05-1555. 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 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 [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 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: [phone], 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.