[Federal Register Volume 70, Number 160 (Friday, August 19, 2005)]
[Notices]
[Pages 48770-48771]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-16472]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10110, CMS-10136, CMS-10162, and CMS-R-0021]


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

[[Page 48771]]

minimize 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 http://www.cms.hhs.gov/regulations/pra/, 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.
    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.

    Dated: August 12, 2005.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations 
and Regulatory Affairs.
[FR Doc. 05-16472 Filed 8-18-05; 8:45 am]
BILLING CODE 4120-01-P