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AUPHA
Health
HAP
Policymaking
in the
United States
Fourth Edition
Beaufort B. Longest, Jr.

HEALTH POLICYMAKING
IN THE UNITED STATES
Fourth Edition
AUPHA/HAP Editorial Board
Louis G. Rubino, Ph.D., FACHE, Chair
California State University–Northridge
G. Ross Baker, Ph.D.

University of Toronto
Sharon Buchbinder, R.N., Ph.D.

Towson University
Caryl Carpenter, Ph.D.

Widener University
Leonard Friedman, Ph.D.

Oregon State University
Sarah B. Laditka, Ph.D.

University of South Carolina
Thomas Mcllwain
Medical University of South Carolina
Michael A. Morrisey, Ph.D.

University of Alabama at Birmingham
Janet E. Porter, Ph.D.

University of North Carolina at Chapel Hill
Sandra Potthoff, Ph.D.

University of Minnesota
Lydia Reed
AUPHA
Nancy H. Shanks, Ph.D.

Metropolitan State College of Denver
Dennis G. Shea, Ph.D.
Penn State University
Dean G. Smith, Ph.D.
University of Michigan
Mary Stefl, Ph.D.
Trinity University
HEALTH POLICYMAKING
IN THE UNITED STATES
Fourth Edition
Beaufort B. Longest, Jr.
Health Administration Press, Chicago, IL

AUPHA Press, Washington, DC
AUPHA
HAP
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information on quantity discounts, contact the Health Administration Press Marketing
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The statements and opinions contained in this book are strictly those of the author(s)
and do not represent the official positions of the American College of Healthcare
Executives or of the Foundation of the American College of Healthcare Executives, or of
the Association of University Programs in Health Administration.
Copyright © 2006 by the Foundation of the American College of Healthcare Executives.

Printed in the United States of America. All rights reserved. This book or parts thereof
may not be reproduced in any form without written permission of the publisher.
10 09 08 07 06 5 4 3 2 1
Library of Congress Cataloging-in-Publication Data
Longest, Beaufort B.
Health policymaking in the United States / Beaufort B. Longest.— 4th ed.
p. ; cm.
Includes bibliographical references and index.
ISBN-13: 978-1-56793-245-4 (alk. paper)
ISBN-10: 1-56793-245-2 (alk. paper)
1. Medical policy—United States. 2. Health planning—United States. 3. Medical laws
and legislation—United States. 4. Policy sciences—Methodology. I. Title.
[DNLM: 1. Health Policy—United States. 2. Health Planning—legislation & jurispru-
dence—United States. 3. Policy Making—United States. WA 525 L852h 2005]
RA395.A3 L66 2005
362.1'0973—dc22 2005050217
The paper used in this publication meets the minimum requirements of American
National Standard for Information Sciences—Permanence of Paper for Printed Library
Materials, ANSI Z39.48-1984. ⬁™
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designer: Trisha Lartz
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CONTENTS IN BRIEF
List of Acronyms and Initials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xii
List of Web Sites . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xviii
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xxi
1 Health and Health Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
2 Impact of Health Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
3 Context and Process of Health Policymaking . . . . . . . . . . . . . . . . . . . 75
4 Policy Competency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
5 Policy Formulation: Agenda Setting . . . . . . . . . . . . . . . . . . . . . . . . . 161
6 Policy Formulation: Development of Legislation . . . . . . . . . . . . . . . 203
7 Policy Implementation: Rulemaking . . . . . . . . . . . . . . . . . . . . . . . . . 239

8 Policy Implementation: Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . 269
9 Policy Modification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 303
Appendix A: Overview of Medicare . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 355
Appendix B: Overview of Medicaid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 367
Appendix C: Briefly Annotated Chronological List of Selected

U.S. Federal Laws Pertaining to Health . . . . . . . . . . . . . . . . . . . . . . . . . . . 379
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 419
About the Author . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 439
vii
DETAILED CONTENTS
List of Acronyms and Initials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xii
List of Web Sites . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xviii
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xxi
1 Health and Health Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Health Defined . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Health Policy Defined . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Forms of Health Policies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Categories of Health Policies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
The Connection Between Health Policy and Health . . . . . . . . . . . . . . . . . 24
Health Policy in the States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
The Role and Importance of Policy Competency in the Pursuit
of Health . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Discussion Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
2 Impact of Health Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Health Policy and Health Determinants . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Health Policy and Individuals, Organizations, and Interest Groups . . . . . 54
Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Discussion Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
3 Context and Process of Health Policymaking . . . . . . . . . . . . . . . . . . . 75

The Context of Health Policymaking: The Political Marketplace . . . . . . . 76
Demanders and Suppliers of Health Policies . . . . . . . . . . . . . . . . . . . . . . . 81
Interplay Among Demanders and Suppliers in the Political
Marketplace . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
A Conceptual Model of the Public Policymaking Process . . . . . . . . . . . . 107
Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
Discussion Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
4 Policy Competency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125

Organization Design to Support Policy Competency . . . . . . . . . . . . . . . 128
Analyzing Public Policy Environments . . . . . . . . . . . . . . . . . . . . . . . . . . 132
Influencing Public Policy Environments . . . . . . . . . . . . . . . . . . . . . . . . . 144
The Human Element in Analyzing and Influencing Public Policy
Environments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152 ix
x Detailed Contents
Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157
5 Policy Formulation: Agenda Setting . . . . . . . . . . . . . . . . . . . . . . . . . 161

Overview of the Policy Formulation Phase . . . . . . . . . . . . . . . . . . . . . . . 161
Agenda Setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163
Interest Group Involvement in Agenda Setting . . . . . . . . . . . . . . . . . . . 176
The Influential Role of Chief Executives in Agenda Setting . . . . . . . . . . 193
The Nature of the Health Policy Agenda . . . . . . . . . . . . . . . . . . . . . . . . 197
Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199
6 Policy Formulation: Development of Legislation . . . . . . . . . . . . . . . 203

The Choreography of Legislation Development . . . . . . . . . . . . . . . . . . . 205
Originating and Drafting Legislative Proposals . . . . . . . . . . . . . . . . . . . . 206
Introducing and Referring Proposed Legislation to Committees . . . . . . 210
House or Senate Floor Action on Proposed Legislation . . . . . . . . . . . . . 219
Conference Committee Actions on Proposed Legislation . . . . . . . . . . . . 220
Presidential Action on Proposed Legislation . . . . . . . . . . . . . . . . . . . . . . 222
Legislation Development for the Federal Budget . . . . . . . . . . . . . . . . . . 222
Legislation Development for the State Budgets . . . . . . . . . . . . . . . . . . . 230
From Formulation to Implementation . . . . . . . . . . . . . . . . . . . . . . . . . . 235
Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 236
7 Policy Implementation: Rulemaking . . . . . . . . . . . . . . . . . . . . . . . . . 239

Responsibility for Policy Implementation . . . . . . . . . . . . . . . . . . . . . . . . 242
Rulemaking: The Beginning of Implementation . . . . . . . . . . . . . . . . . . . 251
Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 266
8 Policy Implementation: Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . 269

The Impact of a Policy’s Design or Construction on Its Own
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 269
The Impact of Implementing Organizations and Their Managers
on Implementation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 273
Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 301
9 Policy Modification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 303

Distinguishing Policy Modification from Policy Initiation . . . . . . . . . . . . 304
Policymaking Is a Cyclical Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 306
Incrementalism in Policymaking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 308
The Mechanics of the Modification Phase . . . . . . . . . . . . . . . . . . . . . . . . 310
The Medicare Program: A Long History of Policy Modification
in Practice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 317
Key Structural Features of Policy Modification . . . . . . . . . . . . . . . . . . . . 329
Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 350
Detailed Contents xi
Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 350
Appendix A: Overview of Medicare . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 355
Appendix B: Overview of Medicaid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 367
Appendix C: Briefly Annotated Chronological List of Selected

U.S. Federal Laws Pertaining to Health . . . . . . . . . . . . . . . . . . . . . . . . . . . 379
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 419
About the Author . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 439

LIST OF ACRONYMS AND INITIALS
AAFP American Academy of Family Physicians

AAHSA American Association of Homes and Services for the Aging
AAMC Association of American Medical Colleges
AAP American Academy of Pediatrics
AARP American Association of Retired Persons
ACHE American College of Healthcare Executives
ACP American College of Physicians
ACS American Cancer Society
American College of Surgeons
ADA American Dental Association
Americans with Disabilities Act
ADL activities of daily living
AFDC Aid to Families with Dependent Children
AHA American Heart Association
American Hospital Association
AHCA American Health Care Association
AHERA Asbestos Hazard Emergency Response Act
AHIP America’s Health Insurance Plans
AHRQ Agency for Health Care Research and Quality
AIAMC Alliance of Independent Academic Medical Centers
AIDS acquired immunodeficiency syndrome
AMA American Medical Association
AMC Academic Medical Center
AMWA American Medical Women’s Association
ANA American Nurses Association
AoA Administration on Aging
ARV antiretroviral medications
AUPHA Association of University Programs in Health Administration
BBA Balanced Budget Act

BBRA Medicare, Medicaid, and SCHIP Balanced Budget
Refinement Act
BIO Biotechnology Industry Organization
BIPA Medicare, Medicaid, and SCHIP Benefits Improvement and
xii Protection Act
List of Acronyms and Initials xiii
CAA Clean Air Act

CAH critical access hospital
CARE Ryan White Comprehensive AIDS Resources Emergency Act
CBA cost-benefit analysis
CBO Congressional Budget Office
CCD Consortium for Citizens with Disabilities
CCU cardiac care unit
CDC Centers for Disease Control and Prevention
CEA cost-effectiveness analysis
CERCLA Comprehensive Environmental Response, Compensation,
and Liability Act
CFR Code of Federal Regulations
CHAMPUS Civilian Health and Medical Program of the Uniformed
Services
CLIA Clinical Laboratory Improvements Act
CMS Centers for Medicare & Medicaid Services
COBRA Consolidated Budget Reconciliation Act
COGR Council on Governmental Relations
CON certificate of need
COTH Council of Teaching Hospitals and Health Systems
CPS Current Population Survey
CPSC Consumer Product Safety Commission
CRS Congressional Research Service
CT computed tomography
CV cardiovascular
CWA Clean Water Act
DEFRA Deficit Reduction Act

DHEW Department of Health, Education and Welfare (now
Department of Health and Human Services)
DHHS Department of Health and Human Services
DI disability insurance
DOJ Department of Justice
DRG diagnosis-related group
DSH disproportionate share
DSHEA Dietary Supplement Health and Education Act
EAB Environmental Appeals Board

EMTALA Emergency Medical Treatment and Labor Act
EPA Environmental Protection Agency
EPCRA Emergency Planning and Community Right-to-Know Act
EPL effective patient life
ERISA Employee Retirement Income Security Act
xiv List of Acronyms and Initials
ESA Endangered Species Act

ESRD end-stage renal disease
FAHS Federation of American Hospitals

FDA Food and Drug Administration
FEC Federal Election Commission
FECA Federal Election Campaign Act
FEHBP Federal Employees Health Benefits Program
FFDCA Federal Food, Drug, and Cosmetic Act
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FQPA Food Quality Protection Act
FR Federal Register
FTE full-time equivalent
GAO Government Accountability Office (formerly General

Accounting Office)
GDP gross domestic product
GI gastrointestinal
GME graduate medical education
GPO Government Printing Office
GPRA Government Performance and Results Act
HCFA Health Care Financing Administration (now Centers for

Medicare & Medicaid Services)
HEAL NY Health Care Efficiency and Affordability Law for New Yorkers
HI (Medicare) Health Insurance
HIPAA Health Insurance Portability and Accountability Act
HIV human immunodeficiency virus
HMO health maintenance organization
HPNEC Health Professions and Nursing Education Coalition
HSA health systems agency
ICD implantable cardioverter defibrillator

ICF intermediate care facility
ICU intensive care unit
IME indirect medical education
IOM Institute of Medicine
IPPS inpatient prospective payment systems
JCAHO Joint Commission on Accreditation of Healthcare

Organizations
LEPC local emergency planning committee

LTC long-term care
List of Acronyms and Initials xv
MA Medicare Advantage (formerly Medicare+Choice)

MA-PD Medicare Advantage prescription drug plan
MBO management by objectives
MedPAC Medicare Payment Advisory Commission
MMA Medicare Prescription Drug, Improvement, and
Modernization Act
MPRSA Marine Protection, Research, and Sanctuaries Act
MRI magnetic resonance imaging
MSA Master Settlement Agreement
NAACP National Association for the Advancement of Colored People

NAAQS national ambient air quality standard
NACH National Association of Children’s Hospitals
NAE National Academy of Engineering
NAS National Academy of Sciences
NCQA National Committee for Quality Assurance
NCSL National Conference of State Legislatures
NEPA National Environmental Policy Act
NGT Nominal Group Technique
NHSC National Health Service Corps
NIH National Institutes of Health
NMA National Medical Association
NOW National Organization for Women
NPR national performance review
NQF National Quality Forum
NRC National Research Council
NSAID non-steroidal anti-inflammatory drug product
OAA Older Americans Act

OALJ Office of Administrative Law Judges
OASDI Old-Age, Survivors, and Disability Insurance
OASI Old-Age and Survivors Insurance
OBRA Omnibus Budget Reconciliation Act
ODA Orphan Drug Act
OECD Organisation for Economic Co-operation and Development
OMB Office of Management and Budget
OPA Oil Pollution Act
OSHA Occupational Safety and Health Administration
OTC over the counter
PAC political action committee

PART Program Assessment Rating Tool
PBM pharmacy benefit manager
xvi List of Acronyms and Initials
PDP prescription drug plan

PhRMA Pharmaceutical Research and Manufacturers of America
PMA president’s management agenda
PPA Pollution Prevention Act
PPBS planning-programming-budgeting system
PPRC Physician Payment Review Commission
PPO preferred provider organization
PPS prospective payment system
PRO peer review organization
ProPAC Prospective Payment Assessment Commission
PSO patient safety organization
PSRO professional standards review organization
QIO quality improvement organization

QMB qualified Medicare beneficiary
RBRVS resource-based relative value scale

RCRA Resource Conservation and Recovery Act
RIN regulation identifier number
RN registered nurse
ROE return on equity
SAP Statement of Administration Policy

SARA Superfund Amendments and Reauthorization Act
SCHIP State Children’s Health Insurance Program
SDWA Safe Drinking Water Act
SERC state emergency response commission
SGR sustainable growth rate
SHCC state health coordinating council
SHPDA state health planning and development agency
SLMB specified low-income Medicare beneficiary
SNF skilled nursing facility
SPAP state pharmaceutical assistance program
SSA Social Security Administration
SSI Supplemental Security Income
TANF Temporary Assistance to Needy Families

TEFRA Tax Equity and Fiscal Responsibility Act
TSCA Toxic Substances Control Act
UFMS Unified Financial Management System

UMRA Unfunded Mandates Reform Act
UPMC University of Pittsburgh Medical Center
List of Acronyms and Initials xvii
USADA U.S. Anti-Doping Agency

USPHS U.S. Public Health Service
VA Department of Veterans Affairs

VHA Veterans Health Administration
WHO World Health Organization
ZBO zero-based budgeting

LIST OF WEB SITES
AcademyHealth www.academyhealth.org
Administration on Aging www.aoa.gov
Agency for Healthcare Research and Quality www.ahrq.gov or www.ahcpr.gov
Alliance of Independent Academic Medical Centers www.aiamc.org
Alliance for Retired Americans www.retiredamericans.org
America’s Health Insurance Plans www.ahip.org
American Academy of Family Physicians www.aafp.org
American Academy of Pediatrics www.aap.org
American Association of Homes and Services for the Aging www.aahsa.org
American Association of Retired Persons www.aarp.org
American Cancer Society www.cancer.org
American College of Healthcare Executives www.ache.org
American College of Physicians www.acponline.org
American College of Surgeons www.facs.org
American Dental Association www.ada.org
American Health Care Association www.ahca.org
American Heart Association www.americanheart.org
American Hospital Association www.aha.org
American Medical Association www.ama-assn.org
American Medical Women’s Association www.amwa-doc.org
American Nurses Association www.ana.org
Americans for Nonsmokers’ Rights Foundation www.no-smoke.org
Association of American Medical Colleges www.aamc.org
Association of University Programs in Health Administration www.aupha.org
Baxter Worldwide www.baxter.com

Biotechnology Industry Organization www.bio.org
Blue Cross and Blue Shield Association www.bluecares.com
Census Bureau www.census.gov

Center for Responsive Politics www.opensecrets.org
Centers for Disease Control and Prevention www.cdc.gov
Centers for Medicare & Medicaid Services www.cms.gov
Code of Federal Regulations www.gpoaccess.gov/cfr
Congressional Budget Office www.cbo.gov
Congressional Research Service www.loc.gov/crsinfo
Consumer Product Safety Commission www.cpsc.gov
Consortium for Citizens with Disabilities www.c-c-d.org
xviii
List of Web Sites xix
Council on Governmental Relations www.cogr.edu

Council of Teaching Hospitals and Health Systems www.aamc.org/members/coth/start.htm
Department of Health and Human Services www.dhhs.gov

Department of Justice www.usdoj.gov
Department of State http://usinfo.state.gov/products/pubs
/legalotln/index.htm
Department of Veterans Affairs www.va.gov
Environmental Protection Agency www.epa.gov
Families U.S.A. www.familiesusa.org

Federal Budget www.whitehouse.gov/omb/budget/fy2006
/budget.html
Federal Election Commission www.fec.gov
Federal Judiciary www.uscourts.gov
Federal Legislation thomas.loc.gov
Federal Register www.gpoaccess.gov/fr
Federation of American Hospitals www.fahs.com
FirstGov www.firstgov.gov
Food and Drug Administration www.fda.gov
Government Accountability Office www.gao.gov

Government Printing Office www.gpoaccess.gov
Health Professions and Nursing Education Coalition www.aamc.org/Advocacy/hpnec

Healthy People 2010 www.healthypeople.gov
Hospital and Healthsystem Association of Pennsylvania www.haponline.org
House Committee on Appropriations http://appropriations.house.gov
House Committee on Energy and Commerce http://energycommerce.house.gov
House Committee on Ways and Means http://waysandmeans.house.gov
House Office of Legislative Counsel http://legcoun.house.gov/public.htm
Institute of Medicine www.iom.edu
Joint Commission on Accreditation of Healthcare

Organizations www.jcaho.org
Kaiser Family Foundation www.kff.org
Library of Congress www.loc.gov
Master Settlement Agreement www.naag.org/upload/1032468605 cigmsa.pdf

Medicare Payment Advisory Commission www.medpac.gov
National Association for the Advancement of

Colored People www.naacp.org
xx List of Web Sites
National Association of Children’s Hospitals www.childrenshospitals.net

National Committee for Quality Assurance www.ncqa.org
National Conference of State Legislatures www.ncsl.org
National Council of Senior Citizens www.ncsinc.org
National Institutes of Health www.nih.gov
National Medical Association www.natmed.org
National Organization for Women www.now.org
National Policy Association www.npa1.org
Occupational Safety and Health Administration www.osha.gov

Office of Administrative Law Judges, Environmental Protection Agency www.epa.gov/oalj
Office of Management and Budget www.whitehouse.gov/omb
Organisation for Economic Co-operation and Development www.oecd.org
Pharmaceutical Research and Manufacturers of America www.phrma.org

President’s Commission to Strengthen Social Security www.csss.gov
president’s management agenda www.whitehouse.gov/omb
/budgintegration/pma index
.html
Social Security Administration www.ssa.gov

Senate Committee on Appropriations http://appropriations.senate.gov
Senate Committee on Finance http://finance.senate.gov
Senate Committee on Health, Education, Labor, and Pensions http://help.senate.gov
Senate Office of Legislative Counsel http://slc.senate.gov/index.htm
Texas Politics http://texaspolitics.laits.utexas.edu

/html/ig/index.html
U.S. Public Health Service www.usphs.gov

University of Pittsburgh Medical Center www.upmc.com
White House www.whitehouse.gov

Wisconsin Medical Society www.wisconsinmedicalsociety.org
World Health Organization www.who.int
PREFACE
T
he myriad decisions that constitute health policy are increasingly im-
portant. Health is a personal, high-priority goal of most people, and
the pursuit of health is of growing significance to the nation’s economy
and to its system of social justice. Thus, it should surprise no one that health
policy receives a great deal of attention from government.
Health policy is defined in this textbook as the set of authoritative
decisions made within government that pertain to health and to the pur-
suit of health. The phrase authoritative decisions is crucial in the definition
and refers to decisions that are made anywhere within the three branches
of government—at any level of government—and are within the legitimate
purview (i.e., within the official roles, responsibilities, and authorities) of those
making the decisions.
Through a long history of incremental and modest steps, an extensive
array of authoritative decisions that comprise health policy has evolved in
the United States. Although this history has been punctuated occasionally by
dramatic developments in health policy, especially the emergence of Medicare
and Medicaid in 1965, health policymaking is mostly a story of slow but
persistent evolution and modification.
Health policy’s role in the pursuit of health is played out across many
fronts because health is determined by many variables: the physical environ-
ment in which people live and work, their biology and behavior, social factors,
and access to health services. The effects of health policies are seen in each of
these determinants of health.
Whether at the federal, state, or local level, governments formulate,
implement, and constantly modify health policies within an intricately chore-
ographed policymaking process. The central and unifying purpose of this book
is to provide a comprehensive model of this process for those who have an
interest in or a curiosity about health policy and the policymaking process.
An understanding of this process is essential to policy competency. For typical
health professionals, policy competency is at most a secondary interest. How-
ever, a degree of policy competency sufficient to permit one to effectively
analyze the public policy environment that affects them and their work—and
to exert influence in that environment—is an increasingly important attribute
for those whose professional lives are devoted to the pursuit of better health
for society.
xxi
xxii Preface
The model of the health policymaking process presented in this book

was first developed, and continues to be refined, for the benefit of my students.
The fact that the model proved useful as a framework for their understanding
of the extraordinarily complicated process of health policymaking stimulated
me to present it to a broader audience, the result of which was the first edition
of this book. Through four editions, the book has been and will continue
to be used in health policy courses as a means to provide students with an
overview of the policymaking process. The model puts the various aspects of
policymaking in perspective and serves as a foundation on which students can
build their more detailed knowledge of the process—that is to say, they can
build their policy competency.
The structure of this textbook largely reflects the model of the pol-
icymaking process. Following definitions of health and of health policy in
Chapter 1, Chapter 2 emphasizes the ways in which policy affects health de-
terminants. An overview of the context (the political marketplace) and the
process of policymaking are presented in Chapter 3. Chapter 4 contains ex-
tensive new (since the previous edition) material on policy competency, which
is defined as the dual abilities to analyze the public policy environment of a
health-related organization or interest group and to exert influence in this en-
vironment. This competency is increasingly important to everyone involved
professionally in the pursuit of health. Information to strengthen both abilities
is also presented. Chapters 5 through 9 describe specific aspects of the poli-
cymaking process and follow the model of the process presented in Chapter
3. Chapters 5 and 6 address the agenda-setting and legislation-development
aspects of policy formulation, respectively. Chapters 7 and 8 address the rule-
making and operation aspects of policy implementation, respectively. Chapter
9 addresses policy modification, reflecting the fact that all policies are subject
to modification.
The book includes three appendixes, one of which lists chronologically
the most important federal laws pertaining to health enacted in the United
States. In addition to providing synopses of these laws, the chronology illus-
trates several important characteristics of the nation’s health policy. The list
clearly shows, for example, that the vast majority of health policies are but
modifications of or amendments to previously enacted laws; incrementalism
has indeed prevailed in the development of American health policy. The list
also shows that health policy mirrors the various determinants of health. There
are policies to address the environments in which people live, their lifestyle,
and their genetics, as well as numerous policies related to the provision of and
payment for health services. The other two appendixes are new to this edition
and provide detailed information about Medicare and Medicaid.
In this edition, a popular feature called The Real World of Health
Policy has been expanded. These highlighted boxes are placed throughout the
text and present excerpts from congressional testimony; examples of rules or
Preface xxiii
proposed rules issued by implementing agencies; and reprints of illustrative

news stories, letters, executive orders, and other documents that illustrate
important real-world aspects of the policymaking process. The intent is to
enliven the text and to provide useful and illustrative examples.
Acknowledgments
I wish to acknowledge the contributions made by several people to this revised

book and to thank them for their help. Denise Warfield provided secretarial
support. Linda Kalcevic provided superb editorial assistance throughout the
revision. Mark Nordenberg, Arthur Levine, Bernard Goldstein, and Judith
Lave provided a professional environment conducive to and supportive of
scholarship. I thank Janet Davis, Amanda Karvelaitis, and Joyce Sherman at
Health Administration Press for their professional competence in bringing
this book to fruition. Most of all, however, I want to thank Carolyn Longest.
Sharing life with her continues to make many things possible for me and to
make doing them worthwhile.
CHAPTER
HEALTH AND HEALTH POLICY

1
H
ealth and its pursuit are tightly interwoven into the social and economic
fabric of all industrialized nations. Health plays a direct and important
role not only in the physical and mental well-being of people but in
nations’ economies as well. The United States is expected to spend more than
$2 trillion in pursuit of health in 2006, representing 16 percent of the nation’s
gross domestic product (GDP), and to spend about $3.6 trillion, or 18.7 per-
cent of GDP, by 2014 (Heffler et al. 2005). Thus, it is not surprising that
government at all levels is keenly interested in health and in how it is pursued.
This book is about the intricate process through which government influences
the pursuit of health that is public policymaking. Attention is focused primar-
ily on the policymaking process at the federal level, although much of what is
covered also applies to policymaking at the state and local levels.
In this chapter, the basic and underpinning definitions of health and
health policy—and their relationship to each other—are discussed. In Chap-
ter 2, the impact of policy on health and its pursuit is considered more fully.
In Chapter 3, a model of the public policymaking process is outlined and de-
scribed; this model is specifically applied to health policymaking. The various
interconnected parts of the model are then covered in detail in subsequent
chapters.
Health Defined
Health is a universally important aspect of human life. Years ago, the World
Health Organization (WHO) (www.who.int) defined health as the “state of
complete physical, mental, and social well-being, and not merely the ab-
sence of disease or infirmity” (WHO 1948). A more contemporary version
of this definition, with an important expansion, is provided by David Byrne
(2004), the European commissioner for health and consumer protection, who
views good health as “a state of physical and mental well-being necessary to
live a meaningful, pleasant and productive life. Good health is also an in-
tegral part of thriving modern societies, a cornerstone of well performing
economies, and a shared principle of European democracies,” which can read-
ily be extended to all democracies. In fact, health is a priority in all nations,
although the resources available for the pursuit of health vary widely across
nations (Reinhardt, Hussey, and Anderson 2004). The reader can find current 1
2 Health Policymaking in the United States
information on international health expenditure comparisons for the 30 mem-

ber countries of the Organisation for Economic Co-operation and Develop-
ment (OECD), all of which share a commitment to democratic government
and market economies, at www.oecd.org.
The way in which health is defined by any nation is important because
it reflects the nation’s values regarding health, the resources it is prepared
to devote to the pursuit of health, and how far the nation would be willing
to go in aiding or supporting the pursuit of health among its citizens. A
nation in which health is defined broadly and in positive terms—such as the
definition provided by Byrne above—will obligate itself to pursue a variety
of significant interventions in its efforts to help its members attain desired
levels of health. The enormous range of possible targets for intervention in
the pursuit of health in any society is illustrated by the fact that health in
human beings is a function of many variables, or health determinants as they
are often called.
Health Determinants
Both for individuals and for a population of individuals, health determinants
include the physical environments in which people live and work; their behav-
iors; their biology (genetic makeup, family history, and physical and mental
health problems acquired during life); a host of social factors that include
economic circumstances, socioeconomic position, and income distribution;
discrimination based on factors such as race/ethnicity, gender, or sexual ori-
entation and on the availability of social networks or social support; and the
health services to which they have access (Blum 1983; Evans, Barer, and Mar-
mor 1994; Berkman and Kawachi 2000).
Healthy People 2010 (www.healthypeople.gov) is a report that details
comprehensive national health promotion and disease prevention agendas.
The following list of health determinants is adapted from its identification
and definition of determinants (U.S. DHHS 2000):
• Biology refers to the individual’s genetic makeup (those factors with

which he or she is born), family history (which may suggest risk for
disease), and the physical and mental health problems acquired during
life. Aging, diet, physical activity, smoking, stress, alcohol or illicit drug
abuse, injury or violence, or an infectious or toxic agent may result in
illness or disability and can produce a “new” biology for the individual.
• Behaviors are individual responses or reactions to internal stimuli and
external conditions. Behaviors can have a reciprocal relationship to
biology; in other words, each can react to the other. For example,
smoking (behavior) can alter the cells in the lung and result in shortness
of breath, emphysema, or cancer (biology), which then may lead an
individual to stop smoking (behavior). Similarly, a family history that
Health and Health Policy 3
includes heart disease (biology) may motivate an individual to develop

good eating habits, avoid tobacco, and maintain an active lifestyle
(behaviors), which may prevent his or her own development of heart
disease (biology).
Personal choices and the social and physical environments
surrounding individuals can shape behaviors. The social and physical
environments include all factors that affect the life of individuals—
positively or negatively—many of which may not be under their
immediate or direct control.
• Social environment includes interactions with family, friends, coworkers,
and others in the community. It also encompasses social institutions
such as law enforcement, the workplace, places of worship, and schools.
Housing, public transportation, and the presence or absence of violence in
the community are among other components of the social environment.
The social environment has a profound effect on individual health, as
well as on the health of the larger community, and is unique because of
cultural customs; language; and personal, religious, or spiritual beliefs. At
the same time, individuals and their behaviors contribute to the quality
of the social environment.
• Physical environment can be thought of as that which can be seen,
touched, heard, smelled, and tasted. However, the physical environment
also contains less tangible elements such as radiation and ozone. The
physical environment can harm individual and community health,
especially when individuals and communities are exposed to toxic
substances; irritants; infectious agents; and physical hazards in homes,
schools, and work sites. The physical environment also can promote
good health, for example, by providing clean and safe places for people
to work, exercise, and play.
• Policies and interventions can have a powerful and positive effect on
the health of individuals and the community. Examples include health
promotion campaigns to prevent smoking; policies mandating child
restraints and safety belt use in automobiles; disease prevention services
such as immunization of children, adolescents, and adults; and clinical
services such as enhanced mental health care. Policies and interventions
that promote individual and community health may be implemented
by a variety of agencies, such as transportation, education, energy,
housing, labor, justice, and other venues, or through places of worship,
community-based organizations, civic groups, and businesses.
• Quality health services can be vital to the health of individuals and
communities. Expanding access to services is important to eliminate
health disparities and to increase the quality and years of healthy life for
all people living in the United States. Health services in the broadest
sense include not only services received through health services providers
but also health information and services received through other venues
in the community.
When considering health in regard to individuals or populations, it is

important to remember that people vary along many dimensions, including
their health and health-related needs. The citizenry of the United States is
remarkably diverse, varying by age, gender, race/ethnicity, and other factors.
As Census 2000 revealed, of a total population of 281.4 million people, about
35 million were over the age of 65, and about 17 million of those were over 75
years of age (U.S. Census Bureau 2000). By 2020, these numbers will increase
to about 55 million and 23 million, respectively (U.S. DHHS 2004). These
demographic changes are important when considering health and its pursuit,
because older people consume relatively more health services and their health-
related needs differ in significant ways from those of younger people. Older
people are more likely to consume long-term-care services and community-
based services intended to help them cope with various limitations in the
activities of daily living.
In Census 2000, approximately 34 million African Americans and 35
million Latinos were included in the U.S. population total of 281.4 million
(U.S. Census Bureau 2000). Each group represented more than 12 percent
of the total population. Both groups are presently disproportionately under-
served for health services and are underrepresented in all of the health pro-
fessions. They experience discrimination that affects their health and, as is
described in The Real World of Health Policy: Race, Ethnicity, and Health
Care, these and other minority populations experience continuing disparities
in the burden of illness and death (Krieger 2000; Henry J. Kaiser Family Foun-
dation 2003).
The Real World of Health Policy

Race, Ethnicity, and Health Care
Racial and ethnic disparities in health care—whether in insurance coverage,

access, or quality of care—are one of many factors producing inequalities in
health status in the United States.1 Eliminating these disparities is politically
sensitive and challenging in part because their causes are intertwined with a
contentious history of race relations in America. Nonetheless, assuring greater
equity and accountability of the health care system is important to a growing
constituency base, including health plan purchasers, payers, and providers
of care. To the extent that inequities in the health care system result in lost
productivity or use of services at a later stage of illness, there are health and
social costs beyond the individual or specific population group.
Background
About 1 in 3 residents of the United States self-identify as either African
American, American Indian/Alaska Native, Asian/Pacific American, or Latino. Few
would disagree that for most of this nation’s history, race was a major factor in
determining if you got care, where that care was obtained, and the quality of
medical care. However, the influence of race today is more subtle. Public policy
efforts, most notably the enactment of Medicaid and Medicare in 1965, along
with enforcement of the 1964 Civil Rights Act, have made an enormous difference
in reducing the health care divides in the U.S. So much progress has been
achieved that many think that the disparities that remain are inconsequential,
but they are not.
The Institute of Medicine (IOM) landmark report Unequal Treatment:
Confronting Racial and Ethnic Disparities in Care provides compelling evidence
that racial/ethnic disparities persist in medical care for a number of health
conditions and services.2 These disparities exist even when comparing individuals
of similar income and insurance. Evidence of racial/ethnic disparities among
patients with comparable insurance and the same illness has been the most
troubling since health insurance coverage is widely considered the “great
equalizer” in the health system.
The momentum to address health care disparities has grown largely in
response to the step taken by the Department of Health and Human Services
(DHHS) in 1999, establishing a national goal of eliminating health disparities
by the end of this decade. Disparities between racial/ethnic groups and
geographic areas were of major concern.3 The decision for the U.S. to have
one set of goals for all Americans, rather than separate goals for the health of
whites and minority populations, has helped to focus public and private sector
attention on racial/ethnic disparities in the nation’s health and thus, health care
system.
Policy Challenges in Addressing Health Care Disparities

Although attention to racial/ethnic disparities in care has increased among
policymakers, there is little consensus on what can or should be done to reduce
these disparities. The U.S. Congress provided early leadership on the issue by
legislatively mandating the Institute of Medicine (IOM) (www.iom.edu) study on
health care disparities and creating in statute, the National Center on Minority
Health and Health Disparities at the National Institutes of Health. Congress also
required DHHS to produce an annual report, starting in 2003, on the nation’s
progress in reducing health care disparities.4 These efforts have provided an
important foundation for addressing health and health care disparities.
The IOM study committee for Unequal Treatment recommended the use of a
comprehensive multi-level strategy to address potential causes of racial/ethnic
disparities in care that arise from circumstances or interactions at the level of the
patient, provider, and health care system. The recommendations point to four
broad areas of policy challenges:
• Raising public and provider awareness of racial/ethnic disparities in care;

• Expanding health insurance coverage;
• Improving the capacity and number of providers in underserved
communities; and
• Increasing the knowledge base on causes and interventions to reduce
disparities.
NOTES:
1. Disparities in “health care” and in “health” are often discussed as if they are one in the same. A
health care disparity refers to differences in, for example, coverage, access, or quality of care that is
not due to health needs. A health disparity refers to a higher burden of illness, injury, disability, or
mortality experienced by one population group in relation to another. The two concepts are related
in that disparities in health care can contribute to health disparities, and the goal of the use of health
services is to maintain and improve a population’s health. However, other factors (e.g., genetics,
personal behavior, and socio-economic factors) also are major determinants of a population’s health.
2. Institute of Medicine. 2002. Unequal Treatment: Confronting Racial and Ethnic Disparities in
Health Care. Washington, DC: National Academies Press.
3. U.S. Department of Health and Human Services, Healthy People 2010. pp.11–16.
4. U.S. Department of Health and Human Services. 2003. 2003 National Healthcare Disparities
Report. Washington, DC: U.S. Department of Health and Human Services.
SOURCE: Henry J. Kaiser Family Foundation. 2004. “Health Care & the 2004 Elections: Race,
Ethnicity and Health Care.” October, Report no. 7187. This information was reprinted with per-
mission of The Henry J. Kaiser Family Foundation. The Kaiser Family Foundation, based in Menlo
Park, California, is a nonprofit, independent national healthcare philanthropy and is not associated
with Kaiser Permanente or Kaiser Industries.
Although the nation’s population is diverse, with differences in health-

related needs and disparities in health status and access to the benefits of the
services of the healthcare system, a rather homogeneous set of values directly
affects the basic approach to health in the United States. To a great extent,
many in American society place a high value on individual autonomy, self-
determination, and personal privacy and maintain a widespread, although not
universal, commitment to justice for all of its members. Other characteristics
of the core society that significantly influence the pursuit of health include
a deep-seated belief in the potential of technological rescue and, although it
may be changing, a long-standing obsession with prolonging life with scant
regard for the costs of doing so. These values help shape the private and public
sectors’ efforts related to health, including the elaboration of public policies
germane to health and its pursuit.
Health Policy Defined

There are many definitions of public policy, and no universal agreement has
been reached on which is best. For example, Peters (2003) defines public
policy as the “sum of government activities, whether acting directly or through

agents, as it has an influence on the life of citizens.” Birkland (2001, 132)
defines public policy as “a statement by government of what it intends to
do or not to do, such as a law, regulation, ruling, decision, or order, or
a combination of these.” Cochran and Malone (1999) define public policy
as “political decisions for implementing programs to achieve societal goals.”
Drawing on these and many other definitions, in this book I define public
policy as authoritative decisions made in the legislative, executive, or judicial
branches of government that are intended to direct or influence the actions,
behaviors, or decisions of others.
The phrase authoritative decisions is crucial in the definition of public
policy. It specifically refers to decisions that are made anywhere within the
three branches of government—at any level of government—that are within
the legitimate purview (i.e., within the official roles, responsibilities, and au-
thorities) of those making the decisions. The decision makers can be legis-
lators, executives of government (presidents, governors, mayors), or judges.
Part of playing these decision-making roles is the legitimate right—indeed, the
responsibility—to make certain decisions. For example, legislators are entitled
to decide on laws, executives to decide on rules to implement laws, and judges
to review and interpret decisions made by others. These relationships are illus-
trated in Figure 1.1. A useful web site for information about all three branches
Figure 1.1
Roles of the
Exe
licy
ins
cut
Three Branches
Po
ma
ive
of Government
cy s
es
do
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Pro
Bra
Ap ulgat
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pro es
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Pro s or les a
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oli
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For
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po veto nd
Im
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i
Leg
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th
nce Creat
authoritative decisions
t
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made within government

la
Ba
Interprets constitutional and statutory law

Develops body of case law
Preserves rights
Resolves disputes
Judicial Branch Interprets Policy

of the federal government, as well as information about state and local govern-
ments, is www.firstgov.gov. FirstGov is an official U.S. government web site.
In the United States, public policies, whether they pertain to health or
to other policy domains such as defense, education, transportation, or com-
merce, are made through a dynamic public policymaking process. This process,
which is modeled in Chapter 3, involves many interactive participants in three
interconnected phases of activities.
When public policies pertain to health or influence the pursuit of health,
they are health policies. Health policies are established at federal, state, and lo-
cal levels of government, although usually for different purposes. Generally,
health policies affect or influence groups or classes of individuals (e.g., physi-
cians, the poor, the elderly, children) or types or categories of organizations
(e.g., medical schools, health plans, integrated healthcare systems, pharma-
ceutical manufacturers, employers).
At any given time, the entire set of health-related policies, or author-
itative decisions that pertain to health, made at any level of government can
be said to constitute that level’s health policy. Thus, health policy is a very
large set of decisions reached through the public policymaking process. Some
countries, Canada and Great Britain most notably, have developed expansive,
well-integrated policies to help shape their society’s pursuit of health in fun-
damental ways. The United States, in contrast, has a few large health-related
policies, such as its Medicare program or its regulation of pharmaceuticals,
but the U.S. government takes a more incremental or piecemeal approach to
health policy. The net result is a very large number of policies, but few of them
deal with the pursuit of health in any broad, comprehensive, or integrated way.
Policies made through the public policymaking process are distin-
guished from policies established in the private sector. Although discussing
private-sector health policies in any depth is beyond the scope of this book,
authoritative decisions made in the private sector by executives of health-
care organizations about such issues as their product lines, pricing, and mar-
keting strategies, for example, are policies. Similarly, authoritative decisions
made within such organizations as the Joint Commission on Accreditation
of Healthcare Organizations (JCAHO) (www.jcaho.org), a private accred-
iting body for health-related organizations, or by the National Committee
for Quality Assurance (NCQA) (www.ncqa.org), a private organization in-
volved in assessing and reporting on the quality of managed care plans, are
also private-sector health policies.
This book focuses on the public policymaking process and on the
public-sector health policies that result from this process. Private-sector health
policies also play a vitally important role in the ways society pursues health.
The rich and complex blend of public policies and private-sector policies and
actions that shape the American pursuit of health is a reflection of the fact
that Americans have been extraordinarily reluctant to yield control of the
healthcare system to government. In part, this reflects a unique feature of the

American psyche that Morone (1990, 1) captures eloquently when he says,
At the heart of American politics lies a dread and a yearning. The dread is no-
torious. Americans fear public power as a threat to liberty. Their government is
weak and fragmented, designed to prevent action more easily than to produce it.
The yearning is an alternative faith in direct, communal democracy. Even after the
loose collection of agrarian colonies had evolved into a dense industrial society,
the urge remained: the people would, somehow, put aside their government and
rule themselves directly.
In no aspect of American life is this “dread and yearning” more visible

or relevant than in regard to health and health policy. Despite government’s
substantive role in health policy, which is more fully explored in subsequent
chapters, and its role as a provider of health services in government facilities,
most of the resources used in the pursuit of health in the United States are
under the control of the private sector. Even when government is involved in
health affairs, it often seeks ways to ensure broader access to health services
that are provided predominantly through the private sector. The operation of
the Medicare and Medicaid programs provide clear examples of this approach.
Public dollars purchase services in the private sector for the beneficiaries of
these programs. Overviews of the Medicare and Medicaid programs are pro-
vided as Appendixes A and B, respectively, at the end of the book. These pro-
grams and the policies that guide them are so important to an understanding
of health policy and its impact on health that it is useful to read the overviews
now; the information provided will be helpful throughout the book.
Forms of Health Policies
Health policies, which were defined earlier as authoritative decisions, take one
of several basic forms. Some policies are the decisions made by legislators that
are codified in the statutory language of specific pieces of enacted legislation.
These are laws. Other policies are the rules and regulations established to
implement laws or to operate government and its various programs. Still
others are the judicial branch’s decisions related to health. Examples of health
policies include
• the 1965 federal public law (P.L. 89-97)1 that established the Medicare
and Medicaid programs;
• an executive order regarding operation of federally funded health centers;
• a federal court’s ruling that an integrated delivery system’s acquisition of
yet another hospital violates federal antitrust laws;
• a state government’s procedures for licensing physicians;
• a county health department’s procedures for inspecting restaurants; and

• a city government’s ordinance banning smoking in public places within
its borders.
Thus, health policies may take any of several specific forms, and each
form is an authoritative decision made within government. These forms of
policy are described in the following sections, with examples of each.
Laws
Laws enacted at any level of government are policies. One example of a fed-
eral law that is also a health policy is the Breast and Cervical Cancer Preven-
tion and Treatment Act of 2000 (P.L. 106-354), which created an optional
Medicaid category for low-income women diagnosed with cancer through
the Centers for Disease Control and Prevention’s (www.cdc.gov) breast and
cervical cancer early detection screening program. State examples include state
laws that govern the licensure of health-related practitioners and institutions.
Laws, when they are “more or less freestanding legislative enactments aimed
to achieve specific objectives” (Brown 1992, 21), are sometimes called pro-
grams. The Medicare program is a federal-level example; many laws, most
being amendments to prior laws, govern this vast program. The National In-
stitute of Biomedical Imaging and Bioengineering Establishment Act of 2000
is reproduced in The Real World of Health Policy: P.L. 106-580 to provide
an example of an actual federal law. Although the reading is lengthy (actually
quite short when compared to many laws, which can run into the hundreds of
pages), it will be useful to see a federal law in written form. Electronic versions
of this and other federal laws dating back to 1973, the 93rd Congress, can be
found at http://thomas.loc.gov/, a web site maintained by the Library of
Congress to make federal laws readily accessible.

P.L. 106-580
National Institute of Biomedical Imaging and Bioengineering Establishment Act
Public Law 106-580
106th Congress
An Act
To amend the Public Health Service Act to establish the National Institute of
Biomedical Imaging and Bioengineering.
Be it enacted by the Senate and House of Representatives of the United

States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the “National Institute of Biomedical Imaging and
Bioengineering Establishment Act”.
SEC. 2. FINDINGS.
The Congress makes the following findings:
(1) Basic research in imaging, bioengineering, computer science, informatics,

and related fields is critical to improving health care but is fundamentally
different from the research in molecular biology on which the current national
research institutes at the National Institutes of Health (NIH) (www.nih.gov) are
based. To ensure the development of new techniques and technologies for the
21st century, these disciplines therefore require an identity and research home at
the NIH that is independent of the existing institute structure.
(2) Advances based on medical research promise new, more effective

treatments for a wide variety of diseases, but the development of new,
noninvasive imaging techniques for earlier detection and diagnosis of disease
is essential to take full advantage of such new treatments and to promote the
general improvement of health care.
(3) The development of advanced genetic and molecular imaging techniques

is necessary to continue the current rapid pace of discovery in molecular biology.
(4) Advances in telemedicine, and teleradiology in particular, are increasingly

important in the delivery of high quality, reliable medical care to rural citizens and
other underserved populations. To fulfill the promise of telemedicine and related
technologies fully, a structure is needed at the NIH to support basic research
focused on the acquisition, transmission, processing, and optimal display of
images.
(5) A number of Federal departments and agencies support imaging and en-
gineering research with potential medical applications, but a central coordinating
body, preferably housed at the NIH, is needed to coordinate these disparate
efforts and facilitate the transfer of technologies with medical applications.
(6) Several breakthrough imaging technologies, including magnetic

resonance imaging (MRI) and computed tomography (CT), have been developed
primarily abroad, in large part because of the absence of a home at the NIH
for basic research in imaging and related fields. The establishment of a central
focus for imaging and bioengineering research at the NIH would promote both
scientific advance and United States economic development.
(7) At a time when a consensus exists to add significant resources to the

NIH in coming years, it is appropriate to modernize the structure of the NIH
to ensure that research dollars are expended more effectively and efficiently
and that the fields of medical science that have contributed the most to the
detection, diagnosis, and treatment of disease in recent years receive appropriate
emphasis.
(8) The establishment of a National Institute of Biomedical Imaging and

Bioengineering at the NIH would accelerate the development of new technologies
with clinical and research applications, improve coordination and efficiency
at the NIH and throughout the Federal Government, reduce duplication and
waste, lay the foundation for a new medical information age, promote economic
development, and provide a structure to train the young researchers who will
make the pathbreaking discoveries of the next century.
SEC. 3. ESTABLISHMENT OF NATIONAL INSTITUTE OF BIOMEDICAL IMAGING

AND BIOENGINEERING.
(a) In General.—Part C of title IV of the Public Health Service Act (42 U.S.C.
285 et seq.) is amended by adding at the end the following subpart:
Subpart 18—National Institute of Biomedical Imaging and Bioengineering
PURPOSE OF THE INSTITUTE
Sec. 464z. (a) The general purpose of the National Institute of Biomedical
Imaging and Bioengineering (in this section referred to as the “Institute”)
is the conduct and support of research, training, the dissemination of
health information, and other programs with respect to biomedical imaging,
biomedical engineering, and associated technologies and modalities with
biomedical applications (in this section referred to as “biomedical imaging and
bioengineering”).
(b)(1) The Director of the Institute, with the advice of the Institute’s advisory
council, shall establish a National Biomedical Imaging and Bioengineering
Program (in this section referred to as the “Program”).
(2) Activities under the Program shall include the following with respect to
biomedical imaging and bioengineering:
(A) Research into the development of new techniques and devices.
(B) Related research in physics, engineering, mathematics, computer

science, and other disciplines.
(C) Technology assessments and outcomes studies to evaluate the

effectiveness of biologics, materials, processes, devices, procedures, and
informatics.
(D) Research in screening for diseases and disorders.
(E) The advancement of existing imaging and bioengineering modalities,

including imaging, biomaterials, and informatics.
(F) The development of target-specific agents to enhance images and to

identify and delineate disease.
(G) The development of advanced engineering and imaging technologies and

techniques for research from the molecular and genetic to the whole organ and
body levels.
(H) The development of new techniques and devices for more effective
interventional procedures (such as image-guided interventions).
(3)(A) With respect to the Program, the Director of the Institute shall
prepare and transmit to the Secretary and the Director of NIH a plan to initiate,
expand, intensify, and coordinate activities of the Institute with respect to
biomedical imaging and bioengineering. The plan shall include such comments
and recommendations as the Director of the Institute determines appropriate.
The Director of the Institute shall periodically review and revise the plan and
shall transmit any revisions of the plan to the Secretary and the Director of NIH.
(B) The plan under subparagraph (A) shall include the recommendations of
the Director of the Institute with respect to the following:
(i) Where appropriate, the consolidation of programs of the National

Institutes of Health for the express purpose of enhancing support of activities
regarding basic biomedical imaging and bioengineering research.
(ii) The coordination of the activities of the Institute with related activities of
the other agencies of the National Institutes of Health and with related activities
of other Federal agencies.
(c) The establishment under section 406 of an advisory council for the
Institute is subject to the following:
(1) The number of members appointed by the Secretary shall be 12.
(2) Of such members—
(A) six members shall be scientists, engineers, physicians, and other

health professionals who represent disciplines in biomedical imaging and
bioengineering and who are not officers or employees of the United States; and
(B) six members shall be scientists, engineers, physicians, and other health
professionals who represent other disciplines and are knowledgeable about the
applications of biomedical imaging and bioengineering in medicine, and who are
not officers or employees of the United States.
(3) In addition to the ex officio members specified in section 406(b)(2),

the ex officio members of the advisory council shall include the Director of
the Centers for Disease Control and Prevention, the Director of the National
Science Foundation, and the Director of the National Institute of Standards and
Technology (or the designees of such officers).
(d)(1) Subject to paragraph (2), for the purpose of carrying out this section:
(A) For fiscal year 2001, there is authorized to be appropriated an amount

equal to the amount obligated by the National Institutes of Health during fiscal
year 2000 for biomedical imaging and bioengineering, except that such amount
shall be adjusted to offset any inflation occurring after October 1, 1999.
(B) For each of the fiscal years 2002 and 2003, there is authorized to be
appropriated an amount equal to the amount appropriated under subparagraph
(A) for fiscal year 2001, except that such amount shall be adjusted for the fiscal
year involved to offset any inflation occurring after October 1, 2000.
(2) The authorization of appropriations for a fiscal year under paragraph (1)
is hereby reduced by the amount of any appropriation made for such year for the
conduct or support by any other national research institute of any program with
respect to biomedical imaging and bioengineering.
(b) USE OF EXISTING RESOURCES.—In providing for the establishment of

the National Institute of Biomedical Imaging and Bioengineering pursuant to the
amendment made by subsection (a), the Director of the National Institutes of
Health (referred to in this subsection as “NIH”)—
(1) may transfer to the National Institute of Biomedical Imaging and

Bioengineering such personnel of NIH as the Director determines to be
appropriate;
(2) may, for quarters for such Institute, utilize such facilities of NIH as the
Director determines to be appropriate; and
(3) may obtain administrative support for the Institute from the other
agencies of NIH, including the other national research institutes.
(c) CONSTRUCTION OF FACILITIES.—None of the provisions of this Act

or the amendments made by the Act may be construed as authorizing the
construction of facilities, or the acquisition of land, for purposes of the
establishment or operation of the National Institute of Biomedical Imaging
and Bioengineering.
(d) DATE CERTAIN FOR ESTABLISHMENT OF ADVISORY COUNCIL.—Not later

than 90 days after the effective date of this Act under section 4, the Secretary of
Health and Human Services shall complete the establishment of an advisory
council for the National Institute of Biomedical Imaging and Bioengineering in

accordance with section 406 of the Public Health Service Act and in accordance
with section 464z of such Act (as added by subsection (a) of this section).
(e) CONFORMING AMENDMENT.—Section 401(b)(1) of the Public Health

Service Act (42 U.S.C. 281(b)(1)) is amended by adding at the end the following
subparagraph:
(R) The National Institute of Biomedical Imaging and Bioengineering.
SEC. 4. EFFECTIVE DATE.
This Act takes effect October 1, 2000, or upon the date of the enactment of
this Act, whichever occurs later.
Approved December 29, 2000.
Rules and Regulations

Another form of policies is the rules and regulations (the terms are used in-
terchangeably in the policy context) established to guide the implementation
of laws. Because such rules are authoritative decisions made in the executive
branch of government by the organizations and agencies responsible for im-
plementing laws, they fit the definition of public policies. The rules associated
with the implementation of complex laws routinely fill hundreds and some-
times thousands of pages. Rulemaking, the processes through which executive
branch agencies write the rules to guide implementation of laws, is an impor-
tant activity in policymaking and is discussed in detail in Chapter 4.
Rules, both in proposed form (for review and comment by those who
will be affected by them) and in final form are published in the Federal Register
(FR) (www.gpoaccess.gov/fr), the official daily publication for proposed and
final rules, as well as notices of federal agencies and executive orders and other
presidential documents. FR is published by the Office of the Federal Register,
National Archives and Records Administration. Examples of the summaries of
a proposed rule and a final rule can be seen in The Real World of Health Policy:
Summaries of a Proposed Rule and a Final Rule. Rules can be read in their
entirety at www.gpoaccess.gov/fr/index.html.

Summaries of a Proposed Rule and a Final Rule
Federal Register: May 18, 2004 (Volume 69, Number 96)

Proposed Rules
Page 28195–28244
DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services
42 CFR Parts 403, 412, 413, 418, 460, 480, 482, 483, 485, and 489
Medicare Program; Proposed Changes to the Hospital Inpatient

Prospective Payment Systems and Fiscal Year 2005 Rates, Proposed Rule
AGENCY: Centers for Medicare and Medicaid Services (CMS), DHHS.
ACTION: Proposed rule.
SUMMARY: We are proposing to revise the Medicare hospital inpatient

prospective payment systems (IPPS) for operating and capital-related costs to
implement changes arising from our continuing experience with these systems;
and to implement a number of changes made by the Medicare Prescription
Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108-173), enacted
on December 8, 2003. In addition, in the Addendum to this proposed rule, we
describe the proposed changes to the amounts and factors used to determine
the rates for Medicare hospital inpatient services for operating costs and
capital-related costs. These proposed changes would be applicable to discharges
occurring on or after October 1, 2004. We also are setting forth proposed
rate-of-increase limits as well as proposed policy changes for hospitals and
hospital units excluded from the IPPS that are paid on a reasonable cost basis
subject to these limits.
Among the policy changes that we are proposing to make are: Changes to
the classification of cases to the diagnosis-related groups (DRGs); changes to
the long-term care (LTC)-DRGs and relative weights; changes in the wage data,
labor-related share of the wage index, and the geographic area designations
used to compute the wage index; changes in the qualifying threshold criteria
for and the proposed approval of new technologies and medical services for
add-on payments; changes to the policies governing postacute care transfers;
changes to payments to hospitals for the direct and indirect costs of graduate
medical education; changes to the payment adjustment for disproportionate
share rural hospitals; changes in requirements and payments to critical access
hospitals (CAHs); changes to the disclosure of information requirements for
Quality Improvement Organization (QIOs); and changes in the hospital conditions
of participation for discharge planning and fire safety requirements for certain
health care facilities.
Federal Register: January 5, 2005 (Volume 70, Number 3)

Rules and Regulations
Page 943–1019
Air Quality Designations and Classifications for the Fine Particles

(PM2.5) National Ambient Air Quality Standards; Final Rule
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 81
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This rule sets forth the initial air quality designations and
classifications for all areas in the United States, including Indian country, for the
fine particles (PM2.5) National Ambient Air Quality Standards (NAAQS). The EPA
is issuing this rule so that citizens will know whether the air quality where they
live and work is healthful or unhealthful. Health studies have shown significant
associations between exposure to PM2.5 and premature death from heart or lung
disease. Fine particles can also aggravate heart and lung diseases and have been
linked to effects such as cardiovascular symptoms, cardiac arrhythmias, heart
attacks, respiratory symptoms, asthma attacks, and bronchitis. These effects can
result in increased hospital admissions, emergency room visits, absences from
school or work, and restricted activity days.
Individuals that may be particularly sensitive to PM2.5 exposure include
people with heart or lung disease, older adults, and children. This rule establishes
the boundaries for areas designated as nonattainment, unclassifiable, or
attainment/unclassifiable. This rule does not establish or address State
and Tribal obligations for planning and control requirements that apply to
nonattainment areas for the PM2.5 standards. The EPA will publish a separate
rule which will set forth the planning and control requirements that apply to
nonattainment areas for the PM2.5 standards.
Operational Decisions
When organizations or agencies in the executive branch of a government,
regardless of level, implement laws, they invariably must make many opera-
tional decisions as implementation proceeds. These decisions, which are dif-
ferent from the formal rules that also influence implementation, are policies
as well. For example, in implementing the Water Quality Improvement Act
(P.L. 91-224), the several federal agencies with implementation responsibili-
ties establish operational protocols and procedures that help them deal with
those affected by the provisions of this law. These protocols and procedures
are a form of policies because they are authoritative decisions. The Real World
of Health Policy: The FDA Issues a Press Release illustrates ongoing op-
erational decisions made within the federal Food and Drug Administration
(FDA) (www.fda.gov).

The FDA Issues a Press Release
U.S. Food and Drug Administration
December 23, 2004
The Food and Drug Administration (FDA) today issued a Public Health Advisory
(available at www.fda.gov/cder/drug/advisory/nsaids.htm) summarizing the
agency’s recent recommendations concerning the use of non-steroidal anti-
inflammatory drug products (NSAIDs), including those known as COX-2 selective
agents. The public health advisory is an interim measure, pending further review
of data that continue to be collected.
In addition, FDA today announced that it is requiring evaluation of all
prevention studies that involve the Cox-2 selective agents Celebrex (celecoxib)
and Bextra (valdecoxib) to ensure that adequate precautions are implemented in
the studies and that local Institutional Review Boards reevaluate them in light
of the new evidence that these drugs may increase the risk of heart attack and
stroke. A prevention trial is one in which healthy people are given medicine to
prevent a disease or condition (such as colon polyps or Alzheimer’s disease).
FDA is issuing an advisory because of recently released data from controlled
clinical trials showing that the COX-2 selective agents (Vioxx, Celebrex, and
Bextra) may be associated with an increased risk of serious cardiovascular events
(heart attack and stroke) especially when they are used for long periods of time
or in very high risk settings (immediately after heart surgery).
Also, as FDA announced earlier this week, preliminary results from a
long-term clinical trial (up to three years) suggest that long-term use of a
non-selective NSAID, naproxen (sold as Aleve, Naprosyn and other trade name
and generic products), may be associated with an increased cardiovascular (CV)
risk compared to placebo.
Although the results of these studies are preliminary and conflict with
other data from studies of the same drugs, FDA is making the following interim
recommendations:
• Physicians prescribing Celebrex (celecoxib) or Bextra (valdecoxib),

should consider this emerging information when weighing the benefits
against risks for individual patients. Patients who are at a high risk of
gastrointestinal (GI) bleeding, have a history of intolerance to non-selective
NSAIDs, or are not doing well on non-selective NSAIDs may be appropriate
candidates for Cox-2 selective agents.
• Individual patient risk for cardiovascular events and other risks commonly
associated with NSAIDs should be taken into account for each prescribing
situation.
• Consumers are advised that all over-the-counter (OTC) pain medications,
including NSAIDs, should be used in strict accordance with the label
directions. If use of an (OTC) NSAID is needed for longer than ten days, a
physician should be consulted.
Non-selective NSAIDs are widely used in both over-the-counter (OTC) and

prescription settings. As prescription drugs, many are approved for short-term
use in the treatment of pain and primary dysmenorrhea (menstrual discomfort),
and for longer-term use to treat the signs and symptoms of osteoarthritis and
rheumatoid arthritis. FDA has previously posted extensive NSAID medication
information at http://www.fda.gov/cder/drug/analgesics/default.htm.
FDA is collecting and will be analyzing all available information from the most
recent studies of Vioxx, Celebrex, Bextra, and naproxen, and other data for COX-2
selective and nonselective NSAID products to determine whether additional
regulatory action is needed. An advisory committee meeting is planned for
February 2005, which will provide for a full public discussion of these issues.
FDA urges health care providers and patients to report adverse event
information to FDA via the MedWatch program by phone (1-800-FDA-1088), by
fax (1-800-FDA-0178), or by the Internet at http://www.fda.gov/medwatch/index
.html.
Judicial Decisions
Judicial decisions are another form of policies. An example is the U.S. Supreme
Court’s ruling in 2000 (by a 5–4 vote) that the FDA cannot regulate tobacco.
Another example is the Supreme Court’s decision on January 10, 2005, not to
hear an appeal filed by six health insurers in a bid to stop a class-action lawsuit
brought by more than 600,000 doctors who claim the companies underpaid
them for treating patients. This decision allowed a lower court’s ruling to
stand, meaning that a class-action suit could proceed in federal court. Both
decisions are policies because they are authoritative decisions that have the
effect of directing or influencing the actions, behaviors, or decisions of others.
The Real World of Health Policy: Connecticut Supreme Court Decides a Case
contains an example of how court decisions are authoritative decisions that
affect others, often in dramatic ways.

Connecticut Supreme Court Decides a Case
Use of this illustration is restricted.
High Court Deals Doctors Setback
Affirms Dismissal of Lawsuits Against Two Health Insurers
Hartford Courant
Diane Levick
January 4 2005
The Connecticut State Medical Society has lost an attempt to revive lawsuits
against two health insurers that accused them of deceptively denying, shrinking,
and delaying claim payments to doctors.
In an opinion released online Monday, the state Supreme Court affirmed
a trial court’s dismissal of the 2001 suits against Oxford Health Plans and
ConnectiCare.
The Supreme Court agreed with the lower court that the medical society—a
federation of eight county medical associations with a total of more than 7,000
physicians—did not have proper standing to bring the cases.
“We’re naturally disappointed and will look at what options we have,” said
Timothy B. Norbeck, the medical society’s executive director.
The society, alleging violations of Connecticut’s unfair trade practices
law, brought suits against seven insurers in 2001 including Farmington-based
ConnectiCare and Trumbull-based Oxford. Oxford was acquired last July by
UnitedHealth Group.
The society settled its legal actions against Aetna and CIGNA, and Norbeck
says the other litigation against UnitedHealth, Anthem, and Health Net is still
pending.
In its opinion Monday in the Oxford case, the Supreme Court agreed with the
company’s argument that the society lacked standing because its alleged injury
was too indirect or “remote.”
Use of this illustration is restricted.
The medical society had brought the suit on behalf of its member physicians
and itself. However, the doctors who were allegedly hurt by Oxford were free to
sue on their own, though their contracts required them to try to arbitrate their
claims first, the court noted.
Allowing the society to sue Oxford “would be to countenance an end run
around those arbitration provisions,” the court said.
The society had claimed direct injury, saying the actions by Oxford and
ConnectiCare forced it to spend significant time and money helping physicians
deal with the allegedly unfair practices.
The society, for instance, said it had to counsel physicians about the
problems, communicate with the state attorney general’s office and insurance
department, lobby state legislators, and hire outside counsel to assist in
legislative reform efforts.
The doctors’ group also said insurers’ failure to adequately reimburse
physicians meant the society would not be able to increase its dues, even though
it was operating at a deficit.
The Supreme Court Monday rejected the society’s appeal in the ConnectiCare
case, saying the society made a claim that was identical to what it argued in the
Oxford matter.
NOTE: The opinions of the Connecticut Supreme Court can be read on the web site of the State
of Connecticut, Judicial Branch, http://www.jud.state.ct.us/.
SOURCE: Levick, D. 2005. “High Court Deals Doctors Setback: Affirms Dismissal of Lawsuits
Against Two Health Insurers.” Hartford Courant, January 4. © 2004, Hartford Courant. Reprinted
with permission.
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Health and Medicine on Display International Expositions

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Sharon Buchbinder, R.N., Ph.D.

Caryl Carpenter, Ph.D.

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This publication is intended to provide accurate and authoritative information in regard

Copyright © 2006 by the Foundation of the American College of Healthcare Executives.

Library of Congress Cataloging-in-Publication Data

Acquisitions manager: Janet Davis; Project manager: Amanda Karvelaitis; Cover

Health Administration Press Association of University Programs

List of Acronyms and Initials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xii

List of Web Sites . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xviii

1 Health and Health Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

2 Impact of Health Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

3 Context and Process of Health Policymaking . . . . . . . . . . . . . . . . . . . 75

4 Policy Competency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125

5 Policy Formulation: Agenda Setting . . . . . . . . . . . . . . . . . . . . . . . . . 161

6 Policy Formulation: Development of Legislation . . . . . . . . . . . . . . . 203

7 Policy Implementation: Rulemaking . . . . . . . . . . . . . . . . . . . . . . . . . 239

9 Policy Modiﬁcation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 303

Appendix A: Overview of Medicare . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 355

Appendix B: Overview of Medicaid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 367

Appendix C: Brieﬂy Annotated Chronological List of Selected

About the Author . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 439

List of Acronyms and Initials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xii

List of Web Sites . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xviii

1 Health and Health Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

2 Impact of Health Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

3 Context and Process of Health Policymaking . . . . . . . . . . . . . . . . . . . 75

4 Policy Competency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125

5 Policy Formulation: Agenda Setting . . . . . . . . . . . . . . . . . . . . . . . . . 161

6 Policy Formulation: Development of Legislation . . . . . . . . . . . . . . . 203

7 Policy Implementation: Rulemaking . . . . . . . . . . . . . . . . . . . . . . . . . 239

8 Policy Implementation: Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . 269

9 Policy Modiﬁcation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 303

Appendix A: Overview of Medicare . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 355

Appendix B: Overview of Medicaid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 367

Appendix C: Brieﬂy Annotated Chronological List of Selected

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