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Enhancing Evidence Generation by Linking Randomized Clinical Trials to Real-World Data: The INVESTED-Medicare Linkage Study.

Real-world evidence (RWE) derived from real-world data (RWD) can complement randomized controlled trials (RCTs), yet the validity of RWD relative to RCT data remains insufficiently characterized. We obtained post hoc consent and linked individual participant data from the US-based INVESTED trial (2016-2019) with Medicare fee-for-service claims (2012-2020) to validate demographic factors, baseline characteristics (using 183-, 365-, and 730-day lookback periods) and outcomes, and to assess post-trial events. Among 5260 trial participants, 126 were enrolled and eligible for linkage. Among 115 participants with demographic information available from Medicare enrollment files, agreement between RCT- and RWD-based demographic factors was high: only one major age discrepancy, 100% agreement for sex, and an overall agreement of 0.89 for race. Participants with Medicare claims data (n = 65) were older and more likely to be White compared with the overall RCT population. For the 365-day lookback period, baseline comorbidities showed high sensitivity (median 0.80) and specificity (0.89), as did medication use (sensitivity 1.00, specificity 0.88). Lengthening the lookback period to 730 days increased sensitivity but decreased specificity, whereas shortening to 183 days decreased sensitivity but increased specificity. Clinical outcomes showed high specificity (0.88-0.94) but low sensitivity (0.18-0.50). Among those with Medicare coverage beyond the trial end date (n = 45), 22% experienced cardiopulmonary, 18% cardiovascular, and 7% heart failure (HF) hospitalizations, highlighting the value of RWD for extending RCT evidence. Proactive planning of future RCT-RWD linkage initiatives can improve the efficiency of linkage studies, leading to more actionable results.

Journal Article↗

The effects of outpatient psychiatric utilization on the costs of providing third-party coverage.

Although previous studies conducted in prepaid group practice settings have indicated that the cost of providing coverage for outpatient psychotherapy may be offset by lower utilization of medical/surgical services among those who receive the benefit, no such studies have been conducted in a fee-for-service setting, nor have actual before and after claims costs been compared. This study establishes a methodology for using routinely collected Blue Cross claims data to show how the acquisition and use of a given benefit affects total utilization patterns and the overall costs of providing third-party coverage. The use and cost of outpatient psychiatric coverage in one subscriber group is the particular application given to this methodology in this report. Blue Cross claims records of 136 subjects who utilized outpatient psychiatric benefits over a 48-month period were analyzed. Results indicate that overall medical/surgical utilization is reduced for that subgroup who used the outpatient psychotherapy benefit and that average costs dropped by $9.41, from $16.47 per patient per month before outpatient psychotherapy to $7.06 after contact, with costs being adjusted to reflect parity with the base year. Factors other than psychiatric intervention which may have brought about this cost reduction as well as policy implications of these results are discussed.

Ambulatory Care↗

The Canadian health care system: a model for American to emulate?

The American health care system has the world's highest per capita costs and over 30 million citizens uninsured. The neighbouring Canadian system provides coverage for all basic medical and hospital services, at costs per capita that are about US$700 lower. Single-agency public funding allows tighter control of Canadian expenditures, and reduces administrative overheads. Hospitals are run as non-profit private corporations, funded primarily by a fixed annual allocation for operating costs. Most physicians are in private fee-for-service practice, but cannot charge more than the insured tariff negotiated between their provincial government and medical association. This approach, while attractive in its decentralization, tends to separate the funding and management of clinical services. Thus, hospital information systems lag a decade behind the USA, managed care initiatives are few, health maintenance organisations do not exist, and experimentation with alternative funding or delivery systems has been sporadic. Strengths of the system compared to the USA include: higher patient satisfaction, universal coverage, slightly better cost containment, higher hospital occupancy rates, and reduction in income-related rationing with more equitable distribution of services. Weaknesses in common with the United States are: cost escalation consistently outstripping the consumer price index with costs per capita second highest in the world, ever rising consumption of services per capita, inadequate manpower planning and physician maldistribution, poor regional co-ordination of services, inadequate quality assurance and provider frustration. Additional weaknesses include: an emerging funding crisis caused by the massive federal deficit, less innovation in management and delivery of care as compared to the USA, implicit rationing with long waiting lists for some services, and recurrent provider-government conflicts that have reduced goodwill among stakeholders. Thus, while the Canadian model has important advantages, it does not offer a panacea for American health care woes.

Canada↗

A needs-based methodology for allocating health care resources in Ontario, Canada: development and an application.

In an attempt to limit its health care expenditures, Ontario is, as one option, exploring the possibilities of a capitated system for service delivery payments as opposed to the present mixture of global budgets and fee-for-service. After reviewing the literatures on capitation (primarily American) and on resource allocation (primarily British), the paper sets out to establish a capitation rate, based on 'need' and not prior use, for a range of health services in the northern Ontarian community of Fort Frances-Rainy River. The difficulties and limitations of the needs-based approach are explored. The results reported show the setting of the local population characteristics against provincial average health care utilization data to generate expected use rates, which are then adjusted for need and other factors, particularly relative costs and sparsity. Finally these adjusted rates are applied to current provincial expenditures to derive a target share. This target is then expressed in relation to the planning population to derive the capitation rate.

Budgets↗

Anesthesia in Canada's health care system.

Much has been written about Canada's health care system as all countries wrestle with rising health costs. Few, however, have attempted to describe the influence of a system of health care on a nonprimary care specialty such as anesthesia. The purpose of this review is to describe the Canadian system, contrast it with that of the United States, and outline the impact that Canadian Medicare has had on anesthetic practice. A centrally controlled health care system is potentially blessed with the stability (and rigidity) inherent in any program perceived by the public as being their right and privilege. Changes are slow to occur, be they changes of new technology or alterations in the form of physician reimbursement. However, such stability means that control of health care costs can be achieved without intrusion into physician-patient relationships and professional freedom is preserved. Similarly, the acquisition of technological support for the practice of anesthesia, necessary to ensure a high standard of public safety, has not been perceived as a problem in Canada. Anesthesia in Canada is a physician-only specialty, and nurse-administered anesthesia does not exist. It is highly dependent on the functioning of the hospitals, for widespread development of freestanding health care institutions has not occurred. Compensation is on a fee-for-service basis, although alternative compensation for certain aspects of practice exists in some jurisdictions. In general, fees are indexed to the surgical procedure at hand, with time (duration) modifiers, as well as modifiers for specific techniques. Overhead is minimal, so although fees for a given procedure are lower than in the United States, the disparity in earned income is reduced. Unfortunately, recent initiatives to control physician use have limited the ability of the profession to compensate completely for this North American discrepancy in fees. Since health care in Canada is a provincial responsibility, there are eleven separate plans linked only by the guiding principles of the National Health Act of 1971. Each provincial medical association is responsible for negotiating the fee schedules with the provinces on behalf of its members. Since these associations must respond to the majority of their members, it has been the perception of specialty groups such as anesthesia that the emphasis of allocations in recent years has been on primary care fields. Anesthetists have therefore found themselves increasingly involved with the collective negotiation process as an unwanted necessity of practice.(ABSTRACT TRUNCATED AT 400 WORDS)

Anesthesia↗

Cost-financed mental health facility. I. Clinical care pattern in a labor union program.

Cost-financed mental health facilities create opportunities for new patterns of mental health service analogous to community mental health centers in some ways and to HMOs in others. This paper describes the first facility based on such financing. The concept of cost-financed mental health practice is introduced and defined as including a multidisciplinary team serving a defined population of enrollees through prepaid or prebudgeted financing. The financing may be capitation based or generated through an agreed-upon budget for predefined services. Ordinary fee-for-service insurance creates purchasing power but not care system. Cost financing can create service mechanisms. The paper describes the clinical system made possible through such financing. The direct patient service systems for the United Auto Workers at the Johns Hopkins Hospital funded through cost financing included an early case-finding program, intake and evaluations specially designed for blue-collar workers, a full range of continuous treatment modalities, and programs in chronic care and rehabilitation. Programs in prevention, consultation, and education were also included. Conern is described. The authors conclude that this clinical form has the potential to offer both the advantages of the community mental health center and of the private practice system.

Attitude to Health↗

Urgent care in the HMO: evolution of a system in Washington, D.C.

In 1961, Group Health Association, a large, non-hospital based, prepaid group practice in Washington, D.C. established an after-hours walk-in clinic on its premises for the care of medical problems requiring prompt attention. Within a year, this clinic's operation was extended to daytime hours for the use of the consumer-member at his own discretion. After 10 years, in the plan's main health center, the volume of adult visits to the acute care/walk-in center exceeded the number seen in the Department of Internal Medicine; most were of a routine rather than urgent nature. More visits to the acute care service were made during the day, when the full range of ambulatory services were available by appointment, than were made after hours. The choic of immediate first-come, first-served care over the conventional care-by-appointment by so many members was felt to have resulted in discontinuous suboptimal care, segregation of the membership along socioeconomic lines, as well as unnecessary and very costly duplications of service. The background of organizational behavior and community medical practices contribuing to this pattern of utilization are explored. Compared to traditional fee-for-service medicine, demands for outpatient services in the HMO tend to be greater. Acceptable alternatives to off-line channeling of patients with unexpected or acute conditions can be designed. In the general community today, utilization of medical services is strongly influenced by imbalances in available resources and by financial factors which are under no central control. In the HMO, all costs are prepaid and services are planned for a membership of known size. Even so, consumers' use of services in prepaid plans tends to follow the patterns seen in the community. More appropriate distribution of demands requires an active and ongoing system of patient education. A commitment by the HMO's providers and managers toward this goal is indispensable.

Ambulatory Care↗

Factor affecting the choice between two prepaid plans.

This study examines the factors affecting the choice between two comprehensive prepaid plans of medical care available to the staff of Stanford University. One is a Kaiser plan, offered since 1969. Under the other (Clinic plan for short), medical services are provided by a predominantly fee-for-service group practice and hospital services are covered by a standard Blue Cross hospital policy; the Clinic plan has been available since the 1950s. The Kaiser plan has only a token copayment for office and home visit while the Clinic plan has a 25 per cent coinsurance provision applying to all physician and outpatient ancillary services. It was found that the two major factors affecting choice were income and distance to the provider. The preference for the Kaiser plan increased as income decreased. Similarly, as distance from the Clinic increased and distance from a Kaiser facility decreased, the preference for the Kaiser plan increased. However, proximity to the provider was a more important factor for the higher-income Clinic plan subscribers. The data also show that the longer availability of the Clinic plan had a long-term effect on enrollment. A substantial proportion of long time Stanford employees who might have been expected to prefer the Kaiser plan stayed with the Clinic plan.

Attitude to Health↗

Use of physician services under two prepaid plans.

Use of physician services under two prepaid plans offered to Stanford University staff is analyzed and compared. One is a Kaiser plan; under the other (Clinic plan), physician and outpatient ancillary services are provided by a predominantly fee-for-service group practice and hospital services are covered by a Blue Cross policy. The two plans provide much the same benefits but, in addition to the difference in their organization, they differ in their financial provisions. While the Kaiser plan has only a token copayment for office and home visits, the Clinic plan has a 25 per cent coinsurance provision applying to all physician and outpatient ancillary services. Despite these differences, the mean number of physician visits per year is the same for the two groups after account is taken of differences in age composition, socioeconomic status, health status, attitudes toward seeking care, length of plan membership, family size and satisfaction with the plan. However, when adjustment is also made for differences in physician affiliation, the Kaiser rate becomes half a visit higher than the Clinic rate. This is because under both plans, members who have a specific plan physician as regular source of care use more services than those without one, and because only 42 per cent of Kaiser members compared with 87 per cent of Clinic members stated that they had a specific plan physician.

Age Factors↗

Assessing physicians' compliance with guidelines for Papanicolaou testing.

In this study, population-based data were used to examine the appropriateness of Papanicolaou (Pap) testing from the perspective of the women being tested and their physicians. The approach used is unique in its assessment of overtesting and undertesting in the primary care setting. From the data base of the province of Manitoba's universal health insurance plan, 4-year health histories (1981 to 1984) were constructed for each woman from a random sample of the population of women who, in 1982, were between the ages of 25 to 64 years (n = 22,287). At the last visit to a general practitioner, gynecologist, or general surgeon in 1984 (termed the current visit), the authors determined whether a Pap test was given for each woman. Using decision rules from a Canadian task force report on cervical screening and previous health history, the authors evaluated the appropriateness of screening by determining whether a Pap test was given and was needed, or whether a women who had not received a Pap test required one. Overall, 55.7% of women were tested appropriately. Of the 5352 women who received a Pap test at the current visit, 62.8% were overtested. Of the 16,935 women not tested at the current visit, 38.5% required screening (i.e. were undertested). Characteristics of a physician's practice that were significantly related to compliance with the guidelines included having a high proportion of patients visiting for obstetric or gynecologic reasons. Variables that were associated with negative compliance were 1) being a gynecologist; and 2) having a high proportion of patients who lived in inner city or rural areas. Because physicians are paid a fee for every Pap smear taken and the guidelines were well disseminated, these results should be reasonably representative of fee-for-service practice in North America, where preventive care is not subject to user charges. This study supports previous findings that a passive approach to dissemination of guidelines is insufficient to effect practice.

Adult↗

How the medical comorbidity of depressed patients differs across health care settings: results from the Medical Outcomes Study.

OBJECTIVE: Although depression is one of the most common problems of medical and psychiatric outpatients, it has not been clear whether the extent of medical comorbidity among depressed patients varies across major types of clinical settings in which depressed patients receive care--especially by type of treating clinician (general medical versus mental health specialty) or type of payment for services (prepaid versus fee-for-service). METHODS: The authors examined these issues using data on 1,152 adult outpatients with current depressive symptoms and a lifetime history of unipolar depressive disorder who received care in one of three health care delivery systems in three U.S. sites. RESULTS: Depressed patients had a similarly high prevalence (64.9%-71.0%) of any of eight common chronic medical conditions whether they were seen in the general medical or specialty mental health sector; however, those visiting medical clinicians had a significantly higher prevalence of the two most common chronic medical conditions, hypertension and arthritis. Among depressed patients with hypertension, those visiting the general medical sector were more likely to be taking antihypertensive medication than were those visiting the mental health specialty sector. Type of payment (prepaid versus fee-for-service) was unrelated to either prevalence or severity of comorbid medical conditions, suggesting that the typical depressed patient in all types of practices studied had medical comorbidity. CONCLUSIONS: These data suggest that clinicians in all health care settings must be prepared to encounter chronic medical conditions and complaints in the depressed patients who visit them.

Adult↗

Comparison of the quality of ambulatory care for fee-for-service and prepaid patients.

OBJECTIVE: To determine whether the quality of care for common ambulatory conditions is adversely affected when physicians are provided with incentives to limit the use of health services. DESIGN: Retrospective cohort study over a 2-year period. SETTING: Four group practices that cared for both fee-for-service patients and prepaid patients within a network model health maintenance organization (HMO). PATIENTS: Equal numbers of prepaid (HMO) and fee-for-service patients were selected by randomly choosing medical records from each group practice: 246 patients with chronic uncomplicated hypertension and 250 women without chronic diseases who received preventive care. MAIN OUTCOME MEASURES: Adequate hypertension control was defined as a mean blood pressure of less than 150/90. Adequate preventive care was defined as the provision of blood pressure screening, colon cancer screening, breast cancer screening, and cervical cancer screening within guidelines recommended by the 1989 U.S. Preventive Services Task Force. Resource use was measured by the annual number of visits and tests. MAIN RESULTS: The adjusted relative odds of HMO patients having controlled hypertension, compared with fee-for-service patients, were 1.82 (95% CI, 1.02 to 3.27). The relative risks of HMO patients receiving preventive care within established guidelines were 1.19 (CI, 0.93 to 1.51) for colon cancer screening, 1.78 (CI, 1.11 to 2.84) for annual breast examinations, 1.75 (CI, 1.08 to 2.84) for biannual mammography, and 1.35 (CI, 1.13 to 1.60) for Papanicolaou smears every 3 years. Prepaid patients had visit rates that were 18% to 22% higher than those of fee-for-service patients. CONCLUSIONS: In the type of network model HMO we studied, the quality and quantity of ambulatory care for HMO patients was equal to or better than that for fee-for-service patients. In this setting, the incentives for physicians to limit resource use may be offset by lack of disincentives for HMO patients to seek care.

Ambulatory Care↗

Cost-financed mental health facility. III. Economic issues and implications for future patterns of health care.

Data are presened concerning the economics of a cost-financed mental health facility and a lobor union insurance program. The total cost per insured enrolle for all mental health services did not exceed $5.41 per year. The cost per treated patient per year remained under $490. These data strongly support the feasibility of including mental health benefits in national health insurance. Costs are then compared between fee-for-service insurance and cost financing. Average costs per treated patient in the cost-financed facility were $302 over a 4-year period. Similar computations under fee-for services financing showed costs of $824. The difference reflects much greater use of hospitalizations in the fee-for-service system. These data and the data from the preceding two papers on the clinical and utilization partterns of cost-financed facilites suggest that these facilities are practical clinical forms. Implications for national health insurance, HMO legislation, and community mental health centers are explored.

Community Mental Health Services↗

A national long-term care program for the United States. A caring vision. The Working Group on Long-term Care Program Design, Physicians for a National Health Program.

The financing and delivery of long-term care (LTC) need substantial reform. Many cannot afford essential services; age restrictions often arbitrarily limit access for the nonelderly, although more than a third of those needing care are under 65 years old; Medicaid, the principal third-party payer for LTC, is biased toward nursing home care and discourages independent living; informal care provided by relatives and friends, the only assistance used by 70% of those needing LTC, is neither supported nor encouraged; and insurance coverage often excludes critically important services that fall outside narrow definitions of medically necessary care. We describe an LTC program designed as an integral component of the national health program advanced by Physicians for a National Health Program. Everyone would be covered for all medically and socially necessary services under a single public plan, federally mandated and funded but administered locally. An LTC payment board in each state would contract directly with providers through a network of local public agencies responsible for eligibility determination and care coordination. Nursing homes, home care agencies, and other institutional providers would be paid a global budget to cover all operating costs and would not bill on a per-patient basis. Alternatively, integrated provider organizations could receive a capitation fee to cover a broad range of LTC and acute care services. Individual practitioners could continue to be paid on a fee-for-service basis or could receive salaries from institutional providers. Support for innovation, training of LTC personnel, and monitoring of the quality of care would be greatly augmented. For-profit providers would be compensated for past investments and phased out. Our program would add between $18 billion and $23.5 billion annually to current spending on LTC. Polls indicate that a majority of Americans want such a program and are willing to pay earmarked taxes to support it.

Aged↗

Priority setting: a sensible approach to Medicaid policy?

The state of Oregon is attempting a controversial restructuring of its Medicaid program that promises to apply effectiveness research to set priorities for medical care. Will the application of such methods control costs and improve access to necessary care for the poor as intended? This paper argues that the answer may depend more on the system used to deliver care than on the priority list itself. Capitated delivery systems may provide the flexibility to be responsive to individual patient needs, while "rationing" in the fee-for-service system risks denying some necessary services to the poor.

Cost Control↗

Global budgeting and the control of hospital costs.

This paper attempts to answer the question: Would global budgeting control hospital costs in the United States? It reviews the development of health insurance and the growth of specialization in the United States, as well as the experience of Canada in attempting to control costs in a fee-for-service national medical care program. It concludes that the main causes of cost escalation in the U.S. are fee-for-service and overspecialization, and urges adoption of the NAPHP proposal for payment of physicians in a national program, i.e. global budgeting for the entire package of ambulatory and institutional services. It also presents a nine-point program for immediate State action to lower costs.

Canada↗