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Page 51 3 Tuberculosis Elimination and the Changing Role of Tuberculosis Control Programs The steady decline in the incidence of tuberculosis over the last 8 years indicates that the disease is once again under control in the United States, but a number of challenges lie ahead if control is to be maintained. Declining numbers of cases will pose challenges in maintaining the expertise necessary for tuberculosis control and could result in premature decreases in tuberculosis control budgets. At the same time health care delivery systems are changing, as there is a trend toward increased privatization of health care and social services and increased use of managed care organizations for the delivery of services. All of these challenges can also create opportunities. This chapter reviews the changes that lie ahead and outlines strategies for maintaining the decline in the incidence of tuberculosis. RECOMMENDATIONS Recommendation 3.1 To permanently interrupt the transmission of tuberculosis and prevent the emergence of multidrug-resistant tuberculosis, the committee recommends that All states have health regulations that mandate completion of therapy (treatment to cure) for all patients with active tuberculosis. All treatment be administered in the context of patient-centered programs that are based on individual patient characteristics. Such programs must be the standard of care for patients with tuberculosis in all settings.
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Page 52 Recommendation 3.2 To ensure the most efficient application of existing resources, the committee recommends that New program standards be developed and used by the Centers for Disease Control and Prevention (CDC) and state and local health departments to evaluate program performance. Standardized, flexible case management systems be developed to provide the information needed for the evaluation measurements. These systems should be integrated with existing case management systems and other automated public health data systems whenever possible. Recommendation 3.3 To make further progress toward the elimination of tuberculosis in regions of the country experiencing low rates of disease, the committee recommends that Tuberculosis elimination activities be regionalized through a combination of federal and multistate initiatives to provide better access to and more efficient utilization of clinical, epidemiological, and other technical services. Protocols and action plans be developed jointly by CDC and the states for use by state and local health departments to enable planning for the availability of adequate resources. State and local health departments develop case management plans to ensure a uniform high quality of care for patients with tuberculosis and tuberculosis infection in their jurisdictions. Recommendation 3.4 To maintain quality in tuberculosis care and control services in an era of increased use of managed care systems and privatization of services, the committee recommends that When it is determined that tuberculosis treatment can be provided more efficiently outside of the public health department, the delivery of such services be governed by well-designed contracts that specify performance measures and responsibilities. Federal categorical funding for tuberculosis control be retained. Funding at the local level should provide sufficient dedicated resources for tuberculosis control but should be structured to provide maximum flexibility and efficiency. Both public and private health insurance programs be billed for tuberculosis diagnostic and treatment services whenever possible but tuberculosis services should never be denied due to a patient's inability to make a co-payment.
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Page 53 Recommendation 3.5 To promote a well-trained medical (in a broad sense) workforce and educated public, the committee recommends that The Strategic Plan for Tuberculosis Training and Education, which contains the blueprint that addresses the training and educational needs for tuberculosis control, be fully funded. Programs for the education of patients with tuberculosis be developed and funded. Funding be provided for government, academic, and nongovernmental agencies to work in collaboration with international partners to develop training and educational materials. BACKGROUND The future of tuberculosis in the United States is dependent on not one but two competing races to elimination. The first is the race to reduce the incidence of tuberculosis by implementing measures to stop both transmission and reactivation of the disease. As the number of tuberculosis cases declines, however, only the very optimistic could believe that resources for tuberculosis control will, as a matter of course, be protected. Instead, a second race seems likely—one of elimination of local, state, and federal public health tuberculosis control resources by reallocation of those resources to competing priorities. Tuberculosis elimination is dependent on the results of this second race, with the best outcome being that it is never run. Strategies to that end include not only aggressive promotion of the vision of tuberculosis elimination but also continual adaptation and evolution of the tuberculosis control program response to an increasingly uncommon disease. What factors should be considered to make this evolution of programs as productive as possible? The key goals of a successful tuberculosis control program are not controversial. They have been well articulated by the Advisory Council for the Elimination of Tuberculosis and consist of the following: 1. Identify and treat individuals with active tuberculosis. 2. Find and test individuals who have had contact with tuberculosis patients to determine whether they are infected. If they are, provide appropriate treatment. 3. Screen populations at risk for infection to detect infected individuals and provide therapy to prevent progression.
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Page 54 Progress toward tuberculosis elimination will not change these goals. Although the federal government provides substantial resources and technical assistance for public health activities, under the Constitution, states, as the repository of powers not specifically delegated to the federal government, have the responsibility for the health of their citizens. For public health, these responsibilities have been well defined in the Institute of Medicine (1988) report The Future of Public Health. As applied to tuberculosis control programs these responsibilities include assessment, through regular and systematic collection and analysis of information about the extent of tuberculosis infection and disease in a community and the effectiveness of programs and interventions that will reduce this threat; policy development, through comprehensive, evidence-based policy formulation that allows equitable and effective distribution of public tuberculosis control resources and complementary private activities; and assurance that services necessary to achieve tuberculosis control are provided by encouraging and enabling actions by other entities, by requiring such actions through regulation, or by providing services directly. As with tuberculosis control goals, these core functions of tuberculosis control programs will not change as the country moves toward tuberculosis elimination. CHANGES IN TUBERCULOSIS CONTROL PROGRAM STRATEGIES Although tuberculosis control goals and core public health functions are fixed, the strategies that emerge from linking the two are not. Instead, these strategies will be influenced by the two effects of moving toward tuberculosis elimination: declining numbers of cases and competition for tuberculosis control resources. This section discusses the nature of these effects and suggests steps that tuberculosis control programs can take to anticipate and plan for them. Not all tuberculosis control programs will adapt to declining numbers of cases at the same pace. Each program should be guided by the local situation, including the extent to which tuberculosis elimination is becoming a local reality. Key elements of effective tuberculosis control programs (for example, sophisticated public tuberculosis clinics or categorical outreach workers) in relatively high-incidence areas will be justified long after they have been abandoned in other low-incidence areas. Jurisdictions experiencing declining rates of tuberculosis, however, must periodically reassess their approaches to the three tuberculosis control goals.
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Page 55 Identify and Treat Individuals with Active Tuberculosis Traceable partially to sound reasoning of the sanatorium era and partially to tradition, the public health approach to the medical treatment of tuberculosis is unique. Without question, improperly treated tuberculosis poses a risk to society, and as a consequence, tuberculosis control programs must ensure that persons with tuberculosis receive appropriate therapy. For no other disease, however, has this assurance function been translated into so much primary responsibility for the direct provision of medical treatment by the public health system. Data from CDC annual reports on tuberculosis show that since 1993 slightly less than one-half of all tuberculosis patients are treated by health departments and about one-quarter each are either managed by private providers or comanaged by private-sector providers and the health department. It is common for those patients being comanaged to receive medication from the health department; thus, nearly three-quarters of all patients receive medications from their health departments. A primary argument for direct provision of care in health department tuberculosis clinics has been that treatment of tuberculosis is complex and specialized and requires experience (Sbarbaro, 1970). In high-incidence areas, well-functioning public tuberculosis clinics with competent staff serving most patients with tuberculosis are a valuable element of national tuberculosis control. In many jurisdictions, however, as tuberculosis case counts decline, the “experience” rationale for a public health tuberculosis clinic will become increasingly inapplicable and at some point will be outweighed by the costs of this approach. These costs include the increasing inefficiency of maintaining a clinic and a staff capable of providing tuberculosis services as patient loads drop and become increasingly unpredictable. As importantly, perhaps, these costs also include the opportunity costs incurred by focusing scarce tuberculosis control resources on the direct provision of services. The Future of Public Health report observes: The direct provision by health departments of personal health services to patients who are unwanted by the private sector absorbs so much of the limited resources available to public health—money, human resources, energy, time, and attention—that the price is higher than it appears. (Institute of Medicine, 1988, p. 52) As outlined in Chapter 4 , tuberculosis elimination will require increased attention to communitywide screening and to the treatment of those with latent infections. Unwarranted attention to the direct provision of medical services for the treatment of active disease must not stop the prevention of cases through the treatment of latent infection from
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Page 56 become an increasing focus of state and local tuberculosis control programs. Instead, as the numbers of cases decline, jurisdictions that directly provide diagnostic and treatment services to individuals with active disease should continually assess the costs and benefits of this approach. In many areas, declining numbers of cases and shifting priorities will likely result in an increasing reliance on the alternative: ensuring that most or all of these services are provided in the private sector. This shift is already beginning. In Missouri, for example, the state tuberculosis control program has identified and contracted with 80 private providers in rural areas to provide services to uninsured patients with tuberculosis. The Tacoma/Pierce County Health Department has contracted with a private group of infectious disease specialists to provide diagnostic and treatment services for all patients with active tuberculosis. This model is described in the box, A Cooperative Public-Private Model for Tuberculosis Control. Assurance of provision of services in the private sector is not a perfect solution. Public-sector tuberculosis control programs still have the responsibility to ensure that patients are receiving appropriate treatment by monitoring patients on a case-by-case basis. The resources and competence required to provide this assurance function must be available. The extent to which the private sector is up to the task, particularly with respect to the provision of directly observed therapy, is still a subject of debate. However, unpublished data from CDC show that from 1993 to 1997 the proportion of patients who completed therapy within one year when a year or less of therapy was indicated steadily increased both for patients managed by private providers and for patients managed by the health departments. In 1997, 81 percent of patients managed by health departments completed therapy, whereas 77 percent of the patients managed by private providers completed therapy, a possibly important but not large difference. Objectively, the case can be made that tuberculosis diagnostic and therapeutic considerations are not all that difficult relative to those of other complex medical conditions routinely managed by the private sector. In fact, it is possible that the traditional public health approach of assuming direct responsibility for tuberculosis treatment has enabled the disconnection between the private sector and tuberculosis treatment. The increasing shift to managed care in the United States along with the potential ability and interest of managed care to provide the services required for appropriate care for tuberculosis may facilitate this transition. In the final analysis, the debate over whether the private sector is ready may be moot. In many areas, economies of scale are forcing the abolishment of standalone public-sector tuberculosis clinics and may dictate the
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Page 57 integration of this activity into a comprehensive medical practice able to provide this as one of many services. There is a major conceptual and philosophical difference, however, between the public and private sectors when it comes to treatment, and that difference relates to the locus of responsibility for the successful completion of therapy. The responsibility for successful treatment of the patient with tuberculosis rests with the provider rather than the patient. Although the patient cannot be absolved of responsibility, ultimately treatment failure is provider failure. Although treatment of, for example, diabetes or hypertension is both more complex than treatment of tuberculosis and lifelong, the benefits of such treatment largely accrue to the patient. With treatment of tuberculosis the benefits of successful therapy accrue both to the patient and to society. Moreover, treatment failure often leads to drug resistance, thus decreasing the chances for cure and greatly increasing the costs. Therefore, successful treatment of tuberculosis is a societal imperative as well as a benefit to an individual's health. Once the responsibility for successful treatment has been realized and accepted by the provider, exactly how the goal is achieved is somewhat secondary. Find and Test Individuals Who Have Had Contact with Tuberculosis Patients to Determine Whether They Are Infected: If They Are, Provide Appropriate Treatment The declining incidence of tuberculosis will also result in less local experience in conducting case investigations and contact identification and follow-up. In contrast to the provision of diagnostic treatment services to patients with tuberculosis, however, tuberculosis control programs will continue to have direct responsibility for conducting case investigation and contact identification and follow-up, as there is no other appropriate provider of services. The key challenge posed by progress to tuberculosis elimination will be to maintain competency and to develop strategies for ensuring that resources for tuberculosis elimination are available, despite a diminishing and unpredictable demand for services. The complexity and sophistication of these investigations will increase. This area is directly addressed later in the report. Screen Populations at Risk for Infection to Detect Infected Individuals and Provide Therapy to Prevent Progression A primary thesis of this report is that successful elimination of tuberculosis will require much greater attention to the screening of at-risk populations. The notion that the reservoir of people with latent infection
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Page 58 must be actively treated instead of the notion that society should passively wait for infected individuals to die or develop disease must be embraced by tuberculosis control staff and, in turn, promoted to public health policy makers and the practicing medical community in a convincing manner. For most areas, this activity will involve both qualitative and quantitative increases in efforts over current efforts and will require new or redirected resources. The American Thoracic Society (ATS) and CDC have published new guidelines for these efforts (American Thoracic Society, 2000). These guidelines call for targeted tuberculin skin testing of populations at high risk of infection and the treatment of latent infections for all those found to be infected. The guidelines also introduce short-course regimens for the treatment of latent infections. State and local programs must assume leadership roles and be responsible for the development and implementation of effective, practical tuberculin skin testing strategies based on the local epidemiological situation. A Cooperative Public-Private Model for Tuberculosis Control Please refer to the page image for an unflawed representation of this content. Pierce County, in the state of Washington, has a population of 735,000, and Tacoma, with a population of about 195,000, is its largest city. In 1999 the county reported 43 cases of tuberculosis for a rate 5.9 per 100,000 population, compared with the national rate of 6.8 per 100,000. The population of the county has changed from 16 percent nonwhite in 1990 to 24 percent nonwhite in 2000, and the largest component of this population change consists of immigrant from Southeast Asia and the Pacific Islands. Reflecting this change, the proportion of foreign-born individuals with tuberculosis in Pierce County has been about 50 percent over the past year, which is somewhat higher than the proportion of 41 percent foreign-born individuals with tuberculosis for the United States as a whole. There has been one case of multidrug-resistant tuberculosis in the last 5 years, and most years the proportion of isoniazid-resistant cases runs about 12 percent. In general the epidemiological picture of tuberculosis in Pierce County is very similar to that in most parts of the United States with moderate to low rates of tuberculosis. Until 1996 the provision of medical care for tuberculosis and tuberculosis control services in Pierce County were typical of that in most of the rest of the United States. The County Health Department operated a tuberculosis clinic that received referrals from private providers in the county. The clinic was staffed by a part-time pulmonary specialist who evaluated all patients with tuberculosis and a public health nursing staff that provided clinical follow-up, contact tracing, and tuberculin skin testing and that maintained statistics on the rates and characteristics of tuberculosis in the county. An outreach staff provided directly observed therapy. The public health nurse was also responsible for contact tracing, screening high-risk individuals for tuberculosis infection, and maintaining tuberculosis control statistics for the county. In 1996, motivated in large part by the Institute of Medicine report on The Future of Public Health (Institute of Medicine, 1988) and a desire to improve services while decreasing costs, the health department director and the Board of Health decided to contract out clinical care services for patients with tuberculosis. Following a competitive bidding process, a contract between the Board of Health and Infections Limited, a group of infectious disease specialists, was signed in October 1996. The contract provides for a capitated payment for the treatment of tuberculosis and requires adherence with the American Thoracic Society-Centers for Disease Control and Prevention (ATS-CDC) guidelines for the treatment of tuberculosis. The past 3.5 years have shown this approach to be a success. From a cost standpoint, total expenditures for tuberculosis control services, including treatment, fell from about $690,000 before the contract program to about $503,000 afterward. The department pays approximately $100,000 annually to the contractor for clinical care services. The remaining $400,000 is budgeted to provide comprehensive outreach and screening to high-risk populations and surveillance and education to the private provider community. One hundred percent of patients are managed in accordance with ATS-CDC guidelines, whereas before the contract period only 79 percent of patients were managed in accordance with these guidelines and the duration of excess use of pyrazinamide and ethambutol (i.e., use of the drugs for more than 8 weeks in a patient infected with drug-susceptible organisms is considered excess use) dropped from about 16 weeks to about 1 week. Additional benefits from the contract program are that services are now available 24 hours a day from multiple sites, whereas they were available at limited times at only a single clinic before the contract, and a generally improved relationship between the private provider and the public health communities. Keys to the success of this program included the availability of local tuberculosis expertise and an innovative and flexible health department. All agree, however, that the most important component was close communication between all the parties. The Infections Limited and health department staffs hold weekly meetings to exchange information about patients and ensure the quality of care. The cost-savings realized as a consequence of contracting direct clinical care to the private sector has enabled the health department to reinvest in primary, population-based prevention efforts without any diminution of communicable disease control services. SOURCE: Information provided by Alan Tice and colleagues of Infections Limited and Frederico Cruz-Uribe and staff of the Pierce County Health Department.
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Page 59 CROSSCUTTING STRATEGIES In addition to the goal-specific effects on the evolution of tuberculosis control strategies described in the previous section, progress toward tuberculosis elimination will also require crosscutting changes in approach. These changes can be broadly grouped into three categories based on the
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Page 60 two effects of moving toward tuberculosis elimination—declining numbers of cases and increasing competition for tuberculosis control resources—and the trend toward health care reform and reliance on managed care systems. Response to Declining Incidence In 1998, nearly three-quarters of all tuberculosis cases were reported in 99 metropolitan statistical areas with populations of greater than or equal to 500,000, whereas nearly half of the counties in the United States reported no cases of tuberculosis, demonstrating the increasing geographical concentration of tuberculosis in the United States. Tuberculosis elimination is dependent on tuberculosis control activities in the larger jurisdictions, including an increased emphasis on tuberculin skin testing of high-risk populations. Tuberculosis elimination, however, will not substantially influence the activities in these areas until local numbers of cases begin to decline. Instead, it is the lower-incidence jurisdictions that will first face the effects of declining numbers of cases on control strategies. Much of the current competency of public health tuberculosis control relies on the presence of experienced personnel. As part of the normal course of work, these individuals transfer their knowledge to less experienced staff. The result is a core of competency that survives over time. One very important core of competency is the group of public health advisers employed by CDC and assigned to work in state and local health departments as direct federal assistance. Most of these individuals began their careers in public health as field workers in sexually transmitted disease, tuberculosis, or other public health programs and have worked in a variety of field and managerial positions. After a number of years of not hiring new individuals as public health advisers, the CDC Division of Tuberculosis Elimination is again recruiting and hiring new field staff. Over the years, this will help maintain a core of competency that will be invaluable. As tuberculosis becomes less common, the system, rather than individuals within it will need to have the correct knowledge to ensure that the right steps are taken and procedures followed to control and eliminate tuberculosis. Strategies to improve this “system expertise” are described in the following sections. Training and Technical Assistance for Providers The most direct solution for decreased experience is increased training. To address the gap about knowledge in the care and management of
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Page 61 patients with tuberculosis, the Strategic Plan for Tuberculosis Training and Education was recently (January 1999) released as a joint project of the National Tuberculosis Centers and the CDC Division of Tuberculosis Elimination (1999). The plan is a product of a yearlong process by leading experts in tuberculosis education and care. It provides a blueprint for building a strong, coordinated, and effective system for tuberculosis training and education and targets private-sector medical providers and related care providers (nurse practitioners, physician's assistants, etc.). Specifically, the plan calls for a coordinated national effort to strengthen, expand, and increase access to the best ongoing educational and training opportunities in the care and management of patients with tuberculosis. This effort seeks to influence the curriculum of the nation's medical and nursing schools, strengthen training opportunities in the care and management of patients with tuberculosis for the nation's public health sector, and identify and provide training resources to strengthen private-sector and managed care management of tuberculosis. Special training efforts should be focused on those physicians serving impoverished individuals and new arrivals to the United States, such as physicians in community health centers, migrant health centers and public hospitals, and foreign-trained physicians. Distinct educational programs are also needed for correctional institutions and the U.S. military. Finally, the plan makes recommendations to develop linkages and partnerships to improve tuberculosis education and training, identify and catalogue training resources and programs, and improve funding to support tuberculosis training and education. With respect to managed care, the plan outlines a number of strategies and needs that should be addressed to improve private-sector care of patients with tuberculosis. For example, by definition, “managed care” involves a third party—the health plan and its medical director—in care decisions that were previously limited to the patient and the patient's physician. This third-party involvement provides a vehicle through which new standards of care can be implemented, monitored, and when necessary, enforced. In addition, at the provider or clinician level, managed care health plans carefully review and verify through a formal process called “credentialing” the professional training and experience of each of their contracted physicians. Untoward events that might indicate substandard care (e.g., disproportionately high inpatient death rates, surgical failures, excessive return of patients to the operating room within 30 days of their surgery, high rates of malpractice claims, or surgical and diagnostic utilization rates above a regional average) are investigated and, where indicated, subjected to formal peer review by other physicians. Failure to meet a nationally accepted standard of care—especially if promulgated by the managed care organization—can result in the termination of a
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Page 75 Moreover, because of the combined advent of managed care and privatization, many health departments are no longer simply providers of care. Today, many local health departments and virtually all state Medicaid programs are purchasers of care. This newfound role provides them a mechanism by which they can balance their fiscal pressures with their public health obligations. For example, as purchasers, these public organizations can specify the desired relationships, products, and outcomes through their contractual processes. As in the example cited earlier in a box in this chapter describing the experience in Pierce County, Washington, contracts can set performance standards and identify necessary organizational capacities, technical expertise, provider competencies, and the laboratory quality control necessary for private-sector organizations to successfully undertake the treatment and management of tuberculosis patients. Contracts can also can be used to align public and private stakeholders so that tuberculosis control is properly coordinated among these partners and their participating provider and laboratory networks. In an effort to improve the contract process, CDC staff have developed model contract language that can be adopted for managed care or privatization purposes (Miller et al., 1998). However, these model contracts have not been field tested. Quality Assurance Initially adopted as a tool to counter ever rising health care costs, the managed care system is increasingly focusing on improved health outcomes. This focus on quality reflects, in part, recognition that costs and quality are intertwined. Thus, a short-term saving, only to be followed by even worse and more costly-to-treat outcomes, is a poor trade-off. The current climate of reform in health care provides several opportunities to improve and sustain quality care for tuberculosis patients. First, the National Committee on Quality Assurance (NCQA), a body whose board includes representatives from major employer and consumer groups, has developed criteria that can be used to monitor quality in the delivery of health care. The board has strongly endorsed a formal NCQA accreditation process that involves defined standards, measures of achievement, and quality-of-care audits. Failure to achieve NCQA accreditation can adversely affect a managed care organization's ability to successfully compete for employer group insurance contracts. NCQA's board has adopted a wide array of nationally established preventive health standards (e.g., rates of immunizations and rates of ophthalmologic screening for diabetic retinopathy) and has recently moved into establishing standards of treatment (e.g., treatment with beta-
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Page 76 blocking agents after a myocardial infarction). Health plans seeking to acquire or maintain NCQA accreditation are expected to measure and meet these standards. These standards, as well as other key components of managed care programs—from provider clinical responsibilities and duties, to economic incentives and patient and provider risk sharing, access to specialists, patient benefits, and all other aspects of service and financing—are based on legally binding contracts between the health plan and selected physician and institutional providers. In addition, the health plan seeks discounts in physician and institutional payments in exchange for clinical access to its members, but only for those physicians who agree to participate in the health plan and comply with its contract obligations. Through these processes, the health plan becomes responsible for the quality of care provided to its members by those physicians contracted into the plan's provider network. The accreditation body for hospitals and other institutional health providers, the Joint Commission on Accreditation of Healthcare Organizations, is also incorporating patient care and service delivery standards into its accreditation program. CDC, working in conjunction with state and local health departments, professional societies, and voluntary, nongovernmental organizations, has established national standards of care for tuberculosis. These standards are designed to achieve the maximum rate of cure. Not only are these standards important to the individual but they also simultaneously protect the members of the managed care organizations. If NCQA were encouraged to incorporate these standards into its quality assurance program, contracts between state Medicaid agencies and managed care organizations could also incorporate these standards as a condition of contract compliance. Laboratory Performance Standards and Case Reporting Requirements Access to quality microbiological services and prompt case finding and reporting are essential to the successful management of tuberculosis. A more complete discussion of the laboratory is contained in the consultant's report included in Appendix D . Several avenues that will ensure access to quality tuberculosis laboratory services and case reporting are discussed here. As a requirement to do business within a state, commercial health plans must obtain approval of that state's division of insurance and department of health or social welfare, depending upon the state. As a result, state health departments have an administrative opportunity to influence the patient care requirements that must be met by all insurance organizations and health plans through their own regulations or through
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Page 77 the development of a working relationship with the state division of insurance or other administrative department. It is important that health maintenance organizations, private health plans, and contracted providers, as third parties directly involved in the overall care of their member populations, be required to promptly report all cases of tuberculosis to the state health department. Such a requirement is vital to any national effort to eliminate tuberculosis, because to minimize their laboratory expenses, many managed care organizations contract with national vendors for centralized laboratory services. Cultures for tuberculosis are often included in such contracts, with the result that positive cultures may be identified in locations out-of-state and thus may be beyond the direct surveillance powers of the health department in the state where the case of tuberculosis originated. Early case identification followed by prompt case-contact evaluation and treatment of latent infection has been demonstrated to be the most effective means of minimizing the incidence of new cases of tuberculosis. Therefore, in the absence of state requirements for case reporting, national legislation may be necessary to ensure that all positive tuberculosis cultures are reported to the official health agency in the respective jurisdiction. Even when the state's health department lacks independent authority, and cooperation with the Division of Insurance has not developed, state or local boards of health usually have legislatively authorized power to establish rules and regulations that require that the state's physicians and hospital providers adhere to specific behavior or treatment standards. This has been successfully accomplished in Colorado and other states where specific statewide treatment standards require the implementation of directly observed therapy for all tuberculosis patients, unless an exemption is granted from the Department of Health. ERISA plans, which are privately funded and federally regulated, may be more difficult to influence, but a court decision in New York supports the position that state regulations for public health purposes can be extended to ERISA plans. Standards of Care in Case Management There is now clear and compelling evidence, both within the United States and internationally, that a patient-centered approach to care that uses directly observed therapy is a clinically appropriate and cost-effective strategy for the treatment of active tuberculosis (Bayer and Wilkinson, 1995). This approach produces the highest treatment completion rates because the patient is given a meaningful opportunity to work with the case management team in the design and implementation of how therapy can best be provided (Figure 3-1). To maximize treatment completion,
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Page 78 patient-centered programs identify and use a broad range of enablers and incentives based on the individual needs and circumstances of that particular patient. These include treatment at settings convenient for the patient (workplace, home, school); the provision of relevant social and economic enablers and incentives such as food, clothing, books, stipends, transportation, treatment contracts, bilingual staff, and reminder systems; and culturally appropriate outreach and tracking for missed appointments (Chan et al., 1994; Chaulk and Kazandjian, 1998; Chaulk et al., 1995; El-Sadr et al., 1996; Kan et al., 1985; Manalo et al., 1990; Miles and Maat, 1984; Pozsik et al., 1993; Schluger et al., 1995; Sukrakanchana-Trikham et al., 1992; Werhane et al., 1989; Westaway et al., 1991; Wilkinson, 1994). Moreover, these programs are sometimes supplemented with substance abuse treatment and counseling (Chaulk et al., 1995; Schluger et al., 1995; Werhane et al., 1989), housing for homeless patients (during therapy) (Chaulk et al., 1995), comprehensive case management, and referral for other medical and social services as indicated (Chan et al., 1994; El-Sadr et al., 1996; Werhane et al., 1989). Importantly, these patient-centered approaches coupled with directly observed therapy and other aspects of case supervision have been shown to be highly effective across a range of geographical and socioeconomic settings, producing treatment completion rates in excess of 90 percent (Bayer et al., 1998). The provision of incentives without directly observed therapy produces much lower completion rates (Armstrong and Pringle, 1984; Caminero et al., 1996; Cohn et al., 1990; Cowie and Brink, 1990; Dutt et al., 1984; Hong Kong Chest Service/British Medical Research Council, 1984; Jin et al., 1993; Menzies et al., 1993; Ormerod et al., 1991; Samuel, 1976; Snider et al., 1998; Valeza and McCougall, 1990; Van der Werf et al., 1990; Wolde et al., 1992). Similarly, while legal orders mandate completion of treatment, they do not replace patient-centered approaches to care, which have been successful without the use of legal orders (Pozsik et al., 1993). FIGURE 3-1 Range and median treatment completion rates, by treatment intervention, for pulmonary tuberculosis reported in 27 studies. DOT, directly observed therapy; n, number of studies. SOURCE: Chaulk and Kazandjian (1998). Reprinted with permission
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Page 79 Failure to complete a course of recommended therapy can have several adverse outcomes, including the development of drug-resistant disease. The reasons for these failures are multifactorial (Chaulk and Kazandjian, 1998). They may include failure of the patient to take all or part of his or her medications. Studies have clearly documented that 30 to 35 percent of self-administered medications are not taken. Directly observed therapy diminishes this possibility, as long as the third party observing the ingestion of medication (nurse, doctor, or other health care worker) actually watches to confirm that each dose is taken. Other reasons may be either provider or system related. For example, providers may fail to prescribe an appropriate treatment regimen or may inappropriately add drugs to a regimen. The system of care may not address the cultural or lifestyle needs of the patient. Programs that assess and address all of the potential obstacles to treatment delivery (patient as well as system related) are the most successful (Chaulk and Kazandjian, 1998). Tuberculosis treatment in managed care or any private setting must be viewed in this context. Good contract terms for standards of care and quality of care for both managed care and private-sector arrangements define the respective roles of public- and private-sector stakeholders in ensuring that therapy is supervised or closely monitored. Such arrangements should be designed around the respective strengths of these public and private entities and are a key part of the contracts discussed earlier for the city of Tacoma and for Pierce County in Washington State. In addition, state action can further strengthen this arrangement. Colorado's Department of Health has recently established specific statewide treatment standards that require the implementation of directly observed therapy for all patients identified as having active tuberculosis unless an exemption is obtained from the Department of Health. In situations where directly observed therapy can not be used, fixed-dose drug combinations (containing both isoniazid and rifampin) should be used to reduce the risk of developing resistance to either drug. Centralized Data Management Centralized management information systems are becoming increasingly common tools of managed care organizations. An adequate management information system capacity can be used to improve the quality of care for patients with tuberculosis by profiling providers, tracking laboratory services and pharmacological regimens, especially when they are
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Page 80 coordinated with the reporting and surveillance practices of local health departments. Baltimore City Case Study Please refer to the page image for an unflawed representation of this content. For more than 22 years, the Baltimore City Health Department's Tuberculosis Control Program has used directly observed therapy (DOT) for the treatment of patients with pulmonary tuberculosis. The Baltimore City Health Department launched its DOT program in 1978 by targeting tuberculosis patients who were homeless, unemployed, alcoholics, or substance abusers. DOT was provided under nursing supervision at the city's tuberculosis Chest Clinics. In 1982, DOT was brought into the community for all tuberculosis patients. Nurses provided supervised therapy at the patient's home, workplace, or school. Between 1978 and 1995, the incidence of tuberculosis declined 62 percent whereas Baltimore's ranking for tuberculosis (typically ranked highest between 1965 and 1978) fell from 2nd in 1978 to 28th by 1992. The hallmark of this program has been a patient-centered approach that uses nurse outreach to provide care and ongoing evaluation of the patient throughout the course of the patient's therapy. In addition to the dramatic decline in the rate of tuberculosis following implementation of DOT, even during the resurgence years of 1985 to 1992, other program benchmarks indicate other successes. The rate of sputum conversion by 3 months of therapy is twofold higher for patients managed with DOT compared to private-sector patients who receive self-administered therapy. Multidrug resistance has essentially been eliminated (less that 0.05 percent of all cases), therapy completion rates are greater than 95 percent by 12 months of therapy, and the rate of mortality during therapy is fourfold lower for patients managed with DOT than for private-sector patients. These benchmarks apply to AIDS patients as well when they are managed with DOT. Additional research suggests that Baltimore's DOT program is cost-effective compared to self-administered therapy, and the reduction in the number of expected cases under this program has generated savings that are at least double the actual operating costs of this program. SOURCE: Data from P. Chaulk and the Baltimore City Health Department. The contract process can establish minimum performance standards regarding management information system performance that a managed care organization's provider network must adhere to as part of its participation in the managed care organization's plan. Simple sharing of provider inpatient and outpatient care practices on a geographical basis, along with comparing provider comparisons with national practice guidelines, has proved to be a powerful tool for improving quality of patient care.
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Page 81 Community Health Centers The successful control and eventual elimination of tuberculosis in the United States will rest upon the efforts derived from strategic public-private partnerships that can leverage the resources and public will necessary to achieve these goals. In health care, the nation's oldest safety net is made up of publicly funded general hospitals and urban, rural, and migrant health centers. Community health centers are the entry point to the U.S. health care system for more than 10 million people (Davis et al., 1999). Most community health center clients are either uninsured (41 percent) or on Medicaid (33 percent). More importantly, community health centers serve those people most at risk for tuberculosis. In 1996, community health centers provided health care to more than 450,000 homeless children and adults and another 500,000 seasonal and migrant workers. In addition, 65 percent of all community health center clients are ethnic minorities. Although traditionally funded with governmental monies, these institutions—public hospitals, community health center clinics, neighborhood health centers, clinics for refugees and immigrants, and their physicians—provide care under the same principles that the private sector of medicine uses. However, the progressive transfer of Medicaid patients into private insurance plans has required these institutions to seek contracts with managed care organizations to ensure ongoing funding sources. As a result, the discounted payments offered by managed care organizations can produce substantial revenue losses, straining already overburdened and overcrowded health care systems. Nonetheless, this change offers an additional opportunity to establish and enforce nationwide standards of care for patients with tuberculosis. Partnerships between these providers that serve the most vulnerable populations, local health departments, and managed care organizations would result in improved access to tuberculosis services in the primary care setting. Such partnerships could also involve the wide range of other organizations and providers that provide primary care to those most at risk of developing tuberculosis. Such organizations include health and resettlement centers for political refugees and new immigrants, organizations that serve populations on both sides of the United States-Mexico border, programs that serve homeless people, substance abuse treatment centers, programs that serve people with HIV infection and AIDS, the child welfare system, and corrections systems. CDC cooperative grants have been most effective in redirecting the tuberculosis program efforts of health departments. Similar initiatives by federal agencies that support the services of the multiple components of
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Page 82 the safety net could have a significant and long-term nationwide impact on the treatment, prevention, and control of tuberculosis. CONCLUSION Although the goals and functions of tuberculosis control programs are constant, as the United States moves toward tuberculosis elimination, their implementation will require changes in strategies and activities. The directions of change described in this initial assessment can and should evolve over time. The expertise present in federal, state, and local programs should be brought to bear on this process. This same expertise and leadership must also increasingly serve both as a credible voice of advocacy for the vision of tuberculosis elimination and as an agent for change in tuberculosis control activities. In some respects, the latter task may be the most difficult one. Bureaucracies, including public health bureaucracies, are not known for their capacity to change quickly. The skills required for the increased emphasis on the assurance of quality tuberculosis services and care and screening of high-risk populations may not match the existing workforce skills of tuberculosis program staff. Careful attention must be paid to ensuring that tuberculosis control programs become what they need to be rather than maintained as they have been. REFERENCES Addington WW. 1979 . Patient compliance: The most serious remaining problem in the control of tuberculosis in the United States . Chest 76(Suppl) : 741–743 . American Thoracic Society and Centers for Disease Control and Prevention . 2000 . Targeted tuberculin testing and treatment of latent infection . Am J Respir Crit Care Med 161 : 5221–5247 . Armstrong RH , and Pringle D. 1984 . Compliance with anti-tuberculosis chemotherapy in Harare City . Cent Afr J Med 30 : 144–148 . Bandura A. 1977a . Social Learning Theory . Englewood Cliffs, NJ : Prentice-Hall . Bandura A. 1977b . Self-efficacy Toward a unifying theory of behavior change . Psychol Rev 84 : 191–215 . Bandura A. 1986 . Social Foundations of Thought and Action . Englewood Cliffs, NJ : Prentice-Hall . Bayer R , Stayton C , Desvarieux MD , et al. , 1998 . Directly observed therapy and treatment completion for tuberculosis in the United States: Is universal supervised therapy necessary? Am J Public Health 88 : 1052–1058 . Bayer R , and Wilkinson D. 1995 . Directly observed therapy for tuberculosis: History of an idea . Lancet 345 : 1545–1548 . Bialek R , and Chaulk CP. 1999 . Privatization and Public Health: A Study of in initiatives and early lessons learned . Washington, DC : Public Health Foundation .
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Representative terms from entire chapter: