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

AGENCY:

Center for Medicare & 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 & 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 provisions of Section 641 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). We cannot reasonably comply with the normal clearance procedures because of an unanticipated event and possible public harm.

Section 641 of the MMA provides for the implementation of a demonstration under which Medicare would pay under Part B for drugs and biologicals that would not otherwise be covered until Part D is implemented in 2006. Drugs covered under this demonstration must be replacements for existing covered Medicare drugs and biologicals that are provided incident to a physicians service or are replacements for oral cancer drugs that are otherwise covered under Medicare Part B. Cost sharing under the demonstration is to be in the same manner as Medicare Part D. The statute also required that the demonstration begin 90 days after passage of the legislation, which was March 8, 2004. Due to the complexities of implementing this demonstration, we were unable to meet that deadline. However, because of the importance of this demonstration to beneficiaries with serious illnesses and the already delayed time frame, it is urgent that there not be further delay.

CMS is requesting OMB review and approval of this collection by May 28, 2004, with a 180-day approval period. Written comments and recommendation will be accepted from the public if received by the individuals designated below by May 25, 2004.

Type of Information Collection Request: New collection; Title of Information Collection: Application for Participation in Medicare Replacement Drug Demonstration; Use: Section 641 of the MMA mandated a demonstration that would pay for drugs/biologicals prescribed as replacements for existing covered Medicare drugs. A report to Congress evaluating the impact of this demonstration was also mandated. In order to enroll in this demonstration, a beneficiary will be required to submit the application forms. Beneficiaries who wish to be considered for a low income subsidy must also provide the information on the “Application for Financial Assistance”; Form Number: CMS-10113 (OMB#: 0938-NEW); Frequency: Other: Other: once per beneficiary; Affected Public: Individuals or Households; Number of Respondents: 50,000; Total Annual Responses: 50,000; Total Annual Hours: 20,417.

We have submitted a copy of this notice to OMB for its review of these information collections.

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.gov/regs/prdact95.htm,, 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 and/or faxed to the designees referenced below by May 25, 2004: Centers for Medicare & Medicaid Services, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development and Issuances, Attention: Dawn Willinghan, CMS-10113, Room C5-14-03, 7500 Security Boulevard, Baltimore, Maryland 21244-1850; and, Office of Information and Regulatory Affairs,Office of Management and Budget, Room 10235, New Executive Office Building, Washington, DC 20503, Attn.: Brenda Aguilar, Desk Officer, Fax # 202-395-6974.