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###### Department of Health and Human Services

###### Centers for Medicare & Medicaid Services

          - [Document Identifier: CMS-10191]

# 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:*                         Revision of a currently approved collection;                         *Title of Information Collection:*                         Medicare Parts C and D Universal Audit Guide;                         *Use:*                         Under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and implementing regulations at 42 CFR Parts 422 and 423 Medicare Part D plan sponsors and Medicare Advantage organizations are required to comply with all Medicare Parts C and D program requirements. 42 CFR 422.502 describes CMS' regulatory authority to evaluate, through inspection or other means, Medicare Advantage Part C organizations. These records include books, contracts, medical records, patient care documentation and other records that pertain to any aspect of services performed, reconciliation of benefit liabilities, and determination of amounts payable. 42 CFR 423.503 states that CMS must oversee a Part D plan sponsor's continued compliance with the requirements for a Part D plan sponsor. § 423.514 states that the Part D plan sponsor must have an effective procedure to develop, compile, evaluate, and report to CMS, to its enrollees, and to the general public, at the times and in the manner that CMS requires, statistics regarding areas such as cost of operations, patterns of utilization availability, accessibility, and acceptability of services.                    

The explosive growth of these sponsoring organizations has forced CMS to update its current auditing strategy to ensure we continue to obtain meaningful audit results. As a result, CMS' audit strategy will reflect a move away from routine audits to more targeted, data-driven and risk-based audits. CMS will also focus on high-risk areas that have the greatest potential for beneficiary harm. The goal of the audits will be the earliest possible detection and correction of issues and improvement in quality and performance of Part D sponsors and Medicare Advantage organizations.

                        To accomplish these goals, we have combined all Part C and Part D audit elements into one universal guide which will also promote consistency, effectiveness and reduce financial and time burdens for both CMS and Medicare-contracting entities. Please refer to the crosswalk document for a list of changes.                         *Form Number:*                         CMS-10191 (OMB#: 0938-1000);                         *Frequency:*                         Reporting—Yearly;                         *Affected Public:*                         Business or other for-profits and Not-for-profit institutions;                         *Number of Respondents:*                         195;                         *Total Annual Responses:*                         195;                         *Total Annual Hours:*                         24,180. (For policy questions regarding this collection contact Laura Dash at 410-786-8623. 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 at                         *http://www.cms.hhs.gov/​PaperworkReductionActof1995*, 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.                    

                        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                         *September 29, 2009:*

                        1.                         *Electronically.*                         You may submit your comments electronically to                         *http://www.regulations.gov*. Follow the                               ( print page 38209)                            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 (CMS-10078), Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.                    

Dated: July 23, 2009.

Michelle Shortt,

Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs.

[FR Doc. E9-18378 Filed 7-30-09; 8:45 am]

BILLING CODE 4120-01-P