[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