[Federal Register Volume 72, Number 110 (Friday, June 8, 2007)]
[Notices]
[Pages 31839-31840]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-10984]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10185, CMS-10142, CMS-10106 and CMS-116]


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

[[Page 31840]]

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, Sec.  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 [email protected], or call 
the Reports Clearance Office on (410) 786-1326.
    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.
 [FR Doc. E7-10984 Filed 6-7-07; 8:45 am]
BILLING CODE 4120-01-P