Developing a Medicare Quality The Institute of Medicine in medical practice to include ways of using this information in making decisions about the appropriateness of DRG payment rates. The commission is careful to point out, however, that developing standards regarding appropriate rates of surgery or procedures is not within its mandate. Furthermore, its quality-related studies have been designed to address specific policy-relevant questions. The commission does not have authority to support research to develop or evaluate improved quality assurance methodologies. Commission reports have noted the possible development of quality of The Omnibus Budget Reconcilation Act of 1986 requires HHS to arrange for a major study to design a strategy for reviewing and ensuring the quality of care for which payment can be made under Medicare. The legislation specifies eight items to be addressed in this study (without excluding others): 1. identifying the appropriate considerations which should be used in defining "quality of care"; 2. evaluating the relative roles of structure, process and outcome standards in assuring quality; 3. developing prototype criteria and standards for defining and measuring quality of care; 4. evaluating the adequacy and focus of the current methods for measuring, reviewing, and assuring quality of care; 5. evaluating the current research on methodologies for measuring quality of care and suggesting areas of research for further progress; 7Prospective Payment Assessment Commission. Report and Recommendations to the Secretary, U. S. Department of Health and Human Services, April 1, 1987 (Washington, D.C.) p. 50. Developing a Medicare Quality 6. evaluating the adequacy and range of methods available to correct or prevent identified problems with quality of care; 7. reviewing mechanisms available for promoting, coordinating, and supervising at the national level quality review and assurance activities; and 8. developing general criteria which may be used in establishing priorities in the allocation of funds and personnel in reviewing and assuring quality of care. The 1986 budget stipulates that the study plans should ensure that consumer and provider groups, peer review organizations, the Joint Commission on the Accreditation of Healthcare Organizations, hospitals, professional societies, and private purchasers are consulted. HHS was required to request an application for conducting the study from the National Academy of Sciences, acting through its appropriate unit. The Institute of Medicine, which operates under an Academy charter to examine policy matters pertaining to health, submitted an application to HCFA to conduct the study in July 1987. The application was accepted and the study is now underway. A final report is due to the Congress on January 1, 1990. Organizing Quality The information presented to this point illustrates that many relevant research and evaluation activities pertaining to quality assurance in the Medicare program are ongoing within and outside HHS. These activities are not, however, well coordinated, nor is there a systematic strategy for identifying future needs and initiating essential work to meet those needs. Congress acknowledged this by requiring in the 1986 budget act that the Secretary of HHS designate an office with responsibilities for coordinating studies relating to the quality of care for Medicare and Medicaid, including the assessment of the feasibility and cost of alternative studies, overseeing access to needed data, and maintaining a clearinghouse for public and private sector studies. ASPE has been assigned this responsibility. Coordinating quality of care studies and information, however, is only a first step in developing a quality assurance system. 8 ASPE began assembling an inventory of quality of care studies in February 1987. Developing a Medicare Quality A number of informal proposals for creating a research and evaluation program have been offered by health services research experts. These reflect a general consensus that there is no research base to guide physicians in making decisions about the efficacy of alternative approaches to providing care or for determining how to translate established clinical practice into federal policy for ensuring the appropriateness and quality of health care services. 10 These proposals also point to a number of issues and trade-offs that must be addressed in structuring and implementing such a program. One basic consideration is the need to coordinate closely with the clinical research and technology assessment communities, so that available information on the efficacy and effectiveness of medical procedures and treatments can be incorporated into quality review protocols. A related issue is identifying, validating, and updating information on optimal patterns of clinical practice and standards of care as it emerges from clinical research, so quality assurance criteria remain current. This requires a long-term commitment to developing a knowledge base, which will quickly lose its value if it is not continually updated. To monitor quality and evaluate the effects of quality assurance, access to and coordination with HHS data gathering and data analysis operations is necessary. Evaluators will need to use National Center for Health Statistics, NCHSR&HCTA, and Medicare data. They may also need direct access to these data, for example, to conduct studies assessing the usefulness of changing billing systems, screening algorithms, data verification procedures, and the like. Historically, it has been difficult for researchers outside HCFA to use Medicare data because of the size and complicated organization of the data systems. Privacy issues are also important considerations. The redesign of the Medicare data system may alleviate some of these problems, but the close cooperation of Medicare data processing divisions will be very important. The potential for overlapping and possibly conflicting objectives and responsibilities also needs to be considered. Quality of care objectives 9See, for example, R. H. Brook and K. N. Lohr, "Efficacy, Effectiveness and Quality: Boundary-crossing Research," Medical Care, May 1985, pp. 710-22.; J. P. Bunker, et el., “Evaluation of MedicalTechnology Strategies: Proposal for an Institute for Health-Care Evaluation," New England Journal of Medicine (March 18, 1982) pp. 687-92; and A. S. Relman, “Assessment of Medical Practices: A Simple Proposal," New England Journal of Medicine (July 17, 1980), pp. 153-4. 100. R. Bowen, "Shattuck Lecture-What is Quality of Care?," New England Journal of Medicine (June 18, 1987), p. 1579; D. M. Eddy, “Clinical Policies and the Quality of Clinical Practice,” New England Journal of Medicine (August 5, 1982), pp. 343-7. Developing a Medicare Quality may sometimes coincide with cost-containment objectives, as in the case of protecting beneficiaries from the cost and dangers of unnecessary or inappropriate treatment. But the possibility cannot be dismissed that containing costs could lead to withholding needed or appropriate forms of medical care. The tension between utilization review and quality review activities becomes particularly visible when review activities are evaluated on the basis of how much money is recovered from providers' billings for uncovered services.11 In making coverage decisions, the Medicare program needs to examine the effectiveness and other economic considerations (for example, possible effects on the volume or distribution of services) of a growing number of new technologies. But efforts that direct or focus scientific research to answer such policy questions have been perceived as threatening by the medical community. Making decisions about what technologies Medicare will or will not pay for has been perceived as government dictating how medicine ought to be practiced. Strong opposition from NIH as well as the professional medical and medical devices communities were, in the opinion of some experts, key factors in the 1981 dismantling of the National Center for Health Care Technology Assessment.12 Parallels could arise with respect to the development and introduction of methods for measuring quality of care in the Medicare program. The level of effort that would be involved in creating a structure for quality of care research and evaluation activities would be substantial, and it is not likely that these activities could be easily absorbed into any ongoing program. Adding these responsibilities to those of an established organization would, however, reduce start-up costs. The actual cost would depend on the scope of activities involved. As noted above, the Congress authorized about $6 million per year for a program to develop an outcomes assessment research program. Creating a broader system for generating, refining, and testing process-related criteria used 11This tension surfaced, for example, in testimony before the House Subcommittee on Health and the Environment, Committee on Energy and Commerce, on October 26, 1987, when a spokesman for the American Medical Association, William R. Felts, MD., stated that "While the new PRO contracts purport to place increased emphasis on quality issues, a widespread perception continues to exist, and is growing among physicians, that the PRO program emphasizes cost containment often at the expense of the health of Medicare beneficiaries." 12See, for example, D. Blumenthal, "Federal Policy Toward Health Care Technology: The Case of the National Center,” Milbank Memorial Fund Quarterly/Health and Society vol. 61, no. 4 (1983), and S. Perry, "Special Report: The Brief Life of the National Center for Health Care Technology,” New England Journal of Medicine (October 21, 1982). Developing a Medicare Quality in medical records review would add to program costs, as would initiating epidemiological studies such as those discussed in chapter 6. Prioritizing, coordinating, and integrating research findings to be useful for ongoing quality review activities are all functions not systematically performed at present by any agency. Stable funding for such an undertaking is essential if continuing progress is to be expected. Within HCFA, budgets for research in general have been fairly tight. ORD'S funding was cut from $28 million in fiscal year 1987 to $26.8 million in fiscal year 1988. Funding for NCHSR&HCTA quality of care activities has fluctuated considerably due to budgetary constraints and changing research priorities within HHS. Targeted funding for quality of care research-conducted within or outside HHS—would probably be allocated for a fixed time period, which might lead to problems of continuity if the program were not reauthorized. Thus, it would be critical that funding for an extensive quality of care effort be protected from additional budgetary pressures and potential diversion to research on other topics. There are trade-offs in structuring a formal program for quality assurance research and evaluation. Placing it wholly within HCFA could provide efficiencies, both in start-up costs and access to data and the decisionmaking process, but also could present significant problems in terms of generating the support and trust of the professional medical communities. Locating this program within the Public Health Service, as part of the health services research and technology assessment program already in place at NCHSR&HCTA would alleviate some problems of perceived conflict of interest (related to HCFA's need to control Medicare program costs). It might also provide greater opportunities for interaction with the research and professional communities. However, past fluctuations in the Center's budget raise questions about whether the Center can maintain the level of support needed to sustain a large-scale research and evaluation program. Creating a new entity within NIH is another option. Although it might provide an opportunity for a "fresh start," this option would clearly be expensive. More important, NIH has not historically devoted any substantial proportion of its resources to policy-related health services research; the tradition of basic research may conflict with the need to focus on payment, coverage, and quality issues that are inextricably linked to health care delivery and financing. |