Medicare's requirement for research participation as a condition of coverage: is it ethical?
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Biomedical Research↗
Biomedical subjects
Steven D Pearson
Publications and source records attributed to Steven D Pearson.
A trial of disclosing physicians' financial incentives to patients.
BACKGROUND: Concern regarding financial conflict of interest for physicians has led to calls for disclosure of financial incentives to patients. However, limited data on the outcomes of disclosure exist to guide policy. METHODS: This randomized trial was conducted among 8000 adult patients at 2 multispecialty group practices based in the Boston, Mass, and Los Angeles, Calif, areas. Intervention patients were mailed a compensation disclosure letter written by the chief medical officer of their physician group, and all patients were surveyed approximately 3 months later. RESULTS: Disclosure patients were significantly more able to identify correctly the compensation model of their primary care physician, in Boston (adjusted odds ratio, 2.30; 95% confidence interval, 1.92-2.75) and in Los Angeles (adjusted odds ratio, 1.37; 95% confidence interval, 1.03-1.82). Disclosure patients also had more confidence in their ability to judge the possible influence of incentives on their health care: in Boston, 32.5% vs 17.8% (P<.001); and in Los Angeles, 31.8% vs 26.4% (P = .20). The disclosure intervention did not change trust in primary care physicians overall. However, of patients who remembered receiving the disclosure, 21.4% in Boston and 24.4% in Los Angeles responded that the disclosure had increased trust either greatly or somewhat, while in both cities less than 5% of patients responded that the information decreased trust. Patients' loyalty to their physician group was higher among disclosure patients in Boston (73.4% vs 70.2%; P = .03) and Los Angeles (74.1% vs 66.9%; P = .08). CONCLUSIONS: Among diverse patient populations, a single mailed disclosure letter from physician groups was associated with improved knowledge of physicians' compensation models. Patients' trust in their physicians was unharmed, and their loyalty to their physician group was strengthened. For physician groups with similar compensation programs, disclosure to patients should be considered an effective method to enhance the patient-physician relationship.
Boston↗
Quality, innovation, and value for money: NICE and the British National Health Service.
The National Institute for Health and Clinical Excellence (NICE) was established as a part of the British National Health Service in 1999 to set standards for the adoption of new health care technologies and the management of specific conditions. In doing so it was required explicitly to take into account both clinical effectiveness and cost-effectiveness. This article describes how NICE has responded to the challenge and considers whether its experience of balancing quality, innovation, and value for money holds policy lessons for the United States.
Academies and Institutes↗
Use of an electronic medical record to profile the continuity clinic experiences of primary care residents.
PURPOSE: To assess the variation in outpatient educational experiences among residents in a primary care internal medicine residency program. METHOD: The authors conducted an observational study within a primary care residency program in Boston, Massachusetts, involving eight primary care residents in 2001-02. A data management system was created that uses information on clinical experiences collected from an electronic medical record (EMR). The EMR records clinical information from patient encounters in resident continuity clinics, including patient demographics and diagnostic codes entered by the residents. Primary and secondary diagnosis from the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) were assigned to clinical categories (e.g., cardiology, orthopedics) and these assignments were programmed into a spreadsheet that could take the diagnostic data directly from the EMR downloads and produce reports using only the primary diagnosis, using all diagnoses, or using the assigned clinical categories. RESULTS: The EMR download showed 2,468 patient encounters for the eight residents in the primary care program. The most common clinical encounters were for health maintenance (17%), cardiology (14%), and women's health (10%). In contrast, rheumatology (0.5%) and hematology/oncology (2%) encounters were less frequent. There were substantial variations among residents in terms of distribution of encounter diagnoses, and the age and gender of patients seen in continuity clinic. CONCLUSIONS: Abstracting data from an EMR represents a feasible method for assessing programmatic and individual learner experiences in the outpatient setting. Such information may help target curricular adjustments to ensure an appropriate diversity and depth of clinical training.
Adult↗
Physician-citizens--public roles and professional obligations.
Although leaders and other commentators have called for the medical profession's greater engagement in improving systems of care and population health, neither medical education nor the practice environment has fostered such engagement. Missing have been a clear definition of physicians' public roles, reasonable limits to what can be expected, and familiarity with tasks that are compatible with busy medical practices. We address these issues by proposing a definition and a conceptual model of public roles that require evidence of disease causation and are guided by the feasibility and efficacy of physician involvement. We then frame a public agenda for individual physicians and physician organizations that focuses on advocacy and community participation. By doing so, we aim to stimulate dialogue about the appropriateness of such roles and promote physician engagement with pressing health issues in the public arena.
Community Participation↗
Patient attitudes toward continuity of care.
BACKGROUND: Concern has been raised about managed care's effects on continuity of patient care, but little is known about how much value patients place on continuity. METHODS: We surveyed 2500 adult patients of a large New England health maintenance organization about their attitudes toward continuity and their willingness to spend additional time or money to maintain continuity with their primary care physician (PCP). RESULTS: Among the 1171 (46.8%) of patients responding, 460 (39.6%) of 1162 patients had had more than one PCP in the previous 5 years. Nearly all patients (1068 [91.5%] of 1167) rated continuity as very important or important; only 26 (2.2%) rated continuity as unimportant or very unimportant. However, only 256 (22.2%) of 1152 patients were willing to drive more than 60 minutes to maintain continuity with their PCP, and only 200 (18.2%) of 1096 would be willing to spend an additional $20 to $40 per month to maintain it. In multivariable analyses, patients were more willing to drive if they were nonwhite (odds ratio [OR], 2.3; 95% confidence interval [CI], 1.4-3.6), older than 50 years (OR, 1.7; 95% CI, 1.2-2.4), or had less than a college education (OR, 1.6; 95% CI, 1.2-2.2). Patients who had been forced to change PCPs when their physician moved away were less willing to drive (OR, 0.5; 95% CI, 0.3-0.8) or spend more money (OR, 0.7; 95% CI, 0.5-1.0) to maintain continuity. CONCLUSIONS: Most patients in this sample indicated that continuity of care was important to them, but reported being unwilling to spend much additional personal time or money to maintain continuity with their current PCP. Nevertheless, an important subset of older and more vulnerable patients reported being more willing to pay to maintain continuity.
Age Factors↗
Patient reports of coverage denial: association with ratings of health plan quality and trust in physician.
OBJECTIVE: To evaluate whether HMO patients' reports of denial of coverage were associated with their ratings of health plan quality and trust in their physician. STUDY DESIGN: Cross-sectional survey. PATIENTS AND METHODS: Within a mixed-model HMO, we surveyed 2000 adult patients who had seen a clinician at least once during the previous year. RESULTS: Of the 2000 patients, 921 (46%) responded. Denial of coverage within the previous 12 months was reported by 64 (7%) patients. Among the denials, 42% were for specialist referral, 32% were for tests or treatments, 18% were for a certain length of hospital stay, and 8% were for a hospital admission. Patients scoring in the lowest quartile on physical functioning were more than twice as likely as other patients to report denial of coverage (12.2% vs 5.1%, P = .001). In multivariable analyses, poor physical functioning remained the only significant independent variable associated with reporting denial of coverage (odds ratio = 3.0; 95% confidence interval, 2.4, 3.6). More than half (53%) of patients reporting denial of coverage said that they had considered leaving the health plan because of concerns about quality of care. These patients also were less likely to express high trust in their primary care physician (64% vs 78%, P < .001). CONCLUSIONS: Patients with poor physical functioning were more likely to report denial of coverage. Perceived denial of coverage was associated with lower ratings of health plan quality and with significantly less trust in patients' own primary care physicians.
Adult↗
On Track: a database for evaluating the outpatient clinical experience of internal medicine residency training.
Residents in internal medicine training programs spend an increasing amount of time in the outpatient setting, creating the potential for substantial variability in educational experiences among residents. We developed a data management system (On Track) that combines information on clinical experiences collected from an electronic medical record (EMR) and handheld personal data assistants (PDA). This information is translated into easily interpretable graphics and reports that provide insight into the overall residency curriculum as well as the experiences of individual residents.
Ambulatory Care↗
Effects of removing gatekeeping on specialist utilization by children in a health maintenance organization.
BACKGROUND: The "gatekeeping" model of access to specialty care has been an essential managed care tool, intended to control costs of care and promote coordination between generalists and specialists. OBJECTIVE: To investigate the impact of removing gatekeeping on specialist utilization. METHODS: A capitated multispecialty group discontinued a gatekeeping system on April 1, 1998. We assessed the overall number and distribution of patient visits to primary care physicians and specialists and initial patient visits to specialists before and after the removal of gatekeeping. We performed focused analyses for specific specialties, children with chronic conditions, and children with specific diagnoses. RESULTS: Elimination of gatekeeping was not associated with changes in the mean number of visits to specialists (0.28 visits per 6 months before and after gatekeeping was removed) or the percentage of all child visits to specialists (11.6% vs 12.1%; 95% confidence interval, 11.3%-11.9% vs 11.8%-12.4%). The proportion of all specialist visits that were initial consultations increased after gatekeeping was removed, from 30.6% (95% CI, 29.4%-31.8%) to 34.8% (95% CI, 33.6%-36.1%). Visits to any specialist by children with chronic conditions increased from 18.6% (95% CI, 17.7%-19.1%) to 19.8% (95% CI, 19.0%-20.7%). New patient visits to specialists by children with chronic conditions as a proportion of all specialist visits increased from 28.1% (95% CI, 25.9%-30.2%) to 32.3% (95% CI, 30.1%-34.5%). CONCLUSIONS: Replacing a gatekeeping system with open access to all specialty physicians in a managed care organization resulted in minimal changes on the utilization of specialists. Visits to specialists by children with chronic conditions increased after the removal of gatekeeping.
Allergy and Immunology↗
Talking about money: how primary care physicians respond to a patient's question about financial incentives.
Patients sometimes express concern about the influence of "perverse" financial incentives on their care. We recruited a convenience sample of 101 primary care physicians and obtained information on their compensation. Then we audiotaped them as they role-played a response to a videotaped mock patient who asked them how they were paid and how their method of compensation affected clinical decisions. Overall, 36% of the physicians did not give enough information in their role-play response to allow an independent determination of how they were paid. Adopting a broad spectrum of attitudes and approaches, nearly every physician avoided discussing the role of incentives and stressed instead that he or she could be trusted under any circumstance.
Adult↗
Caring for patients within a budget: physicians' tales from the front lines of managed care.
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Adult↗
Leaving the practice: effects of primary care physician departure on patient care.
BACKGROUND: Recent changes in the organization of health care services, coupled with rising rates of primary care physician (PCP) turnover, pose threats to the maintenance of a continuous patient-physician relationship. Little is known, however, about how PCP departure may affect patients' quality of health care. METHODS: Participants were adult patients whose PCPs left a large, multispecialty group practice from July 1, 1994, to June 30, 1996 (n = 3931), and adult patients of a set of matched PCPs who remained in the practice at least 2 years beyond the index PCPs departure dates (n = 8009). We compared the following measures of quality of care: adherence to recommended screening guidelines, adequacy of blood pressure and glycemic control in patients with hypertension and/or diabetes mellitus, and use of urgent care and emergency department services. RESULTS: Among the women who received a mammogram in the 2-year baseline period, a higher proportion of those whose PCP departed did not continue to receive mammograms, although the difference did not reach statistical significance (8.4% vs 5.1%; P =.08). For patients who had screening Papanicolaou smears or fecal occult blood testing during the baseline period, there was no significant difference between study and control groups in the likelihood that patients discontinued screening during the follow-up period (10.9% vs 10.7%; P =.93 and 28.8% vs 25.3%; P =.93, respectively). Similarly, diabetic patients of departed PCPs did not have higher risk of worsening glycemic control (31.7% vs 28.9%; P =.46); and hypertensive patients of departed PCPs actually had lower risks of worsening blood pressure control (16.5% vs 22.5%; P =.02). There was no difference in use of urgent care or emergency department services between patient groups. CONCLUSIONS: In this multispecialty group practice, patients of departed PCPs experienced little or no decrease in quality of care measures for routine screening, management of chronic disease, and use of urgent care and emergency department services.
Continuity of Patient Care↗
Coverage options for promising technologies: Medicare's 'coverage with evidence development'.
In April 2005 the Centers for Medicare and Medicaid Services (CMS) posted on its Web site a draft guidance document describing a new approach to coverage policy called "coverage with evidence development" (CED). CED offered an option for coverage of promising drugs, biologics, devices, diagnostics, and procedures that would not otherwise meet Medicare's evidentiary standards for being "reasonable and necessary." An updated guidance was posted 12 July 2006, clarifying several key statutory, regulatory, and operational issues. This paper traces the history of this policy approach, explains the rationale behind the policy, and describes the major challenges that will need to be addressed for CED to become an important advance in evidence-based coverage decision making.
Biomedical Technology↗