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CHAPTER IV THE PROCES ~ OF DEVELOPING NATIONAL GUIDELINES FOR HEALTH PLANNING The initial set of national guidelines for health planning, formally proposed by REW in September 1977, emphasized short-term opportunities to contain costs and improve quality of care in hospi- tals. Additional guidelines were formally proposed in November 1979. A detailed examination of the process by which the initial guide- lines were developed (Zwick, 1978) is beyond the scope of this study. But the committee is aware of criticisms that issuance of the guide- lines was tardy, that the process was not an orderly one, and that the guidelines pose adverse effects for local influence on health plan- ning, for small health facilities in rural areas, and the like. A particular charge to this committee was to make recommendations to improve the process of development Lessons doubtless will be drawn from the early experience with guidelines. But the committee was primarily interested in a more general view of guidelines development that could be gleaned from the appropriate scholarly literature and a fresh look at the legislative history and various approaches. This chapter summarizes the commit- tee's observations and recommendations. Constraints on the Process of Developing National Health Planning Guidelines In an open and democratic society, the process by which governmen- tal policy is made can be as important as the policy itself. Given a view of the guidelines as a means for establishing and expressing national interests at local and state levels, and for being helpful to the planning agencies in strengthening their knowledge and negotiating ability, it is the committee's judgment that the process by which the national guidelines are developed are important. The im- portance of the process and the methods used should not be a substitute for guidelines that are professionally and scientifically defensible. 41

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- 42 - One set of constraints on a process for developing national health planning guidelines is imposed by the planning Act itself. For example: . . The general goal for health planning activities--achieve- ment of equal access to quality health care at a reasonable cost cannot be incorporated in a single standard. Trade-offs are necessary, which means that the decision process will operate in a politically charged environment. The Act does not require that the guidelines be developed by DHEW. However, a constraint that would apply to standards developed outside of DHEW would be the Department's willingness to adopt and publish them. The Act requires that the guidelines be issued "by regulation" to ensure an open participatory process, but this method was misunderstood by the public in 1977. Using the "rulemaking" process ensures its openness, with required times between proposals and final decisions and announcements in the Federal Register, but the public's perception is that they have more direct power than they do. The open process is bolstered by added requirements that the Secretary of DHEW must solicit opinions and provide options for RSAs, SHPDAs, SHCCs, and the National Council well before proposing standards, according to the 1979 planning amendments. Calling them "guidelines" has implications for the way they are developed. Would a desirable standard be one that HRAs will find useful or could tolerate, or would it be one that assures that a parti- cular set of facts will lead almost automatically to a given decision by an USA. In either event, the circumstances under which deviations are allowed must be understood and agreed upon. The committee believes that an open and collaborative development of guidelines will minimize the areas of disagreement and enhance the usefulness, quality, and acceptability of the guidelines. Thoughtful ., and systematic examination of existing knowledge and the Judgments of experts must be brought together in a public and open process. Governmental actions that bear on health care can arouse substan- tial public reaction. Health care institutions have a great economic stake in the health enterprise. But the interests potentially affected by health planning are broader than health care providers and the people they serve. Health planning also poses an impact on, for example, major industries that train health professionals and conduct biomedical research. Thus the process, representing an attempt to bring more rationality into the health care system, must include means of assess- ing the political as well as substantive effects of the guidelines that are under development.

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- 43 - The process of developing health guidelines also should be consistent with good administrative procedures in general. Procedures and responsibilities should be clear enough that interested persons will know how the standards are developed, how to obtain and provide information, and how to anticipate issues to be addressed in the future. Relevant points of view, especially adversarial, should be represented and have adequate opportunity to present evidence. Interested persons should be able to follow the progress of the guidelines development process. Open hearings and public advice early in the policymaking stages are not sufficient if the process later gets lost in organizational logistics. Objective appeals procedures must be established. Important issues must be addressed in a timely manner and be given commensurate priority for action. Available sources of information must be fully exploited, and all evidence carefully reviewed. Recommendations for Guideline Development The committee identified a number of characteristics and five phases of development of national guidelines. Each phase is discussed separately with specific recommendations for consideration in the immediate future of guidelines development. The primary legal responsibility for development and dissemination of the guidelines is vested in the Secretary of DREW. As noted earlier, the process developed by the Secretary for the establishment of such guidelines, and particularly the method for securing broad participa- tion is critical to the success of the effort and acceptance of the product. Accordingly, the committee urges the Secretary to develop and utilize a formal process of guideline development that is as open and accessible as possible. Development of an Agenda The committee believes that an overall system of priorities is essential to the guideline development process. There are many groups with legitimate concerns and separate agendas for the health enter- prise. The Congress has set forth a group of national priorities under Section 1502 of the Act and augmented in the 1979 amendments, making them a a primary agenda for the guideline development process.

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- 44 The committee believes that the National Council on Health Plan- ning and Development, representative of a variety of interests in the health field, is a suitable body to guide the process of national guidelines development and can play an important role in assisting the Secretary. The National Council should be asked to recommend, perhaps . annually, to the Secretary of Health, Education, and Welfare an agenda for guidelines development, including priorities. The council would consider the special interests and concerns of the federal government as major factors influencing their recommendations for an agenda, but would also seek advice from health planning agencies and other parti- cipants in the health system. Among the tasks that might be assigned to the Council are: -- solicitation of topic suggestions from the public, planners, professional organizations, and other interested parties -- identification of the interests that should be represented in formulating any particular guideline -- conduct of public meetings at which topics would be evaluated in light of congressional and departmental priorities, the needs of the planners, and the concerns of the public and the health establishment -- identification of topics for guidelines development, based on need and technical feasibility, for transmittal to the Secretary -- dissemination of its recommended agenda to the public. To ensure the proper development of such an agenda and advising on related activities, the committee recommends that the Council be given an adequate staff ? reporting directly to the Council for this purpose. To ensure the ability to respond to the issues, a number of staff members should be full-time with the Council. The process of developing the guidelines, as contrasted to developing the agenda, should remain in the Department of Health, Edu- cation, and Welfare, but the National Council should have a role in advising on that process and be called upon to actively concern itself, as an adviser, with both the content and the process of guidelines development. Setting of the Agenda The Secretary would not have to accept all the recommendations and priorities of the Council for guidelines development agenda. But, assuming close coordination of the Council's deliberations with the

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- 45 - Department, disparities between the agenda recommended and the agenda implemented should be minimal. When the Secretary finds it necessary to amend the recommended agenda, the committee feels strongly that the Council should be consulted, and its views sought about the probable effects of the amendments on the process of developing a National Health Planning policy. Advisory committees or councils are not always viewed favorably by administrators, particularly when the advisory role is required by law. But the Council is duly constituted to represent a broad spec- trum of interests, is operational, and could be useful to the Depart- ment in this task of developing acceptable national health planning . . po acres. Guideline Development The committee's study of the process of guideline development included examination of several approaches that have been used in other fields. Although the committee concluded that identification of a specific development process was beyond the scope of this study, it found consensus on several general conditions. The committee recommends that adequate staff within DHEW be assigned to developing the guidelines and that adequacy be recognized as being both a quantitative and qualitative concept. The committee believes that provision of adequate staff support for the guidelines development effort within DHEW will be a critical element in its suc- cess. The locus of responsibility for staffing should be within the Department, which must recognize that as the guidelines development process moves into more highly technical areas, it may be necessary to seek--either through consultants or through staff borrowed from other agencies, nongovernmental entities, or planning bodies--technical expertise not found within the Department. The staff must be free to respond to the responsible committee or consultants charged with developing a guideline or guidelines. A de- gree of separation for the working committee or task force from the Department's administrative structure during the development process is important to maintaining the objectivity and credibility of the process. The committee also recommends the use of "consensus development - groups'' of appropriate technical and operational experts. The committee suggests that the groups be appointed by, and report to, the National Council on Health Planning and Development. The results would be advisory to DHEW. A recruiting method employed in similar exercises in Canada relies on solicitation of nominees from selected professional organizations and groups within particular concerns or interests. The members of the consensus development group (no more than ten) are

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- 46 - then chosen by the appointing authority according to criteria that assure broad representation. A workable guidelines process also requires ample opportunity for various individuals and groups to discuss their interests and concerns. The committee recognizes that the statute and federal pro- cedures provide many opportunities for public reaction to draft guide- lines. The committee is convinced that public participation during the development of drafts is more useful and will facilitate adoption of the national guidelines. These approaches could help to avoid the criticism of the earlier guidelines about the closed aspect of the final stages of the develop- ment process. The committee recognizes that the guideline development process requires time and cannot be accomplished properly on a fast- paced schedule. The amount of time required to establish one or another guideline will vary with the complexity of the topic, the state of knowledge, and the numbers of individuals and groups interested in participating. In the committee's view,-the time is well spent if it provides broad opportunities for participation and a maximum chance of consensus. A desirable process for guidelines development will also set an important example for the development at local and state levels. Features of the Development Process The committee does not suggest that there is any "best" way to develop national health planning guidelines, including goals and standards. However, we wish to call attention to certain important features of the development, to mention some qualities that would be desirable in the guidelines, and to identify some of the strengths and weaknesses of possible methods of developing guidelines. Guidelines for health planning often will be based to an appreci- able extent on informed opinions and value judgments. Scientific evidence will play an indispensable role in a sound process of developing planning guidelines, but in very few cases will such evidence itself dictate what a guideline should be. The public and professional acceptability of a planning guideline will be affected by the adequacy of the evidence that underlies it, and by certain qualities of the process by which it is developed. Who is involved in the development process and under whose auspices it proceeds influence such matters as the emphasis on evidence, the flexibility that is allowed under the guidelines, the values that they emphasize, and the extent to which they realistically address important issues faced by state and local planning agencies. A variety of mechanisms are possible for application in the development of guidelines or other information useful for health plan- ning purposes. Specialty societies and professional associations in

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medicine commonly form committees to assess the current knowledge about a practice or technology and to make recommendations. Such committees may make highly competent use of available research information and may well be concerned with issues such as cost, access, and quality. This can make the standards that they recommend, and the logic by which those recommendations were reached, very useful. The conclusions of such bodies, particularly if their members are well regarded, tend to be respected by those in the field, although such recommendations may also be the subject of bitter disagreement. The fact that such a group could assess the evidence and make recommendations also is a useful indicator of the adequacy of the research evidence that bears on the topic under question. The value of the work of such groups for purposes of developing planning guidelines is limited by the questions addressed. Conclusions may not bear directly on health planning and may require translation or additional study before being useful for such purposes. A state- ment, for example, about the role that a given piece of diagnostic equipment should play in clinical practice may say nothing about how such technologies should be distributed. A further difficulty with guidelines derived by professional associations and specialty societies is that, unless they undergo a credible independent assessment, they may represent too narrow a set of concerns and also may be perceived as self-serving. A second possible source of planning guidelines is governmental agencies concerned with health. Many different agencies are involved in different aspects of assessing the safety, efficacy, and efficiency of medical technologies. A recent report by the Office of Technology Assessment (OTA) describes such activities being performed at the National Center for Health Services Research, the Food and Drug Administration, National Institutes of Health (the "consensus development" process and clinical trials), the Alcohol, Drug Abuse, and Mental Health Administration, the Health Services Administration, the Health Resources Administration, the Office of Health Practice Assess- ment, the Health Standards and Quality Bureau, as well as programs in the Veterans Administration and the Department of Defense. In addi- tion, there were the activities of OTA itself. More recently, Congress has created the National Center for Health Care Technology in the Department of Health, Education, and Welfare to conduct technology assessment activities and to coordinate DHEWs activities in that area. Without liaison with the guidelines development process, existing technology assessment activities may stop short of addressing issues of central importance to health planning. Limitations of the federal activities include an emphasis on technology, and not on facilities, manpower, or resource standards; none of the agencies mentioned above is concerned primarily with health planning, and planning issues may not receive the necessary degree of attention in their activities. A further limitation is the fact that these activities are scattered throughout DHEW (and even outside

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- 48 - of it). They fail to meet the criteria of having a well-understood, orderly, and predictable process by which health planning guidelines are developed. Nevertheless, these agencies are involved in many activities that can be useful for health planning purposes, and linkages should be established so as to make best use of scarce re- sources. Again, the National Council on Health Planning and Develop- ment, which already has an advisory role for the application of technology in planning, could link many of these efforts to the plan- ning structure. A third possible source of information that can be used to develop planning guidelines is the independent advisory committee or commis- sion. A growing body of literature has accumulated about such groups, and many of their strengths and weaknesses have become apparent with experience . Although the advantages of using advisory committees are not all directly applicable to this activity, a number of lessons recur in the literature. For example, groups designed to be independent of the government advisory committees (including commissions) provide expert, disinterested advice and can introduce their ideas directly at the level of decision without going through a cumbersome process in the bureaucracy. Their membership expertise and official status lend credibility and influence to their effort, tending to build support for their policy proposals. This is particularly evident when the group represents a breadth of disciplines and points of view. Furthermore, the very existence of a committee and the publicity that it receives can focus attention on an issue and serve to educate the public, even when the group's recommendations are not implemented. The development of health planning guidelines should concentrate on the problems of planning and address the goals set forth in the planning law. Second, it should be oriented toward the use of scienti- fic evidence from clinical trials, epidemiological research, and health services research. Third, it should involve people with expertise and experience, who will approach the task of developing guidelines in a way that commands respect from the diverse interests that may be affected by those guidelines. This means making wise use of scientific evidence, considering carefully the range of possible effects of guidelines, and being sensitive to the diversity of types of institu- tions and communities that may be affected by the guidelines. Fourth, it should have the resources (money and staff) necessary to assemble research evidence, to be cognizant of relevant research activities conducted by the various federal agencies and private organizations with interests relevant to health planning, and to stimulate research needed for development of future guidelines or revision of current ones. These goals can best be accomplished through a process that com- bines federal and private efforts. Although administration of the plan- ning law is clearly the responsibility of OHEW, and overall impetus and

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- 49 - coordination must come from the Department, much can be done to broaden the knowledge base and range of interests that are involved in the planning process at the national level. There are several alternatives available for assembling and staff- ing the diverse groups suggested by the above discussion. The federal government could perform this function directly, but possible drawbacks include the difficulty of recruiting and hiring the types of people needed, because of suspicions generated by the first proposed regu- lations. More independent auspices could enhance the credibility of whatever guidelines are produced. One possibility would be for DHEW to support the development of planning guidelines by diverse groups assembled outside of government, on a model of NIH's consensus develop- ment process. Done properly, this approach could lend a degree of independence and objectivity that could contribute importantly to the credibility of the guidelines. The Council should play a role in advis- ing on this process as well. Whatever process is used for developing health planning standards, it is important that the statement of a standard include specifica- tion of the goal toward which the standard is directed and the logic that links the standard with the goal. This will help state and local planning agencies determine whether their situation may present alter- native or additional ways of moving toward the goal and avoid disrup- tive misunderstandings. It will also increase the likelihood that, if there are relevant factors in a decision faced by an HSA that were not considered in the development of a standard, the lack can readily be discerned. Dissemination of Guidelines The dissemination stage of the process for developing national health planning guidelines can contribute to the improvement and acceptance of the guidelines. The dissemination process should be viewed initially as an opportunity to gain much wider participation in the development of guidelines. The status of a proposed rule in the federal government is open to different interpretations. Some persons, particularly within DHEW, view the issuance of proposed rules as a way to try out some ideas. Others, particularly outside of DHEW, view the issuance of the proposed rules as the announcement that a series of decisions had been made. It will be beneficial to seek public comment, as required now, on a planning guideline before the issuance of a Notice of Proposed Rule- - making to avoid the implication that decisions have already been made. The 1979 requirement that DHEW provide material, including options under consideration, and to consult with planning agencies, associa- tions, and specialty societies at least 45 days before proposing guidelines will help reduce fears that a decision has been made. This

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- 50 - should help identify possible substantive problems and political pro- blems at an early stage. Evaluation of Planning Guidelines National health planning guidelines are issued to be used in the promotion of goals related to access, quality, and cost control. How- ever, at the present stage of knowiedge,-such guidelines cannot be issued with full confidence that their effects and their usefulness are known. Furthermore, changing conditions may produce the need to change even the most well-founded guideline, as is suggested by the require- ment in the National Health Planning and Resources Development Act that the guidelines undergo periodic revision. Evaluation of the effects and usefulness of planning guidelines should be viewed as the final stage in the guidelines development pro- cess. The evaluation of past guidelines should feed into their revi- sion and the development of new guidelines. The 1979 Amendments to the planning Act add an opportunity to gather evaluative data on the national guidelines. In particular, DREW is required to review annually the goals and standards issued. Part of that review includes an analysis of the Health Systems Plans, Annual Implementation Plans, and State Health Plans to establish a closer link between planning at the different levels and to help with revision of guidelines. The Secretary also is required to collect data to determine whether or not the health care systems in each area are moving toward the standards and goals. That information could be used to allocate future financial resources to those areas in the greatest need. Evaluation of the national guidelines should be from two different perspectives. The first is from the standpoint of quality, acceptabil- ity, and usefulness of the guidelines as a part of the planning pro- cess. Evaluation along those lines would be done by separate groups not involved in any of the stages of the guideline development process. The second is from the assessment of the nation's progress toward achievement of goals and standards, which will be primarily a quantita- tive assessment and could most easily be conducted by DREW. The data would serve as a basis for its report to the Congress and the results should be considered as information to help shape the other parts of the guidelines development process. In addition, the information would also help in assessing, over time, the effects of the planning program. Data, Methods, Knowledge Base While the proper development of health planning guidelines is dependent on a firm empirical base, the committee is concerned about the absence of sufficient quantitative information and sound analyses for health planning. Health planning and regulation have been hampered by (a) an inadequate data base (for

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- 51 - example, virtually no small area morbidity data or data on hospital discharges); (b) limitations in the applicability of analytic tech- niques and appropriate research methods (for example, functional classifications for long term care patient placement and assessment, and the concept'of medical need for individual health problems to estimating the need for services or equipment on an area-wide basis); (c) 'insufficient knowledge of the efficacy of services or appropriate conditions or circumstances under which services are useful (for example, electronic fetal monitoring, coronary by pass surgery). This latter problem stems from insufficient attention given to research on the efficacy and effectiveness of services by the medical research community. Progress in the use of such knowledge in planning will be substantially controlled by the amount of the investment in such research. ' ' Individuals and groups, including previous TOM committees, have urged that' the federal government give increased attention and support to the development and dissemination of health information, analytic techniques, and improved health planning methods. This committee would like to reiterate their importance. The support for such research and studies of proper application for research findings will have to come from outside the planning program. Contributions have been made by the Centers for Health Planning, established to provide technical assis- tance to planning agencies, the National Center for Health Services Research (NCHSR) (especially their small grants program to fund research in planning and cost containment), the National Center for Health Statistics' (NCHS) publications and special projects (e.g., Statistical Notes for Health Planners), and the Health Care Financing Administration's (HCFA) data sharing with planning agencies concerning the usefulness and proper deployment of health services. However, the job to be done needs much more rapid movement in similar directions. Research that strengthens the empirical base, tests and refines techni- cal methods for planning is especially needed. A research agenda is needed to cover the many concerns with which the planning program must grapple. There was insufficient time in this study to develop such an agenda. Further, the evolution of the health planning program and the committee's engagement in simulation of guide- line development have helped to reveal the importance of an agenda for needed research. ' A two pronged attack to improve the availability of sound analy- tical methods and research, as well as the dissemination of findings, might include the funding of research in planning methods and applica- tion by NCHSR and HCFA, and an emphasis on synthesizing and disseminat- ing research and experience in applying methods through the Centers for Health Planning and universities involved in research. Basic research on efficacy and effectiveness through NCHCT and the NIH could simultaneously be strengthened.

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- 52 - The base of data and knowledge about the collection and use of statistics could be expanded in several ways, in addition to the acti- vities cited earlier. Existing data systems could be sources of data which are routinely shared with planning agencies. This is already occurring with some data from the National Center for Health Statis- tics, HCFA's Medicare files, and the Bureau of Health Manpower's Area Resource File. While this is a step forward, such data are not current and are most useful as benchmarks. Analysis of such data would help to identify problems that would require special studies. Because they are part of national data sets, they produce data on the local area that can be compared with regional, state, and national figures to identify how an area stands in relation to other areas. The mandate to the agencies is substantial. For example, the agencies are required to assemble and analyze data on (a) the health status (and its determinants) of the residents in their area; (b) the status of the health system; (c) the effects of the system on people's health; (d) the number, location, and utilization of health resources in the area; and (e) environmental and occupational exposure factors which affect health. More concentrated attention should be given to developing and testing less expensive data collection methods especially those which produce data linked to a defined population. The size of most of the agency's grants is not large enough to permit much primary data col- lection. More knowledge is needed about how often patient origin studies are indicated, under which circumstances can sampling be used to reduc)e costs but maintain quality, what are the most critical questions to ask of providers, patients, or residents, what are the best ways for communicating with and informing the public. Finally, evaluation of more systematic and rigorous methods used to make decisions, and assessment of the consequences of decisions and actions in planning are needed. Outstanding examples of fruitful collaboration between statis- tical centers, research centers, and universities in tackling planning problems should be prepared as case studies and disseminated. In time, the results of the acceleration of technoloy assessment at the Office of Technology Assessment (OTA) and the new National Center for Health Care Technology will undoubtedly help planners to know whether and under what conditions equipment and services should be encouraged in the community. The latter could be promulgated in the form of national guidelines, as discussed in Chapter III. In the meantime, planners need more guidance on what services might be useful, what are the high risk populations, and what service capacity is required for a defined population. When more information is available on the efficacy or effectiveness of services, translation of this into terms useful to health planners is most important. Indeed, the problems that planners have to address can and should help to structure the research agenda of the medical research community.

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- 53 - Problems that arise in planning help to provide specificity and possi- ble priorities for the potentially long list of topics on which more knowledge is required. Since they will be some of the prime users, the analysts working on the problems should include trained, experienced planners, and technical reviews should include technically knowledge- able planners. Further, as soon as there is sufficient knowledge which could help to inform and guide planning decisions, it should be shared with planning agencies. Summary In general, the committee believes that the entire process of guidelines development (from agenda development through evaluation and revisions) should be organized in consultation with the National Council on Health Planning and Development to ensure broad public participation and selection of a broadly representative set of perspec- tives and interests as appropriate to each problem. The committee believes that the National Council must become a significant resource as an adviser and as a public forum for improving the effectiveness of the planning process and the Council's role should be strengthened. The Council will be more effective with a small staff of its own selection and supervision. It is recognized that administrative agencies do not always welcome advisory bodies, especially with their own staff, but the Council is a logical place for certain activities (such as bringing together various interests and perspectives), is fully operational (a process that usually takes many months), and it has a firm statutory base. It is, over the long run, in the interest of the Department to have an effective council to help improve the quality of the planning enterprise. Sometimes there will be tension, but most often, the purposes of the planning program and the public interest will be served when the Council and the Department work cooperatively and sensitively with each other. In addition, it is apparent that the process used for guidelines development, and processes used in planning must be credible and publicly and professionally acceptable. Wherever possible, informa- tion and knowledge based on solid research must be used as the founda- tion for planning decisions. To ensure that the knowledge needed to strengthen the empirical underpinnings of planning is available, a more aggressive strategy for increasing the knowledge base and disseminating it to health planning agencies should be undertaken.

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