E7-10984. 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: 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: 42 CFR 423.514, requires each Part D Sponsor to have an effective procedure to provide statistics indicating: The cost of its operations, the patterns of utilization of its services, the availability, accessibility, and acceptability of its services, information demonstrating it has a fiscally sound operation and other matters as required by CMS. In addition, subsection 423.505 of the Medicare Prescription Drug, Improvement, 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 “Revisions to CY 2008 Part D Reporting Requirement” document to view the changes from CY 2007 to CY 2008. Frequency: Reporting—Monthly, Annually, Quarterly and Semi-annually; Affected Public: Business or other for-profit; Number of Respondents: 4,857; Total Annual Responses: 330,276; Total Annual Hours: 291,989.

2. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Bid Pricing Tool (BPT) for Medicare Advantage (MA) Plans and Prescription Drug Plans (PDPs); Use: Under the Medicare Prescription Drug, Improvement, and Modernization (MMA), Medicare Advantage organizations (MAO) and Prescription Drug Plans (PDP) are required to submit an actuarial pricing “bid” for each plan offered to Medicare beneficiaries. CMS requires that MAOs and PDPs complete the BPT as part of the annual bidding process. During this process, organizations prepare their proposed actuarial bid pricing for the upcoming contract year and submit them to CMS for review and approval. The purpose of the BPT is to collect the actuarial pricing information for each plan. The BPT calculates the plan's bid, enrollee premiums, and payment rates. Form Number: CMS-10142 (OMB#: 0938-0944); Frequency: Yearly; Affected Public: Business or other for-profit and Not-for-profit institutions; Number of Respondents: 550 Total Annual Responses: 6,050; Total Annual Hours: 42,350.

3. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Medicare Authorization to Disclose Personal Health Information; Form Number: CMS-10106 (OMB#: 0938-931); Use: Unless permitted or required by law, § 164.508 of the Standards for Privacy of Individually Identifiable Health Information final rule (67 FR 53182) prohibits Medicare, a Health Insurance Portability and Accountability (HIPAA) covered entity, from disclosing an individual's protected health information without a valid authorization. In order to be valid, an authorization must include specified core elements and statements. Medicare will make available to Medicare beneficiaries a standard, valid authorization to enable beneficiaries to request the disclosure of their protected health information. This standard authorization will simplify the process of requesting information disclosure for beneficiaries and minimize the response time for Medicare. The completed authorization will allow Medicare to disclose an individual's personal health information to a third party at the individual's request. Frequency: Reporting—On occasion; Affected Public: Individuals or households; Number of Respondents: 1,000,000; Total Annual Responses: 1,000,000; Total Annual Hours: 250,000.

4. Type of Information Collection Request: Revision of a currently approved collection. In this revision, a number of changes were made to the form and accompanying instructions to facilitate the completion and data entry of the form. Specifically, the enumeration of individuals involved in laboratory testing was eliminated, and the reporting of hours of laboratory operations was streamlined. Some fields were expanded to reflect changes in laboratory demographics (added prison and assisted living facility to location of laboratory testing) and to collect complete information on the number of tests performed in laboratories. There are no program changes; Title of Information Collection: Clinical Laboratory Improvement Amendments Application Form and Supporting Regulations at 42 CFR 493.1-2001; Form Number: CMS-116 (OMB#: 0938-0581); Use: The application must be completed by entities performing laboratory's testing specimens for diagnostic or treatment purposes. This information is vital to the certification process. Frequency: Reporting—Biennially; Affected Public: Business or other for-profit and Not-for-profit institutions; Number of Respondents: 187,000; Total Annual Responses: 17,960; Total Annual Hours: 22,450.

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 at the address below, no later than 5 p.m. on August 7, 2007.

CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development—C, Attention: Bonnie L Harkless, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.

Dated: May 31, 2007.

Michelle Shortt,

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