Annual Responses: 343,976; Total Annual 
Hours: 154,610.
    3. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Electronic Data 
Interchange (EDI Enrollment Form and Medicare EDI Registration Form; 
Form No.: CMS-10164 (OMB  0938-983); Use: Federal law requires 
that CMS take precautions to minimize the security risk to Federal 
information systems. Accordingly, CMS is requiring that trading 
partners who wish to conduct the Electronic Data Interchange (EDI) 
transactions provide certain assurances as a condition of receiving 
access to the Medicare system for the purpose of conducting EDI 
exchanges. Health care providers, clearinghouses, and health plans that 
wish to access the Medicare system are required to complete this form. 
The information will be used to assure that those entities that access 
the Medicare system are aware of applicable provisions and penalties; 
Frequency: Recordkeeping and Reporting--Other (one-time only); Affected 
Public: Business or other for-profit, not-for-profit institutions; 
Number of Respondents: 240,000; Total Annual Responses: 240,000; Total 
Annual Hours: 80,000.
    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 [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 March 17, 2009:
    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: January 8, 2009.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations 
and Regulatory Affairs.
 [FR Doc. E9-685 Filed 1-15-09; 8:45 am]
BILLING CODE 4120-01-P