[Federal Register: October 21, 2005 (Volume 70, Number 203)]
[Notices]
[Page 61292-61293]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21oc05-92]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare and Medicaid Services
[Document Identifier: CMS-10133]
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 Paperwork@cms.hhs.gov, 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 to the
designees referenced below by October 28, 2005:
[[Page 61293]]
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:
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.
[FR Doc. 05-21101 Filed 10-20-05; 8:45 am]
BILLING CODE 4120-01-P