Testimony on Fighting Bioterrorism
The HHS Role in Using America's Scientists and Entrepreneurs to
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Lisa A. Simpson, M.B., B.Ch., M.P.H., Deputy Director, AHRQ, HHS
Testimony Before the Committee on Commerce, Science, and Transportation—Subcommittee on Science, Technology, and Space
United States Senate
Good morning. I am very pleased to be here today to discuss an exciting new effort at the Department of Health and Human Services (HHS) that 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 in Government who have the knowledge to evaluate them.
I would now like to describe the Council to you, focusing specifically on its charge, its composition, the process for submitting request, and its current activities.
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.
- 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.
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.
- 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.
- 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.
Equitable access and consideration is a key principle of the Council. The requests received to date by the Department of Health and 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.
Less than 2 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 three companies, and we have scheduled meetings with an additional eight. Another five 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.
Current as of February 2002