Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

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###### Department of Health and Human Services

###### Centers for Medicare & Medicaid Services

          - [Document Identifier: CMS-R-262, CMS-10142, CMS-10175 and CMS-R-218]

*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:*                     Revision of a currently approved collection;                     *Title of Information Collection:*                     CY 2010 Plan Benefit Package (PBP) and Formulary Submission for Medicare Advantage (MA) Plans and Prescription Drug Plans (PDP)                     *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 formulary file, Plan Benefit Package (PBP) software, and supporting documentation as necessary. MA and PDP organizations will generate a formulary to illustrate their list of drugs, including information on prior authorization, step therapy, tiering, and quantity limits. Additionally, the PBP software will be used to describe their organization's plan benefit packages, including information on premiums, cost sharing, authorization rules, and supplemental benefits. CMS uses the formulary and PBP 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 formulary and PBP 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. Based on operational changes and policy clarifications to the Medicare program and continued input and feedback by the industry, CMS has made the necessary changes to the plan benefit package submission.                     *Form Number:*                     CMS-R-262 (OMB# 0938-0763);                     *Frequency:*                     Yearly;                     *Affected Public:*                     Business or other for-profits b. Not-for-profit institutions;                     *Number of Respondents:*                     475;                     *Total Annual Responses:*                     4987.5;                     *Total Annual Hours:*                     12112.5.                

                    2.                     *Type of Information Collection Request:*                     Revision of a currently approved collection;                     *Title of Information Collection:*                     CY 2010 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 (PDP) 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,                           ( print page 60297)                        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 b. Not-for-profit institutions;                     *Number of Respondents:*                     550;                     *Total Annual Responses:*                     6050;                     *Total Annual Hours:*                     42,350.                

                    3.                     *Type of Information Collection Request:*                     Reinstatement without change of a previously approved collection;                     *Title of Information Collection:*                     Certification Statement for Electronic File Interchange Organizations (EFIOs)                     *Use:*                     Health care providers can currently obtain a National Provider Identifier (NPI) via a paper application or over the Internet through the National Plan and Provider Enumeration System (NPPES). These applications must be submitted individually, on a per-provider basis. The Electronic File Interchange (EFI) process allows provider-designated electronic file interchange organizations (EFIOs) to capture multiple providers' NPI application information on a single electronic file for submission to NPPES. This process is also referred to as “bulk enumeration.” To ensure that the EFIO has the authority to act on behalf of each provider and complies with other Federal requirements, an authorized official of the EFIO must sign a certification statement and mail it to the Centers for Medicare and Medicaid Services (CMS).                     *Form Number:*                     CMS-10175 (OMB# 0938-0984);                     *Frequency:*                     Once;                     *Affected Public:*                     Private Sector—Business or other for-profits;                     *Number of Respondents:*                     300;                     *Total Annual Responses:*                     300;                     *Total Annual Hours:*                     300.                

                    4.                     *Type of Information Collection Request:*                     Revision of a currently approved collection;                     *Title of Information Collection:*                     Information Collection Requirements contained in 45 CFR Part 162; HIPAA Standards for Electronic Transactions.                     *Use:*                     We are revising the currently approved information collection request to include the information collection requirements contained in CMS-0009-P (73 FR 49742). In the aforementioned regulation, we update the adopted standards for electronic transactions and propose the adoption of a new standard transaction for Medicaid subrogation for retail pharmacy claims. The use of these updated and additional standards would improve the Medicare and Medicaid programs and other Federal health programs as well as private health programs, and the effectiveness and efficiency of the health care industry in general, by simplifying the administration of the system and fostering and increase in EDI for exchanging healthcare information. Increased advances in technology and improvements in healthcare business processes have fostered development of updated EDI standards to facilitate efficient and effective flow of administrative operations. Adopting an updated version of the standards and a new standard for Medicaid subrogation would greatly improve EDI standardization for healthcare transactions.                     *Form Number:*                     CMS-R-218 (OMB# 0938-0866);                     *Frequency:*                     Once;                     *Affected Public:*                     Private Sector—Business or other for-profits and Not-for-profit institutions;                     *Number of Respondents:*                     696,026;                     *Total Annual Responses:*                     696,026;                     *Total Annual Hours:*                     6,960,260.                

                    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                     *Paperwork@cms.hhs.gov*, 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 9, 2008:

                    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: October 2, 2008.

Michelle Shortt,

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

[FR Doc. E8-24093 Filed 10-9-08; 8:45 am]

BILLING CODE 4120-01-P