HHS in the 21st Century Charting a New Course for a Healthier America (2009) / Chapter Skim
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Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services
Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services
Pages 209-274
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From page 209... ...
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.
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From page 210... ...
1 of 1953 was issued under the authority of the Reorganization 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, Congress ratified the Reorganization Plan by passing a statue giving it an effective date.
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From page 211... ...
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.
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From page 212... ...
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.
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From page 213... ...
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 instructing 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 offices and agencies as necessary to reflect mission and program changes, and to implement different theories of organization and management.
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From page 214... ...
3 in 1966, which removed the Public Health Services programs from the authority of the surgeon general and vested them in the secretary, 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.)
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From page 215... ...
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.
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From page 216... ...
." This type of provision is also a major impediment to any attempt by the secretary to reassign functions as he or she deems appropriate; accordingly, we examine the effects of such provisions. The remainder of this section attempts to analyze the significant statutory provisions that impinge on the secretary's authority to reorganize the major programs of the department.
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From page 217... ...
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.
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From page 218... ...
The only statutory provisions we have found that appear to affect the organization of CMS are in section 1117 of the SSA. Subsection (a)
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From page 219... ...
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 structure or reporting relationship, these dozens of statutory provisions will have to be taken into account in any restructuring of PHS programs.
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From page 220... ...
The only statutory provisions we could find relating to particular components of FDA are (1) the Best Pharmaceuticals for Children Act, adopted in 2002, which created within FDA an Office of Pediatric Therapeutics, and (2)
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From page 221... ...
All of these reorganization authorities may override the specific statutory organizational provisions discussed above. 12 The relevant committees are the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate.
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, which was created administratively in 1982 by combining several offices (including the Health Resources Administration, the Health Services Administration, the Bureau of Health Facilities, and the Bureau of Health Professions) into a single agency.
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. That section requires that the administrator of the agency shall report directly to the surgeon general, but since all of his functions and authority were transferred to the secretary by the 1966 Reorganization Plan, the direct reporting relationship is to the secretary.
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Indian Health Service The Indian Health Service (IHS) was established by statute as part of the PHS by section 601 of the Indian Health Care Improvement Act of 1988.
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He or she is appointed by the President, with Senate confirmation, and is directly responsible to the secretary of veterans affairs for the operation of the Veterans Health Administration, including all health functions and facilities of the department. Unlike most other presidential appointees in the executive branch, the undersecretary is required to be appointed without regard to political affiliation or activity, but rather on the basis of professional qualifications as a health care practitioner or administrator and prior experience in connection with veterans health programs (38 U.S.C.A.
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From page 226... ...
ADDRESSING STATUTORY ORGANIZATIONAL ISSUES IN A REORGANIZATION As we have seen, statutory provisions that establish or direct organizational features of the department differ in the extent to which they create a serious barrier to administrative reorganization. For example, the mere creation of an office to carry out a given function, does not constrain the ability of the secretary to place that function or office where he or she sees fit.
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From page 227... ...
Section 201 of the PHSA states that "[t] he Public Health Service in the Department of Health and Human Services shall be administered by the Assistant Secretary for Health under the supervision and direction of the Secretary." Yet that provision did not prevent the secretary from reorganizing the functions of PHS to create a direct reporting relationship between the secretary and the major components of the PHS.
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From page 228... ...
In general, [t] he Secretary of Health and Human Services, acting through the Administration of Chil dren and Families, in partnership with the Secretary of Housing and Urban Development, shall award grants, contracts, or coop erative agreements for a period of not less than 2 years to eligible entities to develop long-term sustainability and self-sufficiency options for adult and youth victims of domestic violence, dating violence, sexual assault, and stalking who are currently homeless or at risk for becoming homeless." (42 U.S.C.
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From page 229... ...
§ 299b-1. Subchapter on Agency for Healthcare Research and Quality.
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Improvement of effectiveness and efficiency; (A) In general; To improve the quality, effectiveness, and efficiency of health care delivered pursuant to the programs established under titles XVIII, XIX, and XXI of the Social Security Act … the Secretary acting through the Director of the Agency for Healthcare Research and Quality (in this section referred to as the ‘Director')
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From page 231... ...
Research on effective interventions in the health care setting.) Centers for Disease Control and Prevention • "(e)
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§ 201 et seq.] , the Secretary, acting through the Direc tor of the Centers for Disease Control and Prevention, shall make awards of grants or cooperative agreements to provide technical assistance to State agencies to complement an intramu ral program and to conduct applied research related to newborn and infant hearing screening, evaluation and intervention pro grams and systems." (42 U.S.C.
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From page 233... ...
• "(a) Surveillance on juvenile diabetes; The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall develop a sentinel system to collect data on ju venile diabetes, including with respect to incidence and preva lence, and shall establish a national database for such data." (42 U.S.C.
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From page 234... ...
In general; The Secre tary, acting through the Director of the Centers for Disease Con trol and Prevention and in collaboration with the Director of the Indian Health Service, shall establish a demonstration project that is designed to assist rural water systems in successfully im plementing the water fluoridation guidelines of the Centers for Disease Control and Prevention that are entitled ‘Engineering and Administrative Recommendations for Water Fluoridation, 1995' (referred to in this subsection as the ‘EARWF')
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From page 235... ...
In general; Not later than 180 days after October 27, 1992, the Secretary, acting through the Director of the Centers for Disease Control and Prevention and in consultation with the Administrator of the Health Resources and Services Administration, shall enter into negotiations with manufacturers of vaccines for the purpose of establishing and maintaining agreements under which entities described in para graph (2) may purchase vaccines from the manufacturers at the prices specified in the agreements." (42 U.S.C.
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From page 236... ...
• "(a) In general; The Secretary, acting through the Director of the Centers for Disease Control and Prevention, in collaboration with the Administrator of the Health Resources and Services Administration and the heads of other agencies, and in consulta tion with appropriate health professional associations, shall de velop and carry out a program to educate and train health professionals in effective strategies to -- (1)
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From page 237... ...
In general; The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall, subject to the availability of appropriations, award grants or cooperative agreements for the establishment of regional centers of excel lence in autism spectrum disorder and other developmental dis abilities epidemiology for the purpose of collecting and analyzing information on the number, incidence, correlates, and causes of autism spectrum disorder and other developmental dis abilities." (42 U.S.C.
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From page 238... ...
§ 300cc-15. Subchapter on Research with Re spect to Acquired Immune Deficiency Syndrome.
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From page 239... ...
Establishment of office with respect to minority health and acquired immune deficiency syndrome.)
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From page 240... ...
• "(a) Comprehensive information plan; The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall annually prepare a comprehensive plan, in cluding a budget, for a National Acquired Immune Deficiency Syndrome Information Program.
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§ 371. Federal Food, Drug, and Cosmetic Act.
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Federal Food, Drug, and Cosmetic Act. Miscellaneous.
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in the fields of biomedical and behavioral research." "(i) Data bank of information on clinical trials for drugs for seri ous or life-threatening diseases and conditions; (1)
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General Provisions Respecting National Research In stitutes. Directors of national research institutes.)
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General Provisions Respecting national Research Insti tutes. Program for pediatric studies of drugs.)
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• "(a) Applications for biomedical and behavioral research grants, cooperative agreements, and contracts; regulations; (1)
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ap plications made for biomedical and behavioral research and de velopment contracts to be administered through the National Institutes of Health." (42 U.S.C.
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From page 248... ...
with an outpatient clinical capacity equal to not less than twice the outpatient clinical capacity, with respect to acquired immune deficiency syndrome, possessed by the Clinical Center of the National Institutes of Health on June 1, 1988; and (B) with such personnel, such administrative support, and such other support services as may be necessary." (42 U.S.C.
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From page 249... ...
§ 300cc-45. Subchapter on Research with Re spect to Acquired Immune Deficiency Syndrome.
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From page 250... ...
Agency status The Indian Health Service shall be an agency within the Public Health Service of the Department of Health and Human Ser vices, and shall not be an office, component, or unit of any other agency of the Department." (25 U.S.C.
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From page 251... ...
§ 1621d, which requires the Secretary, acting through the [Indian Health] Service, to conduct a study of the feasibility and desirability of funding hospice services for Indians.
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From page 252... ...
• "(a) Program authorized; The Secretary, acting through the Di rector of the Prevention Center, may make grants to public and nonprofit private entities to develop and implement model sub stance abuse prevention programs to provide early intervention and substance abuse prevention services for individuals of high risk families and the communities in which such individuals re side." (42 U.S.C.
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From page 253... ...
Youth inter agency research, training, and technical assistance centers.) • "In general; The Secretary, acting through the Director of the Center for Mental Health Services, and in consultation with the Director of the Center for Substance Abuse Treatment, the Ad ministrator of the Office of Juvenile Justice and Delinquency Prevention, and the Director of the Special Education Programs, shall award grants on a competitive basis to State or local juve nile justice agencies to enable such agencies to provide aftercare services for youth offenders who have been discharged from fa cilities in the juvenile or criminal justice system and have serious emotional disturbances or are at risk of developing such distur bances." (42 U.S.C.
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From page 254... ...
(B) Dissemination of information; The Secretary, acting through the Administrator of the Substance Abuse and Mental Health Services Administration, shall disseminate infor mation and materials relative to such model programs to the State agencies responsible for the administration of substance abuse prevention, treatment, and rehabilitation activities and shall, to the extent feasible provide technical assistance to such agencies as requested." (42 U.S.C.
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From page 255... ...
Activities of center for substance abuse prevention; Of the amounts reserved under paragraph (1) for a fiscal year, the Secretary, acting through the Director of the Center for Substance Abuse Prevention, shall ob
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From page 256... ...
, acting through the Adminis trator of the Health Resources and Services Administration, shall make awards of grants or cooperative agreements to de velop statewide newborn and infant hearing screening, evalua tion and intervention programs and systems for the following purposes": [To develop and monitor the efficacy of statewide newborn and infant hearing screening, evaluation and intervention programs and systems]
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From page 257... ...
, acting through the Adminis trator of the Health Resources and Services Administration, shall make awards of grants or cooperative agreements to de velop statewide newborn and infant hearing screening, evalua tion and intervention programs and systems for the following purposes…." (42 U.S.C.
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From page 258... ...
Report to Congress; Not later than the end of fiscal year 2011, the Secretary, acting through the Administrator of the Health Resources and Services Administration, shall submit a report to the Congress -- (i) sum marizing the information submitted in reports to the Secretary under subparagraph (B)
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From page 259... ...
Establishment of program; The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall make grants to eligible entities to pay the Federal share of the cost of providing the services speci fied in subsection (b) of this section to families in which a mem ber is -- (A)
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From page 260... ...
• "Grants; The Secretary, acting through the Director of the Health Resources and Services Administration, shall award grants under this section to develop interdisciplinary training and education programs that provide undergraduate, graduate, post graduate medical, nursing (including advanced practice nursing students) , and other health professions students with an under standing of, and clinical skills pertinent to, domestic violence, sexual assault, stalking, and dating violence." (42 U.S.C.
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From page 261... ...
, shall award grants to eligible entities to enable such entities -- [to carry out various activities to enhance, improve or expand the ability of State and local public health agencies to provide screening, counseling, or health care services to newborns and children having or at risk for heritable disor ders]
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From page 262... ...
• "(a) In general; The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall award grants to public and nonprofit private entities (including a health facility operated by or pursuant to a contract with the In dian Health Service)
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From page 263... ...
Beier, J.D., is senior vice president of global government and corporate affairs for Amgen. In this role, he is responsible for shaping Amgen's policy on global health care issues; driving health economics and outcomes research; overseeing corporate communications and philanthropy; and managing relationships with U.S.
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From page 264... ...
In addition to reviewing 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.
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From page 265... ...
Graham has held a number of leadership responsibilities in the federal health sector, including the position of administrator of the Health Resources and Services Administration (HRSA)
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From page 266... ...
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 University of Pennsylvania and later received his M.D.
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From page 267... ...
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.
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From page 268... ...
A member of numerous 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.
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From page 269... ...
He has held numerous positions in the public health sector: From 1994 to 2004, he was president of the American Clinical Laboratory Association; from 1988 to 1994, he was vice president and medical director of American Healthcare Systems, an alliance of not-for-profit multihospital systems. Prior to that appointment, he was an administrator in the Health Resources and Services Administration.
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From page 270... ...
She joined Mars, Inc., in August 2005 and, in this role, manages the company's scientific and regulatory positions on matters of health, nutrition, and food safety. Prior to joining Mars, Inc., Dr.
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From page 271... ...
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 administration's science policy statement "Science in the Public Interest," and served as the deputy undersecretary for research in USDA.
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From page 272... ...
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.
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From page 273... ...
Estep is a program associate with the Board on Health Sciences Policy. She has worked at the National Academies-Institute of Medicine since 1986 and has provided administrative support for more than 56 published reports.
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