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Executive Summary

The National Institute on Aging is taking on a growing role in the debate over how to implement a federal drug utilization review program for the elderly. Drug utilization review (DUR) is a key component of the Medicare Catastropic Care outpatient drug benefit as designed by Congress. A just-released report from the HHS Inspector General's office proposes that the Health Care Financing Administration work with NIA to develop DUR demonstration projects. "It is recommended that HCFA collaborate with the National Institute of Aging . . . in designing and monitoring the demonstration program," the report states. The draft was forwarded to HCFA Administrator William Roper for comment on Jan. 6 and formally released at a Washington press conference Feb. 15. The National Institute on Aging could also "take an active role" in the establishment of a blue ribbon panel for a national drug utilization review program, the report recommends. The blue ribbon panel would be responsible for three tasks: 1) developing drug utilization review criteria that will serve as a national guideline for DUR programs carried out throughout the country; 2) making specific recommendations regarding expansion of curricula in U.S. medical schools in the areas of pharmacology and geriatrics; and 3) making additional policy recommendations, as needed, in regard to improving drug utilization among the elderly." One of the research groups within the National Institute of Health, NIA "has long been concerned with drug therapy for older adults and with the issue of adequate training for physicians in geriatric pharmacology and can serve as a valuable resource in this process," the report notes. NIA has already been involved in preliminary discussions with HCFA on its possible role in implementing a DUR Program. The institute plans to discuss DUR issues with HCFA and others at an upcoming Institute of Medicine forum on drug development, tentatively scheduled for May. NIA Director of Geriatric Research and Training Programs Stanley Slater said that NIA expects the meeting will address what is "reasonable" in terms of HCFA intervening -- through drug utilization review -- in the process of getting drugs to the elderly, and what can be expected from HCFA's DUR data base. In addition to representatives from NIA and HCFA, the meeting will also include congressional staff and academics. Slater, who directs NIA's activities in geriatric pharmacology, is the institute's representative on a planning committee for the meeting. One issue of concern to NIA is maintaining patient confidentiality in the DUR system. "For certain drugs, you automatically know from the drug what the patient's diagnosis is, and who should have access to that ]information[ is one question," Slater observed. Another question has to do with therapeutic review. Slater maintained the HCFA data base is likely to have "severe limitations" because it may include only a single diagnosis that "may not be very good." The concern, he said, is that HCFA may try to intervene in "ways that are unwise, based on data that is poor." The inspector general's report takes a strong advocacy position for HCFA involvement, through DUR, in drugs to the elderly. The report asserts that there is a "widespread problem of mismedication among the older adult population" because of "weaknesses" in the drug therapy delivery system. "In that context," the report continues, "the congressional mandate to establish a Medicare DUR program presents a significant opportunity to design and operate a multi-level system to improve quality of care, avoid unnecessary Medicare and personal expenditures, and maintain program integrity." The proposed demonstration projects would test drug utilization review "interventions" and evaluate the relative benefits compared to costs of each intervention. The report recommends that HCFA and the Public Health Service "make funding available" for the projects. Primary among interventions to be evaluated, the report says, are educational practices to address mismanaged drug regimens in the elderly. In a discussion of funding for the demonstration projects, the report notes that "according to congressional staff interviewed in the course of this study, the primary reason behind the decision to begin collecting revenues through the supplemental premium prior to program start-up was to provide funding for demonstration projects." The inspector general does not estimate the cost of the demonstration projects. However, Kusserow maintained at the Feb. 15 press conference that "in the long run, if you're providing the elderly with bad advice or with drugs that are not as effective as they think they are, it would be far more costly than any demonstration projects or any efforts that we may make to correct the system. So I will tell you that it would be a cost-saver as well as a life-saver." The report also suggests that the drug utilization review mechanism extend beyond outpatient prescription drugs covered by Medicare in order to gather data on OTCs. The document states that DUR interventions could be focused on "quality issues related to use of OTC as well as prescription drugs." The report suggests: "This appears to be one of the areas with the greatest need for additional research." The inspector general pointed out that "the elderly consume OTC drugs at an even more disproportionate rate than prescription drugs, and, with more potent drugs being reclassified for OTC use, this aspect of drug consumption behavior has serious implications for the broader mismedication problem." The inspector general suggested that FDA's geriatric clinical testing guidelines be expedited to "ensure adequate testing of drugs on elderly populations." For the past five years, the report notes, FDA has been in the process of developing and promulgating guidelines that would require inclusion of the elderly in premarketing clinical tests. The agency released draft guidelines in 1986 but as yet, no final version. Recommendations for the demonstration projects, blue ribbon panel, and the FDA guidelines are three "immediate actions" recommended in the report. In terms of the broader agenda, the inspector general states that "HCFA should develop a Medicare DUR program that incorporates review and education functions at three levels of the drug therapy process: pharamcist/dispensing level; fiscal intermediary/claims processing level; and post payment level." Asked at the press conference whether "mismedication" problems identified among the elderly were serious enough to support a delay in implementation of the drug benefit in the Catastrophic Care Act, Kusserow said: "]The law has[ a phase-in that goes over the next several years. So, we have adequate lead time to make corrective action before the payments actually go into effect. We, for once, are ahead of the power curve." Medicare coverage of home I.V. drugs and immunosuppressives begins in 1990. On Jan. 1, 1991, all other outpatient prescription drugs will be covered. Establishment of the DUR program is mandated by the Medicare Catastrophic Care Act.(ITEM 200)#050928M001J59307# #970804M001XFCWP5# (ITEM 201)(COPYRIGHT) 1989 F-D-C Reports, Inc., The Pink Sheet, February 20, 1989

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