[Federal Register: August 9, 2006 (Volume 71, Number 153)]
[Notices]
[Page 45568-45569]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09au06-96]
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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 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 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