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.
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.
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.
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.
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.
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.
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
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
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
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
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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.
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
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
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
physician's contract with the organization and access to the health plan's members
Moreover, any such formal action can have a significant and permanent negative impact on a physician's career both through the state's physician licensing board and through the National Practitioner Data Bank, an organization established by the federal government to maintain a historical database on every physician. Hospitals, licensing organizations, insurance companies as well as governmental and military agencies, routinely review this file before establishing or renewing any formal relationship with a physician.
As the number of tuberculosis cases decline, so too will local public health and private provider experience in assessing and managing difficult tuberculosis diagnostic or treatment issues. Although informal consultation and referral systems have been established in many areas, there is a danger that these will become less used as local experience wanes and neither provider nor local tuberculosis control program will know whom to call. An example of one local health department physician's use of a “warm line” for consultation and assistance is described in the box Use of a Warm Line in a Low-Incidence Area and demonstrates the value of these systems.
Increasingly, the Internet can be used to ensure tuberculosis program staff training and competency. The recent appropriation of federal bioterrorism dollars for the creation of a Health Alert Network will result in dedicated, high-speed Internet connections, computer hardware and software to take advantage of this resource, and an increased capacity to participate in distance-based learning in most local health departments. These new tools provide a perfect opportunity to increase the “system expertise” in tuberculosis control by making the Internet a site of user-friendly training, education, and reference material. Training and Technical Assistance for Patients and Their Significant Others
The vulnerable populations at high risk for tuberculosis infection and tuberculosis diagnosis have changed during recent years. Now, at the beginning of the 21st century, populations at high risk for tuberculosis include homeless people, substance abusers, foreign-born persons from countries with a high prevalence of tuberculosis, persons living with human immunodeficiency virus (HIV) infection or AIDS, and persons living in congregate settings, particularly correctional facilities.
The four states that report the largest number of tuberculosis cases also report the highest incidence of patients with HIV infection or AIDS. Consequently, because of the vulnerability of the immune systems of patients with HIV infection or AIDS, the number of individuals at risk for
tuberculosis and HIV infection in these cities is greatly increased, which leads to the subsequent complications of treatment and adherence to multiple treatment regimens.
Use of a Warm Line in a Low-Incidence Area
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“We had a woman come to us recently with an extremely complex case of tuberculosis that wouldn't respond to any of the drugs physicians usually count on,” says Mark Lundberg, M.D., M.P.H. “But with advice from the National Tuberculosis Warm Line, we were able to develop an effective treatment regimen, and our patient is doing very well.”
Dr. Lundberg is the health officer and sole physician at the Butte County Department of Public Health in Oroville, California. Situated some 75 miles north of Sacramento, the county is largely rural, with a population of approximately 200,000.
In all, Dr. Lundberg says, it is not the kind of place where physicians expect to encounter patients with tuberculosis, let alone with patients with multidrug-resistant tuberculosis. In 1999, the county reported 4 cases of tuberculosis, in 1998 it reported 5 cases, and in 1997, the year with the largest number, it reported 13 cases.
“This disease can be a challenge for our local physicians,” he says. “Although doctors do receive some training about tuberculosis in medical school, actually coming face to face with a tuberculosis patient often seems to create uncertainty in how to proceed with treatment.”
Some physicians, especially those who moved into the county from larger metropolitan areas, respond by “referring the patient to the county chest clinic,” he says. “But we don't have a chest clinic, nor do many other small and medium-sized counties. We simply don't have the resources to maintain such a level of specialization.”
Dr. Lundberg believes that medical schools may unwittingly contribute to this problem. Since most medical schools are located in major cities, he says, it is perhaps natural for instructors to cite “refer to county chest clinic” as an appropriate course of action.
When a physician reports a case of tuberculosis to the county health department—as required by law—Dr. Lundberg offers to help the physician develop a course of treatment. The department's staff also handles the “public health” aspects of managing tuberculosis, such as conducting “directly observed therapy” to ensure that patients comply with prescribed treatments, notifying any individuals who have been exposed to the patients, and arranging shelter for patients who are homeless.
“In straightforward cases of tuberculosis, we believe that the actual treatment of patients—who often have other medical conditions—is best handled by their own physicians,” says Dr. Lundberg. “We work with the physicians to provide whatever help they want. In particular, we provide them with the latest information on how to treat this disease.”
When patients have multidrug-resistant tuberculosis, Dr. Lundberg takes responsibility for the medical treatment as well. In such cases, he typically seeks help from the Warm Line—in this instance, the line based at the Francis Curry Tuberculosis Center in San Francisco.
“This help has proved invaluable,” Dr. Lundberg says. “Some of these cases are far more complex than any I've ever seen, and I've had little or no experience with some of the less common drugs. But the Warm Line consultants deal with tuberculosis every day. And by working together, we can develop treatment regimens tailored to my patients' needs. It's been great.”
Although the populations at greatest risk for tuberculosis infection and tuberculosis have been identified, systematic studies for determination of intervention strategies for each of the high-risk populations have not been conducted. Studies are needed to determine how basic behavioral theories can enhance understanding for the creation of tailored interventions for each of the high-risk populations. Well-established theories such as the health belief model (Hachbaum, 1958; Rosenstock, 1990), empowerment (Rappaport, 1984), locus of control (Walton and Wallston, 1978), social learning theory (Bandura, 1977a, 1986; Perry et al., 1990), social support (Cohen and Davis, 1985; Israel, 1985), and diffusion theory (Orlandi, 1986; Orlandi et al. 1990; Rogers, 1962) can provide powerful insights for the development of educational programs targeted to each of the high-risk populations. However, these models have not been tested with the populations at high risk for tuberculosis to determine which educational strategies will be the most effective in supporting patient compliance and adherence to therapy.
The health belief model, developed in the 1950s by Hachbaum and colleagues in the Public Health Service, was conceptualized to examine the factors that motivate some people to participate in free tuberculosis screening programs compared with the factors that lead others to not participate. Through this early work, a model has evolved that individuals will take action to prevent damage to their health, screen for disease, or control a disease if the following factors are present. First, they must regard themselves as personally susceptible to a given condition; second, they believe that the condition has serious consequences; third, they believe that an action will either reduce their susceptibility or reduce the severity of the condition; and fourth, they believe that the anticipated barriers to taking action are outweighed by the benefits. This model, combined with Bandura's concept of self-efficacy (Bandura, 1977b) or with the three levels of prevention—primary, secondary, and tertiary (White et al., 1995)—can provide insights for critical behavioral change strategies.
There is very little information on the impacts that these models, such as the health belief model or concepts of self-efficacy, will have on adherence to treatment for populations at high risk for tuberculosis. As previously noted, “technology assessment and transfer in our society is a complex process involving many participants” (Centers for Disease Control, 1989, p. 24). Understanding cultural barriers to prevention, treatment, and control as well as the incentives and enablers that are most effective in enhancing compliance by specific target groups, such as increasing the return rate for reading of tuberculin skin test results among drug users at
high risk of tuberculosis infection (Malotte et al., 1998), will be critical as efforts to bring about further reductions in the number of new cases are made. Research has also indicated the need to provide educational programs (Morisky et al., 1990) and to develop standardized protocols of health education to enhance the rates of adherence to treatment (Dick and Lombard, 1997).
Citing the earlier work of Addington (1979), a CDC update on tuberculosis elimination in the United States (Centers for Disease Control and Prevention, 1990) noted that noncompliance with prescribed therapy is the greatest remaining obstacle to elimination. Adherence to therapy must be tailored to patients' needs, lifestyles, social support system, and beliefs about health, and the cultural appropriateness of the educational materials must be determined. Any treatment plan should include an assessment of these factors (Centers for Disease Control and Prevention, 1994; Sumartojo, 1993). The need to understand these factors is also critical if further reductions in the numbers of new cases of Mycobacterium tuberculosis infection or tuberculosis are to be achieved. Performance Measurement
The purpose of performance measurement is to explicitly assess whether progress toward the desired goals is being made and whether appropriate program activities are being undertaken to achieve those goals. It rests on the premise that what does not get measured does not get done. As staff become increasingly inexperienced, such measures will help ensure that the right information is monitored and will allow an ongoing objective assessment of whether tuberculosis control programs are performing adequately. Tuberculosis control is well suited to performance measures, as goals, strategies, and standards of practice are better delineated for tuberculosis than for many other public health programs. CDC's Tuberculosis Division already uses performance measures as an important part of its cooperative agreements with state and local programs. Current measures, however, are most complete for patient treatment, are less complete for case and contact investigations, and are least complete for tuberculin skin testing of high-risk populations. In addition, more attention is required for the development of “upstream” process measures that are better direct measures of the implementation of evidence-based best practices. The following are examples of performance indicators that would identify system delays and communication barriers:
percentage of smear results received within 24 hours of specimen collection,
percentage of tuberculosis cases diagnosed and percentage of patients treated as inpatients,
percentage of tuberculosis patients requiring rehospitalization for treatment of tuberculosis or its complications,
percentage of positive results reported within 2 weeks,
percentage of isolates for which susceptibility data are reported (percentage for which susceptibility data are reported within 2 weeks of a positive culture),
percentage of patients whose initial therapy is adequate on the basis of the subsequent susceptibility pattern for the patient's isolate,
percentage of patients on therapy appropriate for the isolate's susceptibility pattern at 1 month,
percentage of patients completing therapy,
percentage of patients completing therapy within 9 or 12 months, and
percentage of patients with documented conversion to negative smear and culture results.
At most three or four of these indicators should be selected for close monitoring to obtain an overall view of the program's status.
Implicit in the notion of performance measures is that the systems that collect and analyze the required information are in place, but as discussed in more detail later in this chapter, they are not. Data collection is an expensive process, and measurement of data on a more complete list of performance indicators for tuberculosis will require additional resources and carries the risk of reducing the resources available for program services. Ways to reduce this expense include the enhancement of existing systems rather than the building of new systems, whenever possible, and investment in unified systems capable of meeting local, state, and federal needs.Investigative Guidelines, Instructions, and Templates
Increasingly, public health staff called on to investigate tuberculosis may not be experienced or may not have experience with on-site supervision. As is described in detail in Chapter 4 , accessible, up-to-date, user-friendly, locally relevant, comprehensive guidelines, including step-by-step instructions, investigative algorithms, and checklists, are currently not available but could provide structure and supervision to inexperienced staff. The utility of these guidelines would be enhanced if they were integrated with or developed in tandem with tuberculosis control data and information systems.
Although improved cultural competency, incentives programs, and
other measures have increased the likelihood of successful voluntary treatment, ensuring completion of antituberculosis therapy remains the public health practice situation most likely to require the invocation of coercive public health measures, including quarantine. As the numbers of tuberculosis cases decline, it will become increasingly unlikely that tuberculosis control personnel facing a situation in which legal actions may be warranted will have any firsthand experience with the risks and benefits or with the mechanics of implementing these measures. Tuberculosis regulations and laws are state specific. Synopses of these laws understandable to the nonlegally trained local public health professional, including step-by-step instructions for implementation of the necessary measures and templates of required forms and public health orders, may help ensure appropriate use and implementation of these measures. Information Management Systems
Standardized, flexible surveillance and case-monitoring information systems that are designed to simultaneously meet local, state, and federal data needs are needed to monitor program efforts and to improve effectiveness. As a guide to ensuring complete and proper investigation, such systems become increasingly important as staff sophistication and experience become more unpredictable. Surprisingly, perhaps, such systems are not yet in place. Although in concept CDC's Tuberculosis Information Management System (TIMS) was meant to meet this need, in practice, it is a surveillance system and has failed as a case management system. Since TIMS meets primarily federal needs rather than state or local needs, adoption has been limited, at least in part due to its inability to import data (thus requiring double data entry) from existing case management systems that states and localities developed in the vacuum left by the absence of a national system. The result of the failure to implement TIMS in a timely manner has been that CDC has missed a window of opportunity to provide leadership. Instead, a number of individual tuberculosis control programs have invested considerable resources in their own (often incompatible) systems. Declining numbers of cases and less local and state experience increase the need for a more comprehensive approach designed with input from all relevant partners.
There is a pressing need for tuberculosis case reporting systems to be integrated with the systems used to report other notifiable conditions. CDC and the states are engaged in the initial development of systems for computerized electronic laboratory reporting (ELR) of notifiable diseases from public and private laboratories directly to public health departments. ELR would greatly ease some of the logistic issues around the reporting of laboratory results for tuberculosis from a regionalized system. The
need for program information and management systems includes not only case reporting and management but, as importantly, contact investigation and management, monitoring of individuals receiving treatment for latent infection, and screening of high-risk populations. These systems should incorporate the data elements needed for performance measurement and a system for ongoing assessment of the preventability of local cases.
Response to Increasing Competition for Tuberculosis Control Resources
As tuberculosis elimination proceeds, the expectation (or hope) that tuberculosis control resources will remain at their current level is less than an optimum strategic approach. In the absence of daily demonstration of need, the historical example of the 1970s showed that there will be pressure to shift tuberculosis control funding to other, more visible priorities, as discussed in the previous chapter. Although the rallying cry for continued categorical funding may continue to resonate loudly in the halls of tuberculosis control programs, as a single message it may not be heard in the larger policy discussion arenas of public health departments, local city councils, or legislative assemblies. Promoting the vision of tuberculosis elimination and advocating for the necessary resources are essential parts of the response, but equally important is anticipating reductions in resources and the loss of economies of scale resulting from declining numbers of cases. Strategies to that end are described in the following sections. Integration of Tuberculosis Control with Other, Similar Health Department Activities
The survival of tuberculosis control efforts may depend on the dissolution of aspects of tuberculosis control programs. Federal funding and much of the state and local funding for tuberculosis control are categorical; that is, the funding is specifically appropriated by the U.S. Congress or state legislatures specifically for this purpose. Advantages of this categorical funding approach include both advocacy and accountability. Legislators can clearly see the connections between funding, needs, and program activities.
Programs funded on a disease-specific basis tend to be organized and implemented on a disease-specific basis, and there is little opportunity or incentive to communicate or collaborate across program lines. As the numbers of cases decline, stable or even modestly increasing resources for tuberculosis control on a per-case basis may likely result in an abso
lute drop in resources. In many areas, the critical mass of funding needed to maintain tuberculosis-specific efforts might be lost. To preserve services in the face of this decreased funding, tuberculosis control programs at the state and local levels must actively search for ways to integrate activities with comparable activities performed by other categorical health department programs. Examples of such activities might include (1) merging of tuberculosis reporting and surveillance activities with HIV, sexually transmitted disease, and other infectious disease programs that rely on the same underlying notifiable disease system; (2) integrating appropriate tuberculosis case and contact investigation activities into the job descriptions of individuals performing activities related to partner notification for sexually transmitted diseases; or (3) coinvesting in activities related to outreach to high-risk populations of interest to other categorical programs, for example, programs for injection drug users and individuals with HIV, programs for urban inner-city minority populations affected by lead paint, or programs for migrant and seasonal workers affected by pesticides.
The need for these integration activities will be felt most acutely where resources are thinnest: first at the local level and then at the state level. While categorical funding is retained for tuberculosis at the national level, as the leader of tuberculosis control activities and a primary source of funding, CDC can lead the effort to ensure efficient integration at the local level. The Division of Tuberculosis Elimination can advocate and promote integration activities, develop and pilot potential approaches, and systematically identify and correct procedures or fiscal policies that are barriers to this transition. Examples of such barriers include CDC's current requirement to use reporting software that is not compatible with other CDC or state infectious disease reporting software and a time-activity reporting system for federally funded personnel that makes it cumbersome to the point of impracticality to fund the same staff from a mix of different categorical grants. Cost Shifting to Nontuberculosis Control Budgets
As the numbers of cases of tuberculosis decrease, pressure to shift funding now allocated to tuberculosis control programs is bound to increase. Effective advocacy (as described in Chapter 7 on mobilization) may prevent the total defunding of tuberculosis control programs, as occurred in 1972 (described in Chapter 2), but the programs visited by committee members during the site visits all indicated that their program funding had decreased or was under significant pressure. A key strategy that can be used to preserve the continued availability of resources to oversee tuberculosis control is to aggressively seek appropriate opportu
nities to shift treatment and screening costs out of tuberculosis control budgets. State and local tuberculosis control programs can work to ensure that private insurers rather than public resources pay for diagnostic and treatment costs whenever possible. Pressure on tuberculosis control budgets could also be reduced by establishing directly observed therapy, targeted tuberculin skin test screening, and provision of treatment of latent infection as performance-based standards in the private sector. In 1993, the Medicaid Act was amended to allow states to provide Medicaid eligibility for anyone who tests tuberculin skin test positive and who also meets that state's income eligibility criteria. Medicaid funding could then be used for the diagnosis of both latent infection and active disease and the provision of treatment for both latent infection and active disease. As was pointed out by T. Westmoreland during his presentation at the second committee meeting, Medicaid has the advantage of being an entitlement: funding can expand to meet the need, and resources do not fluctuate with the interest of legislators and policy makers. Medicaid funding applies only to the poorest individuals, but these are also some of the individuals at the highest risk for tuberculosis. While many states have not included a tuberculosis option in their Medicaid program (see the Georgia and Maine site visits in Appendix C), the box, Maximizing Medicaid Reimbursement Allows Local Tuberculosis Programs to Expand Services, describes a very successful experience with the use of Medicaid funding in a county in California. Another opportunity to shift costs from the direct tuberculosis control program budget is to ensure that targeted tuberculin skin testing and treatment of latent infection are standards of practice in other publicly funded health care settings, such as correctional institutions, migrant, and community health facilities. The importance of treatment of latent infection in these facilities is addressed in the next chapter. Regionalization
As the incidence of tuberculosis declines, economies of scale dictate that the geographical public health unit of tuberculosis control intervention in which investment of resources makes sense becomes larger. In states where the responsibility for tuberculosis control has been devolved to counties or local boards of health, regionalization will first occur among the local jurisdictions within the state. Where the state has retained sole jurisdiction, regionalization becomes relevant when economies of scale would dictate combining services among states. As a practical matter, it probably is not reasonable to expect patients to travel to regional centers for screening or treatment purposes. However, regionalization of case and contact investigation resources for the increasing number of jurisdic
tions with low incidences of tuberculosis is a practical way to ensure continuity of effective services. Although this might be achieved by using resources from adjacent local jurisdictions, in many cases the coordination role will fall to the state tuberculosis control program in the form of personnel with specific job responsibilities to serve as ad hoc providers of services, including case and contact investigations and perhaps administration of directly observed therapy. Similar regionalization of services will also be required among states. CDC can promote this regionalization through pilot programs that could be funded within cooperative agreements with the states.
The issue of regionalization of laboratory services may already be an issue for many areas. As noted in the consultant's report in Appendix D , 10 to 15 specimens a week need to be examined to maintain proficiency in a Level I tuberculosis laboratory. A Level I laboratory prepares and examines smears only. Laboratories that provide more sophisticated services, including culture, species determination, and susceptibility testing should be processing at least 25 isolates per week to maintain proficiency, according to the consultant's report. It is likely that many state laboratories already have workloads too small to maintain proficiency, and again, CDC could promote regionalization through pilot programs.
CDC may also be able to promote regionalization if it maintains personnel with the expertise for backup during outbreak situations and for complex investigations. Public health advisers, Epidemic Intelligence Service officers and staff epidemiologists and clinical field staff employed by the Division of Tuberculosis Elimination have successfully supplied this type of expertise in the past. If this capability is not maintained within CDC, it is difficult to identify where it should be obtained when needed. Capacity Measures
As the numbers of cases of tuberculosis decline, the perceived need for active tuberculosis control programs will become less apparent. Policy makers will lose touch with the issue and health departments may be unsure or unable to effectively articulate their specific resource requirements. Public health capacity measures (measures of the system's “ability to provide specific services, such as clinical screening or disease surveillance, made possible by the maintenance of the basic infrastructure of the public health system, as well as specific program resources”) provide part of the answer. For example, adherence to capacity measures for case investigation will help ensure that a jurisdiction with no cases of tuberculosis for several years will have the required competency when the next case arises. In general, such measures are not available, and better definition and promotion of expert-generated, nationally accepted measures of
the capacities of effective tuberculosis control programs are needed. These measures, linked to accountability and funding, can serve as a useful adjunct to process and outcome performance measures to ensure continued competency to respond to increasingly uncommon events.
Maximizing Medicaid Reimbursement Allows Local Tuberculosis Programs to Expand Services: A Success Story in California
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In 1994, the California legislature enacted legislation that created the California Medicasi (Medi-Cal) Tuberculosis (MCTB) program benefit. Persons with known or suspected tuberculosis infection or disease who cannot qualify for full-scope Medi-Cal benefits but who meet less stringent criteria that are federally defined, can qualify as beneficiaries for the MCTB program.
The California Department of Health Services developed the MCTB program to provide a new funding source for local health jurisdiction (LHJ) tuberculosis programs to cover costs that would otherwise be incurred by categorical local, state, and federal dollars. For those persons who qualify only for the tuberculosis treatment benefit, the program covers outpatient tuberculosis treatment services including directly observed therapy (DOT) and directly observed preventive therapy (DOPT) at $19.23 per encounter. An LHJ can also receive reimbursement for DOT and DOPT provided to full Medi-Cal beneficiaries. A crucial first step, however, is the ability of the tuberculosis program to enroll beneficiaries.
Tuberculosis programs have encountered several challenges to identifying potential beneficiaries and enrolling them in MCTB. Foreign-born clients often fear that enrollment in the program will prevent them from obtaining citizenship. Other challenges include the absence of a well-established working relationship between the tuberculosis control program and the Department of Social Services or decentralized tuberculosis care systems with multiple clinics necessitating screening and enrollment at numerous sites.
Santa Clara County, through a partnership of its Tuberculosis Program and Ambulatory Care Tuberculosis Clinic, has been the most successful of the California tuberculosis control programs. In 1998, Santa Clara County reported 251 cases of tuberculosis; 87.6 percent were foreign-born Asians. Each year Santa Clara County evaluates approximately 400 new immigrants suspected of contracting tuberculosis overseas (B notification). About 25 percent of the tuberculosis clinic patients qualify for full Medi-Cal benefits. An additional approximately 14 percent of patients are enrolled in the MCTB program. The annual budget for the tuberculosis clinic is $1.4 million.
For fiscal year 1999–2000 Santa Clara County is estimating $300,000 in revenue to the tuberculosis clinic from Medi-Cal reimbursements for outpatient tuberculosis testing and treatment services, including DOT-DOPT. Significant savings are gained through direct billing of Medi-Cal for medications and laboratory services. Approximately $100,000 in additional income is projected through the Health Care Finance Administration's Medi-Cal Administrative Services reimbursement.
Santa Clara County's success is due to several factors: two full-time financial counselors in the tuberculosis clinic, a dedicated tuberculosis clinic, good marketing skills that result in a win–win approach that both benefits patients and enhances clinical services, development of a strong relationship with the Department of Social Services, and perseverance.
The financial counselors play a key role. At the first visit each patient is interviewed regarding his or her financial status. Although some credibility is gained because they are immigrants themselves, the counselors' effectiveness results largely from their knowledgeable, culturally sensitive approach. Patients are told that they may be eligible for a variety of programs that will cover the cost of their care. It is clearly explained why enrollment will not prevent the granting of citizenship, and the benefits of coverage, even for Nontuberculosis conditions, are emphasized. Patients are assisted with their applications and are told to bring to the counselors any bills that they receive while waiting for approval for participation in the program. It is also emphasized that no one will be denied services on the basis of an ability to pay, whether or not they qualify for Medi-Cal. The patients appreciate the concern and assistance with their financial problems.
In the face of level state and federal categorical funding for tuberculosis, the MCTB program has enabled Santa Clara County to expand and improve tuberculosis treatment services. MCTB program revenues are paying for the financial counselors and have helped the tuberculosis program upgrade several positions. SOURCE: Karen Lee Smith, MD, MPH, and Elizabeth Kinoshita, PHN, Santa Clara County Tuberculosis Control Program, and Deborah Tabor, RN, Tuberculosis Branch, California Department of Health Services.
Response to Managed Care
The percentage of individuals with tuberculosis who receive care in the private sector is likely to grow, as Medicaid and Medicare recipients are increasingly being enrolled in the health plans of private for-profit insurance companies and managed care organizations. In 1997, the last
year for which data are available, more than 14 percent of Medicare patients and 52 percent of Medicaid patients were in some type of managed care program. Moreover, academic medical centers, public hospitals, veteran's facilities, and community and migrant health centers, once closely cooperative with health departments are also increasingly functioning as private providers, competing for patient populations and billing on a fee-for-service basis.
Another health sector reform with the potential to significantly affect tuberculosis control is the growing trend toward privatization by local health departments. Privatization, which consists of outsourcing or contracting with private for-profit or not-for-profit organizations to provide
services and care formerly provided directly by the health department, is being widely adopted by local health departments in response to reductions in public funding by federal, state, and local governments (Bialek and Chaulk, 1999).
Unless these reforms, however, are addressed in a clear, forthright, and consistent manner throughout the country, they could pose a real threat to the elimination of tuberculosis in the United States. For example, local health departments are the focal point for tuberculosis control efforts across the United States. Many local health departments use Medicaid dollars to cross-subsidize wraparound services for more comprehensive management of communicable diseases such as tuberculosis. Moving the responsibility for the care of patients who are recipients of public aid (e.g., Medicaid or Medicare patients) and the concomitant funds for care for those patients to the private sector will make the previously available financial resources inaccessible to public health agencies. The problems associated with an inadequately planned privatization of tuberculosis treatment services were clearly observed in a series of failed pilot projects in Pennsylvania (Lopez, 1999).
At the same time, according to a recent national analysis, state Medicaid managed care contracts are virtually devoid of language delineating the management of tuberculosis patients. Thus, most managed care organizations that care for Medicaid patients are not bound by any standard of care in the treatment of tuberculosis. Since traditional private sector health care models are ill equipped to provide the comprehensive public health services necessary for effective tuberculosis control, these shifts in patients and resources could jeopardize this public health effort. Opportunities
On the other hand, managed care and privatization present, at least in theory, opportunities to redefine and strengthen the respective roles of local health departments and private-sector health care organizations in support of a national tuberculosis control and elimination effort. This is attainable if population-based approaches to care are addressed by managed care organizations and other organizations contracting with state or local health departments. The emergence of managed care and the evolution of its organizational and fiscal technologies present additional opportunities for strengthening tuberculosis control efforts. These opportunities include an emphasis on identifiable points of accountability for client outcomes; varying levels of risk sharing among providers, clients, and managed care organizations; the use of pooled resources across systems; a prevention-focused orientation; ongoing outcome-oriented quality assurance activities; and accreditation requirements.
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-
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
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,
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).
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
coordinated with the reporting and surveillance practices of local health departments.
Baltimore City Case Study
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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.
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
the safety net could have a significant and long-term nationwide impact on the treatment, prevention, and control of tuberculosis.
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.
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