E6-10586. Agency Information Collection Activities: Submission for OMB Review; 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), 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: New Collection.

Title of Information Collection: Organ Procurement Organization/Histocompatibility Laboratory Statement of Reimbursable Cost, Manual Instructions and Supporting Regulations Contained in 42 CFR 413.20 and 413.24.

Use: CMS is requesting reapproval of Form CMS-216-94 (OMB No.0938-0102). The current form implements various provisions of the Social Security Act, including Section 1881(a) which provides Medicare coverage for end-stage renal disease patients who meet certain entitlement requirements and kidney donors. It also implements Sections 1881(b)(2)(B) and 1861(v)(1)(A) of the Act to determine the reasonable costs incurred to furnish treatment for renal patients and transplant patients. The reasonable costs of securing and transporting organs cannot be determined for the fiscal year until the Organ Procurement Organization/Histocompatibility Laboratory files its cost report (Form CMS-216) at year-end and costs are verified by the Medicare fiscal intermediary.

Form Number: CMS-216 (OMB#: 0938-0102).

Frequency: Recordkeeping—Daily, Reporting—Annually.

Affected Public: Business or other for-profit, Not-for-profit institutions, and the Federal Government.

Number of Respondents: 108.

Total Annual Responses: 108.

Total Annual Hours: 4860.

2. Type of Information Collection Request: New Collection.

Title of Information Collection: Medicare Part D Audit Guide, Version 1.0 and Supporting Regulation contained in 42 CFR Section 423.505.

Use: 42 CFR 423.505 provides CMS the regulatory authority to audit, evaluate, or inspect any Part D sponsors' performance related to the law in the areas of medication therapy management, drug utilization management, formulary, and grievances and appeals. The information collected 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.

Form Number: CMS-10191 (OMB#: 0938-New).

Frequency: Recordkeeping and Reporting—Annually.

Affected Public: Business or other for-profit.

Number of Respondents: 564.

Total Annual Responses: 564.

Total Annual Hours: 54,144.

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].

Written comments and recommendations for the proposed information collections must be mailed or faxed within 30 days of this notice directly to the OMB desk officer: OMB Human Resources and Housing Branch, Attention: Carolyn Lovett, New Executive Office Building, Room 10235, Washington, DC 20503, Fax Number: [phone].

Dated: June 28, 2006.

Michelle Shortt,

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