[Federal Register Volume 74, Number 101 (Thursday, May 28, 2009)]
[Notices]
[Pages 25550-25552]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-12419]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Office of the National Coordinator for Health Information 
Technology; Health Information Technology Extension Program

ACTION: Notice and request for comments.

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SUMMARY: This notice announces the draft description of the program for 
establishing regional centers to assist providers seeking to adopt and 
become meaningful users of health information technology, as required 
under Section 3012(c) of the Public Health Service Act, as added by the 
American Recovery and Reinvestment Act of 2009 (Pub. L. 111-5) (ARRA).

DATES: All comments on the draft Plan should be received no later than 
5 p.m. on June 11, 2009.

ADDRESSES: Electronic responses are preferred and should be addressed 
to HealthIT-comments@hhs.gov. Written comments may also be submitted 
and should be addressed to the Office of the National Coordinator for 
Health Information Technology, 200 Independence Ave, SW., Suite 729D, 
Washington, DC 20201, Attention: Health IT Extension Program Comments.

FOR FURTHER INFORMATION CONTACT: The Office of the National Coordinator 
for Health, Information Technology, 200 Independence Ave, SW., Suite 
729D, Washington, DC 20201, Phone 202-690-7151, E-mail: 
onc.request@hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    The American Recovery and Reinvestment Act of 2009 (Pub. L. 111-5) 
(ARRA) includes provisions to promote the adoption of interoperable 
health information technology to promote meaningful use of health 
information technology to improve the quality and value of American 
health care. These provisions are set forth in Title XIII of Division A 
and Title IV of Division B, which may together be cited as the ``Health 
Information Technology for Economic and Clinical Health Act'' or the 
``HITECH Act''.
    The ARRA appropriates a total of $2 billion in discretionary 
funding, in addition to incentive payments under the Medicare and 
Medicaid programs for providers' adoption and meaningful use of 
certified electronic health record technology.
    Providers that seek to adopt and effectively use health information 
technology (health IT) face a complex variety of tasks. Those tasks 
include assessing needs, selecting and negotiating with a system vendor 
or reseller, and implementing workflow changes to improve clinical 
performance and, ultimately, outcomes. Past experiences have shown that 
without robust technical assistance, many EHRs that are purchased are 
never installed or are not used by some providers.
    Section 3012 of the Public Health Service Act (PHSA), as added by 
the HITECH Act, authorizes a Health Information Technology Extension 
Program to make assistance available to all providers, but with 
priority given to assisting specific types of providers. By statute, 
the health information technology extension program (or ``Extension 
Program'') consists of a National Health Information Technology 
Research Center (HITRC) and Regional Extension Centers (or ``regional 
centers'').
    The major focus for the Centers' work with most of the providers 
that they serve will be to help to select and successfully implement 
certified electronic health records (EHRs). While those providers that 
have already implemented a basic EHR may not require implementation 
assistance, they may require other technical assistance to achieve 
``meaningful user'' status. All regional centers will assist adopters 
to effectively meet or exceed the requirements to be determined a 
``meaningful user'' for purposes of earning the incentives authorized 
under Title IV of Division B. Lessons learned in the support of 
providers, both before and after their initial implementation of the 
EHR, will be shared among the regional centers and made publicly 
available.
    The HITECH Act prioritizes access to health information technology 
for uninsured, underinsured, historically underserved and other 
special-needs populations, and use of that technology to achieve 
reduction in health disparities. The Extension Program will include 
provisions in both the HITRC and regional centers awards to assure that 
the program addresses the unique needs of providers serving American 
Indian and Alaska Native, non-English-speaking and other historically 
underserved populations, as well as those that serve patients with 
maternal, child, long-term care, and behavioral health needs.

II. Detailed Explanation and Goals of the Program

    The HITECH Act directs the Secretary of Health and Human Services, 
through the Office of the National Coordinator for Health Information 
Technology (ONC), to establish Health Information Technology Regional 
Extension Centers to provide technical assistance and disseminate best 
practices and other information learned from the Center to support and 
accelerate efforts to adopt, implement and effectively utilize health 
information technology. In developing and implementing this and other 
programs pursuant to the HITECH Act, ONC is consulting with other 
Federal agencies with demonstrated experience and expertise in 
information technology services, such as the National Institute of 
Standards and Technology.
    We propose that the goals of the regional center program should be 
to:

--Encourage adoption of electronic health records by clinicians and 
hospitals;
--Assist clinicians and hospitals to become meaningful users of 
electronic health records; and
--Increase the probability that adopters of electronic health record 
systems will become meaningful users of the technology.

    The HITECH Act states that ``the objective of the regional centers 
is to enhance and promote the adoption of health information technology 
through--
    (A) Assistance with the implementation, effective use, upgrading, 
and ongoing maintenance of health information technology,

[[Page 25551]]

including electronic health records, to healthcare providers 
nationwide;
    (B) broad participation of individuals from industry, universities, 
and State governments;
    (C) active dissemination of best practices and research on the 
implementation, effective use, upgrading, and ongoing maintenance of 
health information technology, including electronic health records, to 
health care providers in order to improve the quality of healthcare and 
protect the privacy and security of health information;
    (D) participation, to the extent practicable, in health information 
exchanges;
    (E) utilization, when appropriate, of the expertise and capability 
that exists in Federal agencies other than the Department; and
    (F) integration of health information technology, including 
electronic health records, into the initial and ongoing training of 
health professionals and others in the healthcare industry that would 
be instrumental to improving the quality of healthcare through the 
smooth and accurate electronic use and exchange of health 
information.''
    To achieve the centers' statutory objectives, we propose to 
establish regional centers to offer to all providers in a designated 
region access to information and to some level of assistance. The 
regional centers will become, upon award, members of a consortium that 
will be coordinated and facilitated by the Health Information 
Technology Research Center (HITRC) that the Secretary is directed to 
establish by Section 3012(b) of the PHSA as added by the HITECH Act. 
Whereas research and analysis of best practices regarding health IT 
utilization rests primarily with the HITRC, dissemination and 
implementation of those best practices learned from the HITRC will rest 
with the regional centers.
    Per Section 3012(c)(4) of the PHSA as added by the HITECH Act, each 
regional center shall ``aim to provide assistance and education to all 
providers in a region but shall prioritize any direct assistance first 
to the following:
     Public or not-for-profit hospitals or critical-access 
hospitals.
     Federally qualified health centers (as defined in section 
1861(aa)(4) of the Social Security Act).
     Entities that are located in rural and other areas that 
serve uninsured, underinsured, and medically underserved individuals 
(regardless of whether such area is urban or rural).
     Individual or small group practices (or a consortium 
thereof) that are primarily focused on primary care.''
    Regional centers will therefore, as a core purpose of their 
establishment, furnish direct, individualized, and (as needed) on-site 
assistance to individual providers. This intensive assistance is, per 
statute, to be prioritized to providers identified in the statute. We 
expect that on-site assistance will be a key service offered by the 
regional centers to providers prioritized by the statute for direct 
assistance, and will represent a significant portion of the regional 
centers' activities.
    Because of the nationwide scope of the Medicare and Medicaid 
payment incentives for adoption and meaningful use of certified EHRs, 
the Extension Program should provide at least a minimal level of 
technical assistance across the nation. We propose that the minimal 
level of support must include the provision of unbiased information on 
mechanisms to exchange health information in compliance with applicable 
statutory and regulatory requirements, and information to support the 
effective integration of health information exchange activities into 
practice workflow.
    It is expected that each regional center will provide technical 
assistance within a defined geographic area, and that each defined 
geographic area will be served by only one center. At a minimum, the 
support should consist of materials designed to be widely and rapidly 
disseminated, both for provider self-study and for use by entities 
other than regional centers that have an interest and the ability to 
provide some assistance and information to providers adopting health 
IT.
    As required by Section 3012(c)(8) of the Public Health Service Act 
as added by the HITECH Act, all regional centers will be evaluated to 
ensure they are meeting the needs of the health providers in their 
geographic area in a manner consistent with specified statutory 
objectives. All lessons learned from these efforts will be exchanged 
across regional centers, and with other stakeholders, including but not 
limited to other federal programs, to promote the availability of 
highly effective support to providers across the nation. All regional 
centers will be expected to use the lessons learned as important, but 
not the only, information to guide their internal self-evaluation and 
ongoing improvement processes.

A. Criteria for Determining Qualified Applicants

    Section 3012(c)(2) of the PHSA as added by the HITECH Act requires 
that: ``Regional centers shall be affiliated with any United States-
based nonprofit organization, or group thereof, that applies and is 
awarded financial assistance under this section. Individual awards 
shall be decided on the basis of merit.'' In addition, we propose the 
following requirements and preference criteria.
    Required Criteria may include:
     Define the geographic region and the provider population 
within that region it proposes to serve.
     Describe proposed levels and approaches of support for 
prioritized and other providers to be served.
     Address how the applicant would structure its organization 
and staffing to enable providers served to have ready access to 
reasonably local health IT ``extension agents'' and provide training 
and on-going support for these critical workers.
     Demonstrate the capacity to facilitate and support 
cooperation among local providers, health systems, communities, and 
health information exchanges.
     Demonstrate that the applicant is able to meet the needs 
of providers prioritized for direct assistance by Section 3012(c)(4) of 
the PHSA as added by the HITECH Act.
     Propose an efficient and feasible strategy to furnish deep 
specialized expertise (in such areas as organizational development, 
legal issues, privacy and security, economic and financing issues, and 
evaluation) broadly to all providers served and intensive, 
individualized, ``local'' presence from an interdisciplinary extension 
agent to smaller groups of providers assigned to individual agents.
    Preference Criteria may include:
     We propose to give preference to proposed regional center 
organizational plans and implementation strategies incorporating multi-
stakeholder collaborations that leverage local resources. The local 
stakeholders and resources that applicants may wish to consider 
including in some combination, though not limited to, the following: 
Public and/or private universities with health professions, 
informatics, and allied health programs; state or regional medical/
professional societies and other provider organizations; federally 
recognized state primary care associations; state or regional hospital 
organizations; large health centers and networks of rural and/or 
community health centers; other relevant health professional 
organizations; the regionally relevant state Area Health Education 
Center(s); health information exchange organizations serving providers 
in the

[[Page 25552]]

region; the Medicare Quality Improvement Organization(s)(QIO(s) serving 
providers that the proposed regional center aims to serve; state and 
tribal government entities in the center's geographic service area 
including, but not limited to, public health agencies; libraries and 
information centers with health professional and community outreach 
programs; and consumer/patient organizations.
     As noted below, we propose to give preference to 
applicants identifying viable sources of matching funds. Viable sources 
could include grants from states, non-profit foundations, and payment 
for services from providers able to make such payment. For example, 
Medicaid providers could choose to contract with a regional center in 
lieu of a corporate vendor for implementation and meaningful use 
support services, for which costs are reimbursable under Section 1903 
of the Social Security Act, as amended by the HITECH Act. A regional 
center could also, theoretically, seek to establish itself as a first-
choice source of assistance that would realize net retained earnings on 
service to non-prioritized providers and use those retained earnings as 
a source of matching funds for its grant-funded activities.

B. Maximum Support Levels Expected To Be Available to Centers Under the 
Program

    Given current national economic conditions, we propose to exercise 
the option in the HITECH Act to not require matching funds for awards 
made in FY 2010. We will encourage use of matching funds and the 
coordination of existing resources to strengthen proposals for regional 
centers and potentially expand the number of providers that can be 
assisted. Review criteria may be established that give preference to 
proposals including matching funds but that do not automatically 
preclude otherwise technically meritorious proposals that do not 
include matching funds.
    We propose using ARRA funding for two-year awards made in FY2010 
and furnishing providers in awardees' areas with robust support. While 
we expect the actual ARRA funding awarded per center will vary based on 
the number and types of providers proposed to be served, and the amount 
of matching funds proposed by each regional center, we anticipate an 
average award value on the order of $1 million to $2 million per 
center. The maximum award value we anticipate making available to any 
one regional center is $10 million. Funding may also be approximately 
allocated to the regional centers in relative proportion to the numbers 
of prioritized direct assistance recipients identified in the HITECH 
Act.

C. Procedures To Be Followed by the Applicants

Timelines
    This notice makes public and invites comments on the draft 
description of the regional centers program and is not a solicitation 
of proposals to serve as extension centers under this program. The 
Federal Government will award funding for the regional centers through 
a solicitation of proposals, after considering the comments obtained 
through this notice. The availability of this solicitation will be 
broadly announced through appropriate and familiar means, including 
publication in the Federal Register of a Notice of the solicitation's 
availability. This announcement of the solicitation will provide 
further details on the finalized requirements and application process 
for regional centers, pursuant to and in compliance with all applicable 
statutes and regulations, including but not limited to the Paperwork 
Reduction Act (44 U.S.C. 3501 et seq.).
    Applicants well prepared to provide robust extension services will 
likely need at least two months to provide high quality proposals. It 
is expected, however, that other potential applicants will need more 
time to prepare proposals.
    We propose to make initial awards for regional centers as early as 
the first quarter of FY2010 and continuing through the fourth quarter 
of FY2010. Multiple, closely spaced proposal submission dates will be 
established to allow each geographic area to begin receiving benefit of 
a regional center as soon as possible. We believe this approach is 
necessary to allow areas with well prepared applicants to begin work 
sooner, without excluding from consideration those areas where the best 
applicants require more time to convene a multi-stakeholder 
collaboration to develop a robust proposal that includes a viable 
organizational plan and implementation strategy. We solicit comment on 
our phased approach to proposal submission dates and issuance of 
awards.
    The target timeframe for awards is intended to enable regional 
centers to begin supporting provider adoption in time for providers to 
receive incentive payments with respect to Fiscal Year (hospitals) or 
Calendar Year (physicians) 2011 and 2012, when potential Medicare 
incentives are greatest.

D. Comments on Draft Description

    ONC requests comments on this draft description of the regional 
centers within the Extension Program. Please send comments to the 
address, for receipt by the due date, specified at the beginning of 
this notice.

    Dated: May 22, 2009.
Charles P. Friedman,
Deputy National Coordinator for Health Information Technology.
[FR Doc. E9-12419 Filed 5-27-09; 8:45 am]
BILLING CODE 4150-45-P