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Strategic Planning' Resource Allocation' and Economic Support OVERVIEW Advocating for public health is often difficult, especially if those people and organizations that are best suited to be advocates are understaffed, have inade- quate resources, and are not experienced in the art of advocacy and communica- tion. Yet, members of the U.S. Congress, state legislators, and managed care organizations need to be educated about the needs of the public health systems, particularly the public health infrastructure. Until public health laboratories and clinical departments have the resources and infrastructures necessary to meet the challenges of emerging infectious diseases, planning may remain reactive rather than strategic. LEGISLATION AND MANDATES AT THE FEDERAL LEVEL Ellen Gadbois, Ph.D. Office of Senator Edward Kennedy, United States Senate Traditionally, the U.S. Congress has been supportive of public health ac- tivities in the area of infectious diseases, including such issues as funding of basic research and concerns about food safety and antimicrobial resistance. Moreover, members of Congress are frequently riveted by media reports of in- fectious diseases or foodborne outbreaks. Other issues receiving congressional attention include managed care. Other factors are at play, however, in Con- gress's response to emerging infectious diseases. Specific diseases are often targeted for earmarks by biomedical research advocates during the congressional appropriations process, and funding for infectious diseases is competing directly 68

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STRATEGIC PLANNING 69 with funding for other types of diseases as well as with other health care priori- ties. Infectious diseases are sometimes disadvantaged in that they are still not seen as a health threat to Americans but, instead, are seen as a problem primarily faced by people in other countries. The larger biomedical research community approaches Congress with a clear message; that research is good for everybody and that it will make people healthier and will save Medicare dollars. This is an opportunity for the public health community to create partnerships with patient advocacy groups. Congress has come to appreciate the value of basic research and could similarly come to appreciate the need for an adequate public health infrastructure and infectious disease surveillance. The Senate Subcommittee on Public Health and Safety plans to convene hearings on issues related to infectious diseases, including bioterrorism, food safety, and antimicrobial resistance. In addition, a number of bills that will regulate food safety have been introduced. Senator Edward Kennedy and other members are especially interested in the issue of antimicrobial resistance, which involves the activities of a number of federal agencies. For example, the National Institutes of Health's (NIH's) re- search portfolio includes vaccines and antibiotics, clinical diagnostics, and mi- crobial genome sequencing, and the Centers for Disease Control and Prevention (CDC) is the lead agency for infectious disease surveillance and prevention. There are also questions about reimbursement policies at the Health Care Fi- nancing Administration (HCFA) and whether it is promoting judicious antimi- crobial use. Through the U.S. Food and Drug Administration (FDA), Congress has taken several relevant actions that bear on antimicrobial resistance, includ- ing allowing fast-track development for certain drugs and exclusivity for pediat- ric studies of antibiotics. In addition, there has recently been considerable inter- est in the use of antimicrobial agents in animals. Review of agricultural issues also includes oversight and review of the activities of the U.S. Department of Agriculture. The U.S. Environmental Protection Agency plays a role with regard to regulating antibacterial household products. In the broader context of health care, Congress is very interested in man- aged care reform. The patients' bill of rights proposed by Democrats allows for access to specialists, which in the case of unusual infectious diseases is impor- tant. It also allows for insurance coverage for routine patient costs associated with participation in clinical trials. These proposed policies are important con- siderations in terms of access to specialists in the case of exposure to unusual or rare infectious diseases. Formulary policies in the managed care systems often limit access to certain drugs, which can be detrimental in the case of someone who is infected with a drug-resistant pathogen. The confidentiality of medical records is another topic of considerable in- terest to Congress and the Executive Branch, and the administration has recom- mended legislation on personally identifiable medical information. Most pro-

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70 PUBLIC HEALTH SYSTEMS AND EMERGING INFECTIONS posals have special provisions for public health activities, but there is an overlap among public health, biomedical research, and health services research. CONGRESSIONAL RESPONSE TO THE THREAT OF INFECTIOUS DISEASES Jack Chow, Ph.D. Senate Appropriations Committee, Labor, Health, and Human Services Subcommittee In fiscal year 1999, the U.S. Congress gave a $3.2 billion (14.5 percent) in- crease to the agencies of the U.S. Public Health Service. Much of the increase was awarded to NIH, but CDC, the Agency for Health Care Policy and Research (AHCPR), and Health Resources Services Administration (HRSA) also received substantial increases. Congress and the President also funded a bioterrorism ini- tiative, which consisted of $217 million in emergency funding, including $139 million for bioterrorism-related programs at CDC and the Office of Emergency Preparedness, as well as $28 million to be dedicated to polio and measles eradi- cation efforts around the world. In developing the public health budget, Congress relies on input from the agencies of the U.S. Department of Health and Human Services, hearings, and contact from a variety of interest groups. The budget for the Labor, Health and Human Services, and Education Bill presents a zero-sum situation, in which if there is increased funding for public health, that funding must come from the education and labor portions, which also have their advocates. Within the health allocations, there is always tension between the allocations for chronic diseases and those for acute diseases. Some groups, however, are more effective at advo- cating their causes than others. Public health, like a lot of other government en- deavors, includes the intangible, but there has been a basic consensus that it is a worthwhile and rational investment. Nevertheless, federal support for public health efforts does not take into account activities at the state or private level. In addition, funding for categorical or discretionary programs often does not take into account infrastructure needs. A legislative view of the public health infrastructure would be that it has a portfolio of material and personnel, technology information flows, and functions that produce a clear relationship between inputs and outcomes. For instance, vaccination programs have a clear value chain; creation and distribution of a product that leads to the outcome of disease suppression. This requires useful benchmarks by which to measure progress. In addition, there must be a profes- sional cadre of public health professionals, and the training pipeline must be sustainable. An idea that has been considered by Congress is a national health index, a singular common number that is a proxy for the state of health in a given region

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STRA TEGIC PLANNING 71 and that is fungible and comparable across regions. Such an index might be help- ful in guiding policy, particularly if it could be broken down into individual com- ponents by disease entity or geographic region. For instance, there might be an infectious disease index with a score that incorporates the power of prevention. Congress is also interested in looking at emerging infectious diseases, as well as other diseases, in the context of health and international security. In the post-Cold War era, the traditional political and military model of conflict is dis- solving into a rapidly changing landscape of threats and of global interdepend- ence that could yield degradations of health and other elements of human secu- rity. Persistent poverty and chronic under- and maldevelopment in many regions of the globe contribute to population vulnerability. Instability is a prime breed- ing ground for emerging diseases, both infectious and noninfectious diseases, which requires that the government act not only to achieve stability but also to be prepared for bioterrorism and pandemics. STATE HEALTH OFFICIAL PERSPECTIVE Fred Edgar Thompson, Jr., M.D. State Health Officer, Mississippi Department of Health State governments have many public health responsibilities. These include conduct of surveillance, maintain the capacity to perform epidemiological in- vestigations, and contain the expertise and experience needed to rapidly mount mass immunization campaigns. Therefore, some of these elements should not be privatized, such as the laboratory functions and epidemiology. The strategy in dealing with emerging infectious diseases and related public health problems must involve state-level public health because government will inevitably exe- cute that strategy. There is a range of public health activities, from investigating the back- ground of sporadic cases of various infectious diseases, to studies of outbreaks of diseases, to the sporadic occurrence of newly emerging or reemerging infec- tions, to bioterrorism. A fundamental infrastructure that addresses every aspect of this continuum at the local and state levels is also evident, and that infra- structure requires public resources. A basic function of states is surveillance, primarily to receive and process reports of diagnosed cases of reportable diseases and to receive calls from local physicians and specialists about an unusual death, or reports of severe diarrhea in children, or reports of extreme respiratory distress in adults. Routine consul- tation is part of this fundamental process and involves a circle of human interac- tions. There must also be routine interaction between the public health labora- tory and physicians and between epidemiologists and physicians. States must have capacities in epidemiological investigation, which requires field staff and a response team. This requires that the state have in place the ap-

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72 PUBLIC HEALTH SYSTEMS AND EMERGING INFECTIONS propriate personnel on an ordinary day in the event that it becomes an extraordi- nary day. For contact tracing and case finding, public health nurses, disease in- vestigators, and public health environmentalists might be required. Generally, states and large local jurisdictions have the expertise and expe- rience needed to quickly mobilize mass immunization campaigns. Large-scale administration of medications is a function of many state health departments. It may be as simple as prophylaxis for meningococcal disease in a family or in an entire kindergarten classroom. The logistics of how to do this are skills held by state health departments, which can refine techniques based on actual experi- ence rather than theory. Finally, state health departments are essential in disas- ter response. Communicationócoordination, education, and outreach is essential to ex- changing information to generate hypotheses, and it must be secure. Public health officials who are a regular, daily source of public health information for elected officials and the public are also the most effective communicators in an emergency. With regard to resource and economic support, public health departments have inadequate resources for investigation of deaths that may be due to infec- tious diseases. One of the most critical needs across the country is the universal medical examiner system; however, this is not the case in every jurisdiction. Far too many fatal cases of unknown origin are under the jurisdiction of a coroner, whose only qualification might be that he or she is a registered voter in the dis- trict. Until there is regular investigation of suspicious deaths by sufficiently qualified persons, there will never be adequate surveillance for emerging infec- tious diseases or for a number of other potential public health problems. In addition to sufficient financial and human resources, state health officials would also benefit from the establishment of standards of personnel qualifica- tions and case definitions. The Council of State and Territorial Epidemiologists, the Association of Public Health Laboratories, the Association of State and Ter- ritorial Health Officials, and the National Association of City and County Health Officials must develop these standards with input from CDC and NIH. LABORATORY-BASED REPORTING ISSUES Robert J. Rubin, M.D. President, The Lewin Group Both the public and the private sectors have a role to play in effective sur- veillance efforts. Private-sector laboratories are more likely to detect unusual infections, report them to public health officials, and forward isolates of unusual pathogens to public-sector laboratories. It is the responsibility of public-sector laboratories to document and identify the occurrence of unusual infections. They need to know what kinds of tests to perform, such as serotyping studies, and

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STRA TEGIC PLANNING 73 increasingly, they must sequence the genomes of pathogens that may threaten the public health. Because the public health system is at a crossroads as to how to define and sustain its role, the changing face of health care poses new challenges for the detection, treatment, and prevention of infectious diseases. While historically local public health departments, hospitals, and clinics have been the main source for infectious disease outbreak detection and treatment, this trend has been changing. Now, the numbers of members of managed care organizations and the rate of privatization of public health laboratories continue to increase in re- sponse to the needs of the communities they serve. This transformation has been a controversial issue. A study of public health laboratory directors inquired about the effects of managed care on the public health mission (Office of the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services, 1997; Public Health Infrastructure and the Private Sector: Public Health Laboratories and Managed Care; http://aspe.hhs.gov/health/reports/phlabs/front.htm). Forty- seven percent responded negatively (i.e., managed care has no impact); 43 per- cent said yes (i.e., managed care has adverse impacts), 10 percent were unsure, and 2 percent did not answer. In terms of the potential positive effects, managed care plans have integrated patient databases that may be precisely what is needed to track infectious diseases that occur in that plan's population. In addition, there is a potential for seamless communication between laboratories, managed care organizations, and public health officials. Some of the negative effects include an overemphasis on economic efficiency that creates disincentives for reporting and isolate submission. In addition, comprehensive contracts with large national labo- ratories may create barriers to complying with state and local disease reporting requirements. There is some sense of loss of ownership and control when speci- mens move across state borders in an attempt to find the best price. The public sector is behind in leveraging the potential advantages for man- aged care, and there are a variety of reasons for this. One of these is the fact that it is hard to obtain adequate funds for infrastructure. In addition, because many state public health laboratories consider managed care's impact to be a negative, adversarial relationships among public health officials, managed care organiza- tions, and state legislators may develop. Another study, funded by the American Society for Microbiology, looked at the impact of managed care and health system change on clinical laboratories (The Impact of Managed Care and Health System Change on Clinical Microbi- ology. Prepared by The Lewin Group, 1998; available at http://www.asm.org/ pasrc/pdfs/lewinrep.pdf). The investigators interviewed 369 people throughout the country in a statistically valid sample of microbiologists, clinical laboratory directors, and administrators. Roughly 61 percent were from academic hospitals, 23 percent were from nonacademic hospitals, 11 percent were from independent reference laboratories, and 5 percent were from public health laboratories.

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74 PUBLIC HEALTH SYSTEMS AND EMERGING INFECTIONS Among these respondents, managed care was perceived to be the most important market force affecting clinical laboratories. Yet, two-thirds of the respondents reported overall increases in test volumes. More respondents reported an in- crease than a decrease for every single type of laboratory test queried. However, 10 percent said that they had decreased the amount of antimicrobial susceptibil- ity testing done, even though this is an era of increasing drug resistance. About one-third of clinical directors and laboratory directors reported that they spent decreasing amounts of time actually performing tests. Two-thirds of the laboratories reported a decrease in overall staffing, and equal numbers of respondents reported an increase and a decrease in pathologists, Ph.D. microbi- ologists, laboratory technicians, and laboratory assistants. Between three and four times as many respondents reported a decrease than an increase in the num- ber of mid-level positions (e.g., M.S.- or B.S.-level microbiologists or technical supervisors). More than half the laboratories surveyed had been downsized; half had developed either partnerships or affiliations with other laboratories. The vast majority of respondents reported implementing measures to control costs.