05-21101. 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 use of normal clearance procedures will jeopardize program implementation by a statutorily mandated deadline and could contribute to impaired beneficiary access to Part B drugs.

Section 303(d) of the MMA provides an alternative payment methodology for Part B drugs that are not paid on a cost or prospective payment basis. In particular, Section 303(d) of the MMA amends Title XVIII of the Social Security Act (the Act) by adding a new section 1847B, which establishes a competitive acquisition program for the acquisition of and payment for Part B covered drugs and biologicals furnished on or after January 1, 2006. Beginning in 2006, physicians will have a choice between acquiring and billing for Part B covered drugs under the Average Sales Price (ASP) drug payment methodology or electing to receive these drugs from vendors/suppliers selected for the Competitive Acquisition Program (CAP), through a competitive bidding process. The provisions for this new payment system are described in the proposed rule (42 CFR Part 414 Subpart K) published March 4, 2005 (70 FR 10746), the interim final rule published July 6, 2005 (70 FR 39022), and a final rule that is expected to be published in November 2005.

1. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Competitive Acquisition Program for Medicare Part B Drugs: Vendor Application and Bid Form; Use: The CAP Vendor Application and Bid Form is a collection tool which will be used by potential vendors to provide information related to the characteristics of their company and to submit their bid prices for CAP drugs. The information collected on the CAP Vendor Application and Bid Form will be used by CMS during the bidding evaluation process to evaluate the vendors bid prices, their credentials, experience and to assess their ability to provide quality service to physicians and beneficiaries. Competitive bidding is seen as a means of using the dynamics of the marketplace to provide incentives for suppliers to provide reasonably priced products and services of high quality in an efficient manner. The CAP's objectives include providing an alternative method for physicians to obtain Part B drugs to administer to Medicare beneficiaries and reducing drug acquisition and billing burdens for physicians; Form Number: CMS-10133 (OMB#: 0938-0955); Frequency: Reporting—Other, during enrollment; Affected Public: Business or other for-profit; Number of Respondents: 12; Total Annual Responses: 12; Total Annual Hours: 480.

CMS is requesting OMB review and approval of this collection by November 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 October 28, 2005.

To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access the 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 to the designees referenced below by October 28, 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: William N. Parham, III and, OMB Human Resources and Housing Branch, Attention: CMS Desk Officer, New Executive Office Building, Room 10235, Washington, DC 20503.

Dated: October 17, 2005.

Michelle Shortt,

Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs.