Health Care Fraud and Abuse: Lessons From One of the Largest Scandals of the 21st Century in the Field of Spine Surgery.

Up to hundreds of billions of dollars are annually lost to fraud and abuse in the US health care, making it a significant burden on the system. This study investigates a specific instance of health care fraud in spine surgery, in which a medical device company ended up paying $75 million to settle violations of the False Claims Act. We review the surgical background regarding the kyphoplasty procedure, as well as its billing and reimbursement details. We also explore the official legal complaint brought by the US Department of Justice to tell the story of how one of the most significant medical innovations in spine surgery in the 21st century turned into a widespread fraudulent marketing scheme. In the sequence, we provide a detailed root cause analysis of this scandal and propose some proactive measures that can be taken to avoid such type of unfortunate events. Ultimately, this historical health care scandal constitutes a valuable lesson to surgeons, health care administrators, medical device companies, and policymakers on how misaligned incentives and subsequent unscrupulous practices can transform a medical innovation into an unfortunate tale of fraud and deceit.

Workplace microaggressions: results of a survey of the American College of Surgeons members.

BACKGROUND: Workplace microaggressions are a longstanding but understudied problem in the surgical specialties. Microaggressions in health care are linked to negative emotional and physical health outcomes and can contribute to burnout and suboptimal delivery of patient care. They also negatively impact recruitment, retention, and promotion, which often results in attrition. Further attrition at the time of an impending surgical workforce shortage risks compromising the delivery of health care to the diverse US population, and may jeopardize the financial stability of health care organizations. To date, studies on microaggressions have consisted of small focus groups comprising women faculty or trainees at a single institution. To our knowledge, there are no large, multiorganizational, gender-inclusive studies on microaggressions experienced by practicing surgeons. OBJECTIVE: This study aimed to examine the demographic and occupational characteristics of surgeons who do and do not report experiencing workplace microaggressions and whether these experiences would influence a decision to pursue a career in surgery again. STUDY DESIGN: We developed and internally validated a web-based survey to assess surgeon experiences with microaggressions and the associated sequelae. The survey was distributed through a convenience sample of 9 American College of Surgeons online Communities from November 2022 to January 2023. All American College of Surgeons Communities comprised members who had completed residency or fellowship training and had experience in the surgical workforce. The survey contained demographic, occupational, and validated microaggression items. Analyses include descriptive and chi-square statistics, t tests, and bivariable and multivariable logistic regression. RESULTS: The survey was completed by 377 American College of Surgeons members with the following characteristics: working as a surgeon (80.9%), non-Hispanic White (71.8%), general surgeons (71.0%), aged ≥50 years (67.4%), fellowship-trained (61.0%), and women (58.4%). A total of 254 (67.4%) respondents reported experiencing microaggressions. Younger surgeons (P=.002), women (P<.001), and fellowship-trained surgeons (P=.001) were more likely to report experiencing microaggressions than their counterparts. Surgeons working in academic medical centers or health care systems with teaching responsibilities were more likely to experience microaggressions than those in private practice (P<.01). Surgeons currently working as a surgeon or those who are unable to work reported more experience with microaggressions (P=.003). There was no difference in microaggressions experienced among respondents based on surgical specialty, race/ethnicity, or whether the surgeons reported having a disability. In multivariable logistic regression, women had higher odds of experiencing microaggressions compared with men (adjusted odds ratio, 15.9; 95% confidence interval, 7.7-32.8), and surgeons in private practice had significantly lower odds of experiencing microaggressions compared with surgeons in academic medicine (adjusted odds ratio, 0.3; 95% confidence interval, 0.1-0.8) or in health care systems with teaching responsibilities (adjusted odds ratio, 0.2; 95% confidence interval, 0.1-0.6). Among surgeons responding to an online survey, respondents reporting microaggressions were less likely to say that they would choose a career in surgery again (P<.001). CONCLUSION: Surgeons reporting experience with microaggressions represent a diverse range of surgical specialties and subspecialties. With the continued expansion of surgeon gender and race/ethnicity representation, deliberate efforts to address and eliminate workplace microaggressions could have broad implications for improving recruitment and retention of surgeons.

The Alabama Embryo Decision-The Politics and Reality of Recognizing "Extrauterine Children".

This Viewpoint discusses the Alabama Supreme Court's opinion on in vitro fertilization and how it plays into a larger push for fetal and embryonic personhood.

Including E-Cigarettes in the FDA Rule Limiting Nicotine.

This Viewpoint discusses why the US Food and Drug Administration (FDA) should include e-cigarettes in its proposed cap of the nicotine concentration in combustible cigarettes to address the public health problem of vaping among adolescents.

Court Intrusion Into Science and Medicine-The Mifepristone Decisions.

This Viewpoint discusses recent US court decisions on the availability of mifepristone, a drug used to terminate pregnancies, and how these conflicting court decisions affect the scientific process and decision-making of the US Food and Drug Administration.

Differences in Diabetic Prescription Drug Utilization and Costs Among Patients With Diabetes Enrolled in Colorado Marketplace and Medicaid Plans, 2014-2015.

Importance: Increasing prices of antidiabetic medications in the US have raised substantial concerns about the effects of drug affordability on diabetes care. There has been little rigorous evidence comparing the experiences of patients with diabetes across different types of insurance coverage. Objective: To compare the utilization patterns and costs of prescription drugs to treat diabetes among low-income adults with Medicaid vs those with Marketplace insurance in Colorado during 2014 and 2015. Design, Setting, and Participants: This cross-sectional study included diabetic patients enrolled in Colorado Medicaid and Marketplace plans who were aged 19 to 64 years and had incomes between 75% and 200% of the federal poverty level during 2014 and 2015. Data analysis was conducted from September 2020 to April 2021. Exposures: Health insurance through Colorado Medicaid or Colorado's state-based Marketplace. Main Outcomes and Measures: Primary outcomes were drug utilization (prescription drug fills) and drug costs (total costs and out-of-pocket costs). The secondary outcome was months with an active prescription for noninsulin antidiabetic medications. An all payer claims database was combined with income data, and linear models were used to adjust for clinical and demographic confounders. Results: Of 22 788 diabetic patients included in the study, 20 245 were enrolled in Medicaid and 2543 in a Marketplace plan. Marketplace-eligible individuals were older (mean [SD] age, 52.12 [10.60] vs 47.70 [11.33] years), and Medicaid-eligible individuals were more likely to be female (12 429 [61.4%] vs 1413 [55.6%]). Medicaid-eligible patients were significantly more likely than Marketplace-eligible patients to fill prescriptions for dipeptidyl peptidase 4 inhibitors (adjusted difference, -3.7%; 95% CI, -5.3 to -2.1; P < .001) and sulfonylureas (adjusted difference, -6.6%; 95% CI, -8.9 to -4.3; P < .001). Overall rates of insulin use were similar in the 2 groups (adjusted difference, -2.3%; -5.1 to 0.5; P = .11). Out-of-pocket costs for noninsulin medications were 84.4% to 95.2% lower and total costs were 9.4% to 54.2% lower in Medicaid than in Marketplace plans. Out-of-pocket costs for insulin were 76.7% to 94.7% lower in Medicaid than in Marketplace plans, whereas differences in total insulin costs were mixed. The percentage of months of apparent active medication coverage was similar between the 2 groups for 4 of 5 drug classes examined, with Marketplace-eligible patients having a greater percentage of months than Medicaid-eligible patients for sulfonylureas (adjusted difference, 5.3%; 95% CI, 0.3%-10.4%; P = .04). Conclusions and Relevance: In this cross-sectional study, drug utilization across multiple drug classes was higher and drug costs were significantly lower for adults with diabetes enrolled in Medicaid than for those with subsidized Marketplace plans. Patients with Marketplace coverage had a similar percentage of months with an active prescription as patients with Medicaid coverage.

EACH Person's Right: The Importance of Federal Abortion Care Funding to Health Care Reform.

The United States has a long and controversial history with abortion that did not end with Roe v. Wade. Almost immediately thereafter, anti-choice politicians commenced a decades-long effort to restrict access to abortion, recently culminating in the Dobbs decision that overturned Roe. One successful attempt to restrict access immediately following Roe was the Hyde Amendment. With more Americans covered by federally funded health insurance than ever, the Hyde Amendment creates an insurmountable barrier to abortion care for those who lack other sources of financing.Despite the impacts of the Hyde Amendment, support for discontinuing the amendment has been weak. For the first time in over forty years, the United States is in a position to change its abortion funding policy. Beyond ending Hyde, the EACH Act has been introduced in Congress to ensure permanent funding for abortion through all federally funded insurance programs. To secure funding for abortion and reduce barriers to access, advocates must press the federal government to pass legislation such as the EACH Act.

De Novo Powered Air-Purifying Respirator Design and Fabrication for Pandemic Response.

The rapid spread of COVID-19 and disruption of normal supply chains has resulted in severe shortages of personal protective equipment (PPE), particularly devices with few suppliers such as powered air-purifying respirators (PAPRs). A scarcity of information describing design and performance criteria for PAPRs represents a substantial barrier to mitigating shortages. We sought to apply open-source product development (OSPD) to PAPRs to enable alternative sources of supply and further innovation. We describe the design, prototyping, validation, and user testing of locally manufactured, modular, PAPR components, including filter cartridges and blower units, developed by the Greater Boston Pandemic Fabrication Team (PanFab). Two designs, one with a fully custom-made filter and blower unit housing, and the other with commercially available variants (the "Custom" and "Commercial" designs, respectively) were developed; the components in the Custom design are interchangeable with those in Commercial design, although the form factor differs. The engineering performance of the prototypes was measured and safety validated using National Institutes for Occupational Safety and Health (NIOSH)-equivalent tests on apparatus available under pandemic conditions at university laboratories. Feedback was obtained from four individuals; two clinicians working in ambulatory clinical care and two research technical staff for whom PAPR use is standard occupational PPE; these individuals were asked to compare PanFab prototypes to commercial PAPRs from the perspective of usability and suggest areas for improvement. Respondents rated the PanFab Custom PAPR a 4 to 5 on a 5 Likert-scale 1) as compared to current PPE options, 2) for the sense of security with use in a clinical setting, and 3) for comfort compared to standard, commercially available PAPRs. The three other versions of the designs (with a Commercial blower unit, filter, or both) performed favorably, with survey responses consisting of scores ranging from 3 to 5. Engineering testing and clinical feedback demonstrate that the PanFab designs represent favorable alternatives to traditional PAPRs in terms of user comfort, mobility, and sense of security. A nonrestrictive license promotes innovation in respiratory protection for current and future medical emergencies.

The Other Three Waves: Re-assessing the Impact of Industry-Prescriber Relations on the Opioid Crisis.

As the opioid crisis in the United States evolved, so did the relationship between prescribers and pharmaceutical companies that manufacture prescription opioids, with policymakers at both the state and national levels focused on the issue of prescription opioid misuse. This article discusses the role of the prescriber-pharmaceutical company relationship with respect to opioid over- and underprescribing, the evolution of that relationship over time, and its contribution to what is now commonly known as the U.S. opioid crisis or overdose epidemic. The United States saw several "waves" of prescription opioid misuse, and this article characterizes the relationship between prescribers and pharmaceutical companies in similar waves. The article proposes several prescriber- and manufacturer-focused "solutions" that can be implemented to address and lessen the effects of the ongoing crisis. Changes directed at prescribers and manufacturers must be implemented in tandem to ensure such solutions do not, in attempting to fill the existing cracks in the system, create even more.

Assessing the filtration efficiency and regulatory status of N95s and nontraditional filtering face-piece respirators available during the COVID-19 pandemic.

BACKGROUND: The COVID-19 pandemic has severely disrupted supply chains for many types of Personal Protective Equipment (PPE), particularly surgical N95 filtering facepiece respirators (FFRs; "masks"). As a consequence, an Emergency Use Authorization (EUA) from the FDA has allowed use of industrial N95 respirators and importation of N95-type masks manufactured to international standards; these include KN95 masks from China and FFP2 masks from the European Union. METHODS: We conducted a survey of masks in the inventory of major academic medical centers in Boston, MA to determine provenance and manufacturer or supplier. We then assembled a testing apparatus at a university laboratory and performed a modified test of filtration performance using KCl and ambient particulate matter on masks from hospital inventories; an accompanying website shows how to build and use the testing apparatus. RESULTS: Over 100 different makes and models of traditional and nontraditional filtering facepiece respirators (N95-type masks) were in the inventory of surveyed U.S. teaching hospitals as opposed to 2-5 models under normal circumstances. A substantial number of unfamiliar masks are from unknown manufacturers. Many are not correctly labelled and do not perform to accepted standards and a subset are obviously dangerous; many of these masks are likely to be counterfeit. Due to the absence of publicly available information on mask suppliers and inconsistent labeling of KN95 masks, it is difficult to distinguish between legitimate and counterfeit products. CONCLUSIONS: Many FFRs available for procurement during the COVID-19 pandemic do not provide levels of fit and filtration similar to those of N95 masks and are not acceptable for use in healthcare settings. Based on these results, and in consultation with occupational health officers, we make six recommendations to assist end users in acquiring legitimate products. Institutions should always assess masks from non-traditional supply chains by checking their markings and manufacturer information against data provided by NIOSH and the latest FDA EUA Appendix A. In the absence of verifiable information on the legitimacy of mask source, institutions should consider measuring mask fit and filtration directly. We also make suggestions for regulatory agencies regarding labeling and public disclosure aimed at increasing pandemic resilience.

De novo Powered Air-Purifying Respirator Design and Fabrication for Pandemic Response.

The rapid spread of COVID-19 and disruption of normal supply chains resulted in severe shortages of personal protective equipment (PPE), particularly devices with few suppliers such as powered air-purifying respirators (PAPRs). A scarcity of information describing design and performance criteria represents a substantial barrier to new approaches to address these shortages. We sought to apply open-source product development to PAPRs to enable alternative sources of supply and further innovation. We describe the design, prototyping, validation, and user testing of locally manufactured, modular, PAPR components, including filter cartridges and blower units, developed by the Greater Boston Pandemic Fabrication Team (PanFab). Two designs, one with a fully custom-made filter and blower unit housing, and the other with commercially available variants (the "Custom" and "Commercial" designs respectively) were developed. Engineering performance of the prototypes was measured and safety validated using NIOSH-equivalent tests on apparatus available under pandemic conditions, at university laboratories. Feedback on designs was obtained from four individuals, including two clinicians working in an ambulatory clinical setting and two research technical staff for whom PAPR use is a standard part of occupational PPE. Respondents rated the PanFab Custom PAPR a 4 to 5 on a 5 Likert-scale 1) as compared to current PPE options, 2) for the sense of security with use in a clinical setting, and 3) for comfort. The three other versions of the designs (with a commercial blower unit, filter, or both) performed favorably, with survey responses consisting of scores ranging from 3-5. Engineering testing and clinical feedback demonstrate that the PanFab designs represents favorable alternative PAPRs in terms of user comfort, mobility, and sense of security. A nonrestrictive license promotes innovation in respiratory protection for current and future medical emergencies.

A Crisis-Responsive Framework for Medical Device Development Applied to the COVID-19 Pandemic.

The disruption of conventional manufacturing, supply, and distribution channels during the COVID-19 pandemic caused widespread shortages in personal protective equipment (PPE) and other medical supplies. These shortages catalyzed local efforts to use nontraditional, rapid manufacturing to meet urgent healthcare needs. Here we present a crisis-responsive design framework designed to assist with product development under pandemic conditions. The framework emphasizes stakeholder engagement, comprehensive but efficient needs assessment, rapid manufacturing, and modified product testing to enable accelerated development of healthcare products. We contrast this framework with traditional medical device manufacturing that proceeds at a more deliberate pace, discuss strengths and weakness of pandemic-responsive fabrication, and consider relevant regulatory policies. We highlight the use of the crisis-responsive framework in a case study of face shield design and production for a large US academic hospital. Finally, we make recommendations aimed at improving future resilience to pandemics and healthcare emergencies. These include continued development of open source designs suitable for rapid manufacturing, education of maker communities and hospital administrators about rapidly-manufactured medical devices, and changes in regulatory policy that help strike a balance between quality and innovation.

Factors Affecting Buprenorphine Utilization and Spending in Medicaid, 2002-2018.

OBJECTIVE: Buprenorphine is an essential medication for the treatment of opioid use disorder (OUD), but studies show it has been underused over the last 2 decades. We sought to evaluate utilization of and spending on buprenorphine formulations in Medicaid and to evaluate the impact of key market and regulatory factors affecting availability of different formulations and generic versions. METHODS: We first identified all buprenorphine formulations approved by the Food and Drug Administration for OUD using Drugs@FDA. We then used National Drug Codes to identify each drug in the Medicaid State Drug Utilization Data and extracted annual utilization rates and spending between 2002 and 2018 by drug and according to whether a brand-name or generic version was dispensed. We compared these trends to market and regulatory factors that affected competition, which we identified through searching the Federal Register, Westlaw, PubMed, and Google News. RESULTS: Brand-name buprenorphine-naloxone sublingual tablet and film formulations (Suboxone) were dispensed 2.7 times more (n = 634 213 140) and reimbursed 4.4 times more (n = $4 440 556 473) than all other formulations combined (n = 237 769 689; $1 018 988 133). We identified numerous market and regulatory factors that contributed to an estimated 9-year delay in generic versions of the tablet formulation and 6-year delay for generic versions of the film formulation. CONCLUSIONS: Brand-name buprenorphine formulations have been widely used in Medicaid, leading to substantial costs, in part because generic versions were delayed by multiple years owing to market and regulatory factors. Timely availability of low-cost generics could have helped encourage OUD treatment with buprenorphine during the height of the opioid crisis.

Analysis of SteraMist ionized hydrogen peroxide technology in the sterilization of N95 respirators and other PPE.

The COVID-19 pandemic has led to widespread shortages of personal protective equipment (PPE) for healthcare workers, including of N95 masks (filtering facepiece respirators; FFRs). These masks are intended for single use but their sterilization and subsequent reuse has the potential to substantially mitigate shortages. Here we investigate PPE sterilization using ionized hydrogen peroxide (iHP), generated by SteraMist equipment (TOMI; Frederick, MD), in a sealed environment chamber. The efficacy of sterilization by iHP was assessed using bacterial spores in biological indicator assemblies. After one or more iHP treatments, five models of N95 masks from three manufacturers were assessed for retention of function based on their ability to form an airtight seal (measured using a quantitative fit test) and filter aerosolized particles. Filtration testing was performed at a university lab and at a National Institute for Occupational Safety and Health (NIOSH) pre-certification laboratory. The data demonstrate that N95 masks sterilized using SteraMist iHP technology retain filtration efficiency up to ten cycles, the maximum number tested to date. A typical iHP environment chamber with a volume of ~ 80 m3 can treat ~ 7000 masks and other items (e.g. other PPE, iPADs), making this an effective approach for a busy medical center.