[Federal Register: May 25, 2007 (Volume 72, Number 101)]
[Notices]
[Page 29323]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25my07-57]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10207]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers 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) 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.
1. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Physician Self-
Referral Exceptions for Electronic Prescribing and Electronic Health
Records (CMS-1303-F); Form Number: CMS-10207 (OMB: 0938-1009);
Use: Section 101 of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) directs the Secretary to create an
exception to the physician self-referral prohibition in section 1877 of
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, the regulation CMS-1303-F (71 FR 45140)
created 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, or receive electronic health records. These exceptions are
consistent with the President's goal of achieving widespread adoption
of interoperable electronic health records to improve the quality and
efficiency of health care while maintaining the levels of security and
privacy that consumers expect.
The conditions for both exceptions require that arrangements for
the items and services provided must be set forth in a written
agreement, be signed by the parties involved, specify the items or
services being provided and the cost of those items or services, and
cover all of the electronic prescribing and/or electronic health
records technology to be provided by the donating entity. We have
suggested that, instead of one master agreement 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 of agreements.
The requirements associated with the exception for electronic
prescribing items and services are limited to donations made by
hospitals to members of their medical staffs; by group practices to
their physician members; and by PDP sponsors and MA organizations to
prescribing physicians. The requirements associated with the exception
for electronic health records software or information technology and
training services include donations by entities furnishing DHS to
physicians. The paperwork burden is the creation and execution of the
written agreements. The burden associated with the written agreement
requirement is the time and effort necessary for documentation of the
agreement between the parties, including the signatures of the parties.
Frequency: Recordkeeping and Reporting--On occasion; Affected Public:
Business or other for-profit and Not-for-profit institutions; Number of
Respondents: 27,440; Total Annual Responses: 54,730; Total Annual
Hours: 17,545.
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/PaperworkReductionActof1995,
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.
To be assured consideration, comments and recommendations for the
proposed information collections must be received at the address below,
no later than 5 p.m. on July 24, 2007.
CMS, Office of Strategic Operations and Regulatory Affairs,
Division of Regulations Development--B, Attention: William N. Parham,
III, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-
1850.
Dated: May 21, 2007.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations
and Regulatory Affairs.
[FR Doc. E7-10097 Filed 5-24-07; 8:45 am]
BILLING CODE 4120-01-P