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

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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. Start Printed Page 45569

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(a)(2)(ii). This is necessary to ensure compliance with an initiative of the Administration. We cannot reasonably comply with the normal clearance procedures because of an unanticipated event, as stated in 5 CFR 1320.13(a)(2)(iii).

The Centers for Medicare & Medicaid Services (CMS) is submitting an emergency information collection request for the approval of the information collection requirements associated with two new exceptions to section 1877 of the Social Security Act (the Act). The approval of this collection process is essential to protect the Medicare program and its beneficiaries against fraud and abuse. In addition, emergency approval is essential to permit members of the health care industry to immediately reap the benefits of this important regulation. Once the new exceptions are effective, entities that furnish certain designated health services to Medicare beneficiaries will be permitted to assist physicians with the implementation of electronic prescribing and electronic health records technology. The benefits of this technology include reducing medical errors, coordinating care, improving efficiency, and decreasing health care costs by eliminating unnecessary and/or duplicative diagnostic services.

1. Type of Information Collection Request: New collection; Title of Information Collection: Physician Self-Referral Exceptions for Electronic Prescribing and Electronic Health Records; Use: Section 101 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), directs the Secretary of the Department of Health and Human Services (“HHS”) to create an exception to the physician self-referral prohibition in section 1877 of the Social Security Act (the Act) for certain arrangements in which a physician receives compensation in the form of items or services (not including cash or cash equivalents) (“nonmonetary remuneration”) that is necessary and used solely to receive and transmit electronic prescription information. In addition, using our separate legal authority under section 1877(b)(4) of the Act, this rule creates a separate regulatory exception for certain arrangements involving the provision of nonmonetary remuneration in the form of electronic health records software or information technology and training services necessary and used predominantly to create, maintain, transmit, and receive electronic health records.

The conditions for both exceptions require that arrangements for the items and services provided must be set forth in a written agreement, signed by the involved parties, specify the items or services being provided and the value of those items or services, and cover all of the electronic health records technology to be furnished by the entity. We have suggested that instead of one master contract that is updated with each new donation, the parties may choose to create a specific new contract and then reference other agreements or cross-reference a master list.

The requirements associated with these exceptions are limited to donations made to physicians by providers, members of integrated delivery systems, Federally Qualified Health Centers, or rural health clinics (for purposes of this Collection of Information Requirement, “Providers”); by group practices to their physician members, and by Prescription Drug Plan (PDPs) sponsors and Medicare Advantage (MA) organizations to prescribing physicians. The paperwork burden is the creation of the written contracts. The burden associated with the written agreement requirement is the time and effort necessary for documentation of the agreement between the parties, including signatures of the parties. Form Number: CMS-10207 (OMB#: 0938-NEW); Frequency: Recordkeeping and Reporting—On occasion; Affected Public: Business or other for-profit and Not-for-profit institutions; Number of Respondents: 87,230; Total Annual Responses: 87,080; Total Annual Hours: 50,731.

CMS is requesting OMB review and approval of this collection by September 22, 2006, with a 180-day approval period. Written comments and recommendations will be considered from the public if received by the individuals designated below by September 18, 2006.

To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS' Web site address at​regulations/​pra or E-mail your request, including your address, phone number, OMB number, and CMS document identifier, to, 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 September 18, 2006: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development—B, Attn: William N. Parham, III, Room C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850 and, OMB Human Resources and Housing Branch, Attention: Carolyn Lovett, New Executive Office Building, Room 10235, Washington, DC 20503, Fax Number: (202) 395-6974.

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Dated: August 2, 2006.

Michelle Shortt,

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

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[FR Doc. 06-6773 Filed 8-3-06; 4:04 pm]