Testimony
Before the Committee
on Commerce, Science, and
Transportation
Subcommittee on Science, Technology, and Space
United
States Senate
Fighting
Bioterrorism:
The
HHS Role in Using America's Scientists and Entrepreneurs
to Find Solutions
Statement of
Lisa
A. Simpson, M.B., B.Ch., M.P.H.
Deputy
Director,
Agency
for Healthcare Research and Quality
Department
of Health and Human Services
For Release on
Delivery
Expected
at 9:30 am
on
Tuesday, February 5, 2002
Good morning, I am very
pleased to be here today to discuss an exciting new effort
at the Department of Health and Human Services which will
give the Federal Government an opportunity to learn what
the private sector is doing that could enhance the security,
safety, and quality of the nation's health care system.
We have heard from private-sector
companies that they are frustrated because it is difficult
for them to find the right place in government for their
products and ideas to be considered. Alleviating this
frustration - and forging a strong collaboration between
government and industry - is especially important as the
Nation comes together to improve security in the face
of recent bioterrorist attacks.
To that end, on December
6, 2001, Secretary Thompson established the Council on
Private Sector Initiatives to Improve Security, Safety,
and Quality of Health Care. CPSI, or the Council as we
call it, will help us to manage in a fair, systematic,
and consistent manner the requests the Department has
received from individuals and firms seeking review of
their innovative ideas and products.
In a memo creating the
Council, Secretary Thompson noted, "The Council will ensure
that our focus on public health preparedness is complemented
by careful attention to the preparedness of our health
care delivery system. This Council will also enhance our
responsiveness to innovation by providing the private
sector with a single point of contact at the Department."
In essence, the Council
offers "one stop shopping" for companies seeking to present
their ideas to HHS. Requests will be reviewed and sent
to the appropriate Federal Agency or Department for action
in coordination with the department performing similar
functions. However, we do recognize that not all requests
can be met fully because they are outside the scope of
what HHS and other government agencies can do. Our goal
is to reduce the time and potential duplication of effort
that companies may face in bringing their ideas to experts
within Government who have the knowledge to evaluate them..
I would now like to describe
the CPSI to you, focusing specifically on its charge,
its composition, the
process for submitting request, and its current activities.
CHARGE
Secretary Thompson laid
out a mission for the Council with five very specific
charges:
- Triage requests from
individuals and firms seeking HHS review of their ideas
for improving the security, safety, and quality of our
health care delivery system.
- Ensure that HHS responds
systematically and consistently to these requests, providing
constructive feedback as appropriate.
- Ensure that our focus
on public health preparedness is complemented by careful
attention to the preparedness of our health care delivery
system.
- Provide the private
sector with a single point of contact at the Department
of Health and Human Services for these initiatives.
- Report to the Secretary
periodically on:
- the nature of the requests
received,
- the timeliness with
which they are handled,
- their disposition, and
- the opportunities they
present for supporting new and existing Secretarial
initiatives.
In addition to reporting
to the Secretary, CPSI will provide feedback to the agencies
and Departments so that they can see the progress of other
requests, examine the reporting of their own activities,
and avoid the processing of duplicate requests within
their own organizations.
COMPOSITION
Recognizing the breadth
of expertise required to evaluate the private-sector requests
and the need to foster interagency and even interdepartmental
collaboration, the Secretary invited a a wide array of
Federal Agencies and Departments to serve on the Council.
As necessary, the Council can be expanded beyond these
original members.
The current members of
CPSI are heads, or their designees, of the following agencies
of the Department of Health and Human Services:
- Centers for Disease
Control and Prevention;
- Food and Drug Administration;
- National Institutes
of Health;
- Centers for Medicare
and Medicaid Services;
- Agency for Healthcare
Research and Quality;
- Assistant Secretary
for Health;
- Assistant Secretary
for Planning and Evaluation; and
- Director of the Office
of Public Health Preparedness.
In addition, the Council
also includes the heads or their designees, from the:
- Department of Defense;
- Department of Veterans
Affairs; and
- Federal Bureau of Investigation.
Invitations are being extended
to the Environmental Protection Agency and the Department
of Energy to ensure appropriate coordination across other
relevant departments.
The CPSI is being chaired
by John M. Eisenberg, M.D., Director of the Agency for
Healthcare Research and Quality.
PROCESS
Equitable access and consideration
is a key principle of the Council. The requests received
to date by the Department of Health Human Services represent
a broad range of private sector entrepreneurs ranging
from a major pharmaceutical manufacturer offering its
production capabilities to a recently disabled man, whose
company consists of only him and his wife, whose letter
presented an idea for a compact respirator.
Many large companies have
learned how to gain entry to the government; many small
companies do not have the resources and the knowledge
to even know where to begin. The HHS Council will help
level this playing field. To help ensure that all are
treated in a fair, systematic, and consistent manner,
we have set out clear process to triage requests, refer
them to the proper Agency or Department, and follow up
on the disposition.
Once received, requests
are reviewed by Council staff to determine
in which agency's (or agencies') purview the request falls.
Requests that fall under a single Agency or Department
are forwarded to a designated contact who will take whatever
action is deemed appropriate. Requests that involve multiple
Departments or Agencies may be invited to a meeting where
representatives of those agencies are present. This fosters
collaboration among the agencies and reduces the burden
that private sector companies face in trying to gain access
to multiple agencies or offices separately.
After the referral and
contact are completed, Agencies and Offices report their
actions back to the Council for tracking and reporting
purposes. Since the Council is newly formed, this process
will be evaluated and refined as we gain more experience.
CURRENT ACTIVITIES
Less than two weeks ago,
on January 23, 2002, the Council held its first meeting
at the Hubert H. Humphrey
Building. The goal of this meeting was to ensure that
the HHS agencies and our sister Federal Departments involved
in the Council had an opportunity to provide input into
the formation of the Council, its structure, and processes.
To date, we have received
requests from approximately 18 companies. Although the
Council is newly established, we have already started
work. The Council already has met with 3 companies, and
we have scheduled meetings with an additional 8. Another
5 requests are being referred to specific agencies. Two
requests are in the process of consideration.
Having attended some of
the meetings myself, I found it exciting to learn about
what is being done
in the private sector which can extend and strengthen
current public sector investments.
We have also established
a Web site - www.cpsi.ahrq.gov
- that will give companies instructions on how to submit
a request as well as provide access to the contact persons
within the Council who can provide further information.
We hope the Council will
provide opportunities for the Department of Health and
Human Services, our
Agencies, and our fellow Federal Departments to learn
from innovation in the private
sector. Further, we also hope that the Council will reduce
the frustration and burdens that
private-sector companies have faced in bringing their
ideas and products to us.
This concludes my prepared
statement. At this time, I would be happy to answer questions
from you and other Members of the Subcommittee.
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Last
revised: February 5, 2002