2010-25053. 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 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 [e-mail], or call the Reports Clearance Office on [phone].

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.

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.