Michelle M. Mello

National Costs Of The Medical Liability System

Concerns about reducing the rate of growth of health expenditures have reignited interest in medical liability reforms and their potential to save money by reducing the practice of defensive medicine. It is not easy to estimate the costs of the medical liability system, however. This article identifies the various components of liability system costs, generates national estimates for each component, and discusses the level of evidence available to support the estimates. Overall annual medical liability system costs, including defensive medicine, are estimated to be

The Havasupai Indian Tribe Case — Lessons for Research Involving Stored Biologic Samples

55.6 billion in 2008 dollars, or 2.4 percent of total health care spending.

The Role of Medical Liability Reform in Federal Health Care Reform

On April 20, 2010, Arizona State University (ASU) agreed to pay

Relationship Between Malpractice Litigation Pressure and Rates of Cesarean Section and Vaginal Birth After Cesarean Section

700,000 to 41 members of the Havasupai Indian tribe to settle legal claims that university researchers improperly used tribe members’ blood samples in genetic research. The settlement closes a difficult chapter for both parties but leaves open a bedeviling question for genetic research: What constitutes adequate informed consent for biospecimens collected for research to be stored and used in future, possibly unrelated studies? The case illuminates the clashing values that have driven debate in this area and the importance of understanding the study population’s perspectives.

Implementing Resident Work Hour Limitations: Lessons from the New York State Experience

Should the health care reform package include reforms to the medical liability system, which is often blamed for contributing to rising health care costs? Michelle Mello and Dr. Troyen Brennan discuss the pros and cons.

Work hours reform: perceptions and desires of contemporary surgical residents

Background:Since the 1990s, nationwide rates of vaginal birth after cesarean section (VBAC) have decreased sharply and rates of cesarean section have increased sharply. Both trends are consistent with clinical behavior aimed at reducing obstetricians’ exposure to malpractice litigation. Objective:To estimate the effects of malpractice pressure on rates of VBAC and cesarean section. Research Design, Subjects, Measures:We used state-level longitudinal mixed-effects regression models to examine data from the Natality Detail File on births in the United States (1991–2003). Malpractice pressure was measured by liability insurance premiums and tort reforms. Outcome measures were rates of VBAC, cesarean section, and primary cesarean section. Results:Malpractice premiums were positively associated with rates of cesarean section (&bgr; = 0.15, P = 0.02) and primary cesarean section (&bgr; = 0.16, P = 0.009), and negatively associated with VBAC rates (&bgr; = −0.35, P = 0.01). These estimates imply that a

Preparing for Responsible Sharing of Clinical Trial Data

10,000 decrease in premiums for obstetrician-gynecologists would be associated with an increase of 0.35 percentage points (1.45%) in the VBAC rate and decreases of 0.15 and 0.16 percentage points (0.7% and 1.18%) in the rates of cesarean section and primary cesarean section, respectively; this would correspond to approximately 1600 more VBACs, 6000 fewer cesarean sections, and 3600 fewer primary cesarean sections nationwide in 2003. Two types of tort reform—caps on noneconomic damages and pretrial screening panels—were associated with lower rates of cesarean section and higher rates of VBAC. Conclusions:The liability environment influences choice of delivery method in obstetrics. The effects are not large, but reduced litigation pressure would likely lead to decreases in the total number cesarean sections and total delivery costs.

Understanding Biased Selection in Medicare HMOs

ObjectiveTo determine the impact of work hour limitations imposed by the 405 (Bell) Regulations as perceived by general surgery residents in New York State. Summary Background DataNew Accreditation Council for Graduate Medical Education (ACGME) requirements on resident duty hours are scheduled to undergo nationwide implementation in July 2003. State regulations stipulating similar resident work hour limitations have already been enacted in New York. MethodsA statewide survey of residents enrolled in general surgery residencies in New York was administered. ResultsMost respondents reported general compliance with 405 Regulations in their residency programs, a finding corroborated by reported work hours and call schedules. Whereas a majority of residents reported improved quality of life as a result of the work hour limitations, a substantial portion reported negative impacts on surgical training and quality and continuity of patient care. Negative perceptions of the impact of duty hour restrictions were more prevalent among senior residents and residents at academic medical centers than among junior residents and residents at community hospitals. ConclusionsImplementation of resident work hour limitations in general surgery residencies may have negative consequences for patient care and resident education. As surgical residency programs develop strategies for complying with ACGME requirements, these negative consequences must be addressed.

A New Era in Noninvasive Prenatal Testing

BACKGROUND New Accreditation Council for Graduate Medical Education (ACGME) requirements on resident duty hours are scheduled to undergo nationwide implementation in July 2003. General surgery residents, because of their long duty hours, are likely to be among those most affected by changes imposed to comply with the ACGME requirements. There are few contemporary data on their attitudes toward work hours reform. STUDY DESIGN The study entailed a region-wide survey of residents enrolled in general surgery residencies in New England to characterize the perceptions and desires of surgical residents on the issue of work hours reform. RESULTS Respondents reported working a mean of 105 +/- 0.7 hours per week, considerably more than the 80-hour limit stipulated by the ACGME. Of the respondents, 81% reported that sleep deprivation had negatively affected their work. A strong majority of respondents believe that work hours reform would improve their quality of life but less than one half expect it to have a positive impact on patient care. A greater percentage of senior residents than junior residents (p < 0.05) have negative perceptions of work hour limitations, particularly with respect to consequences for patient care. Other findings suggest that residents who have actually experienced work hour restrictions are less positive about such restrictions than these residents who had not yet experienced them. CONCLUSIONS Changes imposed by residency programs to comply with work hour requirements might have detrimental effects on senior residents and patient care. The impact of such changes should be carefully monitored as the ACGME requirements are implemented.

HPV Vaccination Mandates - Lawmaking amid Political and Scientific Controversy

The authors review the potential benefits and unintended consequences of the broad sharing of participant-level data from clinical trials. Several options for governance structures that could be implemented to provide expanded access to clinical trial data are discussed.