[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