05-22903. 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; (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#: 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 [e-mail], or call the Reports Clearance Office on [phone].

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: [phone]. 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.