[Federal Register Volume 70, Number 222 (Friday, November 18, 2005)]
[Notices]
[Pages 69973-69974]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-22903]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare and Medicaid Services

[Document Identifier: CMS-10174]


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

AGENCY: Center for Medicare and Medicaid Services.
    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 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;

[[Page 69974]]

(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, however, 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 
the Administration. We cannot reasonably comply with the normal 
clearance procedures because the regular clearance process will exceed 
the MMA mandated prescription drug benefit effective date and thereby 
result in public harm to enrolled Medicare prescription drug 
beneficiaries.
    The Social Security Act as amended by the Medicare Prescription 
Drug Improvement and Modernization Act of 2003 (MMA) mandates that the 
prescription drug benefit be available to beneficiaries on January 1, 
2006. The conditions under which Medicare Advantage prescription drug 
plans (MA-PD), private prescription drug plans (PDP) and Fallout Plans/
Sponsors receive payment for the Part D drug benefit upon collection of 
Prescription Drug Event (PDE) data are specified in sections 1860D-
15(c)(1)(C), 1860D-15(d)(2) and 1860D-15(f) of the MMA and 42 CFR 
sections 423.322 and 422.310.
    1. Type of Information Collection Request: New Collection; Title of 
Information Collection: Collection of Prescription Drug Data from MA-
PD, PDP and Fallout Plans/Sponsors for Medicare Part D Payments and 
Supporting Regulations in 42 CFR 423.301, 423.322, 423.875, 423.888 and 
422.310; Use: The MMA requires Medicare payment to Medicare Advantage 
(MA) organizations, PDP sponsors, Fallbacks and other plan sponsors 
offering coverage of outpatient prescription drugs under the new 
Medicare Part D benefit. The Act provided four summary mechanisms for 
paying plans: Direct subsidies, subsidized coverage for qualifying low-
income individuals, Federal reinsurance subsidies and risk corridor 
payments. In order to make payment in accordance with these provisions, 
CMS has determined to collect a limited set of data elements for 100 
percent of prescription drug claims or events from plans offering Part 
D coverage. The transmission of the statutorily required data will be 
in an electronic format. The information users will be Pharmacy Benefit 
Managers (PBM), third party administrators and pharmacies and the PDPs, 
MA-PDs, Fallbacks and other plan sponsors that offer coverage of 
outpatient prescription drugs under the new Medicare Part D benefit to 
Medicare beneficiaries. The statutorily required data will be used 
primarily for payment, claims validation, quality monitoring, program 
integrity and oversight; Form Number: CMS-10174 (OMB<greek-i>: 0938-
NEW); Frequency: Monthly, Quarterly and Annually Affected Public: 
Business or other for-profit, and Not-for-profit institutions; Number 
of Respondents: 455; Total Annual Responses: 2,418,000,000; Total 
Annual Hours: 4,836.
    CMS is requesting OMB review and approval of these collections by 
December 19, 2005, with a 180-day approval period. Written comments and 
recommendation will be considered from the public if received by the 
individuals designated below by December 18, 2005.
    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 <a href="/cdn-cgi/l/email-protection#cc9cadbca9bebba3bea78cafa1bfe2a4a4bfe2aba3ba"><span class="__cf_email__" data-cfemail="8edeeffeebfcf9e1fce5ceede3fda0e6e6fda0e9e1f8">[email protected]</span></a>, 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 December 18, 2005: Centers for 
Medicare and Medicaid Services, Office of Strategic Operations and 
Regulatory Affairs, Room C4-26-05, 7500 Security Boulevard, Baltimore, 
MD 21244-1850. Fax Number: (410) 786-5267. Attn: Bonnie L Harkless; 
and, OMB Human Resources and Housing Branch, Attention: Carolyn 
Lovett,New Executive Office Building, Room 10235, Washington, DC 20503.

    Dated: November 9, 2005.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations 
and Regulatory Affairs.
[FR Doc. 05-22903 Filed 11-17-05; 8:45 am]
BILLING CODE 4120-01-P


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