[Federal Register: May 28, 2009 (Volume 74, Number 101)]
[Notices]
[Page 25550-25552]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28my09-67]

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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.

<Comment: While a generalized statement which may or may not be supportable with factual material, the statement is misleading in at least three respects:
1)	Technical assistance alone may be sufficient to install an application, but it typically cannot assist in the implementation and use of the application. It is our observation that the purchaser must be willing and able to adopt changes in practice and workflow to adapt to how such applications function to successfully implement and make beneficial use of such products. Many products are purchased without a foundational understanding by the purchasers of what kinds of changes will be required by them to adapt to the newly acquired application.
2)	Beyond “technical” assistance, construction and implementation of clinical support pathways is a very time-consuming and both technically and clinically exacting process. Products purchased without already existing pathways require intensive support from clinically-trained support personnel to build useful pathways and decision support mechanisms. Products should NOT be supported through this program that do not come with a robust set of modifiable pathways.
3)	As alluded to in #2, clinically-trained support personnel are required in addition to IT technical support personnel to effectively implement an EHR.
</Comment>

    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.

<Comment: We would suggest that there already exist, at least in California and other states which are already well along in EHR adoption, well organized “how-to” kits and training materials, as well as an abundance of assistance resources to help providers make system selections. We recommend that the HITRC research existing proprietary materials and other publically available materials on system selection, and from those materials create an open source workbook capable of walking a non-technical individual through system selection, including the decision-support process itself used to narrow the focus to a short list of appropriate candidates. This “workbook” could be disseminated to the RECs for distribution to providers & other purchasers of EHR technology, but the amount of personnel support time associated with the process should be de-emphasized, and should NOT be a major focus of the REC.
</Comment>

<Comment: One of the other most significant failures of the EHR industry directly leading to misuse and eventual disuse of their products is the consistent lack of software maintenance. Vendors make it difficult and expensive for providers to install / implement upgrades to their software which directly leads to versioning fatigue, and eventually non-use of new features (such as e-Rx), because providers are either unwilling or unable to commit to the time and cost of making the required software and configuration upgrades. This problem will become very apparent as the RECs start surveying their constituencies, and should, more appropriately be a much larger focus of their efforts. Also note: this chronic problem should be addressed by the ONC as it considers certification requirements.
</Comment>


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.

<Comment: As indicated, the term “technical” needs to be taken in its broadest definition, to include clinically-trained support analysts who can assist clinicians in designing & modifying pathways which will promote best practices and beneficial use of the software.
</Comment>

 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;
<Comment: This is an over-broad statement with many ramifications, not the least of which is application of the term “best practices”. While the context is vague, we would hope that it includes both the methodology of implementation, and also the inclusion of practice pathways attuned to products which will, ultimately, lead to improvement in quality care.
</Comment>

    (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.

<Comment: We would agree that the RECs, as a core purpose, should be focused on providing individualized assistance, with on-site visits AS NEEDED. We would caution, however, regarding over-use of onsite assistance, recognizing that there are many excellent “virtual” assistance mechanisms available today that allow support personnel to remotely service and support their customers.  In an effort to optimize the effectiveness of the RECs, would recommend de-emphasis on “on-site” support and training in deference to the much more efficient and timely use of remote support applications and web-based CAI.
</Comment>

    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.

<Comment: We take this statement to imply that the successful REC candidate will structure its organization in such a way as to have a distributed workforce. While we don’t take issue with that statement, we also would point out that the use of distributed educational and support technologies can provide the same benefits as “local staff”, and should be included as part of this criteria.
</Comment>

     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.

<Comment: Consistent with our comments above regarding de-emphasis on the acquisition phase of the product life cycle, we would question the need for “deep specialized expertise” in “organizational development”, “legal issues”, “economic and financing issues”, and “evaluation”, assuming that term is associated with system acquisition. We would instead add understanding of clinical processes, practice pathways, and workflow redesign as requisite knowledge.
</Comment>

    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]

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