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[Federal Register Volume 75, Number 195 (Friday, October 8, 2010)]
[Notices]
[Pages 62401-62403]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-25053]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-18F5, CMS-R-262, CMS-10142 and CMS-R-26]

Agency Information Collection Activities: Proposed Collection; 
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) is publishing the

[[Page 62402]]

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: Extension of a currently 
approved collection; Title of Information Collection: Application for 
Hospital Insurance; Use: Individuals who are not entitled to or 
eligible for railroad retirement board (RRB) or Social Security 
Administration benefits must file an application for Part A. This group 
includes individuals who defer filing an application for monthly 
benefits, individuals who are transitionally insured, government 
employees who pay only the Hospital Insurance portion of the Federal 
Insurance Contributions Act tax and individuals eligible for Premium 
Part A for the Working Disabled. The Application for Hospital Insurance 
CMS-18F5 was designed to capture all the information needed to make a 
determination of an individual's entitlement to Part A and 
Supplementary Medical Insurance (Part B). Form Number: CMS-18F5 
(OMB: 0938-0251); Frequency: Once; Affected Public: 
Individuals or households; Number of Respondents: 50,000; Total Annual 
Responses: 50,000; Total Annual Hours: 12,495. (For policy questions 
regarding this collection contact Naomi Rappaport at 410-786-2175. For 
all other issues call 410-786-1326.)
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: CY 2012 Plan 
Benefit Package (PBP) Software and Formulary Submission; Use: Under the 
Medicare Modernization Act (MMA), Medicare Advantage (MA) and 
Prescription Drug Plan (PDP) organizations are required to submit plan 
benefit packages for all Medicare beneficiaries residing in their 
service area. The plan benefit package submission consists of the Plan 
Benefit Package (PBP) software, formulary file, and supporting 
documentation, as necessary. MA and PDP organizations use the PBP 
software to describe their organization's plan benefit packages, 
including information on premiums, cost sharing, authorization rules, 
and supplemental benefits. They also generate a formulary to describe 
their list of drugs, including information on prior authorization, step 
therapy, tiering, and quantity limits. Additionally, CMS uses the PBP 
and formulary data to review and approve the plan benefit packages 
proposed by each MA and PDP organization.
    CMS requires that MA and PDP organizations submit a completed PBP 
and formulary as part of the annual bidding process. During this 
process, organizations prepare their proposed plan benefit packages for 
the upcoming contract year and submit them to CMS for review and 
approval. Refer to the supporting document ``Appendix B'' for a list of 
changes. Form Number: CMS-R-262 (OMB: 0938-0763); Frequency: 
Yearly; Affected Public: Business or other for-profits and not-for-
profit institutions; Number of Respondents: 655; Total Annual 
Responses: 6,878; Total Annual Hours: 18,020. (For policy questions 
regarding this collection contact Kristy Holtje at 410-786-2209. For 
all other issues call 410-786-1326.)
    3. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: CY 2012 Bid 
Pricing Tool (BPT) for Medicare Advantage (MA) Plans and Prescription 
Drug Plans (PDP); Use: Under the Medicare Prescription Drug, 
Improvement, and Modernization Act of 2003 (MMA), and implementing 
regulations at 42 CFR, Medicare Advantage organizations (MAO) and 
Prescription Drug Plans are required to submit an actuarial pricing 
``bid'' for each plan offered to Medicare beneficiaries for approval by 
CMS.
    MAOs and PDPs use the Bid Pricing Tool (BPT) software to develop 
their actuarial pricing bid. The information provided in the BPT is the 
basis for the plan's enrollee premiums and CMS payments for each 
contract year. The tool collects data such as medical expense 
development (from claims data and/or manual rating), administrative 
expenses, profit levels, and projected plan enrollment information. By 
statute, completed BPTs are due to CMS by the first Monday of June each 
year. CMS reviews and analyzes the information provided on the Bid 
Pricing Tool. Ultimately, CMS decides whether to approve the plan 
pricing (i.e., payment and premium) proposed by each organization. Form 
Number: CMS-10142 (OMB: 0938-0944); Frequency: Yearly; 
Affected Public: Business or other for-profits and not-for-profit 
institutions; Number of Respondents: 550; Total Annual Responses: 
4,950; Total Annual Hours: 34,650. (For policy questions regarding this 
collection contact Diane Spitalnic at 410-786-5745. For all other 
issues call 410-786-1326.)
    4. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Clinical 
Laboratory Improvement Amendment (CLIA) of 1988 and Supporting 
Regulations in 42 CFR 493.1-.2001; Use: The information collection 
requirements in 42 CFR 493 outline the requirements necessary to 
determine an entity's compliance with CLIA. CLIA requires laboratories 
that perform testing on human beings to meet performance requirements 
(quality standards) in order to be certified by the Department of 
Health and Human Services (DHHS). DHHS conducts inspections to 
determine a laboratory's compliance with CLIA requirements. CLIA 
implements the certificate, laboratory standards and inspection 
requirements. Form Number: CMS-R-26 (OMB: 0938-0612); 
Frequency: Occasionally; Affected Public: Federal Government; State, 
Local, or Tribal Governments; Private Sector: Business or other for-
profits and Not-for-profit institutions; Number of Respondents: 
168,688; Total Annual Responses: 756,240; Total Annual Hours: 
11,363,280. (For policy questions regarding this collection contact 
Raelene Perfetto at 410-786-6876. 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 [email protected], 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 December 7, 2010:
    1. Electronically. You may submit your comments electronically to 
http://www.regulations.gov. Follow the instructions for ``Comment or 
Submission'' or ``More Search Options'' to find the information 
collection document(s) accepting comments.

[[Page 62403]]

    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, Room C4-26-05, 7500 Security Boulevard, Baltimore, 
Maryland 21244-1850.

    Dated: September 30, 2010.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations 
and Regulatory Affairs.
[FR Doc. 2010-25053 Filed 10-7-10; 8:45 am]
BILLING CODE 4120-01-P
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