[Federal Register Volume 70, Number 18 (Friday, January 28, 2005)]
[Notices]
[Pages 4128-4129]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-1555]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare and Medicaid Services

[Document Identifier: CMS-10132]


Emergency Clearance: Public Information Collection Requirements 
Submitted to the Office of Management and Budget (OMB)

    Agency: Center for Medicare and 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 and Medicaid 
services (CMS), Department of Health

[[Page 4129]]

and Human Services, 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.
    We are requesting an emergency review of the information collection 
referenced below. In compliance with the requirement of section 
3506(c)(2)(A) of the Paperwork Reduction Act of 1995, we have submitted 
to the Office of Management and Budget (OMB) the following requirements 
for emergency review. We are requesting an emergency review because the 
collection of this information is needed before the expiration of the 
normal time limits under OMB's regulations at 5 CFR part 1320. This is 
necessary to ensure compliance with an initiative of section 641 of the 
Medicare Modernization Act of 2003. We cannot reasonably comply with 
the normal clearance procedures because the normal procedures are 
likely to cause a statutory deadline to be missed.
    Section 641 of the MMA provides for the implementation of a 
demonstration in which Medicare would pay for selected self-
administered drugs or biologicals that replace currently-covered Part B 
drugs. Apart from under this demonstration, Medicare outpatient drug 
coverage is limited to drugs that are provided incident to a 
physician's service or are oral cancer drugs with the same chemical 
composition as physician-administered agents. This demonstration 
project offers temporary, early coverage for selected prescription 
drugs before the new prescription drug benefit (Medicare Part D) begins 
in January 2006. The evaluation is required to address the effects of 
the program on beneficiary access, outcomes, and costs. Survey results 
are necessary for CMS to complete its mandated Report to Congress. The 
survey also represents a unique opportunity to inform CMS on the 
magnitude of effects on access and health status that result from 
expanding coverage of a select set of drugs to a well-defined group or 
seriously ill beneficiaries, and to provide CMS information on how 
enrollees learned about the demonstration.
    CMS is requesting OMB review and approval of this collection by 
March 1, 2005, with a 180-day approval period. Written comments and 
recommendations will be considered from the public if received by the 
individuals designated below by January 31, 2005.
    Type of Information Collection Request: New collection; Title of 
Information Collection: Beneficiary Survey on the Medicare Replacement 
Drug Demonstration; Use: The statute authorizing the Medicare 
Replacement Drug Demonstration mandates a report to Congress on the 
effects of the demonstration, to be submitted not later than July 2006. 
This report is to include an evaluation of patient access to care and 
patient outcomes under the project. The Medicare Replacement Drug 
Demonstration Evaluation is necessary to collect information on the 
demonstration's effects on access and outcomes for this report; Form 
Number: CMS-10132 (OMB: 0938-NEW); Frequency: Other--once per 
beneficiary; Affected Public: Individuals or Households; Number of 
Respondents: 3200; Total Annual Responses: 3200; Total Annual Hours: 
800. We have submitted a copy of this notice to OMB for its review of 
these information collections. A notice will be published in the 
Federal Register when approval is obtained.
    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.
    Interested persons are invited to send comments regarding the 
burden or any other aspect of these collections of information 
requirements. However, as noted above, comments on these information 
collection and recordkeeping requirements must be mailed and/or faxed 
to the designees referenced below by January 31, 2005:

Centers for Medicare and Medicaid Services, Office of Strategic 
Operations and Regulatory Affairs, Room C5-13-27, 7500 Security 
Boulevard, Baltimore, MD 21244-1850, Fax Number: (410) 786-0262, Attn: 
William N. Parham, III, CMS-10056.
and,

OMB Human Resources and Housing Branch, Attention: Christopher Martin, 
New Executive Office Building, Room 10235, Washington, DC 20503.

    Dated: January 13, 2005.
Dawn Willinghan,
Acting, CMS Paperwork Reduction Act Reports Clearance Officer, Office 
of Strategic Operations and Regulatory Affairs, Regulations Development 
Group.
[FR Doc. 05-1555 Filed 1-27-05; 8:45 am]
BILLING CODE 4120-03-P