Developing a Medicare Quality Care Technology were transferred to NCHSR&HCTA. Part of these responsibilities involves advising HCFA on coverage questions that arise in the Medicare program. This continues a tradition of relying on the Public Health Service to provide scientific and medical advice in the management of the Medicare and Medicaid programs. The coverage and technology assessment activities, which include collecting, analyzing and synthesizing medical and scientific evidence and professional opinion, require frequent contact between the Center's Office of Health Care Technology Assessment and NIH, the Food and Drug Administration, and the Council of Medical Specialties Societies, as well individual specialty societies and clinical researchers. In fiscal year 1987, NCHSR&HCTA had a total of 139 staff (71 professionals) and a total budget of about $36 million (including $16 million from the Public Health Service's evaluation funds to support the National Medical Expenditures Study). The budget for extramural research was about $10 million. The director of the Center is a career Senior Executive Service member appointed by the Secretary of HHS. New legislation to reauthorize NCHSR&HCTA was passed in 1987 (Public Law 100-177). In addition to increasing the Center's authorization ceiling, the legislation prohibits altering the administrative relationship between the Center and the Office of the Assistant Secretary of Health as in effect during fiscal year 1986. Following the NIH model, NCHSR&HCTA relies heavily on the peer review process and close interaction with medical professionals and technical experts; approximately 400 persons in disciplines including medicine, biomedical research, nursing, and a variety of social sciences have consultant agreements with the Center. Applications for research grant support are reviewed for technical and scientific merit by formally constituted peer review panels composed entirely of nonfederal researchers chosen for their substantive expertise. The review panels are chaired by full-time executive secretaries who are federal employees. Contract proposals are reviewed according to the usual government procurement process. The 1987 legislation (Public Law 100-177) requires that grants and contract applications exceeding $50,000 undergo peer review and that only those that have been recommended for approval by a peer review panel be funded. In addition to research proposals targeted to specific areas, such as medical practice variations and patient outcomes, NCHSR&HCTA encourages investigator-initiated projects through both the general grants solicitation and its small grants program. The latter provides support (up to Developing a Medicare Quality $50,000) for innovative approaches to addressing "significant problems in the delivery of health services," for exploratory and pilot projects and for work fostering the design and testing of new research methods and techniques. Between 1970 and 1975, the Center was actively involved in a utilization and quality review demonstration program that included the establishment of area-wide Experimental Medical Care Review Organizations (EMCROS). These organizations were the "prototypes" for the first generation of Medicare and Medicaid peer review organizations, the Professional Standards Review Organizations (PSROS). Despite sizable budget cuts (funding was reduced from $65.4 million in 1973 to under $30 million by 1979), the Center continued to focus on quality of care issues until the early 1980s. In several instances the Center supported the initial research in areas that were subsequently developed by others. For example, NCHSR supported early development of the computer stored ambulatory record system, which was further developed elsewhere as a management and quality monitoring tool (see appendix VI). The initial work on DRGS was supported by NCHSR and later picked up by HCFA. In 1979-1981, the Center directed 13 to 15 percent of its approximately $25 million research budget to quality of care studies. The Center has continued to support research in quality of care, but at reduced levels. Much of this work has focused on helping clinicians with decisionmaking under conditions of medical uncertainty, rather than on developing prescriptive quality standards. Extramural projects examining quality of care issues are listed in appendix VI. The Omnibus Budget Reconcilation Act of 1986 mandated that the Secretary of HHS establish a patient outcome assessment research program to be administered by the Center. To support this research, the law authorized the transfer to the Center of $4 million for fiscal year 1987 and $5 million in fiscal years 1988 and 1989 from the Medicare hospital insurance trust fund, and $2 million for fiscal year 1987 and $2.5 million for fiscal years 1988 and 1989 from the Medicare supplementary medical insurance trust fund. The research program is intended to "promote research with respect to patient outcomes of selected medical treatments and surgical procedures for the purpose of assessing their appropriateness, necessity and effectiveness," and requires that the program include (1) reorganization of part A claims data to facilitate research, (2) assessments of the appropriateness of admissions and discharges, (3) assessments of the extent Developing a Medicare Quality National Institutes of Health of professional uncertainty regarding efficacy [of treatments or procedures], (4) development of improved methods for measuring patient outcomes, and (5) evaluation of the effects on physicians' practice patterns of dissemination to physicians and peer review organizations of the findings of its research (listed in points 2 to 5 above). The law also specifies that, in cooperation with appropriate medical specialty groups, the Center shall disseminate the findings of this research as widely as possible, including to Medicare peer review organizations. As of August 1987, however, the trust fund allocations to conduct the The National Institutes of Health have very broad authority to undertake research related to basic biomedical and clinical questions. This work is deeply rooted in the traditions of peer review and consultation with experts. NIH has not, for the most part, focused on the types of issues that require the application of health services research methods or techniques. Although neither we nor HHS identified any studies ongoing at NIH that are directly addressing Medicare quality of care issues, there are clearly important links between NIH studies of clinical efficacy and quality of care. There are also close links between the methodologies being employed to develop consensus about the efficacy of medical procedures and quality assessment research. The methodology for generating explicit case review criteria developed as part of the Rand Corporation's 3 The National Cancer Institute is assessing the quality of life of cancer patients. None of the NIH projects we identified, however, directly addressed quality of care assessment in terms of the processes or outcomes of care in a manner that was immediately relevant to quality measurement in the Medicare program, and we have not included any of these projects in our discussion of quality of care research in appendix VI. Developing a Medicare Quality quality of care reviews, for example, is closely related to the consensus methods used at NIH for assessing treatment modalities and medical technologies.4 Within NIH, the Office for Medical Applications of Research has primary responsibility for translating the results of biomedical research into knowledge that can be used to improve the day-to-day practice of medicine. HHS Office of the Assistant The primary function of the Office of the Assistant Secretary for Planning and Evaluation is the coordination of planning and evaluation activities throughout HHS, particularly as they support the broader HHS policy agenda. Overall, ASPE has a total of about 70 professional staff working on policy, planning, or evaluation issues. About half work either in the health planning division or on long-term care or other health-related issues. In 1987, ASPE reported to us that approximately one full-time staff equivalent worked on quality of care issues. ASPE does coordinate quality of care-related work and was the central figure in responding to the legislative mandate to support outcomes research, as discussed above. However, ASPE's ability to influence the research agendas of particular HHS agencies is limited by the fact that other agencies have their own legislative authority and mandates. ASPE funds studies when information is needed for policymaking. The Aftercare study described in appendix VI represents a fairly large effort jointly planned and funded by ASPE and HCFA to address important questions about the need for and access to appropriate posthospital care for Medicare beneficiaries. It examines issues that were considered to be important by the executive branch (as well as Congress), but were inadequately addressed in HCFA research and evaluation activities at the time the study was initiated.5 ASPE is not, however, charged with any primary responsibilities for conducting research or evaluation in support of the Medicare program and does not have authority to support an ongoing program of health services research. 4A. Fink, et al., “Consensus Methods: Characteristics and Guidelines for Use," American Journal of Public Health, vol. 74, no. 9 (September 1984), pp. 979-983. 5U.S. General Accounting Office, Post-Hospital Care: Efforts to Evaluate Medicare Prospective Payment Effects Are Insufficient, GAO/PEMD-86-10 (Washington D. C.: June 2, 1986). Developing a Medicare Quality Other Congressionally The Prospective Payment Congressional concern about the quality of care provided to Medicare Congress has given a fairly wide quality of care evaluation mandate to the Prospective Payment Assessment Commission. Established under the Social Security Act Amendments of 1983 (Public Law 98-81), which introduced Medicare prospective payment for inpatient hospital services, the commission is composed of independent experts appointed by the Director of the Office of Technology Assessment, and reports its findings to the Congress and to HHS. Its original mandate focused on recommendations to adjust the classification and weighting factors used to establish DRG payments. This requires the commission to analyze changes in treatment patterns or methods of treatment, including the introduction of new technologies, and any other factor that could affect the average cost of providing care for specific diagnostic groups. Subsequently, the commission's mandate was broadened to evaluate the 6The commission has identified three groups, frail beneficiaries (based on age and clinical status), disabled Medicare beneficiaries, and Medicare beneficiaries also eligible for Medicaid, as particularly vulnerable groups. |