E9-11939. Agency Information Collection Activities: Submission for OMB Review; 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), Department of Health and Human Services, 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 function; (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 Part D Reporting Requirements and Supporting Regulations under 42 CFR 423.505; Form Number: CMS-10185 (OMB#: 0938-0992); Use: Title I, Part 423, § 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. Please see the supporting documentation, “Revisions to 2nd Draft of CY 2010 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: 380,184; Total Annual Hours: 157,450. (For policy questions regarding this collection contact Alice Lee-Martin at 410-786-4578. For all other issues call 410-786-1103.)

2. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Medicare Prescription Drug Benefit Plan Program: Use: Part D plans use the information discussed to comply with the eligibility and associated Part D participating requirements. CMS will use this information to approve contract applications, monitor compliance with contract requirements, make proper payment to plans, and to ensure that correct information is disclosed to enrollees, both potential and current enrollees. Form Number: CMS-10141 (OMB#: 0938-0964); Frequency: Reporting—quarterly, semi-annually and yearly; Affected Public: Business or other for-profits and Individuals or households; Number of Respondents: 19,937,772; Total Annual Responses: 38,152,764; Total Annual Hours: 34,730,676. (For policy questions regarding this collection contact Eugenia Mattison-Gibson at 410-786-2564. 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 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].

To be assured consideration, comments and recommendations for the proposed information collections must be received by the OMB desk officer at the address below, no later than 5 p.m. on June 22, 2009: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: [phone], E-mail: [e-mail].

Dated: May 15, 2009.

Michelle Shortt,

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