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Statutory Framework for the Organization and Management of the U.S. Department of Health and Human Services

Darrel J. Grinstead, J.D.

Hogan & Hartson, LLP

BACKGROUND AND PURPOSE

The purpose of this paper is to describe and analyze the relevant statutes and other legal authority under which the U.S. Department of Health and Human Service (the department or HHS) was established and is currently organized. This paper has been commissioned by the Institute of Medicine (IOM) of the National Academies to assist an ad hoc committee assembled by the IOM to examine the current mission, governance, and organizational structure of the department. The committee is charged with making recommendations to Congress and HHS to ensure that the department is aligned to meet the public health and health care challenges that our nation faces.

The department was first established as a cabinet-level entity in 1953 as the Department of Health, Education, and Welfare (HEW). The name was changed to the Department of Health and Human Services in 1980 when the education functions were spun off to the Department of Education.1 From the beginning, the department was charged with administering two major statutes that had been on the books for years prior to that time: the Social Security Act and the Public Health Service Act. These two statutes still comprise the majority of the authorities administered by the department. However, there were many other statutes and programs that completed the mission of the department, and all of this statutory authority continued to grow and change in ways designed to meet the evolving health and human services needs of the nation. This multiplicity of governing laws, and the great variety in the extent to which they con-

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P.L. 96-88, October 17, 1979.



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H Statutory Framework for the Organization and Management of the U.S. Department of Health and Human Services Darrel J. Grinstead, J.D. Hogan & Hartson, LLP BACKGROUND AND PURPOSE The purpose of this paper is to describe and analyze the relevant statutes and other legal authority under which the U.S. Department of Health and Human Service (the department or HHS) was established and is currently organized. This paper has been commissioned by the Insti- tute of Medicine (IOM) of the National Academies to assist an ad hoc committee assembled by the IOM to examine the current mission, gov- ernance, and organizational structure of the department. The committee is charged with making recommendations to Congress and HHS to en- sure that the department is aligned to meet the public health and health care challenges that our nation faces. The department was first established as a cabinet-level entity in 1953 as the Department of Health, Education, and Welfare (HEW). The name was changed to the Department of Health and Human Services in 1980 when the education functions were spun off to the Department of Educa- tion. 1 From the beginning, the department was charged with administer- ing two major statutes that had been on the books for years prior to that time: the Social Security Act and the Public Health Service Act. These two statutes still comprise the majority of the authorities administered by the department. However, there were many other statutes and programs that completed the mission of the department, and all of this statutory authority continued to grow and change in ways designed to meet the evolving health and human services needs of the nation. This multiplicity of governing laws, and the great variety in the extent to which they con- 1 P.L. 96-88, October 17, 1979. 209

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210 HHS IN THE 21ST CENTURY strain management’s organizational decisions, make it difficult to articu- late general principles or rules that will fully describe the statutory land- scape of the department’s structure and the discretion left to the secretary to reorganize the department. For that reason, this paper provides (1) an overview of the general and specific organizational authority of the secretary; (2) a discussion of how that authority has been exercised historically; (3) an analysis, based on the current organization of the department, of the specific statutory provisions that may currently constrain that authority and how those con- straints vary substantially among the different parts of the department; and (4) suggestions of means by which statutory limits on the secretary’s authority to organize the department can be addressed. A more detailed listing of statutory directions and constraints affecting the secretary’s organizational authority over the components of the department is con- tained in the appendix to this paper. GENERAL AUTHORITY OF THE SECRETARY TO ORGANIZE THE DEPARTMENT Reorganization Plan No. 1 of 1953 As noted above, the department was created, and the cabinet-level position of the secretary of health, education, and welfare was estab- lished, when President Eisenhower submitted Reorganization Plan No. 1 of 1953, which was approved by the Congress on April 1, 1953. 2 The Reorganization Plan essentially elevated the Federal Security Agency (which then contained the Social Security Administration, the Public Health Service, the Office of Education, and several smaller agencies) to cabinet status. The combined agencies were taken whole into the new department, along with the head of those agencies, such as the commis- sioner of Social Security and the surgeon general, who thereafter re- ported to the HEW secretary rather than the President. 2 Reorganization Plan No. 1 of 1953 was issued under the authority of the Reorganiza- tion Act of 1949, which gave the President broad authority to reorganize the executive branch. To eliminate any doubt over the constitutionality of such broad authority, Con- gress ratified the Reorganization Plan by passing a statue giving it an effective date. 42 U.S.C.A. § 3501. The broad authority in the Reorganization Act of 1949 has since ex- pired.

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211 APPENDIX H Although the original organization of the department reflected the preexisting organization of its constituent agencies, from the very begin- ning the secretary had broad authority to reorganize the various functions and components of the department. Section 6 of Reorganization Plan No. 1 provides: The Secretary may from time to time make such provi- sions as the Secretary deems appropriate authorizing the performance of any of the functions of the Secretary by any other officer, or by any agency or employee, of the Department. Under this authority, which is still in place, as well as under a broadly applicable statute that gives similar authority to the heads of all executive departments, 3 the secretary has authority to assign the per- formance of functions vested in him by law to subordinate officers or organizations within the department as long as such assignments are not inconsistent with law. With this important qualification, which is exam- ined later, the secretary has broad authority to reorganize the department through the redistribution of functions for which he is responsible. 4 Reorganization Plan No. 3 of 1966 Almost all of the statutory provisions that establish the programs and the mission of the department place the authority to administer those functions in the secretary. Thus, the statutes creating the Social Security Act programs administered by the department, such as Medicare and Medicaid, as well as the Public Health Service Act programs, place the authority to carry out the thousands of program functions, including the making of grants, the payment of program benefits, and the issuance of regulations, in the position of the secretary. This was not always the case. When Reorganization Plan No. 1 was issued, most of the Public Health Service Act (PHSA) authorities were placed in the surgeon general. This remained so until 1966 when Reorganization Plan No. 3 was issued. That 3 5 U.S.C. § 301 reads as follows: The head of an executive department or military de- partment may prescribe regulations for the government of his department, the conduct of its employees, the distribution and performance of its business, and the custody, use, and preservation of its records, papers, and property. 4 1980 WL 16137 (Comp. Gen.), B-199491.

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212 HHS IN THE 21ST CENTURY plan, which was also approved by the Congress, transferred all the func- tions and authority of the surgeon general to the secretary of health, edu- cation, and welfare. With the adoption of Reorganization Plan No. 3, a major statutory impediment to the exercise of the secretary’s reorganiza- tion authority with respect to Public Health Service (PHS) programs was removed. As seen later, however, in the 40-plus years since the adoption of this plan, organizational requirements imposed by statute have in- creasingly reemerged. At the time of Reorganization Plan No. 3, the PHS was composed of four agencies: the National Institutes of Health, the Bureau of Medical Services, the Bureau of State Services, and the Office of the Surgeon General. All the authorities of PHS had to be administered through one of these offices. In submitting the Reorganization Plan, the President stated that this organizational structure was outmoded in light of the many new health problems and issues that had arisen and the many new programs that had been adopted in the 20 years since that organizational structure was created. He pointed out that the secretary also administered other programs not within PHS, such as Medicare, Medicaid, and the regulation of food and drugs through the Food and Drug Administration (FDA), that required the secretary to have the ability to coordinate health activities across program lines. He therefore proposed, and Congress ap- proved, that the secretary should have broad authority to reorganize these programs according to modern principles of organizational design so that all of these programs could be administered in an integrated and efficient manner. 5 Since that time, most of the statutory authorities administered by the department have been placed in the secretary, and the theory of Reor- ganization Plan No. 3 was for the secretary to have broad discretion to organize those functions into subunits of the department; to delegate the performance of those functions to the various officers who are in charge of those subunits; and to reorganize those functions, subunits, and offi- cers largely as he sees fit. However, limits on that authority have been enacted by Congress in numerous statutory provisions creating specific offices and officials in the department and in some cases specifying the reporting relationship between those officials and the secretary. These statutory provisions impose the most significant legal constraints on the secretary’s ability to reorganize the department, and as we see later, most of these statutory directions as to how functions of the department should 5 42 U.S.C.A. § 202, note.

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213 APPENDIX H be organized apply to the programs authorized by the Public Health Ser- vice Act. HISTORY OF THE SECRETARY’S EXERCISE OF REORGANIZATION AUTHORITY Over the past 65 years of the department’s existence, secretaries have used their authority to reorganize the department in many ways. Initially, the department was organized somewhat along the lines of the combined components. Public Health Service components were originally organ- ized under the surgeon general, who reported to the secretary. The Old- Age, Survivors, and Disability Insurance (OASDI) programs remained with the commissioner of Social Security, but various other programs authorized by the Social Security Act, mainly those providing assistance to state-operated welfare programs, were delegated to a new entity cre- ated by the secretary, the commissioner of Social and Rehabilitation Ser- vices (SRS). To this new entity, through secretarial delegation, also went such programs as the Older Americans Act and the Rehabilitation Act. When Medicare and Medicaid were enacted in 1965, the secretary dele- gated Medicare to the commissioner of Social Security, presumably be- cause it was a direct assistance program with eligibility established under Title II of the Social Security Act, like the OASDI program. Medicaid, on the other hand, being a state grant program, was delegated to the commissioner of SRS. These organizational decisions were made by the secretary administratively, under his reorganization authority discussed above, because the Social Security Act and the other authorities affected were vested by statute in the secretary and contained no provisions in- structing the secretary how to organize them. In the ensuing years, the secretary used the reorganization authority discussed above to move programs around and to abolish and create of- fices and agencies as necessary to reflect mission and program changes, and to implement different theories of organization and management. Thus, in 1977, when a different secretary decided it made more sense to have the two major health care assistance programs, Medicare and Medi- caid, administered under a single administrative unit, the secretary used his authority to move both programs into a new component that he cre- ated, the Health Care Financing Administration (HCFA), under a newly created administrator. Similarly, he abolished the SRS and its commis- sioner and assigned all of its programs to a new assistant secretary for

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214 HHS IN THE 21ST CENTURY human development services. After the enactment of Reorganization Plan No. 3 in 1966, which removed the Public Health Services programs from the authority of the surgeon general and vested them in the secre- tary, the secretary redelegated those programs to the operational control of the assistant secretary for health. Those programs remained with the assistant secretary for health until 1995 when a different secretary choose to have each of the major public health programs (National Institutes of Health, Centers for Disease Control and Prevention, Substance Abuse and Mental Health Services Administration, Indian Health Service, Agency for Healthcare Research and Quality, etc.) report directly to the secretary. The secretary has similar broad authority to reorganize and assign functions to his senior staff (i.e., those officials at the assistant secretary level). Reorganization Plan No. 1 initially assigned an undersecretary (executive level 3) 6 and two assistant secretaries to the department. Ad- ditional assistant secretaries and a general counsel were subsequently added, but the functions and responsibilities of the assistant secretaries (with the exception of the assistant secretary for aging, the assistant sec- retary for families and children, and the assistant secretary for admini- stration and management) are not specified in the statute. Thus, the secretary was and remains free to change the title, role, and responsibili- ties of most of the assistant secretaries. Of the secretary’s senior staff, only the general counsel’s title and functions are specified in law. 7 The remaining senior staff positions (chief of staff, executive secretary, direc- tor of intergovernmental affairs, director of the Office for Civil Rights, etc.) are all positions created under the secretary’s general organizational authority and those positions may be abolished or changed at the secre- tary’s discretion. The purpose of the foregoing discussion has been to demonstrate the extent of the secretary’s reorganization authority over a large portion of the department’s programs. Virtually all of the programs vested in the secretary under the Social Security Act, and the remaining programs cur- rently administered through the Administration for Families and Chil- dren, are not subject to statutory constraints as to their organizational placement within the department. Nor is the secretary limited in his au- thority to organize and assign functions to his senior staff. For reasons beyond the scope of analysis in this paper, however, the programs au- 6 The position of undersecretary was elevated to deputy secretary (executive level 2) in 1990. 7 42 U.S.C.A. § 3504.

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215 APPENDIX H thorized under the Public Health Service Act and related statutes are sub- ject to considerably more direction from Congress with regard to how they should be organized and to which official they are to be assigned. The extent of those statutory constraints is discussed in the following section. Statutory Provisions Affecting the Authority to Reorganize the Department As indicated in the preceding discussion, there is great variety among the statutes authorizing the department’s programs in the extent to which they impose organizational limitations. There is also considerable variety in the types of statutory organizational directives that Congress has placed on those programs. Some discussion of the means by which Con- gress has adopted organizational instructions for the various programs may be useful. There are numerous examples in which Congress has directed that a specifically named program office be established to administer a specific program or group of programs. For example, section 306 of the PHSA provides: “There is established in the Department of Health and Human Services the National Center for Health Statistics. . . .” The act says noth- ing more about where the center is to be placed organizationally, thus giving the secretary discretion as to where it is to be located and through what official it is to report to the secretary. Where the statute creates an office to administer only a single pro- gram, this type of provision creates little or no organizational constraint on the secretary because he can place that office where he wants. This paper does not focus on such provisions. However, where Congress has created a major organizational entity that is charged with the administra- tion of a entire subset of the department’s programs (e.g., the establish- ment of the Substance Abuse and Mental Health Services Administration [SAMHSA] by section 501 of the PHSA), compliance with that statute may substantially restrict the secretary’s options for organizing his pro- grams. Those are the types of provisions examined in this paper. Some statutes, particularly the PHSA, specify that the secretary is to perform a particular program function “acting through” a particular pro- gram official or “through” a named program office (which may or may not have been created by statute). For example, numerous provisions in the PHSA provide, “The Secretary, acting through the Director of the

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216 HHS IN THE 21ST CENTURY Centers for Disease Control and Prevention [or some other PHSA agency], shall carry out a program to [make grants or conduct research in a particular area of concern].” This type of provision is also a major im- pediment to any attempt by the secretary to reassign functions as he or she deems appropriate; accordingly, we examine the effects of such pro- visions. The remainder of this section attempts to analyze the significant statutory provisions that impinge on the secretary’s authority to reorgan- ize the major programs of the department. (We do not look at the hun- dreds of advisory committees and boards created by statute, because those provisions do not affect basic organizational decisions, and in any event the secretary is able to manage and control those entities through the Federal Advisory Committee Act.) For convenience, this analysis has been organized according to the existing operating components of the department. Organizing the paper in this way is not meant to suggest that any such component must be preserved in any reorganization because, as we have seen, some of those components do not have statutory status. To make this task manageable and the paper useful, we do not list every such statutory provision. Where a type of statutory provision ap- plies to several programs within an operating component, those provi- sions are discussed generically. However, for the convenience of the committee, we have attached an appendix listing statutory provisions that we believe have to be considered in the context of any reorganization study of the department. 8 Administration for Children and Families The Administration for Children and Families (ACF) was created administratively in 1991 as the successor to the Office of Human Devel- opment Services. The programs it administers are established under title IV of the Social Security Act (including Temporary Assistance for Needy Families, Child Welfare Services, Adoption Assistance, and Child Support Enforcement) and under a variety of other statutes providing for assistance to disadvantaged and vulnerable populations (refugees, disad- vantaged children, Native Americans, and individuals with disabilities). 8 While we have attempted to be thorough in identifying the relevant statutory provi- sions, given the time allotted and the size of the task, we cannot guarantee that our listing is exhaustive. Further research may be warranted in light of particular options that are developed by the committee.

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217 APPENDIX H ACF is headed by an assistant secretary appointed by the President and confirmed by the Senate. That position was created by section 416 of the Social Security Act as the “Assistant Secretary for Family Support.” The only duty of that office specified by law is administration of the Tempo- rary Assistance for Needy Families block grant program and the Child Support and Establishment of Paternity program; however, nothing pre- vented the secretary from assigning the assistant secretary additional du- ties, so the title of that position was changed administratively to the “Assistant Secretary for Children and Families.” We could find no other statutory provisions limiting the secretary’s authority to reorganize or reassign any of these programs or officials to other parts of the depart- ment. Administration on Aging Of the non-PHS agencies in the department, the Administration on Aging (AoA) is subject to the most limiting statutory provisions dictating its organizational placement and structure. Section 201 of the Older Americans Act 9 establishes the Administration on Aging and creates the position of assistant secretary for aging, appointed by the President with the advice and consent of the Senate. The statute requires that there be a direct reporting relationship between the assistant secretary and the sec- retary, and in performing his functions under the statute the assistant sec- retary must be directly responsible to the secretary. None of the functions of AoA (including those carried out in the regional offices) may be dele- gated to an official who is not directly responsible to the secretary. The statute also specifies the creation of certain offices within AoA, including an Office for American Indians, Alaskan Natives, and Hawai- ian Programs; an Office of Long-Term Ombudsman Program; and an office responsible for elder abuse and prevention services. Centers for Medicare and Medicaid Services (CMS) As discussed earlier, programs authorized under the Social Security Act (SSA), such as Medicare and Medicaid, are subject to almost no statutory directions or limitations with respect to how or where they are 9 42 U.S.C.A. § 3011.

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218 HHS IN THE 21ST CENTURY organized. The secretary has discretion to assign the administration of those programs to whatever entity within the department he may choose or create and to designate the official he chooses to be in charge of those programs. Likewise, there are no statutory directions or limitations on the internal organization of whatever unit he specifies to administer those programs. As we have seen, no statutory provision directs that Medicare and Medicaid, or any of the components thereof, be administered by the same organizational unit within the department. The only statutory provisions we have found that appear to affect the organization of CMS are in section 1117 of the SSA. Subsection (a) thereof requires that the administrator of the Health Care Financing Ad- ministration (HCFA) shall be appointed by the President with the advice and consent of the Senate. Subsection (b) establishes within the admini- stration the position of chief actuary, requires that he be in direct line authority to the administrator, and specifies that he may be removed only for cause. Interestingly, section 1117 does not create the position of ad- ministrator; it merely requires that it be an advice and consent position. That provision did not prevent the secretary from renaming HCFA as the Centers for Medicare and Medicaid Services in 2001, nor would it seem to prevent the secretary from eliminating that position and/or reorganiz- ing the functions thereof. Agency for Healthcare Research and Quality Section 901 of the PHSA establishes within PHS the Agency for Healthcare Research and Quality (AHRQ) and specifies that it be headed by a director appointed by the secretary. The statute requires that the functions of the agency specified in title IX of the PHSA shall be carried out through the director. Title IX contains no other organizational directions or limitations on AHRQ. However, other parts of the PHSA contain a number of provi- sions directing the secretary to carry out certain functions through AHRQ (e.g., the conduct of studies to support organ donation and organ recov- ery, preservation, and transportation [sec. 377C]; the conduct of a re- search, evaluation, and assessment program on the impact and cost- effectiveness of HIV treatments [sec. 2673]). (The appendix to this paper contains a list of the provisions.) There are other provisions requiring or encouraging consultation with AHRQ by the secretary and other officials

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219 APPENDIX H with respect to certain of their functions, but these do not seem to im- pinge on organizational decisions. Centers for Disease Control and Prevention The Centers for Disease Control and Prevention (CDC) began life as the Communicable Disease Center in 1946. It was transferred to the new Department of Health, Education, and Welfare along with other parts of the Public Health Service in 1953 under Reorganization Plan No. 1. Its name was changed to the Center for Disease Control in 1970 (apparently without statutory direction or ratification) and changed again administra- tively to the Centers for Disease Control and Prevention in 1980 to re- flect a new organization of the agency. So far as we can ascertain, all this was done without explicit statutory authority, because we can find no statute creating or naming the agency, although by this date there were many references in the Public Health Service Act and other statutes to the Center for Disease Control. However, in 1992, P.L. 102-531 amended all statutory references to the Center for Disease Control to the Centers for Disease Control and Prevention. Since there is no statute establishing CDC or its director, or directing how or through whom it reports to the secretary, the secretary has con- siderable discretion as to how it is organized, where it should be placed within the department, and what its relationship should be to other com- ponents that have related missions. However, the statute is very specific with respect to the programs that are to be administered through CDC. Although there are few directions in law as to the internal organization of CDC, 10 the Public Health Service Act is replete with provisions directing that various programs or activities of the PHS shall be carried out “through” the CDC. While not dictating a particular organizational struc- ture or reporting relationship, these dozens of statutory provisions will have to be taken into account in any restructuring of PHS programs. The functions and activities that the statute requires to be performed through CDC are listed in the appendix. 10 Section 317C of the PHSA establishes within CDC a center to be known as the Na- tional Center for Birth Defects and Developmental Disabilities. We are not aware of other organization entities that are made part of CDC by statute. The National Institute of Oc- cupational Safety and Health was established within HHS in 1970 (29 U.S.C.A. § 671), but its organizational placement within CDC was an administrative decision.

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264 HHS IN THE 21ST CENTURY in the U.S. House of Representatives. He received a B.A. from Colgate University and his J.D. from Albany Law School. Kathleen Buto, M.P.A., is vice president for health policy, government affairs, at Johnson & Johnson (J&J). She has responsibility for providing policy analysis and developing positions on a wide range of issues, in- cluding the Medicare drug benefit, government reimbursement, coverage of new technologies, and regulatory requirements. In addition to review- ing how federal, state, and international government policies affect J&J products and customers, she is responsible for helping to identify areas of opportunity for J&J to take leadership in shaping health care policy. Prior to joining J&J, Kathy was a senior health adviser at the Congressional Budget Office, helping to develop the cost models for the Medicare drug benefit. Before that, she spent more than 18 years in senior positions at the Health Care Financing Administration, including deputy director, Center for Health Plans and Providers, and associate administrator for policy. In these positions, she headed the policy, reimbursement, and coverage functions for the agency, as well as managing Medicare’s fee- for-service and managed care operations. Ms. Buto received her bachelor of arts from Douglass College and her master’s in public administration from Harvard University. Molly Joel Coye, M.D., is founder and CEO of the Health Technology Center (HealthTech), a nonprofit education and research organization established in 2000 to advance the use of beneficial technologies in pro- moting healthier people and communities. Dr. Coye is vice chair of the Board of Directors of the Program for Appropriate Technology in Health, one of the largest and most innovative nonprofit organizations working in international health; a member of the Board of Directors of Aetna, Inc.; and a member of the Advisory Council for the Health Evolu- tion Partners Innovation Network and the Institute of Medicine. Dr. Coye has served as commissioner of health for the State of New Jersey and director of the California Department of Health Services; head of the Di- vision of Public Health at the Johns Hopkins School of Hygiene and Pub- lic Health; executive vice president for HealthDesk Corp. and the Good Samaritan Health System in San Jose, California; and director of the Lewin Group West Coast office. She has served on the Board of Trustees of the American Hospital Association and the American Public Health Association, the Board of Directors of the California Endowment, and

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265 APPENDIX I the China Medical Board, and as a member of the National Academy of Public Administration. Robert Graham, M.D., is professor of family medicine, and the Robert and Myfanwy Smith Chair in the Department of Family Medicine at the University of Cincinnati, School of Medicine, a position he has held since March of 2005. Dr. Graham has previously been associated with the discipline of family medicine as the executive vice president-CEO of the American Academy of Family Physicians (1985–2000), the head of the Academy’s Foundation (1988–1997), and the administrative officer of the Society of Teachers of Family Medicine (1973–1975). In addition to his activities in family medicine, Dr. Graham has held a number of leadership responsibilities in the federal health sector, including the posi- tion of administrator of the Health Resources and Services Administra- tion (HRSA) (1981–1985), during which time he held the rank of rear admiral in the Commissioned Corps of the U.S. Public Health Service and served as an assistant surgeon general. He also served in senior posi- tions at the Agency for Healthcare Research and Quality (2001–2004), HRSA (1976–1979), and the Health Services and Mental Health Admini- stration (1970–1973). From 1979–1980, he served as a professional staff member of the U.S. Senate Subcommittee on Health. Mark B. McClellan, M.D., Ph.D., is the director of the Engelberg Cen- ter for Health Care Reform at the Brookings Institution. McClellan is also the Leonard D. Schaeffer Chair in Health Policy. Dr. McClellan has a highly distinguished record in public service and in academic research. He is the former administrator for the Centers for Medicare and Medi- caid Services (2004–2006) and the former commissioner of the Food and Drug Administration (2002–2004). He also served as a member of the President’s Council of Economic Advisers and senior director for health care policy at the White House (2001–2002). In the Clinton administra- tion, Dr. McClellan was deputy assistant secretary of the treasury for economic policy from 1998–1999, supervising economic analysis and policy development on a range of domestic policy issues. Dr. McClellan was also an associate professor of economics and associate professor of medicine (with tenure) at Stanford University, from which he was on leave during his government service. He directed Stanford’s Program on Health Outcomes Research and was also associate editor of the Journal of Health Economics, and coprincipal investigator of the Health and Re- tirement Study, a longitudinal study of the health and economic status of

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266 HHS IN THE 21ST CENTURY older Americans. A graduate of the University of Texas at Austin, Dr. McClellan earned his M.P.A. from Harvard’s Kennedy School of Gov- ernment in 1991, his M.D. from the Harvard-Massachusetts Institute of Technology (MIT) Division of Health Sciences and Technology in 1992, and his Ph.D. in economics from MIT in 1993. He completed his resi- dency training in internal medicine at Brigham and Women’s Hospital, Boston. Dr. McClellan has been board certified in internal medicine and has been a practicing internist during his academic career. Stanley B. Prusiner, M.D., is the director of the Institute for Neurode- generative Diseases at the University of California, San Francisco (UCSF). Dr. Prusiner discovered prions, a class of infectious self- reproducing pathogens primarily or solely composed of protein. For his prion research he received the Albert Lasker Award for Basic Medical Research in 1994 and the Nobel Prize in physiology or medicine in 1997. He received a bachelor of science degree in chemistry from the Univer- sity of Pennsylvania and later received his M.D. from the University of Pennsylvania School of Medicine. He then completed an internship in medicine at UCSF. Later he moved to the National Institutes of Health (NIH), where he studied glutaminases in Escherichia coli in the labora- tory of Earl Stadtman. After three years at NIH, Dr. Prusiner returned to UCSF to complete a residency in neurology. Upon completion of the residency in 1974, he joined the faculty of the UCSF Neurology Depart- ment. Since that time, he has held various faculty and visiting faculty positions at both UCSF and UC Berkeley. Dr. Prusiner won the Nobel Prize in physiology or medicine in 1997 for his discovery of prions—a new biological principle of infection. He coined the term prion, which comes from “proteinaceous infectious particle” to refer to a previously undescribed form of infection due to protein misfolding. He was elected to the National Academy of Sciences in 1992 and to its governing coun- cil in 2007. He is also an elected member of the American Academy of Arts and Sciences (1993), the Royal Society (1996), the American Phi- losophical Society (1998), the Serbian Academy of Sciences and Arts (2003), and the Institute of Medicine. Donna E. Shalala, Ph.D., became professor of political science and president of the University of Miami on June 1, 2001. President Shalala has more than 25 years of experience as an accomplished scholar, teacher, and administrator. Born in Cleveland, Ohio, President Shalala received her A.B. in history from Western College for Women and her

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267 APPENDIX I Ph.D. from the Maxwell School of Citizenship and Public Affairs at Syracuse University. A leading scholar on the political economy of state and local governments, she has also held tenured professorships at Co- lumbia University, the City University of New York (CUNY), and the University of Wisconsin–Madison. She served as president of Hunter College of CUNY from 1980 to 1987 and as chancellor of the University of Wisconsin–Madison from 1987 to 1993. In 1993, President Clinton appointed her secretary of the Department of Health and Human Services (HHS), where she served for eight years, becoming the longest-serving HHS secretary in U.S. history. Stephen M. Shortell, Ph.D., M.P.H., is the Blue Cross of California Distinguished Professor of Health Policy and Management and professor of organization behavior at the University of California, Berkeley, and is dean of the School of Public Health. Dr. Shortell is known as a leading academic voice advocating reform of the nation’s health system. His re- search has helped establish determinants of health outcomes and quality of care for health care organizations. As the Blue Cross of California Distinguished Professor of Health Policy and Management, Shortell holds a joint appointment at University of California (UC) Berkeley’s School of Public Health and the Haas School of Business. He also is af- filiated with UC Berkeley’s Department of Sociology and UC San Fran- cisco’s Institute for Health Policy Studies. Dr. Shortell has received the Baxter-Allegiance Prize, considered the highest honor worldwide in the field of health services research. He also has received the Distinguished Investigator Award from the Association for Health Services Research and the Gold Medal from the American College of Healthcare Execu- tives for his contributions to the field. Dr. Shortell received his bache- lor’s degree from the University of Notre Dame, his master’s degree in public health from the University of California at Los Angeles, and his Ph.D. in behavioral science from the University of Chicago. Before com- ing to UC Berkeley in 1998, Dr. Shortell held teaching and research posi- tions at Northwestern University, the University of Washington, and the University of Chicago. Susanne A. Stoiber, M.P.A., M.S., is currently consulting with the Commonwealth Fund High Performance Health Care System project. Previously, she has served in a series of senior positions in the National Academies and the U.S. Department of Health and Human Services from 1975 through 2007. She was named executive director (chief operating

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268 HHS IN THE 21ST CENTURY officer) of the Institute of Medicine in 1998. Her responsibilities in- cluded management of IOM program operations and support of the Insti- tute’s governance and membership functions. In the Department of Health and Human Services, Ms. Stoiber held a number of senior posi- tions in the Office of the Secretary and at the National Institutes of Health. She was three times appointed as a deputy assistant secretary for health—planning and evaluation (1979 and 1995); health promotion and disease prevention (1996); and deputy assistant secretary for planning and evaluation, program systems (1997). Her accomplishments included coordination of Healthy People 2010—the nation’s prevention agenda, and oversight of the department’s evaluation program and Government Performance and Results Act–related strategic planning. She received her bachelor of arts and master of public administration degrees from the University of Colorado, and a master of science degree from the London School of Economics. Louis W. Sullivan, M.D., is the founding dean and first president of the Morehouse School of Medicine (MSM). With the exception of his tenure as secretary of the U.S. Department of Health and Human Services from 1989 to 1993, he was president of MSM for more than two decades. On July 1, 2002, he left the presidency, but continues to assist in national fundraising activities on behalf of the school. A native of Atlanta, Geor- gia, Dr. Sullivan graduated magna cum laude from Morehouse College in 1954 and earned his medical degree cum laude from Boston University School of Medicine in 1958. He is certified in internal medicine and he- matology. In 1975, Dr. Sullivan became the founding dean and director of the medical education program at Morehouse College. In 1989, he accepted an appointment by President George H. W. Bush to head HHS. In this post, Sullivan managed the federal agency responsible for the ma- jor health, welfare, food and drug safety, medical research, and income security programs serving the American people. In January 1993, he re- turned to MSM and resumed the office of president. A member of nu- merous medical organizations, including the American Medical Association and the National Medical Association, Dr. Sullivan was the founding president of the Association of Minority Health Professions Schools. He is a former member of the Joint Committee on Health Policy of the Association of American Universities and the national Association of Land Grant Colleges and Universities. He was a member of the Sulli- van Commission on the Future of Higher Education (2007) and chairman of the Sullivan Commission on Diversity in the Healthcare Workforce

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269 APPENDIX I (2003–2004). He is chairman of the Sullivan Alliance to Transform the Health Professions and is chairman of the National Health Museum. David N. Sundwall, M.D., is a primary care physician who has more than two decades of experience in public policy and service. After 23 years of working in various government and private-sector health posi- tions in Washington, DC, he has returned home to lead the Utah Depart- ment of Health. He currently serves as president of the Association of State and Territorial Health Officers. Dr. Sundwall earned his medical degree at the University of Utah College of Medicine and completed fur- ther training at the Harvard Family Medicine Residency Program. He remains on the faculty of the University of Utah School of Medicine as associate professor in the Department of Family and Preventive Medi- cine. In a distinguished career of academic appointments, public service, and policy development, Dr. Sundwall has been widely recognized for his professional achievements and contributions to health care policy and advocacy. He holds three medical school faculty appointments, including clinical associate professor, Department of Community and Family Medicine, Georgetown University College of Medicine, Washington, DC. He has held numerous positions in the public health sector: From 1994 to 2004, he was president of the American Clinical Laboratory As- sociation; from 1988 to 1994, he was vice president and medical director of American Healthcare Systems, an alliance of not-for-profit multihos- pital systems. Prior to that appointment, he was an administrator in the Health Resources and Services Administration. Dr. Sundwall has served as an adviser, task force member, and chairman of numerous committees involved with public health policy and quality, including those connected with the Centers for Disease Control and Prevention and the Food and Drug Administration. In addition, his federal experience included serving as the assistant surgeon general in the Commissioned Corps of the U.S. Public Health Service. During this period, he had adjunct responsibilities at the Department of Health and Human Services (HHS), including co- chairman of the HHS secretary’s Task Force on Medical Liability and Malpractice, and was the HHS secretary’s designee to the National Commission to Prevent Infant Mortality. Gail L. Warden, serves as president emeritus of the Detroit-based Henry Ford Health System and served as its president and CEO from April 1988 to 2003. Prior to this role, Mr. Warden served as president and CEO of Group Health Cooperative of Puget Sound as well as executive

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270 HHS IN THE 21ST CENTURY vice president of the American Hospital Association. He serves as a di- rector of Picker Institute Inc. He has been a director of National Research Corp. since January 2005. He served as a director of Comerica Inc. from July 2000 to December 31, 2006. Mr. Warden serves in numerous lead- ership positions as chairman of several national health care committees and as board member for many other health care–related committees and institutions. In addition, he is a professor of health management and pol- icy for the University of Michigan School of Public Health. He serves the Detroit, Michigan, community through memberships on various local governing committees and groups. Mr. Warden received an honorary doctorate in public administration from Central Michigan University and an honorary doctorate of humane letters from Rosalind Franklin Univer- sity of Medicine and Science; a master of hospital administration from the University of Michigan; and a bachelor of arts from Dartmouth Col- lege. Myrl Weinberg, M.A., is president of the National Health Council, the only organization of its kind that brings together all segments of the health care community to provide a united voice for 100 million people with chronic diseases and disabilities and their family caregivers. Made up of 120 national health-related organizations, its core membership in- cludes 50 of the nation’s leading patient advocacy groups. Ms. Weinberg has served on the health sciences policy board of the Institute of Medi- cine, the board of the AcademyHealth Coalition for Health Services Re- search, as a founding member of the Association for the Accreditation of Human Research Protection Programs, and is chair of the governing board of the International Alliance of Patients’ Organizations. She also served on the congressionally mandated IOM committee created to as- sess how research priorities are established at the National Institutes of Health (NIH) and was a member of the National Research Council- Institute of Medicine committee on the organizational structure of NIH. Ms. Weinberg earned a bachelor’s degree in psychology at the Univer- sity of Arkansas and a master’s degree in special education at George Peabody College. Catherine E. Woteki, Ph.D., is global director of scientific affairs for Mars, Inc., a multinational food, confectionery, and pet care company. She joined Mars, Inc., in August 2005 and, in this role, manages the company’s scientific and regulatory positions on matters of health, nutri- tion, and food safety. Prior to joining Mars, Inc., Dr. Woteki held posi-

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271 APPENDIX I tions in academia and government. From 2002 to 2005, she was dean of agriculture and professor of human nutrition at Iowa State University. From 1997 to 2001, she served as the first undersecretary for food safety at the U.S. Department of Agriculture (USDA), overseeing the Food Safety and Inspection Service and the U.S. government’s Office for the Codex Alimentarius Commission, and coordinating U.S. government food safety policy development and USDA’s continuity of operations planning. She also worked for two years in the White House Office of Science and Technology Policy, where she coauthored the Clinton ad- ministration’s science policy statement “Science in the Public Interest,” and served as the deputy undersecretary for research in USDA. Dr. Woteki is a nutritional epidemiologist, and her research interests include nutrition and food safety policy, risk assessment, and health survey de- sign and analysis. Staff Biographies Judith A. Salerno, M.D., M.S., is executive officer of the Institute of Medicine of the National Academies. Dr. Salerno served as deputy direc- tor of the National Institute on Aging (NIA) at the National Institutes of Health from 2001 to 2007, where she had oversight of more than $1 bil- lion in aging research conducted and supported annually by the NIA, including research on Alzheimer’s and other neurodegenerative diseases; frailty and function in late life; and the social, behavioral, and demo- graphic aspects of aging. A geriatrician, Dr. Salerno is vitally interested in improving the health and well-being of older persons, and has de- signed public-private initiatives to address aging stereotypes, novel ap- proaches to support training of new investigators in aging, and award- winning programs to communicate health and research advances to the public. Before joining the NIA in 2001, Dr. Salerno directed the contin- uum of geriatrics and extended care programs across the country for the U.S. Department of Veterans Affairs (VA), Washington, DC. While at the VA, she launched widely recognized national initiatives for pain management and improving end-of-life care and directed a national pro- gram of geriatric and long-term care services of more than $3 billion an- nually. Dr. Salerno earned her M.D. degree from Harvard Medical School in 1985 and a master of science degree in health policy from the Harvard School of Public Health in 1976. She also holds a certificate of added qualifications in geriatric medicine and was associate clinical pro-

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272 HHS IN THE 21ST CENTURY fessor of health care sciences and of medicine at the George Washington University until 2001. Andrea M. Schultz, M.P.H., is an associate program officer in the Ex- ecutive Office of the Institute of Medicine. Ms. Schultz joined the IOM Board on Health Sciences Policy in 2004 where she worked on a number of reports, including Genes, Behavior, and the Social Environment: Mov- ing Beyond the Nature/Nurture Debate; Reusability of Facemasks Dur- ing an Influenza Pandemic: Facing the Flu; Organ Donation: Opportunities for Action; and Cord Blood: Establishing a National He- matopoietic Stem Cell Bank Program. In 2006 she moved to the IOM’s Executive Office and Office of Reports and Communications where she provided health policy research support on a variety of issues for the IOM president and executive officer, coordinated an effort to collect and catalog impact data on IOM reports, and helped lead the IOM’s Quality Improvement effort. Currently Ms. Schultz is working with the IOM’s Committee on Improving the Organization of the U.S. Department of Health and Human Services to Advance the Health of Our Population. She received her M.P.H. in health policy with honors in August 2007 from George Washington University. Her capstone project analyzed key state-level health care reform initiatives. Ms. Schultz received her B.S. in cellular molecular biology from the University of Michigan in 2004. Katharine Bothner is a research associate in the Institute of Medicine’s Executive Office. She began working with the IOM in October 2006 as a senior program assistant with the Roundtable on Evidence-Based Medi- cine. She received a B.S. in chemistry with high distinction from the University of Virginia in 2004. With a focus in biochemistry, she con- ducted her thesis research on a cytostatic cancer therapy involving cal- cium channels. After completing her undergraduate studies, Ms. Bothner taught high school science for two years in Baltimore, Maryland, with Teach for America. More than 70 percent of her biology students passed the Maryland High School Assessment test, a figure nearly twice the city average. Amy Packman is the administrative assistant for the Board on Health Sciences Policy. She previously served as a senior project assistant for the Clinical Research Roundtable. Prior to joining the IOM, she worked as a project manager for a medical education and publishing firm in

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273 APPENDIX I Washington, DC. She graduated from Whitman College in Walla Walla, Washington, with a B.A. in biology. Judith L. Estep is a program associate with the Board on Health Sci- ences Policy. She has worked at the National Academies-Institute of Medicine since 1986 and has provided administrative support for more than 56 published reports. Her interests outside the Institute of Medicine include family (13 grandchildren), reading, needlework, 4-wheeling, and working her draft horses for competition.

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