Government and the Healthcare System PDF

CHAPTER 5 GOVERNMENT AND THE HEALTH CARE SYSTEM LEARNING OBJECTIVES After completing this chapter, students will be able to: Explain the constitutional basis of government authority in health care in the United States. Discuss the major health care functions of the federal government. Ide...

CHAPTER 5 GOVERNMENT AND THE HEALTH CARE SYSTEM LEARNING OBJECTIVES After completing this chapter, students will be able to: Explain the constitutional basis of government authority in health care in the United States. Discuss the major health care functions of the federal government. Identify and explain the roles of the key federal departments and agencies that are involved in the health care system. Describe the state and local governments’ role in health care. INTRODUCTION The U.S. government operates neither the health care delivery system nor the health services financing system in anything close to their entirety. In fact, in the United States, government is less involved with the provision of health care (in contrast to the payment for health services, with which it is heavily involved) than in any other industrialized country in the world. The government’s role in the U.S. health care system has developed and expanded gradually over a long period of time. In his preface to Stern’s (1946) seminal book on governmental medical services in the 1940s, Smillie, one of the first medical sociologists (as was Stern) and a noted public health authority of the day, said: Our forefathers certainly had no concept of responsibility of the Fed- eral Government, nor of the state government, for health protection of the people. This was solely a local governmental responsibility. When Benjamin Franklin wrote “Health is Wealth” in the Farmers’ Almanac, he was saying that health was a commodity to be bought, to be sold, to be conserved, or to be wasted. But he considered that health conservation was the responsibility of the individual, not of government. The local community was responsible only for the 173 174 I: U.S. Health Care System: Present State protection of its citizens against the hazards of community life. Thus govern- ment responsibility for health protection consisted of (a) promotion of sanita- tion and (b) communicable disease control. The Federal Constitution, as well as the Constitutions of most of the states, contains no reference or intimation of a federal or state function in medical care. The care of the sick poor was a local community responsibility from earliest pioneer days. This activity was assumed first by voluntary philanthropy; later, it was transferred, and became an official governmental obligation. (p. xiii) Nevertheless, the government at all levels—federal, state, and local—now plays a major role in the U.S. health care system. Although it is restricted compared with the gov- ernments of other nations, in terms of dollars spent and policies developed, its role looms rather large. THE CONSTITUTIONAL BASIS OF GOVERNMENTAL AUTHORITY IN HEALTH CARE It is argued that a very significant role for government in health care delivery is justified by the amount of money government spends on it. This says nothing about the calls for major reforms that could be undertaken by no agency other than government that echo down to us from the early 1930s and resonate in many voices today. But such a role has a constitutional basis as well. To understand government operations in the health care delivery system, it is essential to understand the structure of the government itself.1 A basic principle of the U.S. Consti- tution is that sovereign power is to be shared between the federal and state governments, a principle called federalism. At its heart, the U.S. Constitution is an agreement among the original 13 states to delegate some of their inherent powers to a federal government, on behalf not of themselves as separately sovereign entities, but of, as the preamble to the Constitution says, “the people of the United States.” As part of this agreement, in the 10th Amendment to the Constitution, the states explicitly reserved to themselves the rest of the power: “The powers not delegated to the United States by the Constitution, nor prohib- ited by it to the states, are reserved to the states respectively, or to the people” (U.S. Const. amend. X). Because it is not explicitly mentioned in the Constitution, among the powers reserved to the states is the “police power.” It is the latter that forms the basis of the states’ role in health (Mustard, 1945). As Grad (2005) points out: In the states, government authority to regulate for the protection of public health and to provide health services is based on the “police power”—that is, the power to provide for the health, safety, and welfare of the people. It is not necessary that this power be expressly stated, because it is a plenary power that every sovereign government has, simply by virtue of being a sovereign 1 The Public Health Law Manual by Grad (2005), Health and the Law by Christoffel (1982), and “The Legal Basis for Public Health” by Richards and Rathbun, Chapter 4 in Scutchfield and Keck’s Prin- ciples of Public Health Practice (1996), are valuable guides to the legal basis of governmental activity in health care and to the many legal procedures involved in the enforcement of public health law.  5: Government and the Health Care System 175 government. For purposes of the police power, the state governments—which antedate the federal government—are sovereign governments …. [T]he exer- cise of the police power is really what government is about. It defines the very purpose of government. (p. 11) Among the states’ other inherent powers are those of delegation of their own authority. The states used this power to create a third tier of government, local government. Most states have delegated some of their own health powers to that tier. The constitutional basis of the federal government’s health authority is found in the powers to tax and spend to provide for the general welfare, and regulate interstate and foreign commerce (see the pre- amble and Article 1, Section 8 of the Constitution; Grad, 2005, pp. 11–15). The other basic constitutional principle affecting health and health services is “separa- tion of powers.” The Constitution divides the sovereign power of the federal government among three branches of government: executive, legislative, and judicial. Under separa- tion of powers, each branch of the federal government has its own authority and responsi- bility, spelled out in the Constitution. Furthermore, the Constitution spells out curbs on the powers of each branch, exercised by the other two. This arrangement is called the system of checks and balances. One very important check on the power of both the federal legislative and executive branches, “judicial review” of the constitutionality of their actions, is not found in the Constitution, however. It was established early in the 19th century by the third chief justice of the Supreme Court, John Marshall, and his colleagues on the bench. It has become an accepted part of the U.S. constitutional system only because the other two branches have granted the court that authority in practice and have followed its determinations. In organizing themselves, the state governments have followed fairly closely the tri- partite form of government established under the U.S. Constitution, with checks and balances and separation of powers. At the tertiary level of government, the boundaries between the branches at times become blurred, however. For example, in some suburban and rural areas, the local chief executive officer presides over the local legislative body. Nevertheless, in most U.S. jurisdictions, separation of powers is a major principle of gov- ernment. THE HEALTH CARE FUNCTIONS OF GOVERNMENT The health care functions of government can be summarized as follows: (a) purchase health care, (b) provide health care, (c) ensure access to quality care for vulnerable pop- ulations, (d) regulate health care markets, (e) support acquisition of new knowledge, (f) develop and evaluate health technologies and practices, (g) monitor health care quality, (h) inform health care decision-makers, (i) develop the health care workforce, and (j) convene stakeholders from across the health care system (Tang et al., 2004). Each branch of the gov- ernment has a unique role in these processes. The Legislative Branch At each level of government, federal, state, and local, the three branches of government have responsibility and authority for health and health services. Legislatures create the laws that establish the means to safeguard the public’s health in matters ranging from the assurance of a pure water supply to protecting the health of workers in their 176 I: U.S. Health Care System: Present State places of employment. The legislatures also enact the legal framework within which the health care delivery system functions, determining which individuals and institutions are authorized to deliver what services to which persons under what conditions and requirements. In the past, legislatures have imposed certain requirements for planning and devel- opment on the system, although in most jurisdictions that function has been minimized or has disappeared entirely. If the government is to participate in health care financing, directly deliver services, or support research efforts, the legislature must first establish the legal authority for those programs. The Judicial Branch The judiciary generally supports the work of the other two branches of government. The judicial branches at the three levels of government have important powers relating to health and health services. In the criminal law arena, working in concert with the law enforcement arms of the executive branches under the authority granted to them by their respective legislatures, the judiciary can try apprehended transgressors of the criminal law and determine punishment for those successfully prosecuted. For example, although it is a state legislature that creates the licensing law for physicians and the executive branch that administers it, it is the judicial system that determines the guilt or innocence of a person charged with “practicing medicine without a license.” The criminal justice system also plays a vital role in safeguarding the public’s health. For example, it enforces sanitary pro- tection and pollution control legislation, with criminal sanctions if necessary. In the civil arena, the judicial system handles disputes arising from the provision of health services, for example, through the process of malpractice litigation. The judi- cial system adjudicates contract cases arising from health care system disputes, such as those between providers or patients, on one side, and a third-party payer on the other. It protects the rights of individuals under the due process and equal protection clauses of the Fifth and 14th Amendments to the Constitution. Together, then, the judicial and executive branches form the civil and criminal justice systems at the federal, state, and local levels. The Executive Branch In common parlance, the term government in health care refers to the executive branch that delivers health care services, drafts and enforces provider/payer regulations, and admin- isters financing programs, not the legislature that creates the programs or regulatory authority, nor the courts that settle disputes arising under the laws and adjudicate viola- tions of them. Therefore, in the remainder of this chapter the term government refers to the executive branch of government. Provision of Personal Health Services At the federal level, personal health services are provided, for the most part, to “categories of persons”: members of the uniformed services and their families, Native Americans, and military veterans, for example. State governments provide personal health services, for the most part, to “persons who have specific diseases,” such as mental illness and tuberculosis. Local governments’ personal health services are “stratified by class.” Generally, they are for the poor. There are occasional overlaps; for example, governments at all levels provide health services for prisoners, one category of person.  5: Government and the Health Care System 177 Provision of Community Health Services Government at all levels is the major provider of the traditional communitywide public health services, such as pure water supply and sanitary sewage disposal, food and drug inspection and regulation, communicable disease control (e.g., immunization and the con- trol of sexually transmitted diseases), vital statistics, environmental regulation and protec- tion, and public health laboratory work. Certain community health activities are shared with the private sector. For example, in public health education, voluntary agencies such as the American Cancer Society and the American Heart Association are important participants. Private refuse companies do much of the solid waste collection and, in certain states, supply the water. Private organizations such as the Sierra Club and the Natural Resources Defense Council are active in environmental protection. Private institutions also play a vital role in health sciences education and research. Health Care Financing As will be described in more detail in Chapter 6, Financing the Health Care System, gov- ernment participates in the financing system in three ways. First, it pays for the opera- tion of its own programs, both personal and community. It does this directly, for example, through the federal government’s Department of Veterans Affairs (VA) hospital system or a municipal hospital serving primarily the poor. It also does this indirectly, for example, through the federal government’s provision of grants to state governments to help pay for personal care in state mental hospitals and for the operation of the state’s public health agencies at the community level. The states, in turn, indirectly support local governmental public health activities by providing money for that purpose. Second, through grants and contracts to nongovernmental agencies (and, in certain cases, other government agencies), governments support other types of health-related pro- grams, for example, in biomedical research and medical education. Third, and this is by far the major role of government in financing, under such programs as Medicare and Medic- aid, governments pay providers for the delivery of care to patients. As will be discussed in greater detail in Chapter 6, federal, state, and local public funds accounted for about 49% of National Health Expenditures (NHE) in 2021, up from 43.4% in 2013, 35.5% in 2000, and 32.6% in 1990. Concomitantly, private business’s contribution to NHE dropped from 24.6% in 1990 to 20.9% in 2013 and 17% in 2021. The household contribution declined from 34.9% in 1990 to 28.2% in 2013 to 27% in 2021 (Centers for Medicare & Medicaid Services [CMS], 2023b; National Center for Health Statistics [NCHS], 2015, Table 109). THE FEDERAL GOVERNMENT’S ROLE IN HEALTH CARE The federal government plays a very large role in the U.S. health care system. The two pow- ers constitutionally delegated to the federal government mentioned before—the power to tax and spend for the general welfare and the power to regulate interstate commerce— provide the basis for most federal activity in the health arena. The federal government’s key activities can generally be categorized as falling under at least one of four groups: (a) allocation and distribution of resources to the health care system, (b) information gener- ation and distribution, (c) health care access assurance, and (d) regulation and enforcement of laws and policies related to the health care system. In many cases, an activity may be characterized as falling under more than one category. 178 I: U.S. Health Care System: Present State The power to tax and spend is exactly what it sounds like: The federal government is authorized to collect and distribute funds to promote the welfare of the nation. Spending may be either the funding of projects and programs carried out by the government itself, financing contracts with external parties, or making direct contributions of funds (e.g., through grants). Most of the federal government’s health activities are based on its power to tax and spend. For example, pursuant to this power, the federal government funds or provides access to personal health services through programs including Medicaid, Medicare, Children’s Health Insurance Program (CHIP), community health centers, and the health care plans for active military members and veterans; conducts extensive health monitoring, surveillance, and epidemiologic studies regarding the nation’s health status and health needs; conducts and funds health and biomedical research; develops policies, guidelines, and standards for health care practice; provides direct and indirect funding to state and local health agencies, as well as pri- vate organizations, to provide health services; supports public information and education campaigns on health-related matters; conducts and funds public health education and research; and provides standards for training the health workforce. The taxing power is also used to encourage or discourage certain behaviors. For exam- ple, the federal government may encourage private business to provide health insurance to employees through tax credits, and it may discourage the consumption of tobacco prod- ucts or alcohol through the imposition of excise taxes. The federal government’s health-related regulatory authority is generally derived from the Commerce Clause—the constitutional provision permitting the federal government to regulate interstate commerce. Although generally more limited in scope than its activities financing public health research and services or providing access to health care, the federal government does impose and enforce regulations and laws in several public health areas affecting the country generally. For example, federal agencies enforce regulations concern- ing drug, food, and occupational safety, as well as environmental protection. The federal government’s regulatory activities in each of these arenas are based in its authority under the Commerce Clause. If there were political will, federal control could be imposed. See the Clean Air Act case; the same reasoning could be applied to communicable disease moni- toring—disease affects business and does not respect political boundaries. Several examples indicate the type, scope, and impact of federal government actions related to health care in the United States. First is the federal Employee Retirement and Income Security Act (ERISA), which aims to protect employees of private companies by regulating the benefits they receive. ERISA was enacted in 1974, largely to regulate employee pension funds, although it also covers employer-sponsored health insurance. Thus, ERISA prevents states from directly regulating employee welfare benefits, including employer-sponsored health plans. (U.S. Department of Labor [DOL], 2023). As a result, the federal government, through ERISA, has an enormous impact on the health plans that are offered to employees of private companies. Second is the federal Health Insurance Portability and Accountability Act (HIPAA), which aims to protect patient privacy. HIPAA was enacted in 1996. A major goal of the legislation was “to assure that individuals’ health information would be protected while  5: Government and the Health Care System 179 allowing the flow of health information needed to provide and promote high quality health care and to protect the public’s health and well-being” (U.S. Department of Health and Human Services [DHHS], 2023b, para. 3). HIPAA has had an immense impact on the way health care is delivered in the United States, affecting standardization of health care information, methods of health data transfer, and the interactions between patients, pro- viders, and payers. The HIPAA privacy rule establishes national standards to protect individuals’ medical records and other individually identifiable health information (collec- tively defined as “protected health information”) and applies to health plans, health care clearinghouses, and those health care providers that conduct certain health care transactions electronically. The rule requires appropriate safeguards to protect the privacy of protected health information and sets limits and condi- tions on the uses and disclosures that may be made of such information without an individual’s authorization. The rule also gives individuals rights over their protected health information, including rights to examine and obtain a copy of their health records, to direct a covered entity to transmit to a third party an electronic copy of their protected health information in an electronic health record, and to request corrections. (DHHS, 2023a, para. 1) Third are the Alternative Payment Model (APM) and the Merit-Based Incentive Pay- ment System (MIPS), which fund incentives to clinicians to provide high-quality and cost-efficient care through the CMS Quality Payment Program (QPP). QPP was autho- rized in 2015 with the Medicare Access and Chip Reauthorization Act (MACRA). QPP gave CMS the ability to reward high-value, high-quality Medicare clinicians with payment increases, while also reducing payments to those clinicians who did not meet performance standards. APM is a program that gives added incentive payments for cost and quality improvement for a specific clinical condition, care episode, or population. MIPS applies to the entire clinical practice (CMS, 2023c). The differences were explained from the clinician perspective as follows: Out of the two options, MIPS is closer to fee-for-service, but it also allows the Centers for Medicare & Medicaid Services (CMS) to incrementally adjust its fees based on scores in clinical quality, meaningful use of electronic health records, efficiency and practice improvement. Under the model, physicians will be compared either to their peers in the same specialty or to themselves to determine how they have maximized resources from year to year. In 2019, the range of positive or negative payment adjustments in the MIPS program is minus 3.5 percent to plus 4.5 percent, and gradually increase until it settles at plus or minus 9 percent in 2022. APM, on the other hand, offers the highest possible reimbursement—a guaranteed 5 percent annual payment increase from CMS over the first 6 years of the program, within the construct of an accountable care organization (ACO) of the practice’s choice. What’s more, if a practice is a certified patient-cen- tered medical home, “right away you are guaranteed the highest possible clin- ical improvement score,” which represents 15 percent of the total value score. (Beaulieu-Volk, 2015, paras. 3–4) 180 I: U.S. Health Care System: Present State Many federal agencies are involved in the health care system in ways big and small, among them provision of patient care, biomedical and health policy research, health work- force training, and financing health care. There is a particularly important role in develop- ing data and methods for evaluating health care, which will be discussed in more detail in Chapter 7, Health Care System Performance. The DHHS is the most important federal actor in health and health care. However, there are two other federal agencies with major health care services responsibilities: the VA and the Department of Defense (DOD). Other federal agencies with significant health- related responsibilities include the Department of Agriculture (USDA; nutrition policy, meat and poultry inspection, food stamps), the Environmental Protection Agency (EPA), and the DOL, which administers the Occupational Safety and Health Administration (OSHA) and the Bureau of Labor Statistics (BLS). Department of Health and Human Services The mission of the DHHS is “to enhance the health and well-being of all Americans, by pro- viding for effective health and human services and by fostering sound, sustained advances in the sciences underlying medicine, public health, and social services” (DHHS, 2022a, para. 1). Through 12 operating divisions, the DHHS administers more than 100 health- related programs in a wide range of areas, including health and biomedical research, epi- demiology and surveillance, disease prevention and immunization, food and drug safety, providing access to primary health care for certain populations, and bioterrorism response preparedness. These programs “protect the health of all Americans and provide essential human services, especially for those who are least able to help themselves” (DHHS, 2022c, para. 1). In 2022, the DHHS directly employed approximately 84,000 people and had a budget with $1.7 trillion in outlays. About 80% of the budget funded the Medicaid and Medicare programs. Many of the other mandatory programs concerned children and family well- being (DHHS, 2022b; see Table 5.1). TABLE 5.1 Composition of the U.S. Department of Health and Human Services Budget: Mandatory Programs Mandatory Programs (Outlays)1 2020 2021 2022 2022 +/− 2021 Medicare 768,618 720,312 767,325 +47,013 Medicaid 458,468 521,127 570,687 +49,560 Temporary Assistance for Needy 17,182 17,278 17,878 +600 Families (TANF)2 Foster Care and Adoption Assistance 8,836 10,764 10,241 −523 Children’s Health Insurance Program3 16,880 17,220 17,142 −78 Child Support Enforcement 4,424 4,388 4,157 −231 Child Care Entitlement 2,979 3,187 13,973 +10,786 (continued)  5: Government and the Health Care System 181 TABLE 5.1 Composition of the U.S. Department of Health and Human Services Budget: Mandatory Programs (continued") Mandatory Programs (Outlays)1 2020 2021 2022 2022 +/− 2021 Social Services Block Grant 1,727 1,583 1,640 +57 Other Mandatory Programs4 14,938 65,913 90,460 +24,547 Offsetting Collections −1,219 −1,169 −597 +572 Subtotal, Mandatory Outlays 1,292,833 1,360,603 1,492,906 +132,303 Total, HHS Outlays 1,504,270 1,547,463 1,662,293 +114,830 1 Totals may not add due to rounding. 2 Includes outlays for the TANF, and the TANF Contingency Fund. 3 Includes outlays for the Child Enrollment Contingency Fund. 4 Includes outlays for No Surprises Implementation Fund, Defense Production Act Medical Supplies Enhancement, Prepare Americans for Future Pandemics, Invest in Maternal Health, the Public Health Resilience and all other remaining mandatory outlays not broken out in the Mandatory Programs table. NOTE: Data are in millions of dollars. SOURCE: U.S. Department of Health and Human Services. (2022b). Fiscal year 2022: Budget in brief: Strengthening health and opportunity for all Americans. https://www.hhs.gov/sites/default/files/fy-2022-budget-in-brief.pdf Discretionary programs accounted for 10% of the budget (DHHS, 2022b; see Figure 5.1). Of the 12 operating divisions within the DHHS, nine are components of the U.S. Public Health Service. There are two staff offices within the Office of the Secretary, which are also designated components of the U.S. Public Health Service, and which operate to coordinate the agency’s public health activities. They are the Office of Global Affairs (OGA) and Office of the Assistant Secretary for Preparedness and Response (ASPR). These operating divi- sions and staff offices themselves each contain many subagencies and offices, administer- ing hundreds of programs within the DHHS. Table 5.2 lists the DHHS operating divisions and their respective missions and budgets. As Table 5.2 indicates, the scope of activities and services undertaken by the DHHS is vast, and indeed, many of the identified subagencies and offices have their own branches and divisions, each with its own mission and program responsibilities. A comprehensive discussion of the activities and programs of the DHHS agencies is far beyond what can be accomplished here. Furthermore, reorganization at the federal level is occurring rap- idly, particularly in response to the COVID-19 pandemic. What follows should not, by any means, be considered an exhaustive or complete description of the agencies discussed, but rather is intended to give an idea of some of the key programs and activities of the DHHS agencies and how the federal government interacts with the health care system. Collectively, the 12 operating divisions of the DHHS carry out a variety of vital health care functions: regulation, direct provision of personal and community health services, provision of financial support for a variety of health services through grants and contracts, direct biomedical research, and provision of the principal federal support of biomedical research in nongovernmental agencies. Although all divisions have relevance to the deliv- ery of health care, some have a greater impact. A brief description of these divisions fol- lows. 182 I: U.S. Health Care System: Present State FIGURE 5.1 The FY 2022 HSS budget—$1.7 trillion in outlays. Children’s entitlement TANF, 1% programs, 3% Other mandatory programs, 5.5% Discretionary programs, 10% Medicaid, 34% Medicare, 46% TANF, Temporary Assistance for Needy Families. SOURCE: U.S. Department of Health and Human Services. (2022b). Fiscal year 2022: Budget in brief: Strengthening health and opportunity for all Americans. https://www.hhs.gov/sites/default/files/fy-2022-budget-in-brief.pdf TABLE 5.2 Department of Health and Human Services (DHSS) Operating Divisions, 2022 Operating Division1 Mission and Budget2 Administration for Children Mission: to foster health and well-being by providing federal leader- and Families (ACF) ship, partnership, and resources for the compassionate and effective delivery of human services. FY2022 Budget Outlays: $98,367 Administration for Commu- Mission: to maximize the independence, well-being, and health of nity Living (ACL) older adults, people with disabilities across the life span, and their families and caregivers. FY2022 Budget Outlays: $5,005 Administration for Stra- Mission: (1) to lead the nation’s medical and public health preparedness for, tegic Preparedness and response to, and recovery from disasters and public health emergencies; Response (ASPR)* and (2) to collaborate with hospitals; health care coalitions; biotech firms; community members; state, local, tribal, and territorial govern- ments; and other partners across the country to improve readiness and response capabilities. FY2022 Budget Outlays: (through Public Health and Social Services Emergency Fund and others) (continued)  5: Government and the Health Care System 183 TABLE 5.2 Department of Health and Human Services (DHSS) Operating Divisions, 2022 (continued) Operating Division1 Mission and Budget2 Agency for Healthcare Mission: to produce evidence to make health care safer, higher quality, Research and Quality more accessible, equitable, and affordable, and to work within the U.S. (AHRQ)* Department of Health and Human Services and with other partners to make sure that the evidence is understood and used. FY2022 Budget Outlays: $344 Agency for Toxic Sub- Mission: to protect communities from harmful health effects related stances and Disease Regis- to exposure to natural and man-made hazardous substances by re- try (ATSDR)* sponding to environmental health emergencies; investigating emerg- ing environmental health threats; conducting research on the health impacts of hazardous waste sites; and building capabilities of and providing actionable guidance to state and local health partners. FY2022 Budget Outlays: (included in CDC budget) Centers for Disease Con- Mission: to protect America from health, safety, and security threats, trol and Prevention (CDC)* both foreign and in the United States. Whether diseases start at home or abroad, are chronic or acute, curable or preventable, human error or deliberate attack, the CDC fights disease and supports communities and citizens to do the same. FY2022 Budget Outlays: $16,108 Centers for Medicare & Mission: to ensure effective and high-quality health care while pro- Medicaid Services (CMS) moting more affordable and accessible care for all. FY2022 Budget Outlays: $1,379,251 Food and Drug Administra- Mission: (1) to protect the public health by ensuring the safety, efficacy, tion (FDA)* and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation; (2) to regulate the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors; (3) to expand the knowledge base in medical and associated sciences in order to enhance the nation's economic well-being and ensure a continued high return on the public investment in research; and (4) to exemplify and promote the highest level of scientific integrity, public accountability, and social responsibility in the conduct of science. FY2022 Budget Outlays: $3,857 Health Resources & Mission: to improve health outcomes and achieve health equity through Services Administration access to quality services, a skilled health workforce, and innovative, (HRSA)* high-value programs. FY2022 Budget Outlays: $17,628 Indian Health Services Mission: to raise the physical, mental, social, and spiritual health of (IHS)* American Indians and Alaska Natives to the highest level. FY2022 Budget Outlays: $10,951 (continued) 184 I: U.S. Health Care System: Present State TABLE 5.2 Department of Health and Human Services (DHSS) Operating Divisions, 2022 (continued) Operating Division1 Mission and Budget2 National Institutes of Mission: to seek fundamental knowledge about the nature and Health (NIH)* behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. FY2022 Budget Outlays: $45,213 Substance Abuse and Mission: to reduce the impact of substance use and mental illness on Mental Health Services America's communities. Administration (SAMHSA)* FY2022 Budget Outlays: $9,651 * Indicates U.S. Public Health Service 1 Alphabetical 2 Budget outlays in millions of dollars SOURCE: U.S. Department of Health and Human Services. (2022a). About HHS. https://www.hhs.gov/about/index. html; U.S. Department of Health and Human Services. (2022b). Fiscal year 2022: Budget in brief: Strengthening health and opportunity for all Americans. https://www.hhs.gov/sites/default/files/fy-2022-budget-in-brief.pdf Centers for Medicare & Medicaid Services CMS administers the largest insurance programs in the country, with a 2022 budget of approximately $1.4 trillion (DHHS, 2022b). The CMS programs include Medicare, Medic- aid, the CHIP, and the Basic Health Program (BHP). Medicare is a health insurance program for: ∙ people aged 65 and older, ∙ people under age 65 with certain disabilities, and ∙ people of all ages with end-stage renal disease (permanent kidney failure requir- ing dialysis or a kidney transplant). Medicaid provides health coverage to low-income people and is one of the largest payers for health care in the United States. It insures the young and old. CHIP provides states with federal matching funds to cover children in families with incomes too high to qualify for Medicaid, but not high enough to afford private health insurance. However, each state has its own rules about the family income that does not exceed eligibility for CHIP. The BHP is an option for states to provide affordable coverage and better continuity of care for those whose income fluctuates above and below Medicaid and CHIP eligi- bility levels (CMS, 2019). These programs are fundamental to providing health care coverage for millions of Americans (CMS, 2021), as evidenced by the number of their enrollees (see Table 5.3). In addition, CMS administers the Center for Consumer Information and Insurance Oversight (CCIIO), which contributes to implementing the Affordable Care Act, signed into law March 23, 2010. CCIIO oversees the provisions related to private health insurance. In particular, CCIIO is working with states to establish new health insurance marketplaces (CMS, 2023a).  5: Government and the Health Care System 185 TABLE 5.3 Centers for Medicare & Medicaid Services Program Enrollment by Populations1 Medicare (avg monthly) CY 2020 CY 2021 CY 20222 Parts A and/or B 62.8 63.9 64.5 Aged 54.5 55.9 56.6 Disabled 8.3 8.0 7.9 Original Medicare Enrollment 37.8 36.4 35.0 MA and Other Health Plan Enrollment 25.1 27.5 29.5 MA Enrollment 24.4 26.9 29.1 Part D (MAPD+PDP) 47.4 48.8 50.0 Medicaid (avg monthly)3 FY 2019 FY 2020 FY 2021 Total 73.9 75.3 83.5 Aged 6.1 6.3 6.5 Blind/Disabled 10.2 10.1 10.2 Children 28.9 29.1 33.5 Adults 15.2 15.4 17.0 Expansion Adult 12.1 12.8 15.0 CHIP (avg monthly) 3 7.2 7.1 7.1 1 Populations are in millions and may not add due to rounding. 2 Preliminary and subject to change. 3 Projected estimates. CHIP, Children’s Health Insurance Program; CY, calendar year; FY, fiscal year; MA, Medicare Advantage; MAPD, Medicare Advantage Prescription Drug; PDP, prescription drug plan. SOURCE: Centers for Medicare & Medicaid Services, Office of Enterprise Data & Analytics, Office of the Actuary. (2022, August). CMS fast facts. Centers for Medicare & Medicaid Services. https://data.cms.gov/sites/default /files/2022-08/4f0176a6-d634-47c1-8447-b074f014079a/CMSFastFactsAug2022.pdf Although primarily considered a health care insurance program for low-income people, Medicaid-reimbursed services may also include such public health activities as Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) services for children, family plan- ning services, cancer screening, school health services, and adult immunizations. Further, Medicaid payments also support public health providers such as health centers, public hos- pitals, community mental health providers, and sexually transmitted infection (STI) clinics, which are dependent on Medicaid revenues to sustain their operations (Perlino, 2006). Agency for Healthcare Research and Quality The Agency for Healthcare Research and Quality (AHRQ) is the lead federal agency charged with improving the quality, safety, efficiency, and effectiveness of health care for all Americans. It does not make policy, but rather, with a budget of approximately $455 million in FY 2022, AHRQ conducts and supports a broad range of health services research 186 I: U.S. Health Care System: Present State within research institutions, hospitals, and health care systems that informs and enhances decision-making, and improves health care services, organization, and financing. AHRQ’s research, which is both conducted internally and through grants and contracts to univer- sities, health care systems, hospitals, and physician practices, focuses on a set of broad issues relating to both clinical services and the system in which those services are pro- vided, including comparative effectiveness, patient safety, health information technology, prevention and care management for chronic conditions, and value research. Overall, AHRQ’s priorities are: “Investing in health systems research that generates evidence about how to deliver high-quality, safe, high-value healthcare. Creating tools and strategies for health systems and frontline clinicians to support practice improvement. Providing data and analytics to help decision makers understand the healthcare sys- tem and identify opportunities for improvement” (AHRQ, 2022, para. 1). Important data tools developed by AHRQ include the Healthcare Cost and Utilization Project (HCUP), the Consumer Assessment of Healthcare Providers and Systems, and the Medical Expenditure Panel Survey (MEPS). Health Resources & Services Administration The activities of the Health Resources & Services Administration (HRSA) are principally to further the essential services related to workforce development and ensure access to health care services. Comprising seven bureaus and 11 offices and with a staff of more than 1,800, HRSA is the primary federal agency for improving access to health care services for people who are uninsured, isolated, or particularly vulnerable. HRSA provides leadership and financial support to health care providers in every state and U.S. territory. Primarily a grant-giving and oversight agency, HRSA distributes funds to community-based organi- zations, colleges and universities, hospitals, local and state governments, associations, and foundations. The bureaus within HRSA include: Bureau of Health Workforce Bureau of Primary Health Care Federal Office of Rural Health Policy Health Systems Bureau HIV/AIDS Bureau Maternal and Child Health Bureau Provider Relief Bureau HRSA’s Bureau of Health Workforce makes grants to health professions’ training pro- grams and funds scholarships and loan repayment programs for health professionals. It also provides scholarship and educational loan repayment opportunities in exchange for clinicians’ agreement to serve in communities with critical shortages of health care pro- viders. The Bureau creates shortage designations, which identify an area, population, or facility experiencing a shortage of health care services. The shortage designations help dis- tribute participants to places of most need. Other federal programs use shortage designa- tions for their own resource distribution. There are several types of shortage designations:  5: Government and the Health Care System 187 Health Professional Shortage Areas (HPSAs) Maternity Care Target Areas (MCTAs) Medically Underserved Areas (MUAs) and Medically Underserved Populations (MUPs) Exceptional Medically Underserved Population (Exceptional MUP) Governor’s-Designated Secretary-Certified Shortage Areas for Rural Health Clinics (Bureau of Health Workforce, n.d.). HRSA’s HIV/AIDS Bureau administers the Ryan White HIV/AIDS Program, which provides funding to grantees for HIV/AIDS outreach and AIDS Drug Assistance Pro- grams (ADAPs). The program is designed to help those who do not have sufficient health care coverage or financial resources to cope with HIV and AIDS. The Maternal and Child Health Bureau administers the Maternal and Child Health Block Grant to states. The grants are designed to expand access to comprehensive prenatal and postnatal care for women; support health assessments, diagnostics, and treatment for children; and expand access to immunization and other preventive care for children. The Federal Office of Rural Health Policy supports many rural health programs including rural health networks, black lung clinics, telehealth, and veterans rural health access programs (HRSA, n.d.). HRSA’s Bureau of Primary Health Care provides funding for nonprofit, community- run health centers delivering comprehensive primary and preventive health care for people who otherwise lack access to health care. “Over the last 58 years, health centers have grown to become the cornerstone of community-based primary health care in the United States. By integrating medical, dental, behavioral, and other health care services, health centers provide patients the right care, at the right time, in the right place” (HRSA, 2023, para. 1). Populations served by community health centers include people with low incomes, the uninsured, those with limited English proficiency, migrant and seasonal farm workers, individuals and families who are homeless, and those living in public housing. Health centers provide care on a sliding fee scale and see patients without regard for their ability to pay. There are approximately 1,400 community health centers delivering health care services at 13,500 sites. The centers serve approximately 29 million people, includ- ing migrant farm workers and homeless persons. One in 11 people in the United States receives medical care from an HRSA-funded health center (HRSA, n.d.). Centers for Disease Control and Prevention Established in 1946 as the Communicable Disease Center, the Centers for Disease Control and Prevention (CDC) is the foremost epidemiological, surveillance, and disease preven- tion agency in the federal government. Among its key functions is to monitor and report on the nation’s health, detect health problems and disease outbreaks, research and imple- ment disease prevention strategies, develop and advocate sound public health policies, promote healthy behaviors, and provide public health leadership and training. The CDC is the nation’s go-to agency for public health. It is the voice of public health for the nation. The CDC houses some of the best epidemiologists; biomedical, behavioral, and social sci- entists; prevention researchers; health policy analysts; and health economists in the world. Many know the CDC for its outstanding work related to infectious diseases. Its staff travels to sites worldwide when infectious disease outbreaks occur. The CDC publishes the essen- tial Morbidity and Mortality Weekly Report (MMWR), which contains the latest information on reportable diseases, new hazards, and other emerging health conditions. The CDC 188 I: U.S. Health Care System: Present State has also been a leader in bioterrorism threats research and practice. The CDC has become actively involved in noninfectious disease prevention, as well as the area of chronic dis- eases and injury control. The CDC has been called “the nation’s premier and largest public health organization” (Hartsaw, 2009, p. 141). At the time of this writing, the CDC was undergoing reorganization, particularly as a result of the COVID-19 pandemic. Data improvement and data analytics are important foci of reorganization. The Public Health Data Modernization Initiative is “at the heart of a national effort to improve the data that can improve health. This cross-cutting strategy will move us from tracking threats to anticipating them” (CDC, 2022, para. 1). The initiative focuses on: accelerating health-related data modernization capabilities across private and public entities, improving the skills of the public health workforce in data science and informatics, and innovating in areas of modeling and predictive analysis, artificial intelligence, and machine learning approaches to improving health. Overall, every CDC division and program is being affected by an increased focus on data improvement and better application of data to meet its mission. In FY 2021, under the CARES Act (Coronavirus Aid, Relief, and Economic Security Act), additional funds were provided for data surveillance and analytical infrastructure: “Leverage data for surveillance, detection, and improving jurisdictions’ situational awareness to allow localized, targeted responses and decision making using more real-time data to respond to outbreaks like COVID-19. Expand the electronic exchange and integration of information between public health and health care, including electronic health records, which is essential for timely, accurate, and accessible disease surveillance. Support for public health’s data science, informatics, and IT workforce; expanding core data, informatics, and IT capacity; advancing interoperable systems and tools; strengthening and expanding collaboration” (CDC, 2022, para. 4). The Data Modernization Initiative’s Strategic Plan summarizes the CDC’s vision for enhanced data utilization: CDC’s Data Modernization Initiative (DMI) is how our nation will move from siloed and brittle public health data systems to connected, resilient, adaptable, and sustainable “response-ready” systems that can help us solve problems before they happen and reduce the harm caused by the problems that do hap- pen. (CDC, 2021b, para. 1) The scope of the CDC’s activities is too great to be presented comprehensively here, but a few examples follow. See Figure 5.2 for all of the centers and offices within the CDC and their organizational structure as of March 2021 (CDC, 2021a). FIGURE 5.2 Organizational chart: Centers for Disease Control and Prevention, 2021. Office of Policy, Performance, and CDC Washington Office CAB Evaluation CAQ Office of Health Equity Office of the Chief of Staff CAG CAT Office of Science Office of Communications CAH CAU Immediate Office of the Director Office of Equal Employment Opportunity Office of Chief Operating Officer CAJ and Workplace Equity CAV Office of Laboratory Science and Safety CAN Office of Public Health Data, Surveillance, and Technology CAK Office of Readiness and Response CAD CA National Center for Health Statistics CAKB Center for Forecasting and Outbreak Analytics CADB National National National National National National National National National Center for State, Center for Center for Center for Center for Center Center on Center for Institute for Tribal, Local, HIV, Viral Chronic Environmental Emerging Global for Injury Birth Defects Immunization Occupational and Territorial Hepatitis, Disease Health/Agency and Health Prevention and and Safety and Public Health STD, and Prevention for Toxic Zoonotic Center and Developmental Respiratory Health Infrastructure TB and Health Substances and Infectious Control Disabilities Diseases and Workforce Prevention Promotion Disease Registry* Diseases CC CE CF CH CJ CK CL CN/J CR CW *ATSDR (J) is an OPDIV within DHHS but is managed by a common director’s office. ATSDR, Agency for Toxic Substances and Disease Registry; CDC, Centers for Disease Control and Prevention; DHHS, U.S. Department of Health and Human Services; OPDIV, operating division; STD, sexually transmitted disease; TB, tuberculosis. SOURCE: Centers for Disease Control and Prevention. (2023). Official organizational chart. https://www.cdc.gov/about/pdf/organization/cdc-org-chart.pdf 190 I: U.S. Health Care System: Present State Infectious Diseases At present, the CDC has three centers to prevent, control, and detect communicable diseases: the National Center for Immunization and Respiratory Diseases (NCIRD); National Center for Emerging and Zoonotic Infectious Diseases (NCEZID); and National Center for HIV/AIDS, Viral Hepatitis, Sexually Transmitted Infection, and Tuberculosis Prevention (NCHHSTP). The NCIRD has four divisions: Bacterial Diseases Influenza Viral Diseases Immunization Services (NCIRD, n.d.) The NCEZID “works to protect people at home and around the world from emerging and zoonotic infections ranging from A to Z—anthrax to Zika. We are living in an intercon- nected world where an outbreak of infectious disease is just a plane ride away” (NCEZID, n.d.-a, para. 1). The work of the NCEZID reflects this broad mandate and encompasses: foodborne and waterborne illnesses, infections that spread in hospitals, infections that are resistant to antibiotics, deadly diseases like Ebola and anthrax, illnesses that affect immigrants, migrants, refugees, and travelers, diseases caused by contact with animals, and diseases spread by mosquitoes, ticks, and fleas (NCEZID, n.d.-b). Noninfectious Diseases and Injuries Many units within the CDC focus on noninfectious diseases and injuries. They are the: National Center on Birth Defects and Developmental Disabilities; National Center for Chronic Disease Prevention and Health Promotion; National Center for Environmental Health, including Agency for Toxic Substances and Disease Registry; National Center for Injury Prevention and Control; and National Institute for Occupational Safety and Health (NIOSH). National Center for Health Statistics The NCHS, within the CDC, is the premier organization for the collection, processing, analysis, and dissemination of health data for the nation. The NCHS collects data from birth and death records, medical records, interview surveys, and through direct physical exams and laboratory testing. Some of NCHS’s major ongoing surveys and data collection systems, from which information is drawn about the nation’s health, health care, and the determinants of health, include the following (NCHS, n.d.): National Health and Nutrition Examination Survey (NHANES) National Health Care Surveys (NHCS) ∙ National Ambulatory Medical Care Survey (NAMCS) ∙ National Hospital Ambulatory Medical Care Survey (NHAMCS) ∙ National Hospital Care Survey (NHCS) ∙ National Post-Acute and Long Term Care Survey  5: Government and the Health Care System 191 National Health Interview Survey (NHIS) National Immunization Surveys (NIS) National Survey of Family Growth (NSFG) National Vital Statistics System (NVSS) ∙ Birth Data ∙ Mortality Data ∙ Fetal Death Data ∙ Linked Births/Infant Deaths See Figure 5.3. Data from the NCHS surveys and systems are available to the public through the NCHS website (www.cdc.gov/nchs) as public use files. The NCHS also produces innumerable standardized reports based on these data. The NCHS data are essential for developing, implementing, and evaluating health care policy in the United States. They allow: FIGURE 5.3 Summary of current surveys and data collection systems. NATIONAL CENTER FOR HEALTH STATISTICS NCHS Fact Sheet | August 2020 Summary of Current Surveys and Data Collection Systems https://www.cdc.gov/nchs/nvss.htm Disparity variables Data source and methods Selected data items Targeted sample size and data collection Frequency FY 2020–2021 plans State vital Birth and death WIC receipt All births: About For births, deaths, Annual Continue monthly, quarterly, and annual reporting registration rates Prenatal care 4 million records and fetal deaths: Assist states in automating or re-engineering their IT Births Birthweight annually Office of systems to enhance timeliness and quality of reporting Breastfeeding All deaths: About Management and Evaluate quality of birth data items added in 2003; evaluate Deaths Teen and nonmarital Maternal weight 2.7 million records Budget (OMB) race potential new items for collection Fetal deaths births and Body Mass annually categories* (1997) Linked Pregnancy outcomes Index Promote e-learning training for birth certificates and fetal Reported fetal deaths Education death reports; assess impact of training Birth/Infant Method of delivery Infant mortality of 20 or more weeks For births and deaths: Death Program Preterm delivery/ Life expectancy Promote mobile app for cause-of-death certification; complete gestation: About Marital status gestational age development of and promote e-learning training for death Causes of death, 26,000 annually Primary language certificates; assess impact of training Multiple births including fetal Counts of marriages causes information Enhance new data access methods and reports Medicaid payment and divorces not collected Occupational Continue to enhance natality and mortality surveillance system mortality Improve timeliness of vital statistics reports and data files Re-engineer or replace the medical coding system Expand cause-of-death coding to include more detailed supplemental codes for specific drugs (i.e., more detail than available in ICD–10) https://www.cdc.gov/nchs/ndi.htm Disparity variables Data source and methods Selected data items Targeted sample size and data collection Frequency FY 2020–2021 plans State registration Facilitates epidemiological follow-up All deaths Semi-annual Continue ongoing operations areas—death studies from 1979–2019 Continue to improve timeliness of data availability for certificates Verifies death for study participants for matching health and medical research purposes only Update NDI website Optional release of coded causes of death Expand outreach to health and medical research community available to users upon request Pilot new funding model to improve and expand use of NDI NCHS surveys can be linked to NDI for National Institutes of Health-funded projects *The primary OMB categories include White, Black or African American, Asian, Native Hawaiian or Pacific Islanders, American Indian or Alaska Native, Hispanic or Latino, not Hispanic or Latino. Multiple races can be reported. While data are collected in the categories indicated, sample sizes do not always allow for reporting in these categories. Some surveys collect more categories than the primary OMB categories. ICD-10, International Statistical Classification of Diseases and Related Health Problems, 10th Revision; IT, information technology; NCHS, National Center for Health Statistics; NDI, National Death Index; OMB, Office of Management and Budget; WIC, Women, Infants, and Children. SOURCE: Centers for Disease Control and Prevention. (2020). Summary of current surveys and data collection systems 2020. https://www.cdc.gov/nchs/data/factsheets/factsheet-summary-current-surveys.pdf 192 I: U.S. Health Care System: Present State documentation of population and subpopulation health status; identification of health and health care disparities by race or ethnicity, socioeconomic status, region, and other population characteristics; description of health care system experiences; monitoring health status and health care delivery trends; identification of health problems; support of biomedical and health services research; provision of information for policy; and evaluation of health policies and programs impact (NCHS, n.d.). Food and Drug Administration The U.S. Food and Drug Administration (FDA) is the agency charged with regulating drugs and most food products in the United States. The FDA is “responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation” (FDA, n.d., para. 1). Among the FDA’s seven centers are the: Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Center for Food Safety and Applied Nutrition Center for Tobacco Products Over-the-counter and prescription drugs, including generic drugs, are regulated by the FDA’s Center for Drug Evaluation and Research. The FDA evaluates drug safety and efficacy and ensures that the labeling and marketing of approved drugs are accurate. Vac- cines, blood, and biologics are regulated by the FDA’s Center for Biologics Evaluation and Research. The Center for Food Safety and Applied Nutrition works to ensure that the food supply is safe, sanitary, and honestly labeled. The Center for Tobacco Products was estab- lished to oversee the regulation of the marketing and promotion of tobacco products and set performance standards for tobacco products to protect the public health. The FDA also operates the National Center for Toxicological Research, which conducts research to eval- uate the biological effects of potentially toxic chemicals or microorganisms and to under- stand toxicological processes needed to inform the FDA’s regulatory decisions (FDA, n.d.). The focus is on the assurance of the efficacy and safety of a product before marketing and on the assurance of continuing quality after approval. Medical devices are regulated in a similar manner. Radiological equipment is also regulated, the goals being to control radiation exposure to the public as well as to ensure efficacy (FDA, n.d.). The FDA also has responsibility for: regulating the manufacture, marketing, and distribution of tobacco products to pro- tect the public health and to reduce tobacco use by minors; assisting to hasten innovations that make medical products more effective, safer, and more affordable and assisting the public to get the accurate, science-based information they need to use medical products and foods to maintain and improve their health; and aiding counterterrorism activities by ensuring food supply security and by fostering medical product developments that respond to deliberate and naturally emerging public health threats.  5: Government and the Health Care System 193 The regulatory programs of the FDA, especially those focusing on the efficacy and safety of drugs and medical devices, are sometimes controversial. Industry spokespeople maintain that the entry of useful drugs to the market is at times unnecessarily delayed by a lengthy and expensive approval process. Supporters of that process recall, for example, the thalid- omide disaster. The COVID-19 pandemic had an impact on FDA timelines. National Institutes of Health The National Institutes of Health (NIH) is the primary federal agency conducting and sup- porting biomedical research. Composed of 27 institutes and centers, the NIH conducts and funds research into the causes, treatment, cure, and prevention of a broad range of disease. Among the NIH institutes and centers are the National Cancer Institute; National Heart, Lung, and Blood Institute; National Institute on Aging; National Human Genome Research Institute; National Center for Complementary and Integrative Health; and National Cen- ter for Advancing Translational Sciences. An important resource for all public health and health care professionals in the United States and throughout the world is the National Library of Medicine, which collects, organizes, and makes available biomedical science information. Its web-based databases include PubMed/Medline and MedlinePlus. The vast majority of the NIH’s budget goes to support extramural research at universi- ties and other research institutions. Included in its portfolio is a substantial body of disease prevention research. Research on disease prevention is an important part of the NIH mis- sion. The institutes and centers have a broad portfolio of prevention research and training, as well as programs to disseminate the findings to scientists, health professionals, and the public. Ultimately, knowledge gained from NIH-supported prevention research enables the application of sound science in clinical practice, health policy, and community health programs, thereby improving the health of the public (NIH, n.d.). Substance Abuse and Mental Health Services Administration The Substance Abuse and Mental Health Services Administration (SAMHSA) is the lead agency within the DHHS to advance the behavioral health of the nation through public health efforts. Congress established the SAMHSA in 1992 to make substance use and men- tal disorder information, services, and research more accessible. The agency “leads public health efforts to advance the behavioral health of the nation and to improve the lives of individuals living with mental and substance use disorders, and their families” (SAMHSA, 2023, para. 1). The SAMHSA supports educational programs for the general public and health care providers, improves substance abuse prevention and treatment services through the iden- tification and dissemination of best practices, and conducts surveillance and monitoring of the prevalence and incidence of substance abuse. Other Federal Departments Many other federal departments have some health services responsibilities, as previously noted. Several are discussed here. Department of Veterans Affairs The VA provides many health services to veterans. After active-duty military service, the U.S. veteran becomes entitled to a remarkably broad range of health services through a health care subsystem, the precise equivalent of which is not found in any other nation. 194 I: U.S. Health Care System: Present State This fact is doubtless related, on the one hand, to the lack of a national health insurance program for the general population, and, on the other, to the political power of the vet- erans’ organizations. Coverage and access to services is based on factors such as service- connected disabilities and veterans’ income and assets. The VA operates the nation’s larg- est integrated health care system, providing care at 1,298 health care facilities, including 171 medical centers and 1,113 outpatient sites of care of varying complexity (VHA outpa- tient clinics). The VA health care system serves 9 million enrolled Veterans each year (VA, 2022). The VA provides a wide range of primary and specialized medical care, as well as social services including primary care services, urgent care services, mental health ser- vices, geriatrics and extended care services, women’s health, rehabilitation services, VA care coordination, postdeployment health services (PDHS), war-related illness and injury study centers (WRIISC), and pain management and opioid safety (VA, 2019a). Services and benefits are provided through a nationwide network of 1,255 health care facilities, includ- ing 170 medical centers and 1,074 outpatient facilities of varying complexity (VA, 2019b). There has been a major shift underway from a primary focus on inpatient care to one on outpatient services, health promotion and disease prevention, and easier access to the system. In this regard, the VA is the largest integrated provider of health care education. The VA also trains physician residents and other health care trainees. The VA supports medical research in areas that most impact veterans and their dependents and other beneficiaries (VA, 2019a). Department of Defense The DOD oversees the health services of the various branches of the military through the Military Health System. Each of the armed forces—the Army, Navy, Air Force, and Marines—has its own network of health facilities and civilian providers: hospitals, clinics, and field posts. All DOD health personnel are members of the military and salaried accord- ing to their military ranks (without relation to the specific services they render). The same basic structure prevails in times of war or peace. Health promotion and disease prevention are emphasized and integrated with the delivery of treatment services. Through both its own facilities and contracting arrangements with civilian providers, the DOD provides health services to members of the armed forces, their dependents, sur- viving dependents of service people killed while on active duty, and military retirees and their dependents. Servicemen and women are eligible for retirement benefits after a min- imum of 20 years of service. The health services component of that package is paid in addition to the VA benefits for which they may be eligible. There are currently 9.4 million persons covered by the Military Health System—active duty personnel, military retirees, and their families (Military Health System, 2019). An unusual aspect of military medical departments is that they are charged not only with providing a full range of direct health services, but also with providing for the environmental health and protection of their military communities. This unification of administrative responsibility for personal and community preventive and treatment ser- vices is rarely found elsewhere in the U.S. health care delivery system. Department of Agriculture The United States Department of Agriculture (USDA) oversees the Food Safety Inspection Service (FSIS); the Food and Nutrition Service (FNS), which includes the Women, Infants, and Children (WIC) nutritional program and school breakfast and lunch programs, and the food  5: Government and the Health Care System 195 stamp program, which helps low income people to buy food; the Center for Nutrition Policy and Promotion (CNPP), which, in cooperation with the DHHS, periodically issues dietary guidelines for the nation; the Animal and Plant Health Inspection Service (APHIS); and the Rural Utilities Service (RUS), which includes telemedicine programs. The USDA conducts research on the nutrient composition of foods, food consumption, and nutritional require- ments. The FSIS and APHIS are operated in cooperation with the FDA (USDA, 2019). Department of Labor The DOL, through the OSHA, regulates the health and safety of workplaces, either directly or through approval of state occupational safety programs that exceed federal require- ments. OSHA regulations are based on NIOSH research and regulate matters ranging from the permissible exposure limits for hazardous substances in the workplace to the use of portable power tools. There are a few industries that are not covered by OSHA; for exam- ple, the health and safety of miners is the province of the Bureau of Mines in the Depart- ment of the Interior. Another vital program of the DOL is the BLS, which collects, analyzes, and dissemi- nates data that describe Americans’ work experience including earnings by demographics, industry, and occupation; worker characteristics; employment by occupation; work expe- rience over time; labor turnover; unemployment; and consumer expenditures (BLS, 2022; OSHA, 2022). Environmental Protection Agency The U.S. Environmental Protection Agency (EPA) is an independent unit of the federal gov- ernment created during the Nixon administration that was elevated to cabinet-level status during the Clinton administration (EPA, n.d.). The mission of the EPA is to protect human health and the environment by regulating the release of pollutants in the air, on land, and in the water and conducting or providing grants for environmental remediation. EPA grant categories are air and radiation, water, drinking water, hazardous waste, and pesticides and toxins. Among the many laws administered, fully or partly, by the EPA are the Clean Air Act, the Clean Water Act, the Comprehensive Environmental Response, Compensation and Lia- bility Act, the Safe Drinking Water Act, and the Toxic Substances Control Act. Nearly half of the EPA’s budget is expended through grants to states, nonprofits, educational institutions, and others for various projects, from scientific studies to site cleanups (EPA, 2021, 2022). STATE GOVERNMENT’S ROLE IN HEALTH CARE Despite the enormous influence of the federal government on the health care system, fed- eralism confers significant powers to the states. The 10th Amendment to the Constitu- tion gives states all powers not specifically given to the federal government, including the power to make laws relating to public health. Thus, in a number of important ways, each state has the autonomy to affect health care in that state, and similarities between states may not be the result of mandates, but choice. … each state has a similar legislative structure (to the federal government). The governor is the highest elected officer, with constitutional powers that include budgetary authority, emergency resources, and even a state militia. State repre- sentatives meet in bicameral (two houses) chambers, a House and a Senate, and full agencies regulate in cabinet-level departments. 196 I: U.S. Health Care System: Present State Within the boundaries of each state, based in a rich history of sovereign rights that have been dedicated to states for more than 240 years, are principles that allow the people to direct their leaders to govern as the people indicate. Hence, California passes laws that Alabama would not consider. (Stone, 2018, paras. 2–3) At the state level, many different agencies and departments are involved in health care. The state public health departments have much responsibility related to health care, including provision of preventive health services and policies. However, other state agen- cies play a role in health care, as well. Following is a description of a number of health care-related activities of states, and their level of autonomy. licensing health care practitioners and facilities controlling infectious disease designing and operating medicaid program developing innovative health programs collecting health statistics It should be remembered that state autonomy pertains to certain situations. States are not autonomous in all circumstances. Further, legal challenges can change interpretations of laws and policies and, therefore, the rules impacting federal and state relationships. The 2022 ruling of the Supreme Court overturning Roe v. Wade demonstrated this potential for change. Prior to 2022, the Court had ruled that all abortion was a right under the 14th amendment, but afterward, the right to abortion became a state decision, which many states reversed. Licensing Health Care Practitioners and Facilities Licensing is a basic government function in health care. The licensing process for indi- vidual practitioners first establishes minimum standards for qualification. It then applies those standards to applicants to determine who may and who may not deliver what kinds of health services. Licensing of health care institutions sets minimum standards for each facility and their personnel as a group, applies the standards, and determines whether the institution may operate. The licensing authority is one of the most significant of the health powers residing with the states. The manner in which it is used is a major determinant of the character of the health care delivery system. The medical licensing system is particularly significant in this regard. Because no one can practice medicine without a license, the system has given phy- sicians tight control over the central product of the health care delivery system—medical services. By exercising this control, physicians have largely determined the structure of the health care delivery system: how it is organized, the types and functions of the institutions, and the powers of the several categories of personnel who work in it. Controlling Infectious Disease The COVID-19 pandemic demonstrated dramatically the effect of federalism on state health care policy and practice. At the outset of the pandemic, the federal government, through the CDC and other federal agencies, supported and encouraged traditional pan- demic control measures including masking and social distancing. After the COVID-19 vac- cine was developed, there were efforts to mandate vaccination, especially for vulnerable groups. However, states differed in their support of COVID-19 control measures includ- ing vaccination. In some states, vaccine mandates were upheld, but other states provided exemptions for those who did not want to be vaccinated. With the end of the COVID-19  5: Government and the Health Care System 197 public health emergency in 2023, many states removed any COVID-19 vaccine mandates they had, including the ability of public and private entities to require COVID-19 vaccina- tions as a condition of employment or access to goods and services (National Academy for State Health Policy [NASHP], 2023). Vaccination for childhood infectious diseases including measles, mumps, and polio demonstrate state autonomy as well. Although COVID-19 mandates are waning, vaccina- tion mandates for children are still in place. However, states vary widely in their approach to childhood vaccinations. The strictest mandates are in five states: California, New York, Maine, Connecticut, and West Virginia, all of which have medical exemptions only. Some states have medical and religious exemptions, one state has medical and personal belief exemptions, and some states have all three: medical, religious, and personal belief exemp- tions (Immunize.org, 2023; see Figure 5.4). It is a jumble of policies. FIGURE 5.4 Exemptions permitted for state childcare and school (Kg–Gr 12) immunization requirements, 2023. WA MT VT ME ND MN OR NH ID SD WI NY MA WY MI RI IA PA CT NV NE OH NJ UT IL IN CA CO WV DE KS MO VA MD KY DC NC TN AZ OK NM AR SC AL GA MS TX LA AK FL HI Notes Type of Exemption(s) Permitted AZ: Religious exemption for childcare only; personal belief Medical only exemption for school (Kg–Gr 12) only CO: Religious and personal belief exemptions combined under Medical, religious category of “nonmedical exemption” DC and VA: Personal belief exemption for HPV only Medical, personal belief MO and NE: Personal belief exemption for childcare only Medical, religious, personal belief WA: Personal belief exemption not allowed for MMR Immunize.org NOTE: For details, see data table: www.immunize.org/laws/exemptions.asp Gr, grade; HPV, human papillomavirus; Kg, kindergarten; MMR, measles, mumps, and rubella. SOURCE: Immunize.org. (2023, March). Exemptions permitted for state childcare and school (Kg-Gr 12) immunization requirements. https://www.immunize.org/laws/exemptions.pdf 198 I: U.S. Health Care System: Present State Designing and Operating Medicaid Programs Medicaid programs serve low-income persons in each state, especially children and preg- nant women, and they are often the largest state budget item. They are administered by the states, but jointly funded by the federal government and each state. A Medicaid program is developed in each state according to multiple and diverse state goals and conditions, although the final plan must be approved at the federal level, where most of the program’s funds originate. As a result, Medicaid programs vary greatly from state to state in eligibility requirements, funding per Medicaid participant, and health services covered. As an exam- ple, four states are compared on Medicaid eligibility requirements: Minnesota, Pennsylva- nia, Texas, and Oregon. Eligibility is based on the modified adjusted income (MAGI) and expressed as a percent of the federal poverty gross level (FPL). Minnesota has the most gen- erous eligibility requirements, followed by Pennsylvania, Texas, and Oregon. Children ages 0 to 1 years are covered by Medicaid at 283% FPL in Minnesota, 215% FPL in Pennsylvania, 198% FPL in Texas, and only 185% FPL in Oregon. The eligibility requirements decline sub- stantially after age 1 year except in Minnesota (Medicaid.gov, 2023; see Table 5.4). Developing Innovative Health Programs Since state and local governments vary substantially in priorities and resources, they can serve as laboratories for innovation in health care delivery—implementing new ideas on a small scale. A number of states—notably California, New York, Massachusetts, Minne- sota, and Oregon—have developed policies that other states and the federal government have emulated. The Maryland value-based payment reform—Maryland All-Payer Model (MDAPM)—is an example of a state health care innovation program that has proved promising to reduce costs and improve access and quality (Emanuel et al., 2022). MDAPM tested whether a statewide all-payer system with capitated hospital payments was an effective model for reducing costs and improving access and quality. The MDAPM exempted Maryland hospitals from Medicare’s inpatient and outpa- tient prospective payment systems and shifted the state’s hospital payment struc- ture to an all-payer, annual global budget. Maryland’s all-payer rate-setting system eliminates the payment differences across payers present in other states by establishing uniform payment rates for all payers. (CMS, 2020, para. 1) TABLE 5.4 Medicaid Eligibility Requirements in Four States, 2020 Population Eligibility Level as % Federal Poverty Level (FPL) Minnesota Pennsylvania Texas Oregon Children Ages 0–1 Years 283 215 198 185 Children Ages 1–5 Years 275 157 144 133 Children Ages 6–18 Years 275 133 133 133 Pregnant Women 278 215 198 185 SOURCE: Medicaid.gov. (2023). State overviews. https://www.medicaid.gov/state-overviews/index.html  5: Government and the Health Care System 199 Collecting Health Statistics Among the oldest and most important of public health functions is the collection and anal- ysis of vital statistics. This is a cooperative arrangement between states and the federal government’s NCHS. In the United States, legal authority for the registration of births, deaths, marriages, divorces, fetal deaths, and induced terminations of pregnancy (abortions) resides individually with the states (as well as cities in the case of New York City and Washington, D.C.) and Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands. In effect, these 57 juris- dictions are the full legal proprietors of the records and the information contained therein and are responsible for maintaining registries according to jurisdiction law, including issuing copies of birth, marriage, divorce, and death certificates. As a result of this state authority, the collection of registration-based vital statistics at the national level has