05-20229. Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB)

AGENCY:

Centers for Medicare & Medicaid Services.

In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & 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 normal procedures are likely to cause a statutory deadline to be missed which may result in public harm.

Section 1860D-23 and 1860D-24 of the Social Security Act, added by the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA), requires the Secretary to establish requirements for prescription drug plans to ensure the effective coordination between Part D plans, State pharmaceutical assistance programs and other payers. These requirements have been codified into the Code of Federal Regulations at 42 CFR 423.464.

Part D sponsors will be responsible for making system changes related to enrollment file sharing, claims processing and payment, reconciliation and tracking of the true out-of-pocket expenditures of beneficiaries prior to the implementation of Part D (January 1, 2006). System changes must also be implemented by State pharmaceutical assistance programs so that they may provide additional drug benefits at the pharmacy to Part D beneficiaries. In addition to making system changes, these changes must be tested, which will require additional time prior to January 1, 2006. Failure to make system changes may result in the delay in the implementation of the program and may result in a direct harm to beneficiaries since delays or mistakes in claims processing may result in beneficiaries not receiving their medications, or being unable to pay for medications out-of-pocket until the system issue is resolved.

CMS is requesting OMB review and approval of this collection by November 8, 2005, with a 180-day approval period. Written comments and recommendations will be accepted from the public if received by the individuals designated below by November 7, 2005.

Type of Information Collection Request: New Collection; Title of Information Collection: Coordination of Benefits between Part D Plans and Other Prescription Coverage Providers; Use: This information is necessary to assist with coordination of prescription drug benefits provided to the Medicare beneficiary at the pharmacy; Form Number: CMS-10171 (OMB#: 0938-NEW); Frequency: On occasion and monthly; Affected Public: Business or other for-profit, Federal, State, Local and Tribal Government; Number of Respondents: 56,320; Total Annual Responses: 2,153,767,270; Total Annual Hours: 1,017,914.

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 at [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 received by the designees referenced below by November 7, 2005: Centers for Medicare & Medicaid Services, Office of Strategic Operations and Regulatory Affairs, Room C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850, Attn: Melissa Musotto, CMS-10171. and, OMB Human Resources and Housing Branch, Attention: CMS Desk Officer, New Executive Office Building, Room 10235, Washington, DC 20503.

Dated: September 30, 2005.

Michelle Shortt,

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