Corporate compliance programs: risk management for the future

The Department of Justice has estimated that the government loses $100 billion annually in health care fraud. Consequently, the government's health care fraud enforcement activities with respect to all health care providers and suppliers continue to grow. Last year alone, the government collected more than $8 billion in settlements, fines, and penalties involving health care fraud. Recent settlements with the government have begun to include corporate compliance programs that require continued government oversight of the health care organization as an essential part of the settlement. The first section of this article describes the legal significance of health care companies' having corporate compliance programs. The second section provides a sample list of topics that should be included in any corporate compliance program. Finally, we describe various issues related to the creation and implementation of corporate compliance programs.     

Detection of interactions in experiments on large numbers of factors

One of the main advantages of factorial experiments is the information that they can offer on interactions. When there are many factors to be studied, some or all of this information is often sacrificed to keep the size of an experiment economically feasible. Two strategies for group screening are presented for a large number of factors, over two stages of experimentation, with particular emphasis on the detection of interactions. One approach estimates only main effects at the first stage (classical group screening), whereas the other new method (interaction group screening) estimates both main effects and key two-factor interactions at the first stage. Three criteria are used to guide the choice of screening technique, and also the size of the groups of factors for study in the first-stage experiment. The criteria seek to minimize the expected total number of observations in the experiment, the probability that the size of the experiment exceeds a prespecified target and the proportion of active individual factorial effects which are not detected. To implement these criteria, results are derived on the relationship between the grouped and individual factorial effects, and the probability distributions of the numbers of grouped factors whose main effects or interactions are declared active at the first stage. Examples are used to illustrate the methodology, and some issues and open questions for the practical implementation of the results are discussed.     

ALL-BIAS DESIGNS FOR POLYNOMIAL SPLINE REGRESSION MODELS

Polynomial spline regression models of low degree have proved useful in modeling responses from designed experiments in science and engineering when simple polynomial models are inadequate. Where there is uncertainty in the number and location of the knots, or breakpoints, of the spline, then designs that minimize the systematic errors resulting from model misspecification may be appropriate. This paper gives a method for constructing such all‐bias designs for a single variable spline when the distinct knots in the assumed and true models come from some specified set. A class of designs is defined in terms of the inter‐knot intervals and sufficient conditions are obtained for a design within this class to be all‐bias under linear, quadratic and cubic spline models. An example of the construction of all‐bias designs is given.     

Individualism—Collectivism and the Vocational Behavior of Majority Culture College Students

This study examined whether variation on the cultural constructs of individualism–collectivism in a sample of predominantly majority culture (i.e., Anglo American) college students accounts for significant amounts of variance in their occupational choices, career plans, and work values. Participants (135 women, 55 men) responded to the “I am” sentence completion method (Kuhn & McPartland, 1954), the Occupational Plans Questionnaire (Hershenson, 1967), and the Work Values Inventory (Super, 1970). Overall, results indicated no significant relationships between level of collectivism and the career-related variables.     

Concentrating on the Worst Performers

There is a substantial variation in the quality of operators of nuclear power plants, and it is therefore widely believed that regulatory attention is best directed at the worst performers. What is not immediately apparent is a strategy for the optimal allocation of regulatory resources. We study a simple model for this problem, and find that, under reasonable assumptions, the optimal allocation does indeed behave as expected. The proper degree of unbalance, however, depends upon the effectiveness of regulation itself and on the variation among performers, ineffective regulation leading to more concentration on the bottom of the list and a net reduction in attention to the top. Not surprisingly, the optimal strategy is to press toward parity in risk, even if it means allowing some plants to become riskier. This strategy leads to a minimized net probability of accident anywhere.     

A Health Risk Benchmark for the Neurologic Effects of Styrene: Comparison with NOAEL/LOAEL Approach

Benchmark dose (BMD) analysis was used to estimate an inhalation benchmark concentration for styrene neurotoxicity. Quantal data on neuropsychologic test results from styrene-exposed workers [Mutti et al. (1984). American Journal of Industrial Medicine, 5, 275-286] were used to quantify neurotoxicity, defined as the percent of tested workers who responded abnormally to > or = 1, > or = 2, or > or = 3 out of a battery of eight tests. Exposure was based on previously published results on mean urinary mandelic- and phenylglyoxylic acid levels in the workers, converted to air styrene levels (15, 44, 74, or 115 ppm). Nonstyrene-exposed workers from the same region served as a control group. Maximum-likelihood estimates (MLEs) and BMDs at 5 and 10% response levels of the exposed population were obtained from log-normal analysis of the quantal data. The highest MLE was 9 ppm (BMD = 4 ppm) styrene and represents abnormal responses to > or = 3 tests by 10% of the exposed population. The most health-protective MLE was 2 ppm styrene (BMD = 0.3 ppm) and represents abnormal responses to > or = 1 test by 5% of the exposed population. A no observed adverse effect level/lowest observed adverse effect level (NOAEL/LOAEL) analysis of the same quantal data showed workers in all styrene exposure groups responded abnormally to > or = 1, > or = 2, or > or = 3 tests, compared to controls, and the LOAEL was 15 ppm. A comparison of the BMD and NOAEL/LOAEL analyses suggests that at air styrene levels below the LOAEL, a segment of the worker population may be adversely affected. The benchmark approach will be useful for styrene noncancer risk assessment purposes by providing a more accurate estimate of potential risk that should, in turn, help to reduce the uncertainty that is a common problem in setting exposure levels.     

Professional development of statisticians in the pharmaceutical sector: evolution over the past decade and into the future

The adoption of The International Conference on Harmonization Tripartite Guideline: Statistical Principles for Clinical Trials (ICH-E9) has provided a foundation for the application of statistical principles in clinical research and raised awareness of the value of a statistical contribution to the wider pharmaceutical R&D process. In addition, over the past decade globalization of the pharmaceutical R&D process and the measures taken to address reduced productivity and spiralling costs have impacted on the roles and career opportunities for statisticians working in the pharmaceutical sector. This has enhanced the need for continuing professional development to equip statisticians with the skills to fully contribute to creating innovative solutions. In the future, key areas of focus are the establishment of professional standards for statistical work and increasing the collaboration between statisticians working in industry, regulatory agencies and academia. In addition, the diversity of roles and potential career paths for statisticians embarking on a career in the pharmaceutical sector emphasizes the importance of mentoring and coaching. For the more experienced statisticians, there are unprecedented opportunities to lead and innovate.     

Design selection criteria for discrimination/estimation for nested models and a binomial response

The aim of an experiment is often to enable discrimination between competing forms for a response model. We investigate the selection of a continuous design for a non-sequential strategy when there are two competing generalized linear models for a binomial response, with a common link function and the linear predictor of one model nested within that of the other. A new criterion, _TE$T_E$-optimality, is defined, based on the difference in the deviances from the two models, and comparisons are made with T$T$-, _Ds$D_s$- and D$D$-optimality. Issues are raised through the study of two examples in which designs are assessed using simulation studies of the power to reject the null hypothesis of the smaller model being correct, when the data are generated from the larger model. Parameter estimation for discrimination designs is also discussed and a simple method is investigated of combining designs to form a hybrid design in order to achieve both model discrimination and estimation. This method has a computational advantage over the use of a compound criterion and the similar performance of the designs obtained from the two approaches is illustrated in an example.     

"BY PUBLIC OPINION I MEAN"--

"Where all people talk on the same subject, they should be agreedabout the vocabulary with which they discuss it: or, at anyrate, they should be aware that they are not agreed."