Predictors of loss due to pharmaceutical fraud: evidence from the U.S.

BACKGROUND: Globally and in the U.S. in particular, pharmaceutical fraud account for a large number out of all crimes in health care, which result into severe costs to the society. The Academy of Managed Care Pharmacists (Fraud, waste, and abuse in prescription drug benefits. 2019. Posted May 20. https://www.amcp.org/policy-advocacy/policy-advocacy-focus-areas/where-we-stand-position-statements/fraud-waste-and-abuse-prescription-drug-benefits .) estimate that pharmacy fraud is 1% of costs, therefore estimating that pharmacy fraud costs at $3.5 billion, given that pharmacy costs are $358 billion (Statista. Prescription drug expenditure in the United States from 1960 to 2020. 2021. https://www.statista.com/statistics/184914/prescription-drug-expenditures-in-the-us-since-1960/ ). AIM: This exploratory study aims to demonstrate a fraudster's profile as well as to estimate average consequences in terms of costs and identify the loss predictors' hierarchy in the pharmaceutical industry in the U.S. MATERIALS AND METHODS: Data from the Corporate Prosecution Registry and mixed-effects models are utilized for this purpose. The dataset covers years 2001-2020 and 75 cases, falling into one of the following broad sub-categories: misbranding, counterfeit, off-label use of drugs/deceptive marketing; violation of the Food, Drug and Cosmetic Act. RESULTS: The main factors positively associated with loss due to pharmaceutical fraud are: (i) duration of , and (ii) the scheme and scheme being executed at a U.S. public company. Surprisingly, presence of collusion negatively and significantly effects the cost. Potential factors include: (a) principal perpetrator being a white American and/or male, and (b) number of employees at individual and organizational level respectively. CONCLUSION: This study empirically justifies considering loss, due to pharmaceutical fraud, from a multi-level perspective. Identified profiles of a typical fraudster helped to elaborate on specific practical recommendations aimed at pharmaceutical fraud prevention in the U.S.

Defendants with intellectual disability and autism spectrum conditions: the perspective of clinicians working across three jurisdictions.

The treatment of vulnerable defendants by criminal justice systems or correctional systems varies within and between countries. The purpose of this paper is to examine three legal jurisdictions - New South Wales in Australia; Norway; England and Wales - to understand the extent of variation in practice within the court systems for defendants with intellectual disabilities (ID) and/or autism spectrum conditions (ASC). Two of the jurisdictions had a process for screening in place, either in police custody or at court, but this was not universally implemented across each jurisdiction. All three jurisdictions had a process for supporting vulnerable defendants through the legal system. Across the three jurisdictions, there was variation in disposal options from a mandatory care setting to hospital treatment to a custodial sentence for serious offences. This variation requires further international exploration to ensure the rights of defendants with ID or ASC are understood and safeguarded.

COVID-19 Contact Tracing in Two Counties - North Carolina, June-July 2020.

Contact tracing is a strategy implemented to minimize the spread of communicable diseases (1,2). Prompt contact tracing, testing, and self-quarantine can reduce the transmission of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19) (3,4). Community engagement is important to encourage participation in and cooperation with SARS-CoV-2 contact tracing (5). Substantial investments have been made to scale up contact tracing for COVID-19 in the United States. During June 1-July 12, 2020, the incidence of COVID-19 cases in North Carolina increased 183%, from seven to 19 per 100,000 persons per day* (6). To assess local COVID-19 contact tracing implementation, data from two counties in North Carolina were analyzed during a period of high incidence. Health department staff members investigated 5,514 (77%) persons with COVID-19 in Mecklenburg County and 584 (99%) in Randolph Counties. No contacts were reported for 48% of cases in Mecklenburg and for 35% in Randolph. Among contacts provided, 25% in Mecklenburg and 48% in Randolph could not be reached by telephone and were classified as nonresponsive after at least one attempt on 3 consecutive days of failed attempts. The median interval from specimen collection from the index patient to notification of identified contacts was 6 days in both counties. Despite aggressive efforts by health department staff members to perform case investigations and contact tracing, many persons with COVID-19 did not report contacts, and many contacts were not reached. These findings indicate that improved timeliness of contact tracing, community engagement, and increased use of community-wide mitigation are needed to interrupt SARS-CoV-2 transmission.

Analysing Texture in Portraits.

This case study is an initial exploration as to whether the depiction of texture in a set of portraits, all portraying the same Sitter, is related to the familiar likeness assessments reported in a companion paper containing a principal component analysis (PCA) of the portraits' depiction of shape. Somewhat unexpectedly, a texture PCA failed to discriminate the high from low likeness portraits, despite experimentation with different pre-processing methods to reduce the portraits' high level of uninformative, image-level texture variability. There were some findings arising from these analyses, and while only indicative at this stage, include that linear histogram matching is effective in reducing variability in portrait brightness; that depicting, and perhaps exaggerating, shading relating to lighting direction may enhance portrait likeness; and, that whether minimised or exaggerated, lighting direction can be portrayed somewhat anomalously. Furthermore, and in agreement with findings from photographs, shape and texture were not found to be independent variables, and shape-free image registration, while very usefully enabling a comparison of closely corresponding pixel coordinate values, could itself be a confounding factor for undertaking a texture PCA with portraits produced under relatively ambient conditions.

Likeness, Familiarity, and the Ambient Portrait Average.

This artist-led research project involved 10 visual artists producing 10 ambient portraits and a portrait average of a locally familiar Sitter, and 10 ambient portraits and a portrait average of a less locally familiar Sitter. All were then assessed for likeness by more than 150 members of the general public attending an exhibition during Australia's 2018 National Science Week. The results of this study are that portrait averages can be highly shape accurate and tend to be seen as a good likeness by all viewers. However, the portrait average is not necessarily the best likeness. Extending and validating our previous findings regarding the relationship of likeness, familiarity, and shape accuracy (as measured using geometric morphometrics) in portraiture, unfamiliar viewers favouring shape accurate depictions of a Sitter attained statistical significance. Familiar viewers, however, although also tending to view shape accurate depictions a good to very good likeness, were shown to have a stronger preference for portraits that exaggerate a Sitter's facial distinctiveness, including an exaggeration of their head pose, providing such exaggerations are in approximate proportional agreement.

Phosphorus excretion by mares post-lactation.

Across the equine literature, estimates of true P digestibility range from -23% to 79%. This large range cannot be explained by differences in P intake or phytate-P intake alone. However, differences in endogenous P secretion into the GI tract may explain the variation. In horses, excess absorbed P is not excreted in the urine but is re-secreted into the GI tract, increasing faecal P and leading to estimates of low P digestibility. Thus, accurate estimates of P digestibility can only be obtained if absorbed P is retained in the horse. The objective of this study was to examine P digestibility in post-lactational mares and control mares that were fed similar amounts of P. It was hypothesized that post-lactational mares would have greater P retention and higher apparent P digestibility than control mares. Prior to the study, four lactating and four non-lactating mares were fed a diet that provided 100% of the control mares' P requirement, but only 55% of the lactating mares' P requirement. During the study, both groups were fed P at the rate recommended for non-lactating mares. Post-lactational mares did not retain more P than control mares but tended to excrete more P than control mares (p = .082), presumably due to differences in endogenous P secretion into the GI tract. Metabolic changes occurring during mammary gland involution may have contributed to the increase in P excretion. However, faecal P excretion exceeded P intake in both groups (p = .08) and both groups lost weight during the study. Tissue mobilization during weight loss may have influenced P secretion into the GI tract.

Variation and Likeness in Ambient Artistic Portraiture.

An artist-led exploration of portrait accuracy and likeness involved 12 Artists producing 12 portraits referencing a life-size 3D print of the same Sitter. The works were assessed during a public exhibition, and the resulting likeness assessments were compared to portrait accuracy as measured using geometric morphometrics (statistical shape analysis). Our results are that, independently of the assessors' prior familiarity with the Sitter's face, the likeness judgements tended to be higher for less morphologically accurate portraits. The two highest rated were the portrait that most exaggerated the Sitter's distinctive features, and a portrait that was a more accurate (but not the most accurate) depiction. In keeping with research showing photograph likeness assessments involve recognition, we found familiar assessors rated the two highest ranked portraits even higher than those with some or no familiarity. In contrast, those lacking prior familiarity with the Sitter's face showed greater favour for the portrait with the highest morphological accuracy, and therefore most likely engaged in face-matching with the exhibited 3D print. Furthermore, our research indicates that abstraction in portraiture may not enhance likeness, and we found that when our 12 highly diverse portraits were statistically averaged, this resulted in a portrait that is more morphologically accurate than any of the individual artworks comprising the average.

Reducing Racial and Ethnic Disparities in Access to Care: Has the Affordable Care Act Made a Difference?

ISSUE: Prior to the Affordable Care Act (ACA), blacks and Hispanics were more likely than whites to face barriers in access to health care. GOAL: Assess the effect of the ACA's major coverage expansions on disparities in access to care among adults. METHODS: Analysis of nationally representative data from the American Community Survey and the Behavioral Risk Factor Surveillance System. FINDINGS AND CONCLUSIONS: Between 2013 and 2015, disparities with whites narrowed for blacks and Hispanics on three key access indicators: the percentage of uninsured working-age adults, the percentage who skipped care because of costs, and the percentage who lacked a usual care provider. Disparities were narrower, and the average rate on each of the three indicators for whites, blacks, and Hispanics was lower in both 2013 and 2015 in states that expanded Medicaid under the ACA than in states that did not expand. Among Hispanics, disparities tended to narrow more between 2013 and 2015 in expansion states than nonexpansion states. The ACA's coverage expansions were associated with increased access to care and reduced racial and ethnic disparities in access to care, with generally greater improvements in Medicaid expansion states.

What's at Stake: States' Progress on Health Coverage and Access to Care, 2013­2016.

Issue: Given uncertainty about the future of the Affordable Care Act, it is useful to examine the progress in coverage and access made under the law. Goal: Compare state trends in access to affordable health care between 2013 and 2016. Methods: Analysis of recent data from the U.S. Census Bureau and the Behavioral Risk Factor Surveillance System. Findings and Conclusions: Between 2013 and 2016, the uninsured rate for adults ages 19 to 64 declined in all states and the District of Columbia, and fell by at least 5 percentage points in 47 states. Among children, uninsured rates declined by at least 2 percentage points in 33 states. There were reductions of at least 2 percentage points in the share of adults age 18 and older who reported skipping care because of costs in the past year in 36 states and D.C., with greater declines, on average, in Medicaid expansion states. The share of at-risk adults without a recent routine checkup, and of nonelderly individuals who spent a high portion of income on medical care, declined in at least of half of states and D.C. These findings offer evidence that the ACA has improved access to health care for millions of Americans. However, actions at the federal level ­ including a shortened open enrollment period for marketplace coverage, a failure to extend CHIP funding, and a potential repeal of the individual mandate's penalties ­ could jeopardize the gains made to date.

A Long Way in a Short Time: States' Progress on Health Care Coverage and Access, 2013-2015.

Issue: The Affordable Care Act's policy reforms sought to expand health insurance coverage and make health care more affordable. As the nation prepares for policy changes under a new administration, we assess recent gains and challenges. Goal: To compare access to affordable health care across the U.S. between 2013 and 2015. Methods: Analysis of most recent publicly available data from the U.S. Census Bureau and the Behavioral Risk Factor Surveillance System. Key findings and conclusions: Between 2013 and 2015, uninsured rates for adults ages 19 to 64 declined in all states and by at least 3 percentage points in 48 states and the District of Columbia. For children, uninsured rates declined by at least 2 percentage points in 28 states. The share of adults age 18 and older who reported forgoing a visit to the doctor when needed because of costs dropped by at least 2 percentage points in 38 states and D.C. In contrast, there was little progress in expanding access to dental care for adults, which is not a required benefit under the ACA. These findings illustrate the impact that policy can have on access to care and offer a focal point for assessing future policy changes.

High-Need, High-Cost Patients: Who Are They and How Do They Use Health Care? A Population-Based Comparison of Demographics, Health Care Use, and Expenditures.

Issue: Finding ways to improve outcomes and reduce spending for patients with complex and costly care needs requires an understanding of their unique needs and characteristics. Goal: Examine demographics and health care spending and use of services among adults with high needs, defined as people who have three or more chronic diseases and a functional limitation in their ability to care for themselves or perform routine daily tasks. Methods: Analysis of data from the 2009­2011 Medical Expenditure Panel Survey. Key findings: High-need adults differed notably from adults with multiple chronic diseases but no functional limitations. They had average annual health care expenditures that were nearly three times higher­and which were more likely to remain high over two years of observation­and out-of-pocket expenses that were more than a third higher, despite their lower incomes. Rates of hospital use for high-need adults were more than twice those for adults with multiple chronic conditions only; high-need adults also visited the doctor more frequently and used more home health care. Costs and use of services also varied widely within the high-need group. Conclusion: These findings suggest that interventions should be targeted and tailored to high-need individuals most likely to benefit.

Health System Performance for the High-Need Patient: A Look at Access to Care and Patient Care Experiences.

Issue: Achieving a high-performing health system will require improving outcomes and reducing costs for high-need, high-cost patients--those who use the most health care services and account for a disproportionately large share of health care spending. Goal: To compare the health care experiences of adults with high needs--those with three or more chronic diseases and a functional limitation in the ability to care for themselves or perform routine daily tasks--to all adults and to those with multiple chronic diseases but no functional limitations. Methods: Analysis of data from the 2009--2011 Medical Expenditure Panel Survey. Key findings: High-need adults were more likely to report having an unmet medical need and less likely to report having good patient-provider communication. High-need adults reported roughly similar ease of obtaining specialist referrals as other adults and greater likelihood of having a medical home. While adults with private health insurance reported the fewest unmet needs overall, privately insured high-need adults reported the greatest difficulties having their needs met. Conclusion: The health care system needs to work better for the highest-need, most-complex patients. This study's findings highlight the importance of tailoring interventions to address their needs.

Closing the Gap: Past Performance of Health Insurance in Reducing Racial and Ethnic Disparities in Access to Care Could Be an Indication of Future Results.

This historical analysis shows that in the years just prior to the Affordable Care Act's expansion of health insurance coverage, black and Hispanic working-age adults were far more likely than whites to be uninsured, to lack a usual care provider, and to go without needed care because of cost. Among insured adults across all racial and ethnic groups, however, rates of access to a usual provider were much higher, and the proportion of adults going without needed care because of cost was much lower. Disparities between groups were narrower among the insured than the uninsured, even after adjusting for income, age, sex, and health status. With surveys pointing to a decline in uninsured rates among black and Hispanic adults in the past year, particularly in states extending Medicaid eligibility, the ACA's coverage expansions have the potential to reduce, though not eliminate, racial and ethnic disparities in access to care.

The Changing Landscape of Health Care Coverage and Access: Comparing States' Progress in the ACA's First Year.

This analysis compares access to affordable health care across U.S. states after the first year of the Affordable Care Act's major coverage expansions. It finds that in 2014, unin­sured rates for working-age adults declined in nearly every state compared with 2013. There was at least a three-percentage-point decline in 39 states. For children, uninsured rates declined by at least two percentage points in 16 states. The share of adults who said they went without care because of costs decreased by at least two points in 21 states, while the share of at-risk adults who had not had a recent checkup declined by that same amount in 11 states. Yet there was little progress in expanding access to dental care for adults, which is not a required insurance benefit under the ACA. Wide variation in insurance coverage and access to care persists, highlighting many opportunities for states to improve.

Access to primary and preventive health care across states prior to the coverage expansions of the Affordable Care Act.

One goal of health insurance is ensuring people have timely access to primary and preventive care. This issue brief finds wide differences in primary and preventive care access among adults under age 65--across states and within states by income--before the Affordable Care Act's major insurance expansions took effect. When comparing experiences of adults with insurance, the analysis finds that state and income differences narrow markedly. When insured, middle- and lower-income adults across states are far more likely to have a regular source of care, receive preventive care, and be able to afford care when needed. The findings highlight the potential of expanding health insurance to reduce the steep geographic and income divide in primary and preventive care that existed across the country before 2014. Success will depend on the participation of all states. This brief offers baseline data for states and the nation to track and assess change.

The Affordable Care Act's new tools and resources to improve health and care for low-income families across the country.

The Commonwealth Fund Scorecard on State Health System Performance for Low-Income Populations, 2013, finds wide gaps by income in access to care, quality of care received, and health outcomes in all states, and major differences between states in health system performance for people with below-average incomes. The Affordable Care Act provides state and local leaders with unprecedented opportunity along with new tools and resources to raise the standard for everyone and to begin to close the geographic and income divide. This issue brief reviews provisions of the law that have the potential to benefit low- and modest-income individuals, including those that expand health insurance coverage; strengthen primary care and improve care coordination; bolster the capacity of providers serving low-income communities; move toward greater accountability for the quality and cost of care; and invest in public health. It concludes by highlighting some of the challenges that lie ahead.

The Establishment of Fibrolytic Bacteria in the Foal Gastrointestinal Tract Is Related to the Occurrence of Coprophagy by Foals.

The consumption of maternal feces (coprophagy) is commonly observed in healthy foals and is a proposed contributor to microbial colonization of the foal's gastrointestinal tract (GIT). This study investigated the role of coprophagy in the establishment of fibrolytic bacteria in the foal GIT. Nine thoroughbred mares were dosed with chromic oxide, an indigestible marker, as a method to detect the occurrence of coprophagy by their foals. Foal fecal samples were collected from 12 h to 21 d after birth to measure chromic oxide and neutral detergent fiber (NDF) and to enumerate cellulolytic bacteria using culture-based techniques. Milk yield was estimated at 7 and 14 d postpartum. Coprophagy was detected as early as 3 d after birth and detected in all foals by 7 d of age. There were strong relationships between coprophagy and cellulolytic bacteria and NDF in foal feces at 7 d of age (r = 0.9703 and r = 0.7878, respectively; p < 0.05). Fecal NDF and chromic oxide concentrations were negatively related to milk yield (r = -0.8144 and r = -0.6966, respectively; p < 0.05), suggesting milk availability affected the incidence of coprophagy. Based on the relationships identified, maternal feces are an important source of fiber and live microbes for the foal, contributing to the development of the microbial community.

Technical Note: A method for determination of titanium dioxide concentration in fecal samples.

Titanium dioxide has been used as a marker for determining diet digestibility indirectly, but some authors have expressed difficulty in measuring TiO2 concentrations in fecal material. We developed an accurate and precise method to determine TiO2 concentrations in equine feces. The method includes dry-ashing samples, digestion with (NH4)2SO4 in concentrated sulfuric acid, followed by the addition of H2O2 to produce a yellow to orange color that can be read spectrophotometrically. Accuracy was tested by spike recovery, and precision was tested by examining the coefficient of variation (CV) between duplicates of 449 individual samples. The method described here was compared with a previously published method by examining CV between duplicates of samples analyzed using both methods and comparing them using a paired t-test. Titanium dioxide spike recovery averaged 106%, and the CV between duplicates averaged 4.0%, with 79% of sample pairs having a CV of <5%. When compared with a previously published method, the method described here had a lower CV between duplicates (P < 0.0001). The method described here provides an accurate and precise quantitative analytical procedure for TiO2 in equine fecal samples.

Titanium dioxide is a marker fed to animals to help determine diet digestibility indirectly by measuring the concentration of TiO2 in fecal samples. This paper describes an accurate and precise method to analyze TiO2 in equine feces. The precision of this method is demonstrated by the low variation between sample duplicates. This method requires fewer sample replicates for analysis, leading to less labor, expense, and waste in the laboratory.

Stimulation of neural regeneration in the mouse retina.

Müller glia can serve as a source of new neurons after retinal damage in both fish and birds. Investigations of regeneration in the mammalian retina in vitro have provided some evidence that Müller glia can proliferate after retinal damage and generate new rods; however, the evidence that this occurs in vivo is not conclusive. We have investigated whether Müller glia have the potential to generate neurons in the mouse retina in vivo by eliminating ganglion and amacrine cells with intraocular NMDA injections and stimulating Müller glial to re-enter the mitotic cycle by treatment with specific growth factors. The proliferating Müller glia dedifferentiate and a subset of these cells differentiated into amacrine cells, as defined by the expression of amacrine cell-specific markers Calretinin, NeuN, Prox1, and GAD67-GFP. These results show for the first time that the mammalian retina has the potential to regenerate inner retinal neurons in vivo.

Evaluation of Racial, Ethnic, and Socioeconomic Disparities in Initiation of Kidney Failure Treatment During the First 4 Months of the COVID-19 Pandemic.

Importance: Persons with kidney failure require treatment (ie, dialysis or transplantation) for survival. The burden of the COVID-19 pandemic and pandemic-related disruptions in care have disproportionately affected racial and ethnic minority and socially disadvantaged populations, raising the importance of understanding disparities in treatment initiation for kidney failure during the pandemic. Objective: To examine changes in the number and demographic characteristics of patients initiating treatment for incident kidney failure following the COVID-19 pandemic by race and ethnicity, county-level COVID-19 mortality rate, and neighborhood-level social disadvantage. Design, Setting, and Participants: This cross-sectional time-trend study used data from US patients who developed kidney failure between January 1, 2018, and June 30, 2020. Data were analyzed between January and July 2021. Exposures: COVID-19 pandemic. Main Outcomes and Measures: Number of patients initiating treatment for incident kidney failure and mean estimated glomerular filtration rate (eGFR) at treatment initiation. Results: The study population included 127 149 patients with incident kidney failure between January 1, 2018, and June 30, 2020 (mean [SD] age, 62.8 [15.3] years; 53 021 [41.7%] female, 32 932 [25.9%] non-Hispanic Black, and 19 835 [15.6%] Hispanic/Latino patients). Compared with the pre-COVID-19 period, in the first 4 months of the pandemic (ie, March 1 through June 30, 2020), there were significant decreases in the proportion of patients with incident kidney failure receiving preemptive transplantation (1805 [2.1%] pre-COVID-19 vs 551 [1.4%] during COVID-19; P < .001) and initiating hemodialysis treatment with an arteriovenous fistula (2430 [15.8%] pre-COVID-19 vs 914 [13.4%] during COVID-19; P < .001). The mean (SD) eGFR at initiation declined from 9.6 (5.0) mL/min/1.73 m2 to 9.5 (4.9) mL/min/1.73 m2 during the pandemic (P < .001). In stratified analyses by race/ethnicity, these declines were exclusively observed among non-Hispanic Black patients (mean [SD] eGFR: 8.4 [4.6] mL/min/1.73 m2 pre-COVID-19 vs 8.1 [4.5] mL/min/1.73 m2 during COVID-19; P < .001). There were significant declines in eGFR at initiation for patients residing in counties in the highest quintile of COVID-19 mortality rates (9.5 [5.0] mL/min/1.73 m2 pre-COVID-19 vs 9.2 [5.0] mL/min/1.73 m2 during COVID-19; P < .001), but not for patients residing in other counties. The number of patients initiating treatment for incident kidney failure was approximately 30% lower than projected in April 2020. Conclusions and Relevance: In this cross-sectional study of US adults, the COVID-19 pandemic was associated with a substantially lower number of patients initiating treatment for incident kidney failure and treatment initiation at lower levels of kidney function during the first 4 months, particularly for Black patients and people living in counties with high COVID-19 mortality rates.