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Agency Information Collection Activities: Proposed Collection; Comment Request

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Information about this document as published in the Federal Register.

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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 Start Printed Page 48771minimize the information collection burden.

1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biologicals And Supporting Regulations in 42 CFR 414.804; Form No.: CMS-10110 (OMB #0938-0921); Use: In accordance with Section 1847A of the Social Security Act (the Act), Medicare Part B covered drugs and biologicals not paid on a cost or prospective payment basis are paid based on the average sales price of the drug or biological, beginning in CY 2005. The ASP data reporting requirements are specified in Section 1927 of the Act. The reported ASP data are used to establish the Medicare payment amounts. Specifically, CMS will utilize the ASP data to determine the drug payment amounts for CY 2005 and beyond. The interim final rule “Medicare Program; Manufacturer Submission of Manufacturer's Average Sales Price (ASP) Data for Medicare Part B Drugs and Biologics” (CMS-1380-IFC), published in the Federal Register on April 6, 2004 (66 FR 17936), set forth the ASP reporting format, Addendum A. The rule stated that, as we gain more experience with the ASP methodology, we may seek to modify the reporting requirements (data elements and format for submission) in the future. Based on our experience during the initial six reporting periods, we have found it necessary for carrying out section 1847A of the Act to expand the ASP data collected from manufacturers. We are proposing that, upon approval of this requested revision, in addition to the data elements in the original Addendum A (manufacturer name, National Drug Code (NDC), manufacturer's ASP, and number of units), the following data elements must be submitted quarterly by manufacturers: name of drug or biological, strength of the product, volume per item, number of items per NDC, wholesale acquisition costs (applies to NDCs assigned to single source drug and biological billing codes and NDCs during the initial period under section1847A(c)(4) of the Act), and expiration date of the last lot manufactured. We are proposing that manufacturers would no longer report ASP data for an NDC beginning the reporting period after the expiration date of the last lot manufactured. For NDCs first marketed or sold on or after October 1, 2005, we are also proposing to collect the date the NDC was first marketed and the date of first sale. We propose that manufacturers would be required to submit these dates to us once with the first data submission for new NDCs. Frequency: Recordkeeping and reporting—quarterly; Affected Public: Business or other for-profit; Number of Respondents: 120; Total Annual Responses: 480; Total Annual Hours: 17,760.

2. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Medicare Care Management Performance (MCMP) Demonstration—Standardized Ambulatory Care Quality Collection Initiative; Use: The MCMP Demonstration was authorized by Section 649 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). This project requires the Secretary to establish a pay-for-performance 3-year pilot with physicians to promote the adoption and use of health information technology to improve the quality of patient care for chronically ill Medicare patients. This demonstration represents the first pay for performance project fostering the adoption of health information technology in small physician group practices and will enable a test of the concept to improve the quality and efficiency of care in Fee-for-Service (FFS) Medicare. Form Number: CMS-10136 (OMB #0938-0941); Frequency: Annually; Affected Public: Business or other for-profit and not-for-profit institutions; Number of Respondents: 800; Total Annual Responses: 800; Total Annual Hours: 19,200.

3. Type of Information Collection Request: New collection; Title of Information Collection: Medicare Care Improvement Survey; Use: The purpose of this beneficiary survey is to obtain information about beneficiary behavioral change, physical functioning and satisfaction with the Chronic Care Improvement (CCI) programs, data required by legislation to form decisions related to expansion of the pilot programs. The chronic care improvement programs are to be designed to incorporate relevant features from private sector programs but also be sufficiently flexible to adapt to the unique needs of their Medicare populations. This survey is required to support the legislative mandate to evaluate the Chronic Care Improvement Programs. Beneficiary participation in the CCI-I program will be voluntary and will not change the scope, duration or amount of Medicare FFS benefits currently received by FFS Medicare participants. Form Number: CMS-10162 (OMB #0938-NEW); Frequency: Reporting—on occasion; Affected Public: Individuals or households; Number of Respondents: 9,449; Total Annual Responses: 9,449; Total Annual Hours: 2,636.

4. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Withholding Medicare Payments to Recover Medicaid Overpayments and Supporting Regulations in 42 CFR 447.31; Use: Overpayments may occur in either the Medicare and Medicaid program, at times resulting in a situation where an institution or person that provides services owes a repayment to one program while still receiving reimbursement from the other. Certain Medicaid providers which are subject to offsets for the collection of Medicaid overpayments may terminate or substantially reduce their participation in Medicaid, leaving the State Medicaid Agency unable to recover the amounts due. These information collection requirements give CMS the authority to recover Medicaid overpayments by offsetting payments due to a provider under the program. Form Number: CMS-R-0021 (OMB #0938-0287); Frequency: Reporting—on occasion; Affected Public: State, local or tribal government; Number of Respondents: 54; Total Annual Responses: 27; Total Annual Hours: 81.

To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS' Web site address at​regulations/​pra/​, or e-mail your request, including your address, phone number, OMB number, and CMS document identifier, to, or call the Reports Clearance Office on (410) 786-1326.

Written comments and recommendations for the proposed information collections must be mailed within 60 days of this notice to: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: William N. Parham, III, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.

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Dated: August 12, 2005.

Michelle Shortt,

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

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[FR Doc. 05-16472 Filed 8-18-05; 8:45 am]