[Federal Register Volume 71, Number 153 (Wednesday, August 9, 2006)]
[Notices]
[Pages 45568-45569]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-6773]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare and Medicaid Services

[Document Identifier: CMS-10207]


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

AGENCY: 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.

[[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 http://www.cms.hhs.gov/regulations/pra or E-mail 
your request, including your address, phone number, OMB number, and CMS 
document identifier, to [email protected], 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.

    Dated: August 2, 2006.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations 
and Regulatory Affairs.
[FR Doc. 06-6773 Filed 8-3-06; 4:04 pm]
BILLING CODE 4120-01-P